(99 days)
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculap™ rigid container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.
The Sonicision Sterilization Tray is a reusable, optional accessory to the Sonicision System (cleared through K180149). This device is specially made to enclose up to one Sonicision Reusable Generator and up to two Sonicision Reusable Battery Insertion Guides in order to provide storage during sterilization, storage, and transportation within the hospital environment. The tray does not provide a sterile barrier on its own: it can only maintain sterility using an FDA-cleared sterilization wrap or rigid container.
The document primarily focuses on the Sonicision™ Reusable Sterilization Tray and its substantial equivalence to a predicate device, focusing on its ability to maintain sterility after specific sterilization cycles. It describes performance data related to cleaning, sterilization, mechanical reliability, and human factors. However, the provided text does not contain the detailed quantitative acceptance criteria and study results for assessing device performance in a typical medical device AI/software context.
Specifically, the document discusses a sterilization tray, which is a physical accessory, not an AI or software device. Therefore, the requested information regarding AI/software performance criteria (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this physical device submission.
Here's a breakdown of what the document does provide in relation to your request, adapted for a physical device, and what it does not provide:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied for Sterilization Efficacy): The primary acceptance criterion for the sterilization tray is its ability to maintain sterility of the enclosed components after specific steam sterilization cycles when used with FDA-cleared sterilization wrap or rigid containers. The specific cycle parameters (temperature, exposure time, dry time) listed are the validated parameters that the device must withstand and enable sterility for.
- Reported Device Performance: The document states, "The performance data support that the Sonicision Reusable Sterilization Tray is as safe, as effective, and performs as well or better than the legally marketed predicate device." However, it does not provide quantitative results such as sterility assurance levels (SAL) or other specific metrics from the cleaning and sterilization testing. It only states that the testing was performed "in accordance with" relevant standards and guidance.
Table based on the provided information (focused on relevant criteria for a sterilization tray):
| Acceptance Criteria (Validated Parameters) | Reported Device Performance (Implied or General Statement) |
|---|---|
| Steam Sterilization Cycles: | |
| Pre-vacuum: | |
| - 132 °C (270 °F), 4 min exposure, 40 min dry time | "Performance data support that the device is as safe, as effective, and performs as well or better than the legally marketed predicate device." (Implied successful validation) |
| - 135 °C (275 °F), 3 min exposure, 40 min dry time | |
| Gravity: | |
| - 132 °C (270 °F), 15 min exposure, 40 min dry time | |
| - 135 °C (275 °F), 10 min exposure, 30 min dry time | |
| Mechanical/Reliability: Device performs as expected at initial use and after repeated cycles. | "Mechanical and reliability testing was carried out to verify that the proposed device performs as expected at initial use and after repeated cleaning and sterilization cycles." (Implied successful validation) |
| Human Factors: Intended users can safely and correctly use the device. | "Human factors testing was performed... to verify that intended users are able to safely and correctly use the device." (Implied successful validation) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not specify sample sizes for cleaning, sterilization, mechanical, or human factors testing in terms of "test sets" as one would for AI/software. It does not mention data provenance (country, retrospective/prospective). This information is typically found in detailed validation reports, not in the 510(k) summary provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This criterion is for AI/software accuracy validation. For a physical sterilization tray, "ground truth" relates to the successful outcome of sterilization (e.g., lack of microbial growth), which is assessed through laboratory methods, not expert consensus in the way a medical image is.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This is an AI/software specific term for resolving discrepancies in expert ground truth.
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: MRMC studies are for evaluating human performance (e.g., radiologists reading images) with and without AI assistance. This device is a physical sterilization tray.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm alone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied Ground Truth (for a physical device): For the sterilization aspects, the ground truth would typically be established through microbiology testing (e.g., using biological indicators or test coupons) to demonstrate the absence of viable microorganisms after the sterilization cycles. For mechanical testing, it would be adherence to engineering specifications and performance under stress. For human factors, it would be observed safe and correct use by intended users. The document does not detail the specific ground truth methods or results.
8. The sample size for the training set
- Not Applicable: This (training set) is a concept for machine learning models.
9. How the ground truth for the training set was established
- Not Applicable: This (ground truth for training set) is a concept for machine learning models.
In summary, the provided FDA 510(k) letter and summary describe a physical medical device (a sterilization tray) and its regulatory clearance based on demonstrating substantial equivalence to a predicate device through various performance testing (cleaning, sterilization, mechanical, human factors). It does not involve AI or software, and therefore, most of your questions are not directly applicable to the content provided.
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Covidien Candice Bautista-Biddle Associate Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K180915
Trade/Device Name: Sonicision Reusable Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: June 26, 2018 Received: June 27, 2018
Dear Candice Bautista-Biddle:
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 comprehensive regulatory information about medical devices and radiation-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.
Clarence W. Murray lii III -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) K180915
Device Name Sonicision™ Reusable Sterilization Tray
Indications for Use (Describe)
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculap™ rigid container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.
