The Sonicision Sterilization Tray is intended to be used to encase and protect reusable battery packs and generators 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 following models and pre-set (non-adjustable) cycles.

Model	Cycle
STERRAD® 100S	Standard
STERRAD® NX®	Standard
STERRAD® 100NX®	Standard
STERIS Amsco® V-PRO® 1	Lumen
STERIS Amsco® V-PRO® 1 Plus	Lumen
STERIS Amsco® V-PRO® maX	Lumen

Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.

Device Description

The Sonicision™ Sterilization Tray 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. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.

The Sonicision™ Sterilization Tray does not contain gaskets, filters, or valves to act as a barrier to microorganisms during storage, handling, and transport. The tray containing its intended content (load) must be wrapped with an FDA-cleared STERRAD or STERIS V-PRO-compatible polypropylene sterilization wrap or pouched with an FDA-cleared STERRAD or STERIS V-PRO-compatible Tyvek® pouch (note: the wrap and pouch are not supplied by Covidien) and sterilized as instructed by the labeling.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Sterilization Efficacy	Achieve a six-log reduction of Geobacillus stearothermophilus in designated worst-case areas of the loaded tray after exposure to specified STERRAD and STERIS "half cycles."	The results show that the indicated STERRAD and STERIS "half cycles" provided a six-log reduction of the indicator organism (Geobacillus stearothermophilus) at the worst-case locations (battery pack, generator, and sterilization tray).
Sterilant Residuals	Adequate dissipation of hydrogen peroxide from the load, comparable to a reference predicate tray.	The results show that the Sonicision Sterilization Tray permits adequate dissipation of hydrogen peroxide on the load when compared to the predicate devices used in the study.
Use Life (Material Compatibility)	Maintenance of key functional/performance specifications after repeated reprocessing (340 cycles) using worst-case sterilization systems (STERRAD 100NX with Standard cycle, STERIS V-Pro with Lumen cycle) as per labeling instructions.	The results show the tray meets its performance specifications when reprocessed repeatedly (340 cycles) in accordance with the labeling.
Biocompatibility	Pass all applicable requirements for cytotoxicity as per ISO 10993-5:2009, Part 5: Tests for In Vitro Cytotoxicity, following exposure to intended sterilization systems.	The results show that the Sonicision Sterilization Tray passes all applicable biocompatibility requirements and is, therefore, considered non-cytotoxic following exposure to the intended sterilization systems. Samples were prepared in accordance with ISO 10993-12:2007 (Part 12).
Mechanical/Bench	Meet all applicable clauses/criteria specified in AAMI ST77:2006.	The results show that all requirements (specified in AAMI ST77:2006) were met.

Study Details:

