(267 days)
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method
Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)
at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method
Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)
at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
This FDA 510(k) clearance letter for the SWEDEN & MARTINA SURGICAL TRAYS focuses on establishing substantial equivalence for a medical device that organizes, sterilizes, and transports dental surgical instruments. It is not an AI/ML powered device, and therefore the majority of the requested information (related to AI model performance, training data, ground truth, expert adjudication, etc.) is not applicable to this document.
The document primarily addresses the device's functionality related to steam sterilization.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The document provides information on the validated sterilization parameters. It doesn't present a table with explicit "acceptance criteria" versus "reported performance" for the device itself in the typical sense of a diagnostic or predictive AI model. Instead, it describes the conditions under which the device's sterilization function was validated.
| Acceptance Criteria (Implied by Validation Parameters) | Reported Device Performance (Validated Parameters) |
|---|---|
| Ability to be steam sterilized | Validated for steam sterilization (pre-vacuum dynamic-air-removal cycles) |
| Withstand specific temperature | 134 °C (273 °F) |
| Withstand specific exposure time | 4 minutes |
| Withstand specific drying time | Minimum 20 minutes |
| Accommodate maximum load | Maximum load of 740 grams for all device configurations |
| Available in specified sizes/dimensions | Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm) |
2. Sample sized used for the test set and the data provenance
- Sample size: Not explicitly stated in terms of a "test set" for performance evaluation in the context of AI. The validation was likely performed on representative samples of the surgical trays following established sterilization protocols.
- Data provenance: Not explicitly stated. However, the validation was "completed by" the manufacturer, Sweden & Martina S.p.A., and is part of their submission to the FDA. The tests would have been performed in a laboratory or clinical setting to a recognized standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device where expert ground truth is typically established. The "ground truth" here is adherence to sterilization standards and physical integrity of the device after sterilization.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML device requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device relates to the effectiveness of sterilization and the structural integrity of the trays after undergoing the specified sterilization cycles. This would be established through:
- Microbiological testing: E.g., using biological indicators or process challenge devices (PCDs) to confirm sterility after the cycle.
- Physical and functional integrity testing: Inspecting the trays for damage, deformation, or impaired function after repeated sterilization cycles.
- Adherence to recognized standards: Compliance with international or national standards for sterilization (e.g., ISO, AAMI).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
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May 26, 2023
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Sweden & Martina S.p.A. Alessia Pezzato Quality Assurance Manager Via Veneto, 10 Due Carrare, Padova 35020 Italv
Re: K222640
Trade/Device Name: Sweden & Martina Surgical Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 27, 2022 Received: April 21, 2023
Dear Alessia Pezzato:
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 (QS) 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.
Image /page/1/Picture/5 description: The image shows a digital signature. The name "Eileen Cadel -S" is prominently displayed on the left side of the image. To the right, the text "Digitally signed by Eileen Cadel -S Date: 2023.05.26 14:38:09-04'00'" is present, indicating the date and time of the digital signature.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222640
Device Name SWEDEN & MARTINA SURGICAL TRAYS
Indications for Use (Describe)
SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.
The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.
The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method
Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)
at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| 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).