WARNING LETTER

Klarity Medical Products LLC MARCS-CMS 606982 — June 08, 2020

Delivery Method:: United Parcel Service
Product:: Medical Devices

Recipient:: Recipient Name

Peter M. Larson; Klarity Medical Products LLC; 600 Industrial Parkway
Newark, OH 43056
United States; peter@klaritymedical.com

Issuing Office:: Division of Medical Device and Radiological Health Operations East; United States

WARNING LETTER

CMS #606982

June 8, 2020

Dear Mr. Larson:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Klarity Medical Products LLC, located at 600 Industrial Parkway, Newark, OH, from February 10 through February 25, 2020. During the inspection, an FDA investigator determined that your firm is a specification developer and manufacturer of various body support devices used during patient radiation therapy treatment. 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 any function of the body.

The inspection revealed that the Klarity BiteLok device is 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. § 360(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify FDA of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

As documented in the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on February 25, 2020, your firm considers the addition of the Klarity BiteLok device to be a design change to your firm’s FDA-cleared thermoplastic device (K022708; classified as an accessory to a radiation therapy device under 21 § 892.5050; product code IYE). We have reviewed your firm’s labeling for the Klarity BiteLok device, your firm’s June 1, 2018, Design Change Assessment, and your firm’s March 6, 2020, response to the FDA 483. FDA concludes that Klarity BiteLok device is a different device than the thermoplastic mask cleared in K022708 and requires its own premarket notification under section 510(k).

According to the 510(k) summary for K022708, the “Klarity thermoplastic is intended for use by licensed physicians and trained radiation therapy professionals for the external support and stabilization of patients undergoing radiation therapy treatments in a licensed clinical setting.” In contrast, your firm’s labeling for the Klarity BiteLokdevice states:

GENERAL INFORMATION

The Klarity BiteLok is a one per patient medical device used with a thermoplastic mask as an aid for precise positioning and immobilization of the tongue and jaw for radiation therapy treatment.

PRODUCT DESCRIPTION

The Klarity BiteLok is specifically designed to help achieve higher precision treatment accuracy. The BiteLok and optional tongue attachments can be easily removed for cleaning. The general size of the BiteLokallows it to fit various mouth sizes and offers an open airway for optimal patient comfort. The BiteLokis custom molded to the patient’s dental anatomy as well as the thermoplastic mask, allowing for accurate reproducibility.

Your statements in the labeling that the Klarity BiteLok device is to be “used with a thermoplastic mask . . . for radiation therapy treatment” demonstrates that it is a separate accessory to a radiation therapy device and not a part of the thermoplastic device cleared under K022708. Furthermore, your statement that the Klarity BiteLok is “for precise positioning and immobilization of the tongue and jaw” demonstrates that it has different indications for use than the “external support and stabilization” indications of the thermoplastic device cleared under K022708.

FDA also notes that devices with designs and indications similar to the Klarity BiteLokdevice have been cleared as class II accessories to a radiation therapy device under 21 CFR § 892.5050, under product code IYE. In response to this Warning Letter, please provide a timeframe for submission of a 510(k) premarket notification.

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the FDA [21 CFR § 807.81(b)]. The information that your firm needs to submit in order to obtain approval or clearance for the device is described here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our inspection further revealed your firm’s “Klarity Vacuum Bags for Radiation Therapy” devices are misbranded under section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], as your firm failed or refused to furnish material or information regarding the device, as required by section 519 of the Act [21 U.S.C. 360(i)], and 21 CFR § 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

1. Failure to submit any report required by 21 CFR § 806.10(a) within ten working days of initiating a correction or removal, as required by 21 CFR § 806.10(b). For example, after Klarity Medical China offered a credit for the bags in a May 30, 2019, email, you destroyed 321 “Klarity Vacuum Bags for Radiation Therapy” from your inventory. The devices were destroyed due to leaking, leading to the inability of the device to be used to ensure precise positioning and immobilization of patients undergoing radiation therapy treatment. Since some products of the lots in inventory had been sold to customers, this action is defined as a recall. We have concluded that this recall is ineffective, as you have failed to communicate this recall to your customers. In your response, please provide us with a draft customer notification letter for our review, as well as, a timeframe for submission of an 806 report to our Division Recall Coordinator.