Sample Size used for the test set and the data provenance:
- Sterilization Efficacy: The trays were loaded with the "intended maximum load (one reusable battery pack and one reusable generator)." The number of trays or replicates is not explicitly stated, but the mention of "the sterilization trays were either wrapped... or pouched" implies multiple test items. The biological indicator used was Geobacillus stearothermophilus. The data provenance is from non-clinical performance studies conducted by Covidien. The location of the testing is not specified, but it's internal company testing supporting a US FDA submission.
- Sterilant Residuals: "Three runs of loaded (one battery pack and one generator), wrapped, or pouched Sonicision trays placed in STERRAD or STERIS systems." Testing of the reference predicate tray involved "at least one run." Provenance is also internal non-clinical testing.
- Use Life (Material Compatibility): The study involved "repeatedly (340 cycles)" of reprocessing the tray. This implies testing on at least one (and likely more) trays. Provenance is internal non-clinical testing.
- Biocompatibility: "Test samples were prepared in accordance with ISO 10993-12:2007, Part 12: Sample Preparation and Reference Materials." The Sonicision Sterilization Tray was exposed to "two full cycles (as indicated) of the STERRAD and STERIS systems." "All biocompatibility assays were performed on neat extracts." The specific number of samples or replicates is not explicitly given, but the methodology suggests controlled lab-based testing. Provenance is internal non-clinical testing.
- Mechanical/Bench: The text does not explicitly state the sample size for mechanical testing beyond "The Sonicision Sterilization Tray was evaluated." Provenance is internal non-clinical testing.
All studies appear to be prospective in nature, designed specifically to test the device's performance against defined criteria. The origin is internal non-clinical testing for the purpose of a 510(k) submission to the US FDA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The studies described are non-clinical performance studies involving laboratory testing, not human expert evaluations of clinical data. Therefore, this question is not applicable in the context of this submission. The "ground truth" for these tests comes from established scientific and engineering principles, accepted standards (e.g., AAMI ST77, ISO 10993), and the documented efficacy of sterilization methods and biological indicators.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The studies are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert adjudication.
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 device is a medical device accessory (sterilization tray), not an AI-assisted diagnostic or imaging device used by human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical medical device accessory, not an algorithm. The performance described is "standalone" in the sense that the tray's performance is measured directly through physical and biological tests without human intervention in the performance aspect, but rather human designers and users are integral to its intended use and reprocessing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For these non-clinical studies, the "ground truth" is established by:
- Sterilization Efficacy: Gold standard biological indicators (Geobacillus stearothermophilus) and their known reduction kinetics represent the ground truth for microbial inactivation.
- Sterilant Residuals: Chemical analytical methods (UV/VIS spectroscopy) with established reference values from predicate devices.
- Use Life (Material Compatibility) & Mechanical/Bench: Adherence to material specifications, functional performance requirements, and conformity to recognized industry standards (AAMI ST77).
- Biocompatibility: In vitro cytotoxicity assays conforming to ISO 10993-5, where the absence of cytotoxic effects is the ground truth.
The sample size for the training set:
Not applicable. This is a physical medical device accessory, not an AI/ML-based device that requires a training set.
How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black and white logo that resembles a plus sign. The logo is made up of black and white squares. The word "COVIDIEN" is in all capital letters.

510(k) Summary

Date summary prepared: August 23, 2013

510(k) Submitter/Holder Covidien 5920 Longbow Drive Boulder. CO 80301

Contact

AUG 2 8 2013

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

Name of (Subject) Device

Trade Name: Sonicision™ Sterilization Tray Common Name: Sterilization Tray Classification Name: Sterilization wrap containers, trays, cassettes & other accessories Device Class: II Classification Regulation: 21 CFR 880.6850 Product Code: KCT

Predicate Devices

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

Trade Name: Sonicision™ Sterilization Tray 510(k) Number: K112536, cleared 4/19/2012 Manufacturer: Covidien

Trade Name: V-PRO® Sterilization Tray 510(k) Number: K070769, cleared 10/5/2007 Manufacturer: STERIS Corporation

Trade Name: FinESS™ Endoscope Sterilization Tray 510(k) Number: K103213, cleared 2/2/2011 Manufacturer: Entellus Medical, Inc.

Device Description

{1}------------------------------------------------

K131170 510(k) Summary

exposure of the sterilant. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.

Intended Use

Model	Cycle
STERRAD® 100S	Standard
STERRAD® NX®	Standard
STERRAD® 100NX®	Standard
STERIS Amsco® V-PRO® 1	Lumen
STERIS Amsco® V-PRO® 1 Plus	Lumen
STERIS Amsco® V-PRO® maX	Lumen

Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.

Technological and Performance Characteristics

The proposed Sonicision tray was found to be similar to the predicate trays in several ways. Three fundamental similarities are identified and discussed below:

(1) Basic design All trays are reusable accessories designed as two-part (lid/base) systems with latches, handles, perforations, and contoured inserts intended to contain items for sterilization, storage, transportation, aseptic presentation of contents, and return of contaminated items to the decontamination area. Notably other design aspects, such as the general shape, size, weight, and materials, though not identical, are similar.
(2) Role in the sterile barrier system Neither the proposed tray nor the predicate trays contain gaskets, valves, or filters - they must all be enclosed with a qualified FDAcleared sterilization wrap or pouch to maintain sterility.
(3) Fundamental technology All trays rely on surface perforations (holes or other openings) to allow the sterilant to penetrate and render its content sterile.

