(390 days)
Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAYS are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument trays are suitable for use in a prevacuum steam method. 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 ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY is a reusable stainless steel sterilization tray and lid fitted with a silicone pin mat and instrument holders designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. Perforations in the tray and lid allow for optimal exposure of the tray's contents to sterilant during the sterilization process.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only refers to "pre-defined acceptance criteria" for sterilization and functional strength testing and states that performance "meets the requirements of its pre-defined acceptance criteria." It does not explicitly list the quantitative acceptance criteria or the specific numerical performance results for these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization | Met pre-defined criteria |
| Functional Strength | Met pre-defined criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only states that "Non clinical validation testing was conducted for sterilization and functional strength."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study involves non-clinical validation testing of a sterilization tray, not a diagnostic device requiring expert interpretation of results.
4. Adjudication Method for the Test Set
This information is not applicable for the type of non-clinical validation study described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a sterilization tray, and the testing performed was non-clinical validation of its physical properties and sterilization effectiveness.
6. Standalone Performance Study
Yes, a standalone study was done. The "Non clinical validation testing was conducted for sterilization and functional strength" for the device itself to demonstrate its safety and effectiveness. This indicates an algorithm-only (device-only in this context) assessment of its performance.
7. Type of Ground Truth Used
The ground truth for the sterilization testing would likely be based on established sterilization standards (e.g., biological indicator kill rates, physical indicators) and for functional strength, it would be based on engineering standards and measurements of mechanical integrity. The document mentions "Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization," indicating that the ground truth for sterilization was aligned with this standard.
8. Sample Size for the Training Set
This information is not applicable as the validation described is for a physical medical device (a sterilization tray) and not for an AI algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device validation.
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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 ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY
Date Prepared: August 19, 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 ACUFEX™ GRAFTMASTER™ III SYSTEM 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 |
Traditional 510(k) Section IV Updated September 14, 2010
Page 1 of 3
0103
(092551
SEP 1 4 2010
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K092551
p²δ3
D. Predicate Devices
The subject Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Instrument Tray cleared under K073551, Smith & Nephew Instrument Trays cleared under K090562, and Smith & Nephew Instrument Trays cleared under K091627.
E. Description of Device
The Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY is a reusable stainless steel sterilization tray and lid fitted with a silicone pin mat and instrument holders designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. Perforations in the tray and lid allow for optimal. exposure of the tray's contents to sterilant during the sterilization process.
F. Intended Use
Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAYS are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument trays are suitable for use in a prevacuum steam method. 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 | 132 C(270 F) | 4 minutes | 60 minutes |
Device model that is subject of this pre-market notification:
| REF | Description |
|---|---|
| Smith & Nephew ACUFEX™ | |
| 72202441 | GRAFTMASTER™ III SYSTEM TRAY |
G. Comparison of Technological Characteristics
The technological characteristics of the proposed Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY are identical to the predicate devices. The material of construction, the type of instruments contained, and the intended use are unchanged from the predicate trays. The internal configuration and number of instrument holders, pin mats, and organizing racks differ to accommodate each trays designated instrument set. These differences do not represent new technological
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Page 2 of 3
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characteristics for the proposed device and therefore do not raise new questions of safety or efficacy.
Summary Performance Data H.
Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization and demonstrates substantial equivalence to the predicates.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird-like figure.
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 150 Minuteman Road Andover, Massachusetts 01810
SEP 1 4 2010
Re: K092551
Trade/Device Name: Smith & Nephew Instrument Trays Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: KCT Dated: September 3, 2010 Received: September 7, 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.
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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/CDRHQffices/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 vours.
h for
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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INDICATIONS FOR USE STATEMENT
510(K) Number:
Device Name:
Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAY ·
Indications for Use: Smith & Nephew ACUFEX™ GRAFTMASTER™ III SYSTEM TRAYS are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument trays are suitable for use in a prevacuum steam method. They are intended to be used in m a previloudin storalidated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameter:
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| Pre-vacuumsteam | 132 C(270 F) | 4 minutes | 60 minutes |
Device models that are the subject of this pre-market notification:
| REF | Description |
|---|---|
| 72202441 | Smith & Nephew Acufex Graftmaster IIISystem Tray |
(Division Sign-Off)
510(k) Number: Ko
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Prescription Use __
AND/OR
Over-The-Counter Use _X (21 CFR 807 Subpart C)
25 5
(Per 21 CFR 801 Subpart D)
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§ 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).