DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® III Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.

DetachaTip® III Plus Multi-Use Instrument Tray is intended for use with DetachaTip® III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg].

Device Description

The ConMed DetachaTip® III Plus Multi-Use Instrument Tray (REF 3-4343) is used to retain reusable instruments during steam sterilization. The tray consists of a perforated tray base and lid made from polypheny sulfone (Radel®). Latches securely hold the tray base, and handles are provided for transportation. A perforated silicone mat protects instruments placed in the bottom of the tray. A Radel® instrument rack separates and secures the DetachaTip® III instruments throughout sterilization processing and/or storage. The tray is not intended to maintain sterility. The instrument tray is to be used with an FDA cleared sterilization wrap.

DetachaTip® III Plus Multi-Use Instrument Tray is designed to fit a standard autoclave, comprised of materials resistant to corrosion, and able to withstand repeat steam sterilization cycles. The tray is designed to withstand repeated use. It is not designed to be serviced or repaired. The materials comprising the tray are biocompatible and will not contaminate reusable medical devices.

AI/ML Overview

The provided document describes a 510(k) summary for the ConMed DetachaTip® III Plus Multi-Use Instrument Tray. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel medical device like an AI algorithm.

Therefore, many of the requested categories for describing an AI study's acceptance criteria and performance cannot be directly extracted from this document, as it pertains to a physical sterilization tray.

Here's an attempt to answer the questions based on the available information, with clear indications where information is not available or not applicable to this type of device submission.

Acceptance Criteria and Device Performance (as much as applicable)

Feature / Criteria (Derived from ANSI/AAMI ST77:2006/(R)2010 and device description)	Reported Device Performance (as stated in submission)
I. Intended Use Match (Sterilization of instruments)	Intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices (DetachaTip® III instruments and ConMed reusable medical devices).
II. Physical Design Compatibility (Autoclave Fit)	Designed to fit a standard autoclave.
III. Material Properties (Corrosion Resistance)	Comprised of materials resistant to corrosion.
IV. Material Properties (Withstand Repeat Sterilization)	Able to withstand repeat steam sterilization cycles.
V. Material Properties (Biocompatibility)	Materials are biocompatible and will not contaminate reusable medical devices.
VI. Durability (Withstand Repeated Use)	Designed to withstand repeated use.
VII. Load Capacity	MAXIMUM recommended load: 25 lb [11.3 kg].
VIII. Compatibility with Sterilization Parameters (Pre-vacuum Steam wrapped)	Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Cycle Time: 30 minutes.
IX. Grounding in Standards	Meets requirements of ANSI/AAMI ST77:2006/(R)2010.
X. Substantial Equivalence to Predicate	Found to be substantially equivalent in intended use, device design, materials, performance, effectiveness, and safety to K092414.

Study Details (Information not present in the document for an AI study)

Sample size used for the test set and the data provenance: Not applicable. This is not an AI algorithm. The performance testing refers to physical tests on the sterilization tray. The details of these tests (e.g., number of cycles tested, specific load configurations) are not provided in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., expert consensus, pathology) is not relevant for a sterilization tray. Compliance with ANSI/AAMI ST77 and functional performance (e.g., ability to hold instruments, withstand sterilization) is the focus.
Adjudication method for the test set: Not applicable. (See #2)
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 device, not an AI or diagnostic algorithm requiring human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. (See #4)
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For this device, the "ground truth" equates to demonstrated performance against established industry standards and defined parameters for sterilization effectiveness and device durability. The predicate device serves as a benchmark for substantial equivalence.
The sample size for the training set: Not applicable. There is no training set for a physical device like this.
How the ground truth for the training set was established: Not applicable. (See #7)

Summary of what the document does provide regarding performance and equivalence:

The document states that the DetachaTip® III Plus Multi-Use Instrument Tray meets requirements of ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. It further asserts that "Based on the nonclinical performance testing, the subject device is as safe and effective as the legally marketed predicate device."

The comparison table (page 2) highlights that the performance testing for both the subject and predicate devices refers to ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. This standard outlines the specific tests and criteria that such devices must meet. While the specific numerical results of these tests are not included in this summary, the statement "meets requirements" implies successful completion of these tests.

In essence, the study (performance testing) mentioned for this device is the demonstration that it complies with the ANSI/AAMI ST77 standard and is substantially equivalent to a previously cleared device (K092414) in terms of its materials, design, and ability to perform its intended function of holding instruments during steam sterilization.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is a horizontal line, and below that is the word "CORPORATION" in a smaller, sans-serif font.

FEB 2 1 2013

DetachaTip® III Plus Multi-Use Instrument Tray

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 for 510(k) number K123175 as of January 8, 2013.

