(155 days)
The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods.
The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
Validated Sterilization Parameters:
Method: Prevacuum Steam, Temperature: 132°C – 135°C (270°F-275°F), Exposure Time: 4 minutes, Drying Time: 30 minutes
Method: High Temperature Gravity Steam, Temperature: 132°C (270°F), Exposure Time: 10 minutes, Drying Time: 70 minutes
The Smith & Nephew instrument tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
The instrument tray is a perforated stainless steel case with latchable lid and handle. The tray is fitted with Radel® organizing racks, silicone instrument holders and protective mats. The instrument tray is marked to facilitate organized instrument placement.
The Smith & Nephew Instrument Tray (K073551) is a medical device designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. It is intended for use with prevacuum steam and high-temperature gravity steam sterilization methods, in conjunction with a validated sterilization wrap to maintain sterility.
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device are its conformity to AAMI ST77:2006 (Containment Devices for reusable medical device sterilization) and its performance in sterilization efficacy, thermal profile, and drying time studies. The submission states that the device successfully met these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Performance | Sterilization Efficacy: Demonstrate effective sterilization of contained instruments using specified steam methods (prevacuum and high-temperature gravity steam). | Performance testing, including sterilization efficacy testing, demonstrated successful performance. |
| Thermal Profile: Maintain appropriate temperature conditions within the tray during sterilization. | Thermal profile studies demonstrated satisfactory performance. | |
| Drying Time: Achieve specified drying times after sterilization. | Drying time studies demonstrated satisfactory performance. | |
| Standard Conformance | Conform to AAMI ST77:2006 (Containment Devices for reusable medical device sterilization). | Device conforms to AAMI ST77:2006. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size for the test set used in the performance studies. However, it indicates that the device model subjected to pre-market notification was the "Tray, ACUFEX® DIRECTOR ELITE® Drill Guide Systems" (REF 72201731).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a new device, it is highly likely that the performance testing was conducted prospectively by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For sterilization device testing, "ground truth" would typically refer to the successful inactivation of biological indicators or the achievement of specified physical parameters (temperature, pressure, time) according to established sterilization standards. The assessment of these parameters is typically done by qualified laboratory personnel and engineers specialized in sterilization validation, rather than an "expert panel" in the diagnostic sense.
4. Adjudication Method for the Test Set:
This information is not explicitly stated. For performance testing of a sterilization tray, adjudication methods like 2+1 or 3+1 (common in diagnostic AI studies) are not typically applicable. Performance is usually assessed against predefined quantitative metrics and pass/fail criteria defined by industry standards like AAMI ST77.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Smith & Nephew Instrument Tray is a device for sterilization and storage, not for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in a sense, the performance testing described can be considered "standalone" in that it evaluates the device's intrinsic ability to function as intended for sterilization and containment. There is no "human-in-the-loop" component in the operational function of the tray itself. The studies assessed the device's physical and biological performance when subjected to specific sterilization protocols.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing would be established by:
- Biological Efficacy: The complete kill of biological indicators placed within the tray, demonstrating successful sterilization.
- Physical Parameters: Confirmation that the specified temperature, pressure, and exposure times were achieved uniformly throughout the tray during sterilization.
- Drying Efficacy: Verification that the instruments and the tray itself were adequately dry after the specified drying cycle.
- Containment Integrity: Assurance that the tray effectively protects the instruments and remains structurally sound throughout the process.
These ground truths are not typically established by expert consensus or pathology in the diagnostic sense, but rather through highly controlled laboratory experiments and adherence to recognized standards.
8. The Sample Size for the Training Set:
This information is not applicable. The Smith & Nephew Instrument Tray is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
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.
