The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses.

The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization.

The validated sterilization cycles are provided in Table II.

The cycles were validated using Kimguard (Kimberly Clark).

The sterilization exposure times are extended. Please refer to Table 2 for cycle tines. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays.

The sterilized contents are for immediate use and should not be stored for any duration.

The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.

Device Description

The ConMed Linvatec sterilization trays consist of base trays, lids and internal individualized insert travs. Each trav is composed of multiple pieces and is designed to be integrated into a single unit, which will contain and protect the interior components during sterilization. The interior structures of the tray have the ability to separately hold each individual piece during the entire duration they are in contact with the tray.

The rigid, multi piece tray holds medical device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain products, which is held to the base by latches designed to fasten the lid to the base not allowing the two to separate. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles in a normal operating room.

The tray is designed to allow repeated sterilization cycles. Though these travs are reusable they will not be serviced or repaired. Like the outer containing trays, the interior trays with individual containment custom brackets have been developed to withstand repeated use and will not be serviced or repaired. These custom brackets are made of materials that do not contaminate the tray or any of the parts or pieces contained within the tray.

The lid, base and insert for the proposed trays are made of Radel R-5000. This material is a polymer resin produced by Solvay Advanced Polymers, LLC. This material is identical to the Radel used in the predicate device cleared under K993535. Attachment I includes the material composition for the Radel R-5000.

The latches, which secure the lid to the base, are constructed of 300 Series Stainless Steel, identical to the stainless steel in the predicate devices cleared under K993535 and K944025.

The instruments to be sterilized in the proposed trays are all non-porous devices and including instruments such as suture snares, various hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obturators, etc.

Each tray includes brackets and containment mats which are made of a biomedical grade silicone. These are used to secure the instruments during transport, sterilization and storage. The drawings in Attachment III include the brackets and mats.

Additional device characteristics can be found in the chart included as Attachment A of this 510(k) Summary.

The brackets and containment mats are both constructed from biomedical grade silicone which has been manufactured to meet FDA CFR 177.2600. This material is identical to the predicate devices cleared under K993535 and K944025.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for an "Instrument Sterilization Tray" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth type) are not applicable or cannot be extracted from this document, as it is not a study report for a novel AI/medical device with such performance claims.

The document states that "The ConMed Linvatec Instrument Sterilization Tray has the same intended use, technological characteristics and performance characteristics as the predicate devices." and that "The sterilization validation of all trays has met the requirements of the same performance standard, AAMI TIR No.12-1994." This indicates that the device's performance is demonstrated by adhering to an established standard, rather than through a comparative effectiveness study with specific acceptance criteria as you might find for an AI-powered diagnostic device.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "validated sterilization cycles" as a key performance characteristic and references a standard. The acceptance criteria are implicitly meeting the requirements of AAMI TIR No.12-1994 and successful completion of the specified sterilization cycles.

Acceptance Criteria (Implied)	Reported Device Performance Summary
Ability to organize, sterilize, transport, and store surgical instruments.	Device is designed for this intended use.
Compatibility with steam sterilization cycles.	Validated for Steam (Pre-vacuum & Gravity) cycles.
Withstand repeated steam sterilization cycles without degradation or contamination.	Made of Radel R-5000 and 300 Series Stainless Steel, materials identical to predicate devices known for this performance. Biomedical grade silicone for brackets/mats also used, identical to predicate.
Allow free steam passage.	Design allows for free steam passage, similar to predicate devices.
Sterilization performance meets AAMI TIR No.12-1994.	Sterilization validation met the requirements of AAMI TIR No.12-1994.
Validated Sterilization Cycles:	Successful Completion:
Steam Pre-vacuum: 270°F (132°C), 5 min exposure, 10 min dry.	Achieved for this device.
Steam Gravity: 270°F (132°C), 30 min exposure, 10 min dry.	Achieved for this device.

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

Sample Size: Not explicitly stated as a "test set" in the context of a dataset for evaluation. The "sample" here refers to the actual trays tested during the sterilization validation. The document lists three specific tray models (9895, 8217, C6355) that were included in the submission and for which characteristics are provided. It's not clear if all trays were tested or representatives, but the total number of distinct tray models is 3.
Data Provenance: Not applicable in the sense of country of origin for retrospective/prospective data. The "study" here is physical testing/validation of material properties and sterilization efficacy conducted by the manufacturer, ConMed Linvatec.

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

Not Applicable. This is a physical device subject to performance standards and material compatibility tests, not an AI/diagnostic device where expert interpretation is used to establish ground truth for a test set.

4. Adjudication method for the test set

Not Applicable. See point 3.

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

No. This is a physical instrument sterilization tray, not an AI-assisted diagnostic tool.

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

Not Applicable. See point 5.

7. The type of ground truth used

For material composition: Chemical analysis and material specifications (e.g., Radel R-5000 properties, 300 Series Stainless Steel, biomedical grade silicone meeting FDA CFR 177.2600).
For sterilization efficacy: Adherence to a recognized industry standard (AAMI TIR No.12-1994) and successful completion of defined steam sterilization cycles (temperature, exposure time, dry time). The "ground truth" is established by the standard itself and physical measurement/bioburden reduction studies performed during validation.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. See point 8.

Summary

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0C7 1 6 2006

510(k) Submission

Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting a 510(k) Summary of Safety and Effectiveness for the ConMed Linvatec Instrument Sterilization Tray.

510(k) # K052992

Submitter A.

