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  1. Warning Letters

WARNING LETTER

CPAPNEA Medical Supply MARCS-CMS 592737 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Overnight Delivery
Product:
Medical Devices

Recipient:
Recipient Name
Sal T. Hakim
Recipient Title
Owner
CPAPNEA Medical Supply

10443 N. Cave Creek Road., #110
Phoenix, AZ 85020
United States

Issuing Office:
Office of Medical Device and Radiological Health Operations Division 3 West

United States


 

 

Sal T. Hakim, Owner
CPAPNEA Medical Supply
10443 N. Cave Creek Road., #110
Phoenix, AZ 85020

Dear Mr. Hakim: 

During an inspection of your firm located in Phoenix, AZ on July 18, 25, and 30, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Optipillows EPAP mask.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are 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. 

FDA has reviewed your firm’s website (www.optipillows.com), printed instructions for use, and packaging and determined that the Optipillows EPAP mask is adulterated under section 501(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) for the device as described and marketed. The Optipillows EPAP mask is also misbranded within the meaning section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a) because its labeling is false or misleading in any particular.  

Your firm has a cleared 510(k), K181219, for the Optipillows EPAP mask for the sole intended use of alleviating snoring during sleep in adults.  However, the labeling for your device and statements on its website indicate that the Optipillows EPAP mask is intended to treat obstructive sleep apnea and that your device may be a substitute for CPAP devices which is beyond the limitations of your cleared indications for use.  

Your device is misbranded under section 502(o) of the Act because you failed to submit a premarket notification as required by section 510(k) and 21 CFR 807.81(a)(3). Specifically, labeling found during FDA’s inspection shows that the Optipillows EPAP Mask is intended to treat obstructive sleep apnea, which is a major change or modification from the cleared intended use of the device requiring a new 510(k), including appropriate performance data in compliance with section 514 of the ActThe Optipillows EPAP Mask is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because statements found in the device labeling are false or misleading because they claim the Optipillows EPAP Mask is as effective as CPAP devices at treating obstructive sleep apnea, suggest that the Optipillows EPAP Mask can be substituted for CPAP devices, and claim that FDA has clear EPAP technology for treating obstructive sleep apnea. 

Marketing your device to treat obstructive sleep apnea and suggesting it is as effective as CPAP masks in treating sleep apnea raises serious public health and safety concerns.  CPAP devices are class II devices that are prescribed after a patient is evaluated by a licensed dentist or other health professional and is determined to be an appropriate candidate for the device. To date, your firm has not provided any evidence that supports use of your device to treat obstructive sleep apnea and FDA is unaware of any evidence supporting use of EPAP masks to treat obstructive sleep apnea or that EPAP devices are as effective and safe as CPAP devices for treating obstructive sleep apnea of any severity level. 

The following are examples of violative statements found in labeling collected during FDA’s inspection and on our website:  

  • “Optipillows uses EPAP technology, which is FDA cleared for treating snoring and obstructive sleep apnea.”
  • “It works as an expiratory resistance device and alleviates snoring and sleep apnea.”
  • “This device is intended for treatment of snoring, however, it may also treat obstructive sleep apnea.”
  • “Expiratory resistance devices have been shown to be safe and effective in treating patients with snoring and with obstructive sleep apnea.”
  • “Works like a nasal pillow CPAP mask but without tubing or a machine.”
  • “The EPAP Mask is an EPAP device integrated onto a nasal pillow mask. It is used like a CPAP mask but does not require a CPAP machine. EPAP devices such as Theravent and Provent were introduced a few year ago, and have been shown in clinical studies to be safe and effective in treating snoring and obstructive sleep apnea.”
  • There is evidence that EPAP devices are as effective as CPAP in some patients with snoring and mild obstructive sleep apnea.”
  • “For people with snoring or with mild to moderate sleep apnea, it is possible that OptiPillows will work as well as a CPAP machine.”
  • “For people with snoring or with mild to moderate sleep apnea, it is possible that OptiPillows will work as well as a CPAP machine.  It is recommended that people with severe obstructive sleep apnea should continue to use their CPAP and perhaps resort to using the EPAP mask only during travels or camping.”
  • “Studies published in medical journals have shown that EPAP devices work well for all severities of obstructive sleep apnea.”
  • “Optipillows uses EPAP technology, which is FDA cleared for treating snoring and obstructive sleep apnea.”
  • “It works as an expiratory resistance device and alleviates snoring and sleep apnea.”
  • “This device is intended for treatment of snoring, however, it may also treat obstructive sleep apnea.”
  • “If you snore or suspect you have obstructive sleep apnea, this mask may be for you.”
  • “Cleared for treatment of snoring but may also alleviate obstructive sleep apnea.” 

