(116 days)
The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "SALUS® - Hygiene Instrument Reprocessing Container." It outlines the FDA's determination of substantial equivalence for the device. Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/Machine Learning medical device.
Instead, this document pertains to a physical medical device (a sterilization container) and its performance is demonstrated through validation of sterilization cycles. The "acceptance criteria" here are inherent in the successful validation of these cycles (e.g., sterilization temperature, exposure time, drying time for specific sterilizer types and loads). The "study that proves the device meets the acceptance criteria" refers to the sterilization validation studies conducted by the manufacturer, the results of which are summarized in the table provided.
Therefore, I cannot extract the information required for an AI/ML device from this document. The questions you've posed (sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the development and validation of AI/ML algorithms, not sterile processing containers.
If you can provide a document describing the regulatory submission and validation for an AI/ML medical device, I would be happy to help answer your questions.
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November 24, 2017
SciCan Ltd. Teresa Boyce Director of Regulatory Affairs 1440 Don Mills Road Toronto, M3B 3P9 Ca
Re: K172292
Trade/Device Name: SALUS® - Hygiene Instrument Reprocessing Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 27, 2017 Received: October 31, 2017
Dear Teresa Boyce:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172292
Device Name
SALUS® - Hygiene Instrument Reprocessing Container
Indications for Use (Describe)
The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
Please refer the chart below for validated sterilization cycles.
| Steam Sterilizer Type | Cycle | SterilizationTemperature-0/+6°F (-0/+3°C) | ExposureTime | RecommendedDrying Time | LoadType | MaximumInstrumentLoad PerContainer |
|---|---|---|---|---|---|---|
| Dynamic-air-removal(pre-vacuum) | Wrapped | 270°F (132°C) | 4 minutes | 16 minutes | Solid HygieneInstruments & | 0.487lb (221g) |
| Dynamic-air-removal(steam-flush, pressure-pulse, SFPP) | Wrapped | 270°F (132°C) | 4 minutes | 30 minutes | Lumen HygieneInstruments | 0.478lb (217g) |
| Dynamic-air-removal(pre-vacuum) | Wrapped | 273°F (134°C) | 4 minutes | 30 minutes | (Ø .028" [0.7mm] x L 3.35"[85 mm], Qty. 1) | 0.473lb (215g) |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).