(210 days)
The Benesta™ Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage.
The Benesta™Sterilization Tray must be used in conjunction wrap that is cleared by the FDA for the indicated sterilization cycles.
STEAM STERILIZATION
| Pre-Vacuum | Gravity | |
|---|---|---|
| Temperature | 132 °C | 132°C |
| Exposure Time | 4 minutes | 15 minutes |
| Dry Time | 45 minutes | 45 minutes |
| Device Storage Conditions | Do not double stack, store in a cool dry location aftersterilization | |
| Sterility using FDA validated wrap | Sterility is maintained until wrap is opened orotherwise compromised | |
| Validated Device Contents | ≤20 lbs. (1) Caldera Medical Rod Lens Hysteroscope(1) Caldera Medical Removable Outflow Channel (2)Light post adapters, (1)Valve Cap (2) Valve Insert End Cap |
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This document is a marketing clearance letter from the FDA for a medical device called the "Benesta Medical Sterilization Tray" (K193603). It is not a study or regulatory approval for an AI/ML medical device. Therefore, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving device performance for an AI/ML device.
The document states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It outlines the intended use and steam sterilization parameters for the tray when used with specific Caldera Medical instruments.
To answer your questions, I would need a document that describes the clinical performance or validation study of an AI/ML medical device. This document is related to a physical sterilization tray, not a software algorithm.
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July 20, 2020
Caldera Medical, Inc Vicki Gail VP, Regulatory Affairs 5171 Clareton Drive Agoura Hills, California 91301
Re: K193603
Trade/Device Name: Benesta Medical Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 18, 2020 Received: May 22, 2020
Dear Vicki Gail:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth F. Claverie-Williams, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No.0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Benesta™ Sterilization Trav
Indications for Use (Describe)
The Benesta™ Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage.
The Benesta™Sterilization Tray must be used in conjunction wrap that is cleared by the FDA for the indicated sterilization cycles.
STEAM STERILIZATION
| Pre-Vacuum | Gravity | |
|---|---|---|
| Temperature | 132 °C | 132°C |
| Exposure Time | 4 minutes | 15 minutes |
| Dry Time | 45 minutes | 45 minutes |
| Device Storage Conditions | Do not double stack, store in a cool dry location aftersterilization | |
| Sterility using FDA validated wrap | Sterility is maintained until wrap is opened orotherwise compromised | |
| Validated Device Contents | ≤20 lbs. (1) Caldera Medical Rod Lens Hysteroscope(1) Caldera Medical Removable Outflow Channel (2)Light post adapters, (1)Valve Cap (2) Valve Insert End Cap |
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).