organize and protect stainless steel, aluminum, and titanium general surgical instruments that will be sterilized
allow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)
maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, and titanium general surgical instruments.
The system is intended for use with lumen instruments as follows:
Lumen inner diameter: 3 mm or larger
Lumen length: 400 mm or less (medium and large size containers), 250 mm or less (small size containers)
Quantity: Up to 4 lumen instruments per container
The system is not intended for the sterilization of endoscopes.
For effective sterilization and drying of any size CODMAN Sterilization Container, the recommended maximum combined weight of the single container, lid, basket and basket contents is 25 lb. (11.3 kg).

Device Description

The Codman Sterile Container System is designed and manufactured on the basis of use to hospitals and operating rooms, where hygienic and sterile conditions are fully provided.

AI/ML Overview

The provided document describes the Codman® Sterilization Containers and details its intended use and sterilization parameters, but it does not contain a study that proves the device meets specific acceptance criteria in the manner of an AI/software medical device.

This document is a 510(k) Summary for a Class II medical device (rigid sterilization container), which is a physical product, not a software or AI-driven diagnostic/therapeutic tool. The "Performance Data" section merely states: "Testing has been completed and supports the safety and effectiveness of the proposed device for its intended use." It does not provide the details of specific acceptance criteria, experimental designs, sample sizes, or results of a study as would be required for a digital health product.

Therefore, I cannot fulfill the request to provide the requested information for acceptance criteria and a study proving device performance, as the nature of the device (physical sterilization container) and the type of regulatory submission (510(k) summary for a physical device) does not typically include the detailed statistical performance metrics you've asked for that are common in AI/software medical device evaluations.

To explain why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: This document lists sterilization parameters (temperature, exposure time, dry time) and limitations (lumen length, quantity, weight), but these are operating instructions and validated limits, not statistical performance metrics against predefined acceptance criteria for a diagnostic/therapeutic AI.
Sample size used for the test set and the data provenance: Not applicable. The document refers to "testing" performed, likely involving microbiology (e.g., sterilization of biological indicators) and physical integrity tests for the container, but specific sample sizes for such tests are not provided nor is data provenance in the context of clinical data for AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to sterility or mechanical integrity, established through laboratory methods, not expert consensus on medical images or patient data.
Adjudication method: Not applicable for a physical device.
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, as this is not an AI or software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI or software device.
The type of ground truth used: For a sterilization container, ground truth would relate to the sterility of contents after the sterilization cycle (e.g., negative growth in biological indicators) and the structural integrity of the container over the stated shelf-life. This is not explicitly detailed in the summary.
The sample size for the training set: Not applicable, as there is no AI algorithm to train.
How the ground truth for the training set was established: Not applicable, as there is no AI algorithm to train.

In summary, the provided text concerns the regulatory approval of a physical medical device. The framework of acceptance criteria and study design requested is tailored for AI/software medical devices, which is not what this document describes.

Summary

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Koa2437

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MAR 2 5 2010

: 上一篇:

SECTION 5 510 (k) Summary

Company Name:	Codman & Shurtleff, Inc.
Company Address:	325 Paramount DriveRaynham, MA 02767
Establishment Registration No.:	1226348
Device Proprietary Name:	Codman® Sterilization Containers
Common Name:	Rigid Sterilization Container
Device Classification Name:	Sterilization wrap containers, trays, cassettes, and otheraccessories.
Classification Panel Name:	General Hospital
FDA Panel Number:	80
Product Code:	KCT
Proposed Device Class:	Class II per 21 CFR § 880.6850Sterilization wrap
Predicate Device(s):	Miltex Rigid Sterilization Container System K072563
Device Description:	The Codman Sterile Container System is designed andmanufactured on the basis of use to hospitals and operatingrooms, where hygienic and sterile conditions are fully provided.
Indications for Use:	The CODMAN Sterilization Container System is indicated for useby hospitals and by health care facilities to:organize and protect stainless steel, aluminum, and titanium general surgical instruments that will be sterilizedallow sterilization of the contained instruments by prevacuum steam sterilization (validated parameters shown in Table 1)maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
	The system has not been tested for maintenance of sterility aftertransportation outside the health care facility.

325 PARAMOUNT DRIVE, RAYNHAM, MASSACHUSETTS 02767-0350 (508) 880-8100

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The system is intended for use with stainless steel, aluminum, and titanium general surgical instruments.

The system is intended for use with lumen instruments as follows:

Lumen inner diameter	3 mm or larger
Lumen length	400 mm or less (medium and large size containers)250 mm or less (small size containers)
Quantity	Up to 4 lumen instruments per container

For effective sterilization and drying of any size CODMAN Sterilization Container, the recommended maximum combined weight of the single container, lid, basket and basket contents is 25 lb. (11.3 kg). Please refer to Appendix A for a table of validated configurations of lids, bottoms, safety covers, and accessories.

Table 1Sterilization Parameters
Cycle Type	Temperature	Exposure Time	Dry Time
Prevacuum	132 ° C	4 minutes	30 minutes

Performance Data

Testing has been completed and supports the safety and effectiveness of the proposed device for its intended use.

Official Contact:

Paul Amaral International Regulatory Affairs Sr. Specialist 325 Paramount Drive Raynham, MA 02767

Phone Number:

(508) 828-3393

Facsimile Number: (508) 828-2777

325 PARAMOUNT DRIVE, RAYNHAM, MASSACHUSETTS 02767-0350 (508) 880-8100

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is facing to the right. 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 2 5 2010

Mr. Paul Amaral Regulatory Affairs Senior Specialist Codman & Shurtleff, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K092437

Trade/Device Name: Codman Sterilization Containers Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: March 17, 2010 Received: March 18, 2010

Dear Mr. Amaral:

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.

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Page 2- Mr. Amaral

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/ 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 yours,

Susan Dunne

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

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SECTION 4 Indications for Use

510(k) Number (if known): K092437

Device Name: Codman Sterilization Containers

Indications

The CODMAN Sterilization Container System is indicated for use by hospitals and by health care facilities to:

organize and protect stainless steel, aluminum, and titanium general surgical . instruments that will be sterilized
allow sterilization of the contained instruments by prevacuum steam sterilization . (validated parameters shown in Table 1)
maintain the sterility of the contents for up to 180 days during storage and . transport within the health care facility, as long as the integrity of the container has not been compromised

The system has not been tested for maintenance of sterility after transportation outside the health care facility.

The system is intended for use with stainless steel, aluminum, and titanium general surgical instruments.

The system is intended for use with lumen instruments as follows:

Lumen inner diameter	3 mm or larger
Lumen length	400 mm or less (medium and large size containers)250 mm or less (small size containers)
Quantity	Up to 4 lumen instruments per container

The system is not intended for the sterilization of endoscopes.

325 PARAMOUNT DRIVE, RA YNHAM, MASSACHUSETTS 02767-0350 (508) 880-8100

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Table 1Sterilization Parameters
Cycle Type	Temperature	Exposure Time	Dry Time
Prevacuum	132 °C	4 minutes	30 minutes

OR Over-The-Counter Use: Prescription Use: (Part 21 CFR 801 Subpart D) (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)

signature

)ivision Sign-Off) ivision of Anesthesiology, General Hospital rection Control, Dental Devices

10(k) Number: _ KO92437

325 PARAMOUNT DRIVE, RAYNHAM, MASSACHUSETTS 02767-0350 (508) 880-8100

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).