(203 days)
Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist Instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table 1 below. The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Intuitive Surgical® Instrument and Accessory Sterilization Trays are intended only for use with Intuitive Surgical® EndoWrist Instruments and Intuitive Surgical Re-usable Accessories. These trays are used to enclose and hold the Instruments and Accessories in an organized manner during the sterilization process and subsequent storage and transportation. The trays are to be used with an approved sterilization wrap in order to maintain the sterility of the enclosed devices. The trays are different sizes of the same basic configuration: a rectangular base with latchable lids. The trays have perforations on the lid, bottom and sides to allow sterilant penetration. The bottom surface of the trays contains grooves custom made to fit and accommodate Intuitive Surgical® EndoWrist Instruments and Accessories. The grooves facilitate the Instruments and Accessory to be arranged in an organized manner when placed in the tray. The sterilization trays have been tested for use ONLY with the Intuitive Surgical® EndoWrist Instruments and Accessories for a sterilization cycle of Pre-Vac steam sterilization 132°C, 4min cycle with a 30 min dry time. This cycle parameter is similar to the current recommended sterilization cycle for the Intuitive Surgical® EndoWrist Instruments and Accessories.
Here's a breakdown of the acceptance criteria and study information for the Intuitive Surgical® Instrument and Accessory Sterilization Trays, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Intended for use ONLY with Intuitive Surgical® EndoWrist Instruments and Intuitive Surgical Re-usable Accessories. | The trays are specifically designed with grooves to fit and accommodate these instruments and accessories. |
| Designed to facilitate pre-vacuum autoclave sterilization process. | Sterilization validation testing was performed to demonstrate successful sterilization. |
| To be used in conjunction with an approved sterilization wrap. | The device description explicitly states: "The trays are to be used with an approved sterilization wrap in order to maintain the sterility of the enclosed devices." |
| Effective sterilization with a pre-vacuum cycle of 132°C, 4 minutes with a 30-minute dry time. | "Sterilization validation testing was performed to demonstrate successful sterilization... using a pre-vacuum cycle of 132°C, 4 mins with a 30 min dry time." |
| Maintain organization and protection of instruments/accessories during sterilization, storage, and transport. | The device description states: "These trays are used to enclose and hold the Instruments and Accessories in an organized manner during the sterilization process and subsequent storage and transportation." |
| Made of standard medical-grade materials. | "The trays are made of standard medical grade materials..." |
| Comparable functional characteristics to predicate devices. | "Design analysis and testing has been conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate devices cited..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size for the sterilization validation testing in numerical terms (e.g., "N=X sterilization cycles were performed"). It states that "Sterilization validation testing was performed."
- Data Provenance: Not explicitly stated, however, the process described (sterilization validation testing for a medical device) typically involves in-house laboratory testing or 3rd party laboratory testing specifically for regulatory submission, rather than clinical data from a country of origin. It is prospective testing designed to prove the device's function.
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. The document describes "sterilization validation testing," but it does not detail the methodology for establishing a "ground truth" through expert review, as would be typical for diagnostic devices. For a sterilization tray, the "ground truth" would be the successful sterility of the instruments, determined by standard microbiological testing methods, rather than expert interpretation of images or other data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the device is a sterilization tray, not a diagnostic device requiring adjudication of human-interpreted results. The "test set" relates to the successful sterilization outcome, which is determined by objective laboratory methods, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable/not provided. The device is an instrument sterilization tray, not an artificial intelligence (AI) diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. As stated, this is a physical medical device (sterilization tray), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device would be the microbiological sterility of the instruments and accessories after undergoing the validated sterilization cycle within the tray. While not explicitly detailed, standard sterilization validation involves biological indicators and microbiological testing to confirm the absence of viable microorganisms.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
§ 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).