(29 days)
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.
The Smith & Nephew instrument trays are designed to contain and protect reusable surgical instruments during processing, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
This 510(k) premarket notification for the Smith & Nephew Instrument Trays does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a comprehensive study proving device performance against those criteria. The provided document is a summary and regulatory approval.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization." It also lists "Validated Sterilization Parameters" which are essentially performance specifications for the sterilization methods the trays are compatible with.
| Acceptance Criteria (from Intended Use/Validated Parameters) | Reported Device Performance (implied by "Performance testing was conducted in accordance with AAMI ST77:2006") |
|---|---|
| Contain Smith & Nephew reusable surgical instruments | Tested in accordance with AAMI ST77:2006 (implying successful containment suitability) |
| Allow for convenient organized storage | Tested in accordance with AAMI ST77:2006 (implying suitability for storage) |
| Allow for sterilization | Tested in accordance with AAMI ST77:2006 (implying suitability for sterilization) |
| Allow for transport between usages | Tested in accordance with AAMI ST77:2006 (implying suitability for transport) |
| Suitable for Pre-vacuum steam sterilization (132C/270F, 4 mins exposure, 30 mins drying) | Tested in accordance with AAMI ST77:2006 (implying successful performance with these parameters) |
| Suitable for High Temperature Gravity Steam sterilization (132C/270F, 15 mins exposure, 70 mins drying) | Tested in accordance with AAMI ST77:2006 (implying successful performance with these parameters) |
| Not intended to maintain sterility individually | Intended to be used in conjunction with a validated sterilization wrap to maintain sterility |
However, the specific quantitative acceptance criteria (e.g., maximum temperature deformation, sterilant penetration rates, etc.) as outlined in AAMI ST77:2006 are not explicitly stated in this document. The "Reported Device Performance" column relies on the statement that testing was "conducted in accordance with AAMI ST77:2006," which implies the device met the requirements of that standard without providing the raw results or specific metrics.
Missing Information for the Study:
The 510(k) summary provided does not contain the following details about the performance testing:
2. Sample size used for the test set and the data provenance:
- The document mentions "Performance testing was conducted," but does not specify the number of trays tested, the type of instruments used, or the number of sterilization cycles performed.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. This type of testing is typically done in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of study does not involve human experts establishing "ground truth" in the way a diagnostic AI study would. The ground truth in this context is the successful sterilization and functionality of the tray and its contents, as determined by adherence to sterilization protocols and relevant standards (AAMI ST77:2006).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of device and testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a sterilization tray, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is adherence to the requirements of the AAMI ST77:2006 standard for containment devices in sterilization, as well as the successful completion of specified sterilization cycles without damaging the instruments or the tray. This is validated through testing protocols, not expert consensus on medical images or pathology.
8. The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
In summary:
The provided document indicates that the Smith & Nephew Instrument Trays underwent performance testing in accordance with AAMI ST77:2006 to establish their substantial equivalence to predicate devices for their stated intended use and sterilization parameters. However, the specific details of this performance study (e.g., sample sizes, raw data, detailed methodologies beyond referencing the standard) are not included in this high-level 510(k) summary. Such details would typically be found in the full 510(k) submission document or supporting test reports, which are not publicly available in this extract.
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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 OtherAccessories |
| 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
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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 TemperatureGravity 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.
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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.
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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
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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-vacuumsteam | 132C (270F) | 4 minutes | 30 minutes |
| HighTemperatureGravity 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
§ 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).