The ConMed" DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.

The 33cm DetachaTip Instrument Tray (1-1027) is designed for use with ConMed's 33cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
CAT. NO. DESCRIPTION
2-1003 METZENBAUM, 33CM LENGTH
2-1004 MINI-METZENBAUM, 33CM LENGTH
2-1005 5MM BABCOCK GRASPER, 33CM LENGTH
2-1008 FENESTRATED GRASPER, 33CM LENGTH
2-1009 CURVED DISSECTOR, 33CM LENGTH
1-1010 STANDARD HANDLE
2-1013 HOOK, 33CM LENGTH
2-1014 10MM BABCOCK, 33CM LENGTH
1-1015 COMPACT HANDLE
2-1017 RIGHT ANGLE MEEKER DISSECTOR 33CM
2-1018 TAPERED DISSECTOR, 33CM LENGTH
2-1019 ALLIS GRASPER, 33CM LENGTH
1-1024 IN-LINE HANDLE
1-1028 ENDOWEAVE GRASPER, 33 CM LENGTH

The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with ConMed's 43cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, DetachaTip multiuse dissectors and DetachaTip handles. The trays are intended to be used specifically with the following:
Cat. No. Description
2-4301 Metzenbaum, 43cm length
2-4304 Mini- Metzenbaum, 43cm length
2-4305 5mm Babcock Grasper, 43cm
2-4308 Curved Dissector, 43cm length
2-4307 Fenestrated Grasper, 43cm length
2-4314 10mm Babcock, 43cm
2-4317 Right Angle Meeker dissector 43cm
2-4318 Tapered Dissector, 43cm
2-4319 Allis Grasper, 43cm
2-4328 Endoweave Grasper, 43cm

Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:
Method: Steam (wrapped)
Cycle: Pre-vacuum
Temperature: 270°F(132°C)
Exposure Time: 4 minutes
Dry Cycle Time: 20 minutes

Device Description

The ConMed™ DETACHATIP® INSTRUMENT TRAYS consist of a Radel R Polyphenylsulfone base, a Radel R Polyphenylsulfone tray, a silicone rubber mat, a Radel R Polyphenylsulfone lid with tray lid clips with perforations to facilitate steam penetration, and stainless steel carrying handles. The tray holds the ConMed™ DETACHATIP® surgical instruments before, during, and after the sterilization process. The tray set has a locking lid to contain the instruments.

AI/ML Overview

The provided document describes the ConMed™ DetachaTip® Instrument Trays, which are perforated containment devices for medical device sterilization. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Performance Aspect	Reported Device Performance
Sterilant Penetration (Pre-vacuum Steam Sterilization)	Effective during pre-vacuum steam sterilization.
Minimum Sterilization Temperature	132°C
Minimum Exposure Time	4 minutes
Minimum Dry Time	20 minutes (required to prevent wet packs when using the prevacuum cycle)
Compatibility with Instrument Sizes	33cm DetachaTip Instrument Tray (1-1027) with 33cm instruments; 43cm DetachaTip Instrument Tray (1-4327) with 43cm instruments. Specifically listed CAT. NO. and DESCRIPTION provided for both tray types.
Material Compatibility	Constructed from Radel R Polyphenylsulfone (base, tray, lid, lid clips), silicone rubber mat, and stainless steel carrying handles.
Containment	Locking lid to contain instruments.
Reusability	Reusable.
Non-Servicable/Non-Repairable	Will not be serviced or repaired.

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

The document states: "Validation was conducted using wrapped trays." It does not specify:

The exact sample size (number of trays or test cycles) used for the validation.
The country of origin of the data.
Whether the study was retrospective or prospective.

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)

This information is not provided in the document. For instrument sterilization trays, ground truth would typically be established through standardized microbiological and physical testing protocols, rather than expert interpretation of results in the way a diagnostic AI might be. The document mentions "biological indicators and thermocouples," which suggests objective measurement, not subjective expert assessment.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads where there's disagreement), to arrive at a consensus "ground truth." For device performance validation related to sterilization, the outcomes are objective (e.g., presence/absence of microbial growth, temperature readings, wet pack detection).

