The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size: (list of instruments provided)

Sterilize the Hip Arthroscopy Master Tray using the following parameters: (steam sterilization parameters provided)

The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces.

Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments.

Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters. (steam sterilization parameters provided)

Device Description

ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitate sterilant penetration, evacuation and drying, These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although these trays are reusable they will not be serviced or repaired.

ConMed Linvatec Anodized Aluminum Sterilization Trays are available under various trade names and in various sizes and tray configurations. Interior structures of the trays have the ability to separately hold each individual instrument during the entire duration they are in contact with the trav.

AI/ML Overview

This document is a 510(k) Summary for ConMed Linvatec Anodized Aluminum Sterilization Trays. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, a "study" in the traditional sense (e.g., a clinical trial with acceptance criteria and reported performance metrics like accuracy, sensitivity, specificity, etc.) was not conducted or reported. This document is a premarket notification for a medical device (sterilization trays), and the "acceptance criteria" and "device performance" described are related to the sterilization parameters and physical characteristics of the trays, rather than a diagnostic or AI-driven system.

Therefore, many of the questions regarding sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.

However, I can extract information related to the performance parameters defined for the sterilization process.

1. Table of Acceptance Criteria and Reported Device Performance

For the ConMed Linvatec Anodized Aluminum Sterilization Trays, the key acceptance criteria and performance are related to the sterilization cycles they can withstand. The "device performance" here refers to the validated sterilization parameters for using the trays.

Acceptance Criteria (Sterilization Parameters)	Reported Device Performance (Validated Parameters for Use)
Hip Arthroscopy Master Tray (ST7900)
Steam (wrapped), Pre-vacuum Cycle:
Minimum Temperature	270°F (132°C)
Minimum Exposure Time	4 minutes
Minimum Dry Cycle	20 minutes
Steam (wrapped), Gravity Cycle:
Minimum Temperature	270°F (132°C)
Minimum Exposure Time	15 minutes
Minimum Dry Cycle	25 minutes
PowerPro® Small System Sterilization Case (PRO5095) & Hall® Sterilization Tray (PRO6000)
Steam (wrapped), Pre-vacuum Cycle:
Minimum Temperature	270°F (132°C)
Minimum Exposure Time	4 minutes
Minimum Dry Cycle	25 minutes
Steam (wrapped), Gravity Cycle:
Minimum Temperature	270°F (132°C)
Minimum Exposure Time	15 minutes
Minimum Dry Cycle	35 minutes (with a caution specifically noting this is required to prevent wet packs)
Material Compatibility	Constructed from durable, biocompatible, corrosion-resistant materials, compatible with repeated steam sterilization.
Sterilant Penetration	Perforated design to facilitate sterilant penetration, evacuation and drying.
Maintenance of Sterility	Requires use of an FDA cleared sterilization wrap to maintain sterility of contents (due to perforations).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document does not describe a test set or data provenance in the context of an AI/algorithmic study. The "testing" mentioned refers to the validation of the sterilization parameters for the physical device. The exact sample size for this physical testing (e.g., number of sterilization cycles, number of trays tested) is not specified. The origin of the testing data would likely be from ConMed Linvatec's internal testing labs, based in Largo, Florida, USA.

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 is a submission for a physical medical device (sterilization trays), not an AI/diagnostic system requiring expert readers for ground truth establishment.

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

Not applicable. There is no adjudication method described as there's no diagnostic or interpretative output from the device.

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 a physical medical device, not an AI system.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is the

Physical and chemical properties of the materials used in the trays (biocompatibility, corrosion resistance).
Effectiveness of sterilization cycles as demonstrated through standardized microbiological indicator tests (e.g., biological indicators, chemical indicators) and physical monitoring. These tests would confirm that the parameters listed achieve sterility and that "wet packs" are avoided. This is an engineering/biology-based ground truth, not an expert consensus or pathology on a patient case.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that undergoes training.

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

Not applicable. This is a physical medical device, not an AI system.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for CONMED LINVATEC. The logo is black and white and includes the company name in a bold, sans-serif font. Below the name is the text "L I N V A T E C" in a smaller font. The image also includes the address "11311 Concept Boulevard • Largo, FL 33773-4908", the phone number "727-392-6464", and the website "www.linvatec.com".

510(k) Summary ConMed Linvatec Anodized Aluminum Sterilization Trays

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 510(k) Number_ 1090560

Submitter	ConMed Linvatec11311 Concept Blvd.Largo, Florida 33773-4908Establishment Registration Number 1017294
		JUN 29 2009
Company Contact	Rebecca Roberts, RACRegulatory Affairs SpecialistTelephone 727-399-5564Fax 727-399-5264
Family Name	ConMed Linvatec Anodized AluminumSterilization Trays
Device Name	Hip Arthroscopy Master Tray, ST7900PowerPro Small System Sterilization Case, PRO5095Hall Sterilization Tray, PRO6000
Classification Name	Sterilization Wrap Containers, Cassettes andother Accessories
& Regulation number	21 CFR 880.6850Infection Control Devices Branch
Proposed Class/Device	Class II
Product Code	KCT
Predicate Device	ConMed Linvatec Microfracture InstrumentSterilization Tray (MFX-TRAY), K080531

Device Description

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Image /page/1/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo consists of the word "CONMED" in large, bold letters, with the word "LINVATEC" underneath in smaller letters. Below the logo is the address "11311 Concept Boulevard, Largo, FL 33773-4908", followed by the phone number "727-392-6464" and the website "www.linvatec.com".

510(k) Summary ConMed Linvatec Anodized Aluminum Sterilization Trays

the contents. Although these trays are reusable they will not be serviced or repaired.

Intended Use:

ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.