Our inspection also revealed that these devices 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 used 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. We have not received a written response to our inspectional findings. These violations include, but are not limited to, the following: 

1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
 
Specifically, you have not established any procedures for implementing corrective and preventive actions.
 

2. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). 
 
Specifically, you have not established procedures for complaint handling.
 

3. Failure to establish and maintain procedures for acceptance activities, which include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). 

Specifically, you have not established procedures for acceptance activities for your incoming components or finished products. 
 

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 have not established purchasing control procedures to ensure your contract manufactured components conform to specified requirements.
 

5. Failure to establish and maintain procedures for quality audits and conduct such 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.  These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22.
 
Specifically, you firm has not established procedure for conducting internal quality audits and your firm has not conducted any internal quality audits.
 

6. Failure to establish and maintain procedures to ensure that device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR part 820, as required by 21 CFR 820.184.
 
Specifically, your firm has not established procedures for maintaining DHR’s for each batch, lot, or unit of products showing compliance with your device master record. You stated you have manufactured approximately 600 units of your Optipillows EPAP device since January 2019; and you have not maintained any DHRs for these manufacturing activities. 

Our inspection also revealed that your Optipillows EPAP masks are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Violations include, but are not limited to: 

7. Failure to establish a procedure for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 C.F.R. 803.17(a)(1). For example, there are no definitions of what your firm will consider to be a reportable event under 21 C.F.R. Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in section 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that meets the criteria for reporting under 21 C.F.R. 803.50(a).

8. Failure to establish a procedure for internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 C.F.R. 803.17(a)(2). For example:

a. There are no instructions for conducting a complete investigation of each MDR reportable event and evaluating the cause of the event. 

b. The procedure, as written does not specify who makes the decision for reporting events to FDA.  

c. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner. 

9. Failure to establish a procedure for internal systems that provide for timely transmission of complete medical device reports, as required by 21 C.F.R. 803.17(a)(3). Specifically, the following are not addressed: 

a. The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, 5-day report and the requirements for such reports. 

b. The procedure process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm 

c. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within its firm. 

10. Failure to establish a procedure for that describes how your firm will address documentation and record-keeping requirements, as required by 21 C.F.R. 803.17(b), including: 

a. Documentation of adverse event related information maintained as Medical Device Reporting (MDR) event files. 

b. Information that was evaluated to determine if an event was reportable. 

c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable. 

d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA. 

Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations 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. Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations 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.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of 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 corrected.  Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices. If you believe that your products are not in violation of the Act please respond to FDA with your reasoning and any supporting information for our consideration.   

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 correct 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 all violations included in this Warning Letter.  

If you have questions regarding any issues in this letter, please contact Compliance Officer, Jeff Wooley at 214-253-5251 or at Jeffrey.wooley@fda.hhs.gov.  Please send your reply electronically to Jessica Mu, Director of Compliance Branch, at jessica.mu@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 the violations, and take prompt actions to correct the violations and bring the products into compliance. 

Sincerely,

/S/

Shari J. Shambaugh
Program Division Director
Office of Medical Devices and Radiological
Health, Division III

Malvinia D. Eydelman, M.D.
Director
OHT1: Office of Ophthalmic, Anestesia,
Respiratory, ENT and Dental Devices

Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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