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WARNING LETTER

Dr. Joel Kaplan Inc. MARCS-CMS 667193 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices

Recipient:
Recipient Name
Mr. Shumuel Itshaki
Recipient Title
Chief Executive Officer
Dr. Joel Kaplan Inc.

3350 Market St. Ste B
San Diego, CA 92102-3348
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Secondary Issuing Offices

United States


WARNING LETTER
CMS # 667193

January 8, 2024

Dear Mr. Itshaki:

During an inspection of your firm, Dr. Joel Kaplan Inc. (DJK or “the firm”), located in San Diego, CA, on June 27, 2023, through June 30, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of male and female sexual health enhancement medical devices such as the MegaVac Pump System, Metal Hand Pump System, STIMULATE: Red Light Therapy Wrap, DEEP: The Ultimate Penis Extender, and the Clitoris Enhancement System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these are devices intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

We received your responses dated July 24, 2023, August 31, 2023, October 02, 2023, and November 30, 2023, concerning our investigator’s observations on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the responses below, in relation to each of the noted violations, and any additional responses will be reviewed as part of your warning letter response.

Misbranded and/or Unapproved Device Violations

MegaVac Pump System

Your firm sells the MegaVac Pump System. The product insert for the Mega Vac System states:

  • “Users report an increase in length and thickness . . . or correction of mild penis curvature.”
  • “For best results, Dr. Joel Kaplan developed a pumping routine that expands and grows the blood vessels that bring blood flow into the penis, leading to bigger, harder erections.”

Additionally, your firm’s website includes the statement that your pump systems are “specifically made or enlargement, enhancement, and sexual health” above an image that includes both a powered pump system and a manual pump system.

Claims or statements that indicate that this product will “increase in length and thickness,” and “correct mild penis curvature” show an intent for use in the treatment of disease or other conditions. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the MegaVac Pump System is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the treatment of disease or other conditions.

Your firm has listed a “Dr. Joel Kaplan Penis Pump” under regulation 876.5020, procode LKY. The statements above also indicate an intended use that differs from devices classified under 21 CFR 876.5020, which states that external penile rigidity devices are devices “intended to create or maintain sufficient penile rigidity for sexual intercourse.”

Please note that, as described in the guidance document “External Penile Rigidity Devices - Class II Special Controls Guidance Document for Industry and FDA Staff,” devices intended for penile enhancement, such as penis enlargement, and for treatment of diseases or conditions of the penis with respect to curvature, are outside the scope of the classification regulation at 21 CFR 876.5020. Therefore, the exemption from premarket notification procedures described at 21 CFR 876.5020(b) does not apply to your MegaVac Pump System.

Metal Hand Pump System

Your firm also sells the Metal Hand Pump System. The product insert for the Metal Hand Pump System states:

  • “Users report an increase in length and thickness . . . or correction of mild penis curvature.”
  • “For best results, Dr. Joel Kaplan developed a pumping routine that expands and grows the blood vessels that bring blood flow into the penis, leading to bigger, harder erections.”

Additionally, your firm’s website includes the statement that your pump systems are “specifically made for enlargement, enhancement, and sexual health” above an image that includes both a powered pump system and a manual pump system.

Claims or statements that indicate that this product will “increase in length and thickness” and “lead to bigger, harder erections” show an intent for use in the treatment of disease or other conditions. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the Metal Hand Pump System is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the treatment of disease or other conditions.

Your firm has listed a “Dr. Joel Kaplan Penis Pump” under regulation 876.5020, procode LKY. As stated above for the MegaVac Pump System, these statements are outside the scope of the classification regulation at 21 CFR 876.5020. Therefore, the exemption from premarket notification procedures described at 21 CFR 876.5020(b) does not apply to your Metal Hand Pump System.

STIMULATE: Red Light Therapy Wrap

Your firm is marketing a device under the name STIMULATE: Red Light Therapy Wrap. Your website includes the following statements about the STIMULATE: Red Light Therapy Wrap:

  • “Reverse Penile Atrophy”
  • “I developed STIMULATE - a Red-Light Therapy Wrap to accelerate gains in thickness, length and erection rigidity while using your favorite penis pump.”
  • “STIMULATE embodies decades of research on Red-Light Therapy to maximize erection quality and size by boosting blood-flow, testosterone, and cellular repair

Claims or statements that indicate that this product will “Reverse Penile Atrophy,” “maximize erection quality and size by boosting blood-flow, testosterone, and cellular repair” show an intent for use in the treatment of disease or other conditions. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the STIMULATE: Red Light Therapy Wrap is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the treatment of disease or other conditions.

You have listed a device under 21 CFR 890.5500 as an Infrared Therapeutic Heating Lamp used to provide topical heating and under product code ILY. As described at 21 CFR 890.5500(a), an infrared lamp under that classification regulation is a device “intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.” (emphasis added). An infrared lamp classified under 21 CFR 890.5500, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of 21 CFR part 807 subject to the limitations in 21 CFR 890.9 and 21 CFR 890.5500(b).