A. Submitter

ConMed Corporation 525 French Road Utica, NY 13502 Establishment Registration Number: 1320894

B. Company Contact

Anna D'Lima, RAC Regulatory Affairs Specialist ConMed Corporation 525 French Road Utica, NY 13502 Phone: 315-624-3439 Fax: 315-624-3225 e-mail: annadlima@conmed.com

C. Device Name

Trade Name: DetachaTip® III Plus Multi-Use Instrument Tray Common Name: Instrument Tray/Sterilization Tray, Classification Name: Sterilization Wrap Containers, Trays, Cassettes, and other Accessories Regulation Number: 21 CFR 880.6850 Class II КСТ Panel: General Hospital and Personal Use Devices

D. Predicate Device Name

ConMed DetachaTip® Instrument Tray ConMed Corporation 510(k) K092414

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

E. Device Description

Radel® is a registered trademark of Solvay Advanced Polymers

F. Intended Use/ Indications for Use

Table 1 – Reusable Medical Device Challenge Conditions
MinimumInner Diameter	MaximumLength
5 mm	45 cm
3 mm	32 cm

Sterilize the DetachaTip® III Plus Multi-Use Instrument Tray using the following parameters:

Method	Cycle	Temperature	Exposure Time	Dry Cycle Time
Steam (wrapped)	Pre-vacuum	270°F(132°C)	4 minutes	30 minutes
The devices should be sterilized using an FDA cleared wrap indicated for these sterilizationcycles. Allow for a 30 minute cool down prior to handling.

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

H. Performance Data

DetachaTip® III Plus Multi-Use Instrument Tray meets requirements of ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization. Based on the nonclinical performance testing, the subject device is as safe and effective as the legally marketed predicate device.

I. Substantial Equivalence

The DetachaTip® III Plus Multi-Use Instrument Tray and predicate device are substantially equivalent in intended use, device design, materials, performance, effectiveness, and safety. The proposed device and the predicate device are containment devices for sterilization of reusable medical devices using steam sterilization by healthcare providers. The proposed device presents no new issues of safety and efficacy. Note: Prior designs of DetachaTip® instruments shall not be used in the DetachaTip® III Plus Multi-Use Instrument Trays.

	DetachaTip® III PlusMulti-Use Instrument Tray	ConMed DetachaTip® Instrument Tray
Feature
	K123175	K092414
Model #/ REF	3-4343	1-4327
Description	Containment devices for sterilization ofDetachaTip® III Instruments and ConMedreusable medical devices meeting challengeconditions defined in Table 1 using steamsterilization by healthcare providers. The deviceshould be used only in conjunction with FDA clearedwrap indicated for the sterilization cycles.	Containment devices for sterilization ofDetachaTip® II Instruments using steamsterilization by healthcare providers. The deviceshould be used only in conjunction with FDA clearedwrap indicated for the sterilization cycles.
SterilizationMethod	Pre-vacuum steam sterilization	Same
Materials	Polyphenylsulfone (Radel), Silicone, Stainless Steel	Same
Device Design	Four part instrument tray1) Tray lid2) Inner tray includes 10 wells for DetachaTip® IIIInstruments and 4 wells for DetachaTip® IIIHandles3) Silicone mat4) Tray base for ConMed reusable medical devicesmeeting challenge conditions defined in Table 1	Four part instrument tray1) Tray lid2) Inner tray includes 10 wells for DetachaTip® IIInstruments3) Silicone mat4) Tray base for DetachaTip® II Handles
PerformanceTesting	ANSI/AAMI ST77:2006/(R)2010 Containmentdevices for reusable medical device sterilization	Same

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.

Public Health Service

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

February 21, 2013

Ms. Anna D' Lima, RAC Regulatory Affairs Specialist ConMed Corporation 525 French Road UTICA NY 13502

Re: K123175

Trade/Device Name: DetachaTip® III Plus Multi-Use Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 8, 2013 Received: January 11, 2013

Dear Ms. D' Lima:

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}------------------------------------------------

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 devicerelated 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 vours.

Image /page/4/Picture/7 description: The image shows a stylized graphic with overlaid text. The text appears to read "for" at the top left, followed by a signature or stylized name in the center, and the word "with" above the word "uroutts." The graphic includes geometric shapes, with a maze-like pattern on the left and a triangular shape on the right, both filled with horizontal lines.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number (if known): K123175

Device Name: DetachaTip® III Plus Multi-Use Instrument Tray

Table 1 - Reusable Medical Device Challenge Conditions
MinimumInner Diameter	MaximumLength
5 mm	45 cm
3 mm	32 cm

Sterilize the DetachaTip® III Plus Multi-Use Instrument Tray using the following parameters:

Method	Cycle	Temperature	Exposure Time	Dry Cycle Time
Steam (wrapped)	Pre-vacuum	270°F(132°C)	4 minutes	30 minutes
The devices should be sterilized using an FDA cleared wrap indicated for these sterilization

cycles. Allow for a 30 minute cool down prior to handling.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)[iZabet]

Page _ of

Elizabeth H. Clavelle
2013.02.20 15:19:01 -05'00'

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