(116 days)
Not Found
No
The device is a simple sterilization tray and the description focuses on its physical properties and sterilization capabilities, with no mention of AI or ML.
No
The device is a sterilization tray used to contain surgical instruments for storage, sterilization, and transport, not to treat or diagnose a medical condition.
No
Explanation: The device is a sterilization tray for holding surgical instruments during sterilization and transport. It is not used to diagnose any medical conditions or diseases.
No
The device description explicitly states it is a "stainless steel tray provided with a Silicone mat," indicating it is a physical hardware device, not software.
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 trays are for containing surgical instruments for storage, sterilization, and transport. This is related to the preparation and handling of surgical tools, not the testing of biological samples or the diagnosis of diseases.
- Device Description: The description details a stainless steel tray with a silicone mat designed to hold surgical instruments and facilitate sterilization. This aligns with a device used in a surgical setting, not a laboratory setting for diagnostic testing.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is a sterilization tray, which is a medical device used in the process of preparing surgical instruments for use.
N/A
Intended Use / Indications for Use
Smith & Nephew Multi-Purpose Sterilization 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 sterilization method. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum steam | 132 C (270 F) | 4 minutes | 30 minutes |
Product codes
KCT
Device Description
The Smith & Nephew Multi-Purpose Sterilization tray is a stainless steel tray provided with a silicone mat. The tray is designed to contain and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
The technological characteristics of the subject tray are identical to the predicates to remove tiers and/or instrument holders.
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.
Non-clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device meets predefined acceptance criteria and intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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.
Smith & Nephew Instrument Trays
Date Prepared: July 28, 2010
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Christina Flores
Requlatory Affairs Specialist II
T: 508-261-3705
F: 508-261-3620
Christina.flores@smith-nephew.com
C. Device Name
| Trade Name: | Smith & Nephew Multi-Purpose Sterilization 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 commercial distribution:
K073551: Tray - ACUFEX™ DIRECTOR ELITE Drill Guide Systems K090562: Tray - ELITE Premium Biceps Tenodesis System K091627: Tray - ELITE Premium Instability System
Smith & Nephew, Inc. Special 510(k) Section IV AI Response to K102122 9-21-10
Page 1 of 2
NOV 2 2 2010
1
Description of Device
The Smith & Nephew Multi-Purpose Sterilization tray is a stainless steel tray provided with a The Smilli & Nephew Mall Parpood StormEation in Childer surgical instruments Sillcone mat. The tray is designed to coman and to allow optimal exposure of the tray's ----contents to sterilant during the sterilization process.
The technological characteristics of the subject tray are identical to the predicates to remeve tio The technological characteristics of the babjoct hay are the predicates to remove tiers and/or instrument holders.
Non-clinical validation testing was conducted for sterilization and functional strengh in order Norlemindal validation testing was condicted for store and whose performance meets to demonotiato that the sablefined acceptance criteria and intended uses.
Intended Use
Smith & Nephew Multi-Purpose Sterilization trays are intended to contain Smith & Nephew Shill & Nephew Mult Purpose Clomized storage, sterilization and transport reusable surgical instrument for soft on the suitable for use in a prevacum steam sterilization method. The subject instrument trays are not intended to maintain sterility, they stenlization method. The subjoc motrament trays are meet sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure
Time | Drying Time |
|---------------------|------------------|------------------|-------------|
| Pre-vacuum
steam | 132 C
(270 F) | 4 minutes | 30 minutes |
E. Comparison of Technological Characteristics
The subject Smith & Nephew Multi-Purpose Sterilization trays have the same fundamental rhe subject Simili & Nephow make Farpodified predicate device. The subject trays are technological ontracterials and intended use to the predicate devices. Substantially equivalent in Googh, matewaen the proposed and predicate devices that raise new questions of safety or efficacy.
H. Summary Performance Data
Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Christina Flores Regulatory Affairs Specialist II Smith & Nephew, Incorporated 130 Forbes Boulevard Mansfield, Massachusetts 02048
NOV 2 2 2010
Re: K102122
Trade/Device Name: Smith & Nephew Multi-Purpose Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 21, 2010 Received: September 22, 2010
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. 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.
: .
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
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/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 yours,
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
INDICATIONS FOR USE STATEMENT
2 2 2010
510(K) Number:
Smith & Nephew Multi-Purpose Instrument Tray Device Name:
Indications for Use:
Smith & Nephew Multi-Purpose Sterilization 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 sterilization method. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a FDA cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuum | |||
| steam | 132 C | ||
| (270 F) | 4 minutes | 30 minutes |
Device model that is the subject of this pre-market notification:
| REF | Description |
|---|---|
| 72202428 | Multi-Purpose Sterilization Tray |
Prescription Use _
(Per 21 CFR §801 Subpart D)
AND/OR
Over-The-Counter Use _X (21 CFR §807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE
IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Smith & Nephew, Inc. | ||
| Special 510(k) Section II | ||
| AI Response to K102122 | ||
| 9-21-10 | (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K102/22 | Page 8 of 8 |