However, based on the evidence reviewed at the April 2023 inspection, including statements made on your firm’s website, the intended use of the STIMULATE: Red Light Therapy Wrap differs from devices classified under 21 CFR 890.5550. As noted above, your website includes several statements about the STIMULATE: Red Light Therapy Wrap.

These claims indicate the device is intended for penile enlargement, increasing testosterone, and initiates cellular repair, which is a different from the intended use of devices classified under 21 CFR 890.5500(b). Therefore, the classification and product code you have listed are not correct for the STIMULATE: Red Light Therapy Wrap and the exemption from premarket notification processes in 21 CFR 890.5500(b) does not apply to this device.

DEEP: The Ultimate Penis Extender

Your firm is marketing a device under the name DEEP: The Ultimate Penile Extender. Your website includes the following statements about the DEEP: The Ultimate Penis Extender:

  • “Reverse Shrinkage due to Aging or Medical Conditions”
  • “Straighten Curvature (Peyronie’s)”
  • “That is why I developed DEEP: The Ultimate Penile Extender – an affordable, medical grade penile traction device that uses proven science to lengthen your penis and straighten curvature that is safe and comfortable to use.”

Claims or statements that indicate that this product will “Reverse shrinkage,” “straighten curvature” show an intent for use in the treatment of disease or other conditions. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the DEEP: Ultimate Penis Extender is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the treatment of disease or other conditions.

You have also listed the DEEP: The Ultimate Penile Extender under 21 CFR 890.3475 as a Limb Brace Orthosis to be used on the upper or lower extremities and under product code IQI. However, based on the evidence reviewed at the April 2023 inspection, including statements made on your firm’s website, the intended use of DEEP: The Ultimate Penis Extender differs from devices classified per 21 CFR 890.3475.

As described at 21 CFR 890.3475, a limb brace orthosis under that classification is a device “intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: “A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.” Your device is not used on an upper or lower extremity. Furthermore, the above claims indicate the device is intended for straightening penile curvature and treating Peyronie’s disease. This is a different intended use from any device regulated under 21 CFR 890.3475. Therefore, the product classification and product code are not correct for the DEEP: The Ultimate Penis Extender, and the exemption from premarket notification process in 21 CFR 890.3475(b) does not apply to this device.

Clitoris Enhancement System

Your firm is marketing a device under the name Clitoris Enhancement System. As was described in our May 1, 2014, Warning Letter to your firm, a clitoral engorgement device is a class II device regulated under 21 CFR 884.5970. A review of our records reveals that you have not addressed our 2014 Warning letter violations.

Your Dr. Joel Kaplan (drjoelkaplan.com) website contains claims for the Clitoris Enhancement System:

  • “INCREASED SENSITIVITY: Vacuum pressure stimulates the nerve-endings of the clitoris, making them more sensitive to touch and increases pleasurable sensations.”
  • “HEIGHTENED AROUSAL: Increased blood-flow to the clitoral region triggers arousal and physical desire.”
  • “Effectively increases clitoral sensitivity and sensation.”
  • “Using vacuum pressure, the pump brings blood-flow into your clitoral region, increasing arousal and stimulation every time you pump. You will be more sensitive to touch and physical stimulation.”
  • “Your sensitivity will increase because the pump increases blood-flow to the clitoris, stimulating your nerve endings in the region.”
  • “You can use the pump before sex to heighten sensitivity so you and your partner will have an easier time bringing yourself to arousal and orgasm.”

Claims or statements that indicate that this product will use vacuum pressure to increase blood flow to the clitoral region and stimulate clitoral nerve endings to treat female sexual arousal disorder shows an intent for use in the treatment of disease or other conditions. See Act § 201(h)(2), 21 U.S.C. § 321(h)(2). Based on this, the Clitoris Enhancement System is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the treatment of disease or other conditions.

Therefore, our inspection and review of the available information, including the firm’s sales website, http://drjoelkaplan.com, revealed that the MegaVac Pump System, Metal Hand Pump System, Red Light Therapy Wrap, The Ultimate Penis Extender, and the Clitoris Enhancement System are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency as stated in 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Quality System Regulation (QSR) Violations

Our inspection also revealed that the MegaVac Pump System, Metal Hand Pump System, Red Light Therapy Wrap, The Ultimate Penis Extender, and the Clitoris Enhancement System are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).

Specifically, your Customer Complaint Handling procedure, QP-0011, states that customer complaints are to be documented on the Customer Complaint Form. You did not document complaints or investigation into complaints for complaint numbers 309288, 262119, 617604, or 722750.