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MAY 2 1 2008
510(k) SUMMARY K073551
Smith & Nephew® Instrument Tray Date Prepared: May 20, 2008
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Julie Acker RAC Regulatory Affairs Specialist T: 508-261-3618 F: 508-261-3620 Julie.acker@smith-nephew.com
C. Device Name
| Trade Name: | Instrument Tray |
|---|---|
| Common Name: | Instrument Tray |
| Classification Name: | Sterilization Wrap Containers, Trays Cassettes and OtherAccessories |
| Class: | Class 2 |
| Product Code | KCT |
D. Predicate Devices
The Smith & Nephew instrument tray is substantially equivalent in design, materials, and intended use to the following devices in commercial distribution: PolyVac Surgical Instrument Delivery System 510(k)# K012105 and Riley Medical, Inc. Meta-Pak Multipurpose Instrument Tray 510(k)# K993535
i. Description of Device
The Smith & Nephew instrument tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
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K073551
i
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The instrument tray is a perforated stainless steel case with latchable lid and handle. The tray is fitted with Radel® organizing racks, silicone instrument holders and protective mats. The instrument tray is marked to facilitate organized instrument placement.
F. Intended Use
The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods.
The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.
| Method | Temperature | Exposure Time | Drying Time |
|---|---|---|---|
| PrevacuumSteam | 132°C – 135°C(270°F-275°F) | 4 minutes | 30 minutes |
| HighTemperatureGravity Steam | 132°C(270°F) | 10 minutes | 70 minutes |
Validated Sterilization Parameters:
Device model that is the subject of this pre-market notification:
| REF | Description |
|---|---|
| 72201731 | Tray, ACUFEX® DIRECTOR ELITE® Drill Guide Systems |
G. Comparison of Technological Characteristics
The Smith & Nephew instrument tray is substantially equivalent in design, materials and intended use to the predicate devices. The proposed instrument tray and predicate devices are used for storage, transport and sterilization of reusable surgical instruments between uses. Both the proposed and predicate devices are suitable for use in steam sterilization processes when used in conjunction with legally validated sterilization wrap and are not intended to maintain sterility on the own.
The Smith & Nephew instrument tray does not incorporate any new technological characteristics as compared to legally marketed devices. The Smith & Nephew instrument tray and the predicate devices are cases constructed of perforated metal with latchable lid. and utilize radel organizing racks, silicone instrument brackets and protective mats to secure encased instruments. There are no significant differences between the proposed and predicate devices.
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073551
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Performance testing including sterilization efficacy testing, thermal profile studies and drying time studies demonstrate that the Smith & Nephew instrument tray conforms to AAMI ST77:2006 Containment Devices for reusable medical device sterilization.
Summary and Conclusions H.
The Smith & Nephew instrument tray has the same intended use, technological characteristics and performance characteristics as the legally marketed predicate devices. The product design is in conformance with recognized consensus standards and does not raise any new issues of safety and efficacy. We consider the Smith & Nephew Instrument Tray to be substantially equivalent to the legally marketed predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" and is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2008
Ms. Julie Acker Regulatory Affairs Smith & Nephew, Incorporated, Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02766
Re: K073551
Trade/Device Name: Smith & Nephew Instrument Tray Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 30, 2008 Received: May 1, 2008
Dear Ms. Acker:
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 such 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. Acker
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
Chiu Lin. Ph.D. 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: | K073551 |
|---|---|
| ---------------- | --------- |
Smith & Nephew Instrument Tray Device Name:
The Smith & Nephew instrument tray is intended to contain Smith & Indications for Use: Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods.
The instrument tray is not intended to maintain sterility; it is 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 |
|---|---|---|---|
| PrevacuumSteam | 132°C – 135°C(270°F–275°F) | 4 minutes | 30 minutes |
| HighTemperatureGravity Steam | 132°C(270°F) | 10 minutes | 70 minutes |
Device model that is the subject of this pre-market notification:
Description REF Tray, ACUFEX® DIRECTOR ELITE® Drill Guide Systems 72201731
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use __X (Per 21 CFR 807 Subpart C)
(Per 21 CFR 801 Subpart D)
(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluati
(Division Sign-Off)
valuation DE
но
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073577
§ 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).