The Sonicision Sterilization Tray (SCST) is intended to encase and protect reusable battery packs (SCB) and generators (SCG) of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (Maximum Load) can be used with the STERRAD® 100S model and pre-set (non-adjustable) Standard cycle. The tray within its sterile barrier is intended to maintain sterility for up to 30 days.

Device Description

The Sonicision™ Sterilization Tray (SCST) is intended to hold and protect Sonicision generators and battery packs during sterilization and storage, as indicated. It is comprised of a polysulfone base containing silicone inserts and a removable/latching polysulfone lid. The tray is reusable and provided to the customer in a non-sterile condition. Perforations on the lid and base permit exposure of the sterilant. The tray containing the intented content/load must be wrapped with an FDA-cleared STERRAD® sterilizer-compatible polypropylene sterilization wrap (not supplied by Covidien) and sterilized as instructed by the labeling. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.

AI/ML Overview

The provided text describes a 510(k) summary for the Sonicision Sterilization Tray (SCST). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in a table format as requested for AI/software-based medical devices.

Therefore, much of the requested information, particularly quantitative performance metrics, sample sizes for training/test sets, ground truth establishment, and details of comparative effectiveness studies (MRMC, standalone), is not applicable or available within this document, as it pertains to a physical sterilization tray and its clearance is based on non-clinical performance and equivalence to a predicate device.

However, I can extract the relevant information and indicate where data is not available or applicable based on the nature of the device and the submission type.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Sterility Assurance Level (SAL)	Achieves a sterility assurance level of at least 10^-6 for its content when used as instructed with an FDA-cleared STERRAD® sterilizer-compatible polypropylene sterilization wrap.	Both the Sonicision tray and the predicate device achieve a sterility assurance level of at least 10^-6. The Sonicision tray assures adequate sterility of its content when used as instructed.
Latching Mechanism Performance	The latching mechanism must adequately secure the lid to the base to protect the contents during sterilization and storage.	The Sonicision tray's latching mechanism performs adequately to secure the lid to the base.
Material Compatibility	Materials (polysulfone, silicone inserts) must be compatible with the sterilization process (STERRAD® 100S with Standard cycle) and intended use.	Both trays are comprised of polysulfone. Cleaning and sterilization processes are very similar. Conforms to ISO 10993-1:2003 (Biological evaluation of medical devices), suggesting biocompatibility and material safety.
Protection of Contents	Intended to encase and protect reusable battery packs (SCB) and generators (SCG) of the Sonicision system during sterilization and storage. The contoured inserts must secure the contents.	The tray is intended to hold and protect Sonicision generators and battery packs. Contoured inserts secure the contents within the tray.
Sterility Maintenance	Intended to maintain sterility for up to 30 days within its sterile barrier (when wrapped in FDA-cleared sterilization wrap).	The tray within its sterile barrier is intended to maintain sterility for up to 30 days.
Conformance to Standards & Guidance	Conforms to applicable clauses of FDA-recognized consensus standard AAMI ST77:2006 and draft FDA Guidance Document, "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA" (March 7, 2002).	Declarations of Conformity to AAMI ST77:2006, the draft FDA Guidance document, ISO 10993-1:2003, AAMI ST81:2004, ISO 14937:2000, and ISO 14971:2007 were provided.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of controlled clinical trials for device performance. The evaluation appears to be based on engineering tests, material compatibility, and adherence to recognized standards, usually involving a limited number of samples or representative units to demonstrate conformity.
Data Provenance: The data provenance is from non-clinical performance testing conducted by the manufacturer, Covidien, to demonstrate conformance to standards and substantial equivalence. This is not a human clinical study, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. For a physical device like a sterilization tray, "ground truth" is established through standardized engineering tests, material science evaluations, and conformity to recognized consensus standards by qualified testing personnel and regulatory affair experts, rather than expert consensus on interpretive data (e.g., radiology reads).
Qualifications of Experts: Not specified. Testing would be conducted by laboratory technicians, engineers, and quality assurance personnel with expertise in sterility testing, material science, and medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. The evaluation relies on direct measurement of physical properties (e.g., integrity of latching mechanism, material compatibility, bacterial challenge tests to confirm SAL) and comparison to established technical specifications and standards, not on interpretive judgments 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

MRMC Comparative Effectiveness Study: No. This is a physical medical device (sterilization tray), not an AI/software-based diagnostic or assistive system. Therefore, MRMC studies are not relevant.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" is established by adherence to pre-defined technical specifications, performance standards as outlined in AAMI ST77:2006 and other ISO standards (e.g., SAL of 10^-6), and documented engineering test results. For example, the sterility assurance level (SAL) is a measurable and objective "ground truth" for sterilization efficacy, and the latching mechanism's performance would be assessed against its functional design requirements.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable. No training set is used for this type of device.