The primary differences between the predicate and proposed trays are variances in shape, size, weight, intended content, and surface perforations. Although a small difference in percent of surface perforations is noted, performance data demonstrate that the difference does not adversely affect safety and effectiveness. A comparison of the proposed device to the predicate devices is provided on the next page.

{2}------------------------------------------------

K131170	510(k) Summary
---------	----------------

	Proposed: Sonicision™Sterilization Tray	Predicate: Sonicision™Sterilization Tray,K112536	Predicate: V-PRO®Sterilization Tray, K070769	Predicate: FinESS™ EndoscopeSterilization Tray, K103213
Intended Use	To encase and protect reusablebatteries and generators of theSonicision system duringsterilization and storage.Compatible sterilization systems areindicated as follows:-STERRAD® 100S-STERRAD® NX®-STERRAD® 100NX®-STERIS Amsco® V-PRO® 1-STERIS Amsco® V-PRO® 1 Plus-STERIS Amsco® V-PRO® maX	To encase and protectreusable batteries andgenerators of the Sonicisionsystem during sterilizationand storage. Compatiblesterilization systems areindicated as follows:-STERRAD® 100S	To contain, transport, and storereusable medical devices forsterilization. Compatiblesterilization systems are indicatedas follows:-STERIS Amsco® V-PRO® 1-STERIS Amsco® V-PRO 1 Plus-STERIS Amsco® V-PRO® maX	To encase and protect the FinESSEndoscope for sterilization.Compatible sterilization systemsare indicated as follows:-STERRAD® NX®-STERRAD® 100NX®
DesignCharacteristics
Composition	Base and lid	Identical to proposed tray	Base and lid	Base and lid
Intended Content(maximum load)	One Sonicision generator and onebattery pack	Identical to proposed tray	Reusable medical instrument(s),as indicated by size and weight	One FinESS™ Endoscope
Inserts	Yes. Designed to secure intendedcontent	Identical to proposed tray	Yes. Various. Designed to secureintended content	Yes. Designed to secure intendedcontent
Handles	Yes	Identical to proposed tray	Yes	No
Latches	Yes	Identical to proposed tray	Yes	Yes
Reusable	Yes	Identical to proposed tray	Yes	Yes
Materials ofConstruction
Lid/Base	Polysulfone	Identical to proposed tray	Noryl resin	Polyetherimide
Inserts	Silicone	Identical to proposed tray	Polypropylene	Silicone
Latch	Polysulfone	Identical to proposed tray	304 Stainless Steel	Polyetherimide

510(k) Summary - Comparison Tabl

{3}------------------------------------------------

70	ummaryS
I	(1) 0 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1lച്ച് ഗ

	Proposed: Sonicision™Sterilization Tray	Predicate: Sonicision™Sterilization Tray, K112536	Predicate: V-PRO®Sterilization Tray, K070769	Predicate: FinESS™ EndoscopeSterilization Tray, K103213
Dimensions	Assembled (L×W)	5.9 in. × 8.1 in.	Identical to proposed tray	10 in. × 14 in.	7.6 in × 4.1 in.
Weight	Containingintended content(Max Load)	1.58 lbs(1 battery and 1 generator)	Identical to proposed tray	5.16 lbs(various reusable medicaldevices)	11.61 oz(one endoscope)
FundamentalTechnology	Percent of surfaceperforations	9.7%	Identical to proposed tray	5%	1%

Page 4 of 6

{4}------------------------------------------------

K 131170 510(k) Summary

Non-Clinical Performance Studies

Objective test evidence supporting sterilization efficacy, hydrogen peroxide residuals, material compatibility, biocompatibility, and mechanical performance were provided in the submission. A brief description of all tests used to support the conclusion of substantial equivalence with the predicate devices is provided as follows:

Sterilization efficacy: Sonicision Trays containing the intended maximum load (one reusable battery pack and one reusable generator) were inoculated with geobacillus stearothermophilus. The biological indictor containing the indicator organism was placed in areas of the battery pack, generator, and sterilization trav determined to be the most difficult (worstcase) for the sterilant to penetrate. Following inoculation, the sterilization trays were either wrapped with an FDA-cleared STERRAD or STERIS V-PRO-compatible polypropylene wrap or enclosed in an FDA-cleared STERRAD or STERIS V-PRO-compatible Tyvek® Pouch. The loaded, inoculated, and wrapped or pouched trays were then exposed to the Standard cycles of the STERRAD® NX® and 100NX® systems, or the Lumen cycle of the STERIS Amsco® V-PRO® system. The results show that the indicated STERRAD and STERIS "half cycles" provided a sixlog reduction of the indicator organism.