The validated sterilization cycle parameters are as follows:
Steam Sterilization Cycles
| Cycle Type | ExposureTemperature | Exposure Time(minutes) | MinimumDry Time1(minutes) | Compatible Sterile Barriers |
|---|---|---|---|---|
| Pre-vacuum | 132 °C (270 °F) | 4 | 40 | Wrap(s) and rigid container2 |
| Pre-vacuum | 135 °C (275 °F) | 3 | 40 | Wrap(s) and rigid container2 |
| Gravity | 132 °C (270 °F) | 15 | 40 | Wrap(s) |
| Gravity | 135 °C (275 °F) | 10 | 30 | Wrap(s) |
| 1Due to variations in autoclave sterilization equipment, actual dry times may vary from the minimumdry times validated for this product.2Validated with Aesculap™* rigid container model JN741/JK789. |
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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510(k) Summary: K180915
Date summary prepared: 7/16/2018
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Candice Bautista-Biddle Associate Regulatory Affairs Specialist Telephone: 303-530-6448 Fax: 303-530-6313 Email: candice.bautista-biddle@medtronic.com
Name of Device
| Trade Name: | Sonicision™ Reusable Sterilization Tray |
|---|---|
| Common Name: | Sterilization Tray |
| Catalog Numbers: | SCSTA |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other Accessories (21 CFR 880.6850, Class II, KCT) |
Predicate Device
| Trade Name: | Signia™ Sterilization Tray |
|---|---|
| Catalog Numbers: | SIGTRAY |
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other Accessories (21 CFR 880.6850, Class II, KCT) |
| 510(k) Number: | K161347 |
| Manufacturer: | Covidien |
Device Description
The Sonicision Sterilization Tray is a reusable, optional accessory to the Sonicision System (cleared through K180149). This device is specially made to enclose up to one Sonicision Reusable Generator and up to two Sonicision Reusable Battery Insertion Guides in order to provide storage during sterilization, storage, and transportation within the hospital environment. The tray does not provide a sterile barrier on its own: it can only maintain sterility using an FDA-cleared sterilization wrap or rigid container.
Indications for Use
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculan™M* Rigid Container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.
The validated sterilization cycle parameters are as follows:
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Steam Sterilization Cycles
| Cycle Type | ExposureTemperature | Exposure Time(minutes) | Minimum DryTime1 (minutes) | Compatible SterileBarriers |
|---|---|---|---|---|
| Pre-vacuum | 132 °C (270 °F) | 4 | 40 | Wrap(s) and rigidcontainer2 |
| Pre-vacuum | 135 °C (275 °F) | 3 | 40 | Wrap(s) and rigidcontainer2 |
| Gravity | 132 °C (270 °F) | 15 | 40 | Wrap(s) |
| Gravity | 135 °C (275 °F) | 10 | 30 | Wrap(s) |
| 1Due to variations in autoclave sterilization equipment, actual dry times may vary from the minimum dry timesvalidated for this product. | ||||
| 2Validated with Aesculap Rigid Container model JN741/JK789 |
Comparison of Technological Characteristics with the Predicate Device
Both the proposed and predicate devices have the same intended use of providing storage for components of their respective systems during sterilization, storage, and transportation within the hospital environment. Additionally, both devices have the same basic design of tray and lid with perforations to allow for steam sterilization of the enclosed devices.
| Subject DeviceSonicision Reusable SterilizationTray | Predicate Device K161347Signia sterilization tray | |
|---|---|---|
| Enclosed devicesfor sterilization | The tray can contain at a maximum:One (1) Sonicision Reusable Generator,Two (2) Sonicision Reusable BatteryInsertion Guides. | The tray can contain at a maximum:One (1) Signia Adapter,One (1) Signia Reusable InsertionGuide andOne (1) Signia Manual Retraction Tool. |
| Dimensions | Approx. 8.5 x 11.0 x 3.0 (H) inches | Approx. 10.0 x 21.4 x 3.0 (H) inches |
| Sterilizationmethods | Steam (Pre-vacuum and Gravity) | Steam (Pre-vacuum) |
| Steam sterilizationparameters | 132 °C Pre-vacuum Steam CycleExposure temperature: 270 °F (132 °C)Exposure time: 4 minutesMinimum dry time: 40 minutes135 °C Pre-vacuum Steam CycleExposure temperature: 275 °F (135 °C)Exposure time: 3 minutesMinimum dry time: 40 minutes132 °C Gravity Steam CycleExposure temperature: 270 °F (132 °C)Exposure time: 15 minutesMinimum dry time: 40 minutes135 °C Gravity Steam CycleExposure temperature: 275 °F (135 °C)Exposure time: 10 minutesMinimum dry time: 30 minutes | 132 °C Pre-vacuum (Hi Vac) SteamCycleExposure temperature: 270 °F (132 °C)Exposure time: 4 minutesVacuum dry time: 20-40 minutes134 °C Pre-vacuum (Hi Vac) SteamCycleExposure temperature: 273 °F (134 °C)Exposure time: 3 minutesVacuum dry time: 20-40 minutesNot applicable |
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| Subject DeviceSonicision Reusable SterilizationTray | Predicate Device K161347Signia sterilization tray | |
|---|---|---|
| Base and LidMaterials | Base: PolyphenylsulfoneLid: Stainless Steel | Base and Lid: Stainless Steel |
| Stacking | Do not stack loaded/wrappedsterilization trays in chamber. | Do not stack cases and trays in thesterilization chamber. |
| Max. LoadCapacity | < 1800 grams (3.97 pounds, includingtray) | 10 pounds |
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Cleaning and Sterilization Testing
Cleaning and sterilization testing was performed in accordance with ANSI/AAMI/ISO 17665-1, AAMI TIR30:2011, AAMI TIR12:2010, and FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" published March 17, 2015.
Mechanical/Reliability Testing
Mechanical and reliability testing was carried out to verify that the proposed device performs as expected at initial use and after repeated cleaning and sterilization cycles.
Human Factors Validation Testing
Human factors testing was performed in accordance with IEC 62366-1:2015 along with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices" published February 3, 2016 to verify that intended users are able to safely and correctly use the device.
Conclusion
The performance data support that the Sonicision Reusable Sterilization Tray is as safe, as effective, and performs as well or better than the legally marketed predicate device.
§ 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).