The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size:

REF	Description	REF	Description
S210GSP	Grasping Forceps, 210mm	25.50014EL	Extended Length Liberator Knife
S210SRF	Suture Retrieval Forceps, 210mm	25.50016EL	Extended Length Liberator Rasp
S210MSC	Micro-scissors, 210mm	C6105EL	Extended Length Crochet Hook
S210AFU	Aggressor Forcep, 15° Up, 210mm	8748EL	Extended Length Knot Pusher
S210AFL	Aggressor Forcep, 15° Left, 210mm	9837	Extended Length Hip Obturator
S210AFR	Aggressor Forcep, 15° Right, 210mm	A55-012-022	Bio Mini Revo® Blunt, Obturator
S210RFR	Rotary Forcep Right, 210mm	A55-012-023	Bio Mini Revo Trocar, Obturator
S210RGF	Retrograde Forceps, 210mm	A55-012-113	Bio Mini Revo Drill Bit
S210RFL	Rotary Forcep Left, 210mm	A55-012-130	Bio Mini Revo Bone Punch, 3mm
C6171EL	Extended Length Drill Guide Fishmouth	A55-012-120	Bio Mini Revo Tap, 3mm
C6172EL	Extended Length Drill Guide Serrated	GU1009EL	Extended Length Katana
SC7900	Slotted Cannula, 6.7mm	GU1004EL	Extended Length Raven, Straight
SC6900	Slotted Cannula, 5.0mm	21.1001EL	XO Button Depth Probe

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Image /page/2/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo features a stylized "C" shape on the left, followed by the text "CONMED" in bold, sans-serif font. Below the company name is the word "LINVATEC" in a smaller font. The address "11311 Concept Boulevard, Largo, FL 33773-4908" and contact information "727-392-6464" and website "www.linvatec.com" are listed below the company name.

510(k) Summary ConMed Linvatec Anodized Aluminum Sterilization Trays

Sterilize the Hip Arthroscopy Master Tray using the following parameters:

Method	Cycle	MinimumTemperature	Minimum Exposure	Minimum Dry Cycle
Steam (wrapped)	Pre-vacuum	270°F(132°C)	4 minutes	20 minutes
Steam (wrapped)	Gravity	270°F(132°C)	15 minutes	25 minutes

Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters.

Method	Cycle	MinimumTemperature	Minimum Exposure	Minimum Dry Cycle
Steam (wrapped)	Pre-vacuum	270°F(132°C)	4 minutes	25 minutes
Steam (wrapped)	Gravity	270°F(132°C)	15 minutes	35 minutes

CAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent wet packs when using the gravity cycle.

Substantial Equivalence

The proposed and the predicate devices are substantially equivalent in design. materials and intended use. The proposed devices and the predicate devices are containment devices for sterilization of reusable medical devices using steam sterilization. The proposed devices present no new issues of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and a caduceus, a symbol of medicine, is visible in the lower right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

Public Health Service

JUN. 29 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Robecca Roberts Regulatory Affairs Specialist ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

. Re: K090560

Trade/Device Name: Hip Arthroscopy Master Tray (ST7900) PowerPro® Small System Sterilization Case, PRO5095, Hall Sterilization Tray, PRO6000 Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 16, 2009 Received: June 17, 2009

Dear Ms. Roberts:

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 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- Mr. Roberts

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 (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.

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runner

Susan Runner, D.D.S., M.A. Acting 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):	K090560/S001
Family Name:	ConMed Linvatec Anodized Aluminum Sterilization Trays
Trade Name:	PowerPro® Small System Sterilization Case, PRO5095Hall® Sterilization Tray, PRO6000

Indications for Use:

ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.

Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters.

Method	Cycle	MinimumTemperature	Minimum Exposure	Minimum Dry Cycle
Steam (wrapped)	Pre-vacuum	270°F(132°C)	4 minutes	25 minutes
Steam (wrapped)	Gravity	270°F(132°C)	15 minutes	35 minutes

CAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent wet packs when using the gravity cycle.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use × (21 CFR 801 Subpart C)

(PLÉASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Charles H. Murphree, M.D.
--	----------------------------------------------------------------------------

(Division Sign-Off)

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K091

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INDICATIONS FOR USE

510(k) Number (if known): K090560

Family Name:

ConMed Linvatec Anodized Aluminum Sterilization Trays

Trade Name:

Hip Arthroscopy Master Tray (ST7900)

Indications for Use:

ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.

The Hip Arthroscopy Master Tray is intended for use only with the following instruments:

REF	Description	REF	Description
S210GSP	Grasping Forceps	25.50014EL	EL Liberator
S210SRF	Suture Retrieval	25.50016EL	EL Rasp
S210MSC	Micro-scissors	C6105EL	EL Crochet Hook
S210AFU	Aggressor Forcep Up	8748EL	EL Knot Pusher
S210AFL	Aggressor Forcep Left	9837	EL Hip Obturator
S210AFR	Aggressor Forcep Right	A55-012-022	BMR Obturator, Blunt
S210RFR	Rotary Forcep Right	A55-012-023	BMR Obturator, Trocar
S210RGF	Retrograde Forceps	A55-012-113	BMR Drill Bit
S210RFL	Rotary Forcep Left	A55-012-130	BMR Bone Punch
C6171EL	EL Drill Guide Fishmouth	A55-012-120	BMR Tap
C6172EL	EL Drill Guide Serrated	GU1009EL	EL Katana
SC7900	Slotted Hip Cannula, 6.7mm	GU1004EL	EL Raven, Straight
SC6900	Slotted Hip Cannula, 5.0mm	21.1001EL	EL Probe

Shale H. Maugher, D

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

510(k) Number: K90 562 C

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).