Sterilant Residuals: Residuals testing by ultraviolet/visible (UV/VIS) spectroscopy compared the measured results of the Sonicision tray's load with those obtained for a reference predicate tray's load. The study consisted of three runs of loaded (one battery pack and one generator), wrapped, or pouched Sonicision trays placed in STERRAD or STERIS systems. Testing of the reference predicate tray consisted of at least one run of loaded placed in STERRAD or STERIS systems. The products were exposed to Standard cycles of each STERRAD NX® and 100NX®, and Lumen cycle of the STERIS Amsco V-PRO® model. The results show that the Sonicision Sterilization Tray permits adequate dissipation of hydrogen peroxide on the load when compared to the predicate devices used in the study.

Use Life (Material Compatibility): Life testing required all key functional/performance specifications of the tray to be evaluated after being subjected to complete reprocessing cycles using a worst-case methodology. The worst-case sterilization systems and cycles chosen for testing were the STERRAD 100NX with Standard cycle, and the STERIS V-Pro with Lumen cycle. The protocol required the tray to be assembled, cleaned, disinfected, dried and sterilized repeatedly (340 cycles) using the methods identified in the labeling. The results show the tray meets its performance specifications when reprocessed repeatedly in accordance with the labeling.

Biocompatibility: Biocompatibility testing was performed using a worst-case methodology by exposing the Sonicision Sterilization Tray to two full cycles (as indicated) of the STERRAD and STERIS systems. Test samples were prepared in accordance with ISO 10993-12:2007, Part 12: Sample Preparation and Reference Materials. All biocompatibility assays were performed on neat extracts. A quantitative assessment was made in accordance with applicable requirements of ISO 10993-5:2009, Part 5: Tests for In Vitro Cytotoxicity. The results show that the Sonicision Sterilization Tray passes all applicable biocompatibility requirements and is, therefore, considered non-cytotoxic following exposure to the intended sterilization systems.

Mechanical/Bench: The Sonicision Sterilization Tray was evaluated in accordance with applicable clauses/criteria specified in AAMI ST77:2006. The results show that all requirements were met.

{5}------------------------------------------------

K131170 510(k) Summary

Conformance to Standards and Guidance

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). Notably, 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 (Biocompatibility), AAMI ST81:2004 (Labeling), ISO 14937:2009 (Sterilization).

Clinical Performance Studies

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

Conclusion

The Sonicision™ Sterilization Tray subject to this submission is substantially equivalent to the Sonicision™ Sterilization Tray (K112536), V-PRO® Sterilization Tray (K070769), and the FinESS™ Endoscope Sterilization Tray (K103213). None of the differences between the Sonicision tray and the predicate trays change the intended use or raise new questions of safety or effectiveness.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The logo is black and white and appears to be a seal or emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 28. 2013

Covidien Mr. David M. Horton Products Manager, Regulatory Affairs 5920 Longbow Drive BOULDER CO 80301

Rc: K131170

Trade/Device Name: Sonicision™ Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: II Product Code: KCT Dated: August 2. 2013 Received: August 6, 2013

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 cither 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.

{7}------------------------------------------------

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K131170

Device Name: Sonicision™ Sterilization Tray

Indications for Use:

Model	Cycle
STERRAD® 100S	Standard
STERRAD® NX®	Standard
STERRAD® 100NX®	Standard
STERIS Amsco® V-PRO® 1	Lumen
STERIS Amsco® V-PRO® 1 Plus	Lumen
STERIS Amsco® V-PRO® maX	Lumen

Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use ✔ 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)

Sreekanth Gutala -S 2013.08.28 13:57:43 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 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).