We reviewed your firm’s responses and conclude that the adequacy cannot be determined. You provided a design/development plan and proposal from your contractor (ATC) and completed complaint forms. You stated that you opened a CAPA and a retrospective review of customer communications for year 2023 initially by 9/30/2023, revised to 12/31/2023, and for year 2022 initially by 11/15/2023, revised to 3/13/2024. You stated that you reviewed 8530 customer feedback forms for year 2023 and identified 169 records to review through your complaint handling procedure. However, you have not provided evidence of a review of year 2023 records. In addition, there is no evidence of CAPA completion.

2. Failure to establish and maintain design history files as required by 21 CFR 820.30(j).

Specifically, you did not have design history files (DHFs) for the MegaVac Pump, Metal Hand Pump, or Red Light Therapy Wrap.

We reviewed your firm’s responses and conclude that the adequacy cannot be determined. You provided a proposal with milestones with your contractor. You stated that you opened a CAPA and will have the contractor retrospectively create DHFs and a design/development plan for the Red Light Therapy Wrap initially by 9/30/2023, revised to 12/31/2023and for the MegaVac Electric Pump E.D. System, and Metal Hand Pump E.D. System by 1/31/2024. However, there is no evidence of CAPA completion or created DHFs/design development plan.

3. Failure to establish and maintain procedures for acceptance activities as required by 21 CFR 820.80(a).

Specifically, you did not have a Device History Record (DHR) or final acceptance activity records for the MegaVac Electric Pump, Metal Hand Pump, or STIMULATE: Red Light Therapy Wrap devices.

We reviewed your firm’s responses and conclude that the adequacy cannot be determined. You provided an agreement with your contractor, but it does not address Device History Records. You stated that your firm opened a CAPA and that you will conduct a retrospective review of procedures initially by 9/30/2023, revised to 11/30/2023, and audit the contractor in December 2023. However, there is no evidence of CAPA completion, retrospective procedure review, or audit of your contractor.

4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50.

Specifically, you did not have an Approved Supplier List or records of evaluation of vendors.

We reviewed your firm’s responses and concluded that the adequacy cannot be determined. You stated that your firm opened a CAPA and provide supplier evaluation records, and supplier list initially by 9/30/2023, revised to 10/31/2023. You only provided a revised Purchasing and Receiving Process procedure on November 30, 2023. You provided a note to file dated 10/21/2023 that stated 10 suppliers were identified, approved, and added to your supplier list. However, there is no evidence of these supplier evaluation/approval activities. In addition, there is no evidence of CAPA completion.

5. Failure to adequately establish procedures for management review as required by 21 CFR 820.20(c).

Specifically, you did not conduct or maintain records of management reviews. Your Management Review and Data Analysis Process, QP-0013, Rev. 01 states that “results of the data analysis from the required areas shall be reviewed by management” and that “records of the data analysis shall be submitted and maintained by the Quality Department”.

We reviewed your firm’s responses and conclude that the adequacy cannot be determined. You provided evidence of conducting a management review in August 2023. You stated that your firm opened a CAPA. You provided a closed CAPA in your November 30, 2023, response. The CAPA states in section 4.0 that there is Attachment 1: Training and Competency Records NW and Attachment 2: Management Review Meeting Memo and Certification. However, there is no evidence of those attachments.

6. Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22.

Specifically, you did not follow your Quality Audit Process procedure, QP-0015, in that you did not have records of conducted quality audits.

We reviewed your firm’s responses and conclude that the adequacy cannot be determined. You provided an audit schedule with audits to be started in 2023 and completed by 2/28/2024. This completion date appears excessive. You stated opening a CAPA as well as audit records. However, there is no evidence of CAPA completion or areas audited.

Listing Violations

According to the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM), you have not listed K974196 or the MegaVac System. However, you have listed the Dr Joel Kaplan Penis Pump under product code LKY. It is not clear if this is the same device as the MegaVac System.

You have listed the Dr Joel Kaplan Infrared Device under product code ILY. It is not clear if this is the same device as the Red Light Therapy Wrap.

You have listed the Dr. Joel Kaplan Penile Extender under product code IQI. It is unclear if this is the same device as The Ultimate Penis Extender.

Therefore, the Metal Hand Pump System, Red Light Therapy Wrap, The Ultimate Penis Extender, and the Clitoris Enhancement System are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).

If you believe these devices are the listed devices, please provide documentation showing the devices are listed and indicate what product codes they have been listed under in FURLS/DRLM.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Jessica Mu, Director of Compliance Branch at oradevices3firmresponse@fda.hhs.gov Refer to CMS # 667193 when replying. If you have any questions about the contents of this letter, please contact: Raymond W. Brullo, Compliance Officer at 949-608-2918 or raymond.brullo@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Kellie B. Kelm, Ph.D.
Acting Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

/S/
Shari J. Shambaugh
Program Division Director, Division 3
Office of Medical Device and Radiological Health
Office of Regulatory Affairs

 
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