(29 days)
Not Found
No
The 510(k) summary describes instrument trays for sterilization and storage, with no mention of AI or ML capabilities.
No
The device is an instrument tray designed for containing, protecting, and facilitating the sterilization of surgical instruments, not for directly treating a medical condition.
No
The device is described as instrument trays used for storage, sterilization, and transport of surgical instruments. It does not perform any diagnostic function.
No
The device description clearly states it is an instrument tray, which is a physical hardware component used for containing and sterilizing surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the trays are for containing, storing, sterilizing, and transporting reusable surgical instruments. This is related to the processing and handling of surgical tools, not the testing of biological samples or the diagnosis of diseases.
- Device Description: The description reinforces the purpose of containing and protecting surgical instruments during processing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or being used in a laboratory setting for testing purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum steam | 132C (270F) | 4 minutes | 30 minutes |
| High Temperature Gravity Steam | 132C (270F) | 15 minutes | 70 minutes |
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Smith & Nephew instrument trays are designed to contain and protect reusable surgical I ho online of replier. It sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
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
Not Found
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)
Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KC091627
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based. I
Smith & Nephew Instrument Trays Date Prepared: June 2, 2009
JUL - 2 2009
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist II T: 508-261-3705 F: 508-261-3620 Christina.flores@smith-nephew.com
C. Device Name
| Trade Name: | Smith & Nephew Instrument Tray |
|---|---|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other |
| Accessories | |
| Class: | II |
| Product Code: | KCT |
| Classification Number: | 21 CFR §880.6850 |
D. Predicate Devices
The subject Smith & Nephew Instrument Trays are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in and I and and betending beternet Nephew Instrument Tray cleared under K073551 and Smith & Nephew Instrument Trays cleared under K090562.
Description of Device E.
The Smith & Nephew instrument trays are designed to contain and protect reusable surgical I ho online of replier. It sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
Page 1 of 2
1
Intended Use F.
Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum steam | 132C | ||
| (270F) | 4 minutes | 30 minutes | |
| High Temperature | |||
| Gravity Steam | 132C (270F) | 15 minutes | 70 minutes |
G. Comparison of Technological Characteristics
The subject Smith & Nephew instrument trays have fundamental technological characteristics as the unmodified predicate device. The subject trays are substantially equivalent in design, materials and intended use to the predicate device. There are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.
Summary Performance Data H.
Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christina Flores Regulatory Affairs Specialist II Smith & Nephew, Incorporated Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
JUL - 2 2009
Re: K091627
Trade/Device Name: Smith & Nephew Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 2, 2009 Received: June 3, 2009
Dear Ms. Flores:
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.
3
Page 2 - Ms. Flores
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/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 yours,
Anthony D. Watts
Susan Duncan, DDS, M.A.
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
4
INDICATIONS FOR USE STATEMENT
K091627 510(K) Number:
Smith & Nephew Instrument Trays Device Name:
Indications for Use: Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum | |||
| steam | 132C (270F) | 4 minutes | 30 minutes |
| High | |||
| Temperature | |||
| Gravity Steam | 132C (270F) | 15 minutes | 70 minutes |
Device models that are the subject of this pre-market notification:
| REF | Description |
|---|---|
| Elite Premium II Shoulder Arthroscopy System | |
| 72202042 | Tray |
| 72202044 | Elite Premium Instability System Tray |
Prescription Use __
AND/OR
Over-The-Counter Use _X (21 CFR 807 Subpart C)
(Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Shule A Murphy, D
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
SECTION II
510(k) Number:
K091627 Additional Information 7/1/09