(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.
§ 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).