(80 days)
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles:
- · STERRAD 100NX sterilization system using the Express and DUO cycles
- · STERRAD 100S sterilization system using the Standard cycle
- · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- · Steris V-PRO 1 using the V-PRO/Lumen cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 12.2 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.
The Endoscope Sterilization Tray is a stainless steel tray with silicone inserts and a stainless steel lid. The tray and lid have a grid pattern to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S and Steris V-PRO maX V-PRO 1 Plus and V-PRO 1 sterilization systems.
The provided text describes the regulatory clearance (K183139) for an "Endoscope Sterilization Tray" by Intuitive Surgical, Inc. It is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to demonstrate substantial equivalence, rather than proving safety and effectiveness de novo. Therefore, the study described is a non-clinical performance study to demonstrate substantial equivalence to the predicate device K180964, not a clinical study to establish new efficacy or safety claims.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial (e.g., a specific sensitivity or specificity threshold). Instead, it lists various tests performed to demonstrate that the device meets its functional requirements and is substantially equivalent to the predicate device. The "reported device performance" refers to the outcome of these tests.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional & Functional | Device meets specified dimensions, functions as intended (e.g., latch security, lid/base interchangeability, weight, markings). Absence of sharp edges and compatible materials. | The subject device successfully passed all requirements described in the protocol related to dimensional and functional specifications. It was assessed for sharp edges, compatible materials, latch security, lid and base interchangeability, weight, and tray markings. These results demonstrate that the Endoscope Sterilization Tray meets the functional requirements. |
| Biocompatibility | Device materials are biocompatible for intended use as a containment device. | Based on toxicological assessment, material characterization, established biocompatibility results of the predicate device (intracutaneous injection, sensitization, hemolysis testing for same materials and clinical use), and ISO 10993-1 provisions, the subject device was determined to be biocompatible for its intended use. |
| Sterilization Validation | Device, in combination with FDA-cleared wrap, must achieve sterilization in specified sterilizers/cycles. | The subject Endoscope Sterilization Tray, in combination with an FDA cleared sterilization wrap, passed the sterilization validations conducted in the STERRAD 100NX (Express and DUO cycles), STERRAD 100S (Standard cycle), and V-PRO maX (Non Lumen cycle). |
| Maintenance of Sterility | Wrapped and sterilized tray must maintain sterility after routine handling (negative growth after spore challenge and incubation). | The wrapped tray, after being sterilized, challenged with an aerosol of spores, and incubated, successfully demonstrated negative growth. This verifies that the wrapped and sterilized tray will maintain sterility after routine handling. |
| Limits of Reuse | Tray maintains integrity and function after repeated sterilization cycles. | The subject tray passed all requirements as described in the protocol regarding repeated sterilization cycles. Inspections for damage to the cover, base, and latches were conducted at the beginning and end of the study. |
| Shipping/Packaging Testing | Product and packaging remain intact/functional after simulated shipping conditions. | Packaged Endoscope Sterilization Trays underwent simulated shipping testing (ASTM D4169-09) including environmental conditioning, initial manual handling (drop testing), vehicle vibration, and vehicle stacking (compression). The packaging and the Endoscope Sterilization Tray passed all inspection criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact numerical sample sizes for each test. Phrases like "The subject Endoscope Sterilization Tray underwent..." or "Each tray was inspected..." suggest that multiple devices were tested for durability and reuse, but precise numbