WARNING LETTER
Adventure Innovations LLC
MARCS-CMS 676842 —
August 07, 2024
Reference #:
CPT2002270
Product:
Medical Devices
Recipient:
Recipient Name
Ryan White
Recipient Title
Owner/Partner
Adventure Innovations LLC
(b)(4)
United States
(b)(6)
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 676842
August 7, 2024
Evolution CPAP LLC
11739 S Digory Drive
South Jordan, UT 84009 United States
Re: Sani Bot D3
Refer to: CPT2002270
Dear Ryan White:
The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the Sani Bot D3 without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
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 to affect the structure or any function of the body.
FDA has reviewed the labeling for the device on your online Evolution CPAP LLC Store at Amazon.com (https://www.amazon.com/Sani-Bot-Sleep-Gear-Cleaner/dp/B0CHWQ13YP/ref=sr_1_2dib=eyJ2IjoiMSJ9.q0O5exwuGmS3TnIdgc5xYEvPCzEUlnYvHHR08wc5lZw.r_JpmgyDF3yRB6yPexIHI5Xeqs00DjIM2ZojoILkYvU&dib_tag=se&m=A10LGMOEV40P8&marketplaceID=ATVPDKIKX0DER&qid=1717534222&s=merchant-items&sr=1-2) (last visited June 04, 2024), and determined that the Sani Bot D3 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. The Sani Bot D3 is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution the device without submitting a 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)(1). 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)(1)).
On your online Evolution CPAP LLC Store at Amazon.com, your device is described as using ultrasonic transducer technology with cleaning solution to deep clean Continuous Positive Airway Pressure (CPAP) therapy devices and CPAP accessories, and your online store website includes the following claims:
Sani Bot D3:
• “The ultrasonic waves penetrates through every solid layer of your equipment and reach the deep, inaccessible surfaces. Breathe easy with clean equipment. Prevent congestion, and sickness without any unpleasant odors! … Sani Bot is compatible with nearly all masks, tubing, headgear, and machines … Improves Sleep, Removes Congestion, Reduces Headaches.”
On September 8, 2022, the FDA sent a letter to Adventure Innovations LLC, stating that the Sani-Bot D3, Sani Bot D3X, and Sani Bot D6 appear to meet the definition of a device under the FD&C Act and that they do not appear to be Class I exempt medical devices. FDA sent follow-up emails on March 3, 2023, and April 21, 2023, noting that pictures and/or content on your website continued to show that you were marketing your products as CPAP cleaner/sanitizer devices. On April 28, 2023, you provided a preliminary response via email that you do not agree with the assessment that your products are medical devices as defined under section 201(h) of the FD&C Act. You reiterated that position in a follow-up email on May 9, 2023, noting that your products “are not for interaction or direct sanitization with humans or individuals. Rather their usage is only applicable for the sanitization and wash of tools and accessories only.”
Your response is inadequate. The definition of “device” in section 201(h) of the FD&C Act includes “any component, part, or accessory” to a device. Your products are medical device accessories because, as evidenced by the labeling, they are intended to support, supplement, and/or augment the performance of one or more parent devices. Specifically, as described above, the labeling for your products indicates they are intended to support the performance of CPAP therapy devices and accessories by cleaning them. The Sani Bot D3 product labeling also indicates that they are intended to prevent disease (e.g., “congestion” and “sickness”). Therefore, your products are devices under section 201(h) of the FD&C Act.
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.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Adventure Innovations LLC cease any activities that result in the misbranding or adulteration of the Sani Bot D3, such as the commercial distribution of the device for the uses discussed above.
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.
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) 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 by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CPT2002270 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Dr. BiFeng Qian at: bifeng.qian@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. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Sincerely yours,
/S/
Binita S. Ashar, MD, MBA, FACS
Director
OHT 4: Office of Surgical and Infection Control
Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
08/28/2024
Regulated Product(s)
Medical Devices