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

B. Company Contact

Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone FAX (727) 399-5264

C. Device Name

Trade Name: Instrument Sterilization Tray

Common Name: Instrument Sterilization Tray

Classification Name: Accessory to Sterilization Wrap, CFR 880.6850

Proposed Class/Device: Class II

Product Code: FRG

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Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 2 of 4

D. Predicate/Legally Marketed Devices

K993535 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc. K023658 - Sterilization cases, trays and cassettes - Carr Medical Products K944025 - MetaPak Multi-Purpose Instrument Tray - Riley Medical, Inc.

E. Device Description

The latches, which secure the lid to the base, are constructed of 300 Series Stainless Steel, identical to the stainless steel in the predicate devices cleared under K993535 and K944025.

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Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 3 of 4

Additional device characteristics can be found in the chart included as Attachment A of this 510(k) Summary.

Intended Use F. Intended Use

The ConMed Linvatec® Instrument Sterilization Trays are for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instrument between uses.

ConMed Linvatec® Instrument Sterilization Trays can be used in a steam sterilization cycles. The validated sterilization cycles are provided in Table II. Important Notes

The cycles were validated using Kimguard (Kimberly Clark) wrap. The sterilization exposure times are extended. Please refer to Table 2 for cycle times. Only sterilization wraps cleared by FDA for extended sterilization exposure times should be used with these trays. The sterilized contents are for immediate use and should not be stored for any duration.

The trays are intended for sterilization of non-porous loads, e.g. hooks, grassers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.

The travs are not intended to be stacked during the sterilization process Substantial Equivalence ت

The ConMed Linvatec Instrument Sterilization Tray is substantially equivalent in materials and is similar in intended use and design to the below identified predicate devices. The proposed Instrument Sterilization Tray and the predicate devices are used for storage, transport, and sterilization of surgical instruments between uses. Both the proposed and predicate devices are suitable for use in steam sterilization processes.

The ConMed Linvatec Instrument Sterilization Tray will be offered in a combination of various metals and plastics.

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Summary of Safety and Effectiveness Instrument Sterilization Tray 510(k) # K052992 Page 4 of 4

There are no significant differences between the proposed device and the predicate devices other than various tray sizes and layout of custom containment brackets. Also see Attachment B of this 510(k) summary for further details.

Substantially Equivalent Predicate Marketed Device:

H. Technological Characteristics

The design and materials used in of the ConMed Linvatec Instrument Sterilization Trays, a perforated plastic tray with a stainless steel latch and silicone containment brackets. that allows free steam passage is the substantially equivalent to the predicate devices. All trays have various dimensions such that the proposed trays and the predicates devices are substantially equivalent in size and volume. The sterilization validation of all trays has met the requirements of the same performance standard, AAMI TIR No.12-1994. The associated procedures for the use of the devices , i.e. the manufacturer's recommended sterilization cycles, are all similar.

I. Summary and Conclusion

The Conmed Linvatec Instrument Sterilization Tray has the same intended use, technological characteristics and performance characteristics as the predicate devices. Thus, the proposed tray does not raise any new issues of safety and efficacy and per the definition under 21 CFR 807.100 is substantially equivalent to the referenced predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background. The overall design is simple and recognizable, representing the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 2006 Manager, Regulatory Affairs

Re: K052992

Ms. Elizabeth M. Paul

11311 Concept Boulevard Largo, Florida 33773-4908

ConMed Linvatec

Trade/Device Name: ConMed Linvatec Instrument Sterilization Tray Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: September 19, 2006 Received: September 21, 2006

Dear Ms. Paul:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 – Ms. Paul

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. 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

510(k) Number (if known): K052992

Device Name: ConMed Linvatec Instrument Sterilization Tray

Indications for Use:

The ConMed Linvatec Instrument Sterilization Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport and store the instruments between uses.

The ConMed Linvatec Instrument Sterilization Tray is for use with steam sterilization.

The validated sterilization cycles are provided in Table II.

The cycles were validated using Kimguard (Kimberly Clark).

The sterilized contents are for immediate use and should not be stored for any duration.

The trays are intended for sterilization of non-porous loads, e.g. hooks, graspers, scissors, knot pushers, probes, extractors, drivers, rasps, obdurators, etc.

Table 1 Tray Characteristics
CatalogNumber	Description	RecommendedMax load(lbs.)*	Length(Inches)	Width(Inches)	Depth(Inches)
9895	ROTATOR CUFF STERILATION CASETRAY	2.54	14.60	9.52	0.82
	ROTATOR CUFF STERILE CASE (BASE)		14.45	9.4	0.4
8217	OSTEOPREP STERILE TRAY (LID)	4.08	20.88	10.13	0.82
	OSTEOPREP STERILE TRAY (BASE)		20.63	9.81	1.19
C6355	SPECTRUM II (LID)	11.90	20.75	9.93	1.116
	SPECTRUM II (UPPER TRAY)		19.75	8.94	1.97
	SPECTRUM II (BASE)		20.46	9.67	4.76

Table 1 lists the trays included in this submission.

*Includes the weight of the tray.

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Table 2
Validated Sterilization Cycles
Method	Cycle	MinimumTemperature	MinimumExposure	MinimumDry Cycle
Steam	Pre-vacuum	270°F (132°C)	5 minutes	10 minutes
Steam	Gravity	270°F (132°C)	30 minutes	10 minutes

Prescription Use______________________________________________________________________________________________________________________________________________________________ OR Over-the-Counter Use __X

(Part 21 CFR 801 subpart D)

(Part 21 CFR 807 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elaine S. Maglull fus. Murphy

(Sign-Off)
n of Anesthesiology, General Hospital.

nesthesiology, General Hospital, tal Devices

K052992

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).