WARNING LETTER

Innovative Sterilization Technologies LLC MARCS-CMS 524761 — March 20, 2019

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

Recipient:: Recipient Name

Scott E. Cohen; Recipient Title

Chief Operating Officer; Innovative Sterilization Technologies LLC; 7625 Paragon Road, Suite A
Dayton, OH 45459-4063
United States

Issuing Office:: Division of Medical Device and Radiological Health Operations East; One Montvale Avenue, 4th Floor
Stoneham, MA 02180
United States

WARNING LETTER
CMS # 524761

March 20, 2019

Re: ONE TRAY Sealed Sterilization Container

Dear Mr. Cohen:

The United States Food and Drug Administration (FDA) has learned that your firm, Innovative Sterilizations Technologies, LLC, is marketing the ONE TRAY Sealed Sterilization Container (One Tray), a rigid reusable sterilization container classified under 21 C.F.R. 880.6850, in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). One Tray is intended to hold reusable medical devices while they are flash sterilized for immediate use. However, as described below, your firm is marketing the product for two different intended uses outside of its original clearance: terminal sterile storage and terminal sterile storage with retained moisture. These intended uses raise new questions of safety and effectiveness not addressed by the original clearance, including, but not limited to, an increased risk of microbial contamination. For example, medical devices terminally stored with retained moisture in One Tray may be used in surgeries, and, if contaminated or improperly sterilized, could result in patient illness, injury, or death. Your firm has not provided evidence to FDA to substantiate the safety and efficacy of these uses, and FDA is currently unaware of any data or literature that supports your firm’s claims related to the safety and efficacy of terminal storage with retained moisture. Further, to date, FDA has not cleared or approved a rigid reusable sterilization container with an intended use for terminal sterile storage with retained moisture. The lack of evidence and potential increased risks raise public health concerns because the marketing creates a misleading impression that FDA has evaluated the safety and effectiveness of One Tray for these new uses.

Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body.

FDA has reviewed your firm’s website (https://www.iststerilization.com)1 and determined that One Tray 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. § 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), for the device as described and marketed. One Tray is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).

Specifically, One Tray was cleared under K052567 as intended for flash sterilization for immediate use with the following indications:

⋅ “ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments, multiple instruments or an instrument set for immediate use following flash sterilization.”

⋅ “After sterilization, ONE TRAY provides for the safe transport and assured delivery for immediate use of the enclosed devices…”

⋅ “The performance and intended use of ONE TRAY Sealed Sterilization Containers should comply at all times with the methods of use and flash sterilization guidelines as recommended by the manufacturer of the devices being sterilized, AAMI (Association for the Advance [sic] of Medical Instrumentation), AORN (Association of periOperative Registered Nurses) . . .”

This clearance describes One Tray as a sterilization wrap intended for the rapid sterilization of instruments in flash cycles, which is referred to as “flash sterilization” or, more recently, “immediate use steam sterilization.” During flash and immediate use steam sterilization, instruments are sterilized with steam for immediate use and are not stored. However, as described below, your firm’s current promotion of the One Tray goes significantly beyond its clearance and provides evidence that it is intended for terminal sterile storage and terminal sterile storage with retained moisture (where contents can remain wet after sterilization and can be stored in the container as such), which constitute major changes or modifications to One Tray’s intended use, for which your firm lacks clearance or approval.

Terminal Sterile Storage

For example, language on your firm’s website indicates that One Tray is intended for terminal sterile storage and not flash sterilization for immediate use. Examples include:

⋅ “ONE TRAY® is a terminal sterilization container not an IUSS [Immediate Use Steam Sterilization] container.” “Offers an option to eliminate Immediate Use Steam Sterilization.”

⋅ “Performance testing for . . . 30, 180, and 365 days of shelf life.”