Summary

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510(k) Summary

Date summary prepared: 3/30/2012

510(k) Submitter/Holder

Covidien, formerly Valleylab, a division of Tyco Healthcare 5920 Longbow Drive Boulder, CO 80301

Contact

David M. Horton Project Manager, Regulatory Affairs Telephone: 303-530-6391 Fax: 303-530-6313 david.m.horton@covidien.com

Name of Device

Trade or Proprietary Name: Sonicision Sterilization Tray Catalog Number: SCST Common Name: Sterilization Tray Classification Name: Sterilization wrap containers, trays, cassettes & other accessories (class II; product code KCT)

Predicate Device

The sterilization tray described in this submission was compared and found to be substantially equivalent to the following sterilization tray in commercial distribution:

Device Name: Sterilization Tray Model Number: 39301 BCTS 510(k) Number: K090818 (cleared 8/18/2009) Manufacturer: Karl Storz Endoscopy-America, Inc.

Device Description

Important note: the tray is not considered a reusable rigid sterilization container (per the definition found in clause 3.4 of the ST77 standard) -- it does not contain gaskets, filters, or valves to act as a barrier to microorganisms during storage, handling, and transport. It must be enclosed in a sterilization wrap in accordance with the instructions for use.

K112536/S2, Sonicision™ Sterilization Tray

7-2 (Attachment C)

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Intended Use

Technological and Performance Characteristics

The Sonicision and Karl Storz sterilization trays were found to be similar in many ways. The following three essential relevant similarities were identified and discussed in the submission: (1) Intended use - specifically, the indications for use of both trays are nearly identical, which is to encase and protect specific reusable medical devices during low-temperature hydrogen peroxide gas plasma (STERRAD®) sterilization and subsequent storage. (2) Basic design and material characteristics - both travs are comprised of polysulfone and designed as a two-part (lid/base) system with latches, handles, perforations, and contoured silicone inserts designed to hold specified content. And (3) cleaning and sterilization - the cleaning and sterilization processes of both trays are very similar. The detailed instructions provided in the labeling require the device to be thoroughly cleaned, rinsed, dried, inspected, and wrapped prior to sterilization. Notably, both trays assure adequate sterility of their content when used as instructed.

Comparison of the Sonicision and predicate device sterilization trays found very few differences. None of the differences (e.g., geometry, size, weight, intended content) were found to be relevant to the potential impact on safety or effectiveness. Two potentially relevant differences are acknowledged: (1) The percent of total surface area perforations and (2) latching mechanism materials and design. These differences do not impact safety or effectiveness - both devices achieve a sterility assurance level of at least 100 , and the Sonicision tray's latching mechanism performs adequately to secure the lid to the base.

Non-Clinical Performance

The Sonicision sterilization tray conforms to applicable clauses of FDA-recognized consensus standard AAMI ST77:2006 and draft FDA Guidance Document, "Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA" (March 7, 2002). Conformance to this standard and guidance document rely on adherence to the requirements and procedures of the following national and international standards: ISO 10993-1:2003, AAMI ST81:2004, ISO 14937:2000, and ISO 14971:2007. Declarations of Conformity to the guidance document and standard were provided in the submission.

Clinical Performance

This premarket notification report does not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

Conclusion

Data submitted in this premarket notification report demonstrate that the subject device (Sonicision Sterilization Tray [SCST]) is at least as safe and effective and, therefore, substantially equivalent to the predicate device with regard to intended use, technological characteristics, and non-clinical performance.

7-3 (Attachment C)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 1 9 2012

Mr. David M. Horton Regulatory Affairs Project Manager Covidien 5920 Longbow Drive Boulder Colorado 80301

Re: K112536

Trade/Device Name: Sonicision Sterilization Tray, Model SCST Regulation Number: 21 CFR §880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 17, 2012 Received: April 18, 2012

Dear Mr. Horton:

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 Eederal Register.

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Page 2- Mr. Horton

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K112536

Device Name: Sonicision™ Sterilization Tray

Indications for Use:

The Sonicision Sterilization Tray (SCST) is intended to encase and protect reusable battery packs (SCB) and generators (SCG) of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (Maximum Load) can be storage: The tray comaining ap to one gand pre-set (non-adjustable) Standard cycle. The tray within its sterile barrier is intended to maintain sterility for up to 30 days.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use V AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Laurie-Willz

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K112536 510(k) Number:

Regulation Number and Section

§ 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).