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

This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic imaging devices or software where human readers interpret medical images. The ConMed™ DetachaTip® Instrument Trays are physical sterilization containers, not diagnostic devices, and thus do not involve human "readers" or AI assistance in their primary function or validation.

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

This information is not applicable and not provided. Standalone performance studies typically refer to the performance of an AI algorithm operating independently. The ConMed™ DetachaTip® Instrument Trays are passive medical devices (trays) and do not contain algorithms or AI. Their performance is assessed through physical and microbiological validation tests directly on the device itself.

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

The ground truth for the sterilization performance was established using objective measurements:

Biological Indicators (BIs): Used to confirm sterility by detecting the killing of a highly resistant microorganism.
Thermocouples: Used to measure and confirm that the required temperature was reached and maintained throughout the sterilization cycle.
Wet Pack Detection: Implicitly part of the drying cycle validation, aiming to ensure no residual moisture.

8. The sample size for the training set

This information is not applicable and not provided. The ConMed™ DetachaTip® Instrument Trays are not an AI/ML device, so there is no "training set." The validation performed is for the physical device itself.

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

This information is not applicable and not provided as there is no training set for this type of device.

Summary

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

K09241.14

Image /page/0/Picture/1 description: The image shows the logo for Conmed Corporation. The logo consists of a stylized "C" shape in a black square on the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller letters. There is a registered trademark symbol next to the "D" in "CONMED".

MAR 1 0 2010

510(k) Summary of Safety and Effectiveness

ConMed™ Detachatip® Instrument Trays

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502 Registration Number: 1320894 Date: August 6, 2009

B. Company Contact

Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502

Phone: 315-624-3435 Fax: 315-624-3225 e-mail: sandy_coveleski@mail.conmed.com

C. Device Name

Trade Name:	ConMed™ Detachatip® Instrument Trays
Common Name:	Instrument Sterilization Tray
Classification Name:	Sterilization Wrap Containers, Trays, Cassettes,and other Accessories
Proposed Class/Device:	Class II
Product Code:	KCT
Regulation Number:	21 CFR 880.6850
Panel:	880 General Hospital

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

D. Predicate Device

Paragon Medical Surgical Instrument Delivery Tray Paragon Medical 510(K) # K032119

E. Intended Use

The ConMed™ DetachaTip® Instrument Trays are perforated containment devices for medical device sterilization. ConMed" DetachaTip® Instrument Trays are a family of containment devices used to conveniently organize, sterilize, and transport Detachatip instruments between uses. The ConMed instrument trays are not intended to maintain sterility. We do not recommend that the trays be used to store sterilized contents.

CAT. NO.	DESCRIPTION
2-1003	METZENBAUM, 33CM LENGTH
2-1004	MINI-METZENBAUM, 33CM LENGTH
2-1005	5MM BABCOCK GRASPER, 33CM LENGTH
2-1008	FENESTRATED GRASPER, 33CM LENGTH
2-1009	CURVED DISSECTOR, 33CM LENGTH
1-1010	STANDARD HANDLE
2-1013	HOOK, 33CM LENGTH
2-1014	10MM BABCOCK, 33CM LENGTH
1-1015	COMPACT HANDLE
2-1017	RIGHT ANGLE MEEKER DISSECTOR 33CM
2-1018	TAPERED DISSECTOR, 33CM LENGTH
2-1019	ALLIS GRASPER, 33CM LENGTH
1-1024	IN-LINE HANDLE
1-1028	ENDOWEAVE GRASPER, 33 CM LENGTH

The 43cm DetachaTip Instrument Tray (1-4327) are designed for use only with The 15cm DetachaTip multiuse scissors, DetachaTip multiuse graspers, Convice 3 +20m Detacha is is and DetachaTip handles. The trays are intended to be used specifically with the following:

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

CAT. NO.	DESCRIPTION
2-4301	METZENBAUM, 43CM LENGTH
2-4304	MINI-METZENBAUM, 43CM LENGTH
2-4305	5MM BABCOCK GRASPER, 43CM
2-4308	CURVED DISSECTOR, 43CM LENGTH
2-4307	FENESTRATED GRASPER, 43CM LENGTH
2-4314	10MM BABCOCK, 43CM
2-4317	RIGHT ANGLE MEEKER DISSECTOR 43CM
2-4318	TAPERED DISSECTOR, 43CM
2-4319	ALLIS GRASPER, 43CM
2-4328	ENDOWEAVE GRASPER, 43CM

Materials The ConMed™ DETACHATIP® INSTRUMENT TRAYS consist of a Radel R Polyphenylsulfone base, a Radel R Polyphenylsulfone tray, a silicone rubber mat, a Radel R Polyphenylsulfone lid with tray lid clips with perforations to facilitate steam penetration, and stainless steel carrying handles. The tray holds the ConMed™ DETACHATIP® surgical instruments before, during, and after the sterilization process. The tray set has a locking lid to contain the instruments.

Sterilant Penetration The the ConMed™ DETACHATIP® INSTRUMENT TRAYS have been validated to perform effectively during prevacuum steam sterilization and drying cycles, using biological indicators and thermocouples to support sterilization and drying processes.

Pre-vacuum

Min temperature =132°C Min. exposure = 4 minutes Min. dry time = 20 minutes

CAUTION: Testing demonstrates that a minimum dry time of 20 minutes is required to prevent wet packs when using the prevacuum cycle.

Note: Validation was conducted using wrapped trays. The device should Note: Vanadion was other with FDA cleared wrap indicated for these sterilization cycles.

SheIf Life The sterilization tray is reusable and will not be serviced or repaired.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

MAR 1 0 2010

Ms. Sandy Coveleski Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, New York 13502

Re: K092414

Trade/Device Name: ConMedTM DetachaTip® Instrument Trays 33cm DetachaTip Instrument Tray (1-1027) 43cm Detachatip Instrument Tray (1-4327) Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 16, 2010 Received: February 17, 2010

Dear Ms. Coveleski:

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.

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

Page 2- Ms. Coveleski

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 /ucm ! 1 5809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours

Susan Runser

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

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

INDICATIONS FOR USE

510(k) Number (if known):		092414

A Property Company Company Company Company Company Company Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Co		C 11 1 M . 1 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 . 0 .

Family Name:	ConMed" DetachaTip® Instrument Trays
Trade Name:	33cm DetachaTip Instrument Tray (1-1027)
	43cm DetachaTip Instrument Tray (1-4327)

Indications for Use

Cat. No.	Description
2-1003	Metzenbaum, 33cm length
2-1004	Mini- Metzenbaum, 33cm length
2-1005	5mm Babcock Grasper, 33cm length
2-1008	Fenestrated Grasper, 33cm length
2-1009	Curved Dissector, 33cm length
1-1010	Standard Handle
2-1013	Hook, 33cm length
2-1014	10mm Babcock, 33cm length
1-1015	Compact Handle
2-1017	Right Angle Meeker dissector 33cm
2-1018	Tapered Dissector, 33cm length
2-1019	Allis Grasper, 33cm length
1-1024	In-line Handle
1-1028	Endoweave Grasper, 33 cm length

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

INDICATIONS FOR USE

Cat. No.	Description
2-4301	Metzenbaum, 43cm length
2-4304	Mini- Metzenbaum, 43cm length
2-4305	5mm Babcock Grasper, 43cm
2-4308	Curved Dissector, 43cm length
2-4307	Fenestrated Grasper, 43cm length
2-4314	10mm Babcock, 43cm
2-4317	Right Angle Meeker dissector 43cm
2-4318	Tapered Dissector, 43cm
2-4319	Allis Grasper, 43cm
2-4328	Endoweave Grasper, 43cm

Sterilize the 33cm DetachaTip Instrument Tray (1-1027) and the 43cm DetachaTip Instrument Tray (1-4327) using the following parameters:

Method	Cycle	Temperature	Exposure Time	Dry Cycle Time
Steam (wrapped)	Pre-vacuum	270°F(132°C)	4 minutes	20 minutes

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

Over-the-Counter Use__X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eshlata T. Queda-Wells

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

510(k) Number: K092414

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).