Terminal Sterile Storage with Retained Moisture

Your website also includes language that indicates dry times following sterilization are unnecessary when One Tray is used for terminal sterile storage, which is not part of One Tray’s cleared intended use. Although a flash sterilization cycle may result in retained moisture, the moisture is less likely to cause contamination because the contents of One Tray are immediately used and not stored when One Tray is used in accordance with its clearance. In comparison, when there is retained moisture following steam sterilization and the contents are terminally stored, the potential for contamination increases because wet barrier surfaces may greatly enhance microbial ingress. Examples of such language include:

⋅ “Eliminates drying time, no dry time or cool time required.”
⋅ “ONE TRAY®'s breakthrough processing capability is accomplished by innovative design features and performance benefits which include the elimination of drying time.”
⋅ “Addresses retained moisture concerns . . .”

The statements on your website cited above provide evidence that you have made major changes or modifications to the intended use of your device that require a new premarket submission because they could significantly affect the safety or effectiveness of the device (see 21 CFR 807.81(a)(3)(ii)). Specifically:

• Sterilization wraps, like rigid sterilization containers such as One Tray, are cleared with an intended use that specifies, among other things, the sterilization cycle for use and duration of sterility assurance (shelf life). One Tray is cleared for use solely for the flash sterilization cycle, which means that its contents are to be used immediately upon sterilization (e.g., to be used in the particular procedure that the contents were sterilized for use in). However, the above language on your website indicates that the One Tray may be used in a terminal sterilization cycle with its contents stored—for example, up to 365 days—instead of immediately used following sterilization. Sterile storage can make the contents more susceptible to contamination, and you did not provide evidence that supports barrier performance of the packaging to the full extent of the promoted sterile storage period.

• Similarly, One Tray is cleared for flash sterilization for immediate use of the contents, which may have retained moisture. However, language on your website indicates that One Tray may be used for terminal sterile storage with retained moisture. Retained moisture following a terminal steam sterilization cycle greatly increases the risk of microbial ingress through filter materials and packaging interfaces. This is not true for flash/immediate use sterilization cycles because the contents are intended to be immediately used, and there is typically no expectation that the rigid reusable sterilization container should maintain the sterility of the load over an extended period of time. Retained moisture, also called “wet loads,” following terminal steam sterilization may be viewed as sterilization process failures,2 and, under certain industry guidelines, terminal sterilization should be repeated until there is no retained moisture. Retained moisture is also considered unacceptable for maintenance of sterility under recognized consensus standards and by certain professional societies.

None of the language, cited above, on your firm’s website relating to One Tray’s terminal storage or terminal storage with retained moisture capabilities is supported by the original report cleared for K052567. Further, we note that your firm is aware that One Tray’s clearance does not support terminal storage or terminal storage with retained moisture uses. During FDA’s November 2015 inspection, FDA investigators notified your firm that these claims represented new intended uses and that you needed to submit a premarket submission which would allow FDA to evaluate the safety and effectiveness of your device for these uses. You (b)(4), prior to the issuance of a March 3, 2016 Warning Letter from the Agency. Your firm (b)(4). During FDA’s April 2017 inspection, your firm (b)(4). You are, therefore, aware that terminal sterile storage and terminal sterile storage with retained moisture both represent major changes or modifications from the One Tray’s cleared intended use that could significantly affect the safety or effectiveness of the device, as described above, and, thus, require a new premarket submission. To date, your firm still has not submitted a premarket submission for these intended uses. Nonetheless, as evidenced by the statements on your website, you continue to promote the One Tray for these new intended uses without the required FDA premarket clearance or approval in violation of the Act.

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. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htmThe FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that your firm immediately cease activities that result in the misbranding or adulteration of One Tray, such as the commercial distribution of the device for the uses discussed above.

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.

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) 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. If your firm does not believe that One Tray is in violation of the Act (as described herein), please include your reasoning and any supporting information for our consideration. 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, Karen Archdeacon at 781-587-7491 or at karen.archdeacon@fda.hhs.gov. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at gina.brackett@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

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1 Last accessed, March 13, 2019.

2 For the purposes of this Warning Letter, “process failure” refers to the inability of the sterilization cycle to meet specified cycle parameters and/or specifications; deliver sufficient lethality; and/or achieve the sterility assurance level specified for the sterilization process.