This 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 21 CFR § 820. We received your response, dated March 6, 2020, concerning our investigator’s observations noted on the Form FDA 483, that was issued on February 25, 2020. We address your response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100. Specifically,

Your firm did not follow your procedure, Corrective and Preventative Action, SOP.007, Revision 03, Effective Date: 12/10/08, which states: “Any employee who becomes aware of a quality incident, an issue requiring action, or a possible preventative action, is to initiate action by completing Section A: Initiation on FSPP007.001: CAPA form”. For example, your firm did not initiate a CAPA in response to multiple complaints that vacuum bags distributed by your firm were leaking (not holding a vacuum). No assessment was performed to determine if this situation required initiation of a corrective action.

Further, your firm’s procedure, SOP.007, Rev. 03, 12/10/08, states the following: "If any complaint is not followed by a CAPA the reason shall be authorized and recorded". Your firm did not open a CAPA or document the reason a CAPA was not opened for at least three complaints (QC7017, QC7020 and QC7029).

This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.

We reviewed your firm’s response and conclude that it is not adequate. You indicated that your established procedure is adequate but was not followed correctly. You further state that the procedure has been reviewed with all appropriate personnel. Your response did not address initiating a CAPA(s) for the above complaints; provide documentation of the retraining on this procedure, and that a retrospective review of quality data sources was performed to determine if additional CAPAs should be initiated.

3. Failure to demonstrate that the design was developed in accordance with the design control requirements of the Quality System Regulation; and failure to establish a Design History File, as required by 21 CFR § 820.30(a) through § 820.30(j). Specifically,

Your firm did not follow your procedure, SOP.011 Product Design and Development Procedure (Revision: 03, Effective Date: 12/10/08) in that your firm failed to perform or document design inputs, outputs, verification, validation and design reviews for the BiteLok device accessory.

This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.

We reviewed your firm’s response and conclude that it is not adequate. Your response included multiple images of emails between your firm and several clinics. You also indicate that you are working on procedures for correctly documenting all developmental work. The images of emails are not adequate in demonstrating that design controls were used during the development of the BiteLok device accessory. Design controls include a design plan, design input, design output, design review, design verification, and design validation (include simulated use testing) was performed under defined operating conditions, including the documentation of the method, date, and individual(s) performing each. Further, you have not provided a copy of your procedure(s) for correctly documenting all developmental work.

4. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR § 820.30(i). Specifically,

Your firm did not follow your procedure, SOP.011 Product Design and Development Procedure (Revision: 03, Effective Date: 12/10/08), which states in section 5.8.1: “Design changes shall be identified, documented, validated or where appropriate verified, reviewed and approved prior to implementation” Your firm did not perform or document these activities, as required, for the following two design changes:

a. The change to a (b)(4) nylon material by your contract manufacture was not identified, documented and validated or where appropriate verified, reviewed and approved. The (b)(4) nylon material caused your devices to fail.

b. The change to a (b)(4) nylon material by your contract manufacturer on or about June 15, 2018, due to failures, was not identified, documented and validated or where appropriate verified, reviewed and approved.

This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.

We reviewed your firm’s response and conclude that it is not adequate. Your response indicates that you are working on procedures for correctly documenting all developmental work. Additionally, you explain that vacuum bag fabric issues have been discussed with your contract manufacturer and that no design changes will be made without written authorization form your firm and at outside clinics. Your response is not adequate as you did not provide documentation of the validation and where appropriate verification, review, and approval of design changes made to your firm’s vacuum bags. Additionally, you did not provide a retrospective review of other design changes your firm has conducted to ensure design files for those devices are complete.

5. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR § 820.70(a). Specifically,

Your firm has not established nor documented instructions, standard operating procedures, or methods to define and control the manner of production for manufacturing processes performed at your firm. Two examples of manufacturing processes conducted at your firm are:

a. (b)(4) in your ProfileFrame perforated thermoplastic masks

b. The addition of air values to your vacuum bags

We reviewed your firm’s response and conclude it is not adequate. You indicate that process control procedures will be revised within 30 days to cover all Klarity manufacturing activities, including the referenced work on masks and vacuum bags. Please provide a copy of your procedures for process control.

6. 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, your SOP.005 Purchase Controls (Rev. 03; Effective 2018/01/01) has not been implemented in that:

a. Your firm has failed to include, where possible, an agreement that the suppliers, contractors, and consultants utilized by your firm agree to notify your firm of changes in the products and/or services so your firm can determine whether the changes may affect the quality of a finished device as required in 21 CFR § 820.50(b). For example, your vacuum bag contract manufacturer did not notify you when they changed the nylon used in manufacturing your vacuum bags to a (b)(4) nylon. This (b)(4) nylon caused the vacuum bags distributed by your firm to leak, resulting in the vacuum bags inability to maintain a vacuum.

b. Your firm has not clearly defined the quality requirements for each of your suppliers as required in 21 CFR § 820.50(a).

This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.

We reviewed your firm’s response and conclude that it is not adequate. You provided copies of your updated Purchase Order, Terms and Conditions of Purchase, Supplier Purchasing Policy, and Supplier Code of Conduct documents. Your response does not include a plan to establish or update specific quality requirements and/or agreements with each of your suppliers.

7. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR, as required by 21 CFR § 820.90(b)(2). Specifically,

Your firm does not have rework procedures. During the inspection, your General Manager stated that repairs of vacuum bags have been made on at least two different occasions. The rework, including the retesting of these vacuum bags, was not documented in the device history record. The only record maintained for one of the repairs is an email stating that your Director of Engineering was able to repair the bag.

This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.

We reviewed your firm’s response and conclude it is not adequate. You indicate that procedures for rework of nonconforming product are being developed and will be instituted within 30 days. Your response does not address a retrospective review of previous rework activities. Additionally, please provide a copy of your procedure for rework of nonconforming product.

8. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR § 820.80. Specifically,

a. Your firm accepts lots of vacuum bags from a contract manufacturer with an accompanying certificate of analysis (CofA). However, information related to the number of bags tested and the actual values/results of completed tests are not included with the CofA, as required in 21 CFR § 820.80(b).

Further, three lots (71108V, 71220V, and 71220T) of vacuum bags you accepted and distributed were identified on your “Vacuum Bag Inventory [List] with Bad Fabric” document. This document was a list of vacuum bags lots identified to be defective.

b. Your firm routinely performs operations such as (b)(4) in your ProfileFrame masks & adding an air valve to your vacuum bags. These operations are performed without the use of established acceptance criteria or documentation of acceptance testing performed, as required in 21 CFR § 820.80(d).

We reviewed your firm’s response and conclude it is not adequate. You indicate that procedures for acceptance activities of items that you repair are being developed and will be instituted within 30 days. Your response did not address the creation of a procedure for other acceptance activities performed (receiving, in-process, and final). Additionally, please provide a copy of your procedure for acceptance activities on items you repair.

9. 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 firm failed to ensure that all complaints were processed in a uniform and timely manner according to your complaint procedure, SOP.008 Complaints (Rev.01; Effective 01/01/2018). For example, your firm failed to initiate complaint records in a uniform and timely manner for the following:

a. Two complaints were not processed in a timely manner (one for a year after becoming aware, the other for two weeks after becoming aware).

b. A vacuum bag was received from a customer for repair, this was not considered to be a complaint and a complaint record was not initiated.

This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.

We reviewed your firm’s response and conclude it is not adequate. You provided an updated customer complaint procedure, SOP.008 Complaints (Rev.03; Effective: 03/03/2020). However, your firm failed to explain if the above examples would be retroactively entered into your complaint handling system. Further you failed to provide documentation of a retrospective review of other data source to determine if additional complaints have been received.

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. 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.

We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:

• Initial certifications by consultant and establishment – December 31, 2020

• Subsequent certifications – December 31, 2021

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, Sean Moynihan at 410-779-5134 or at sean.moynihan@fda.hhs.gov. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at oradevices1firmresponse@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/
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1 – East

/S/

Robert Ochs, Ph.D.
Deputy Director for Radiological Health
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health