(230 days)
Not Found
No
The 510(k) summary describes a sterilization container system, a physical device for organizing and sterilizing surgical instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: This device is a sterilization container system designed to organize, protect, and sterilize surgical instruments, and maintain their sterility. It does not directly treat or diagnose a disease or condition in a patient.
No
The device is a sterilization container system, described as organizing, protecting, and allowing sterilization of surgical instruments, and maintaining their sterility. It does not mention any function related to diagnosing medical conditions.
No
The device description and intended use clearly describe a physical container system for sterilizing surgical instruments, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for organizing, protecting, and sterilizing surgical instruments. It is not used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on its use in hospitals and operating rooms for maintaining sterile conditions for instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a sterilization container system, which is a type of medical device used in the sterilization process of surgical instruments.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and by health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been completed and supports the safety and effectiveness of the proposed device for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Miltex Rigid Sterilization Container System K072563
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Koa2437
: :
MAR 2 5 2010
: 上一篇:
SECTION 5 510 (k) Summary
| Company Name: | Codman & Shurtleff, Inc. |
|---|---|
| Company Address: | 325 Paramount Drive |
| Raynham, 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 other |
| accessories. | |
| Classification Panel Name: | General Hospital |
| FDA Panel Number: | 80 |
| Product Code: | KCT |
| Proposed Device Class: | Class II per 21 CFR § 880.6850 |
| Sterilization wrap | |
| Predicate Device(s): | Miltex Rigid Sterilization Container System K072563 |
| 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. | |
| Indications for Use: | 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 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 after | |
| transportation outside the health care facility. |
325 PARAMOUNT DRIVE, RAYNHAM, MASSACHUSETTS 02767-0350 (508) 880-8100
1
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 1
| Sterilization 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
2
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.
3
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
4
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.
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.
325 PARAMOUNT DRIVE, RA YNHAM, MASSACHUSETTS 02767-0350 (508) 880-8100
5
| Table 1
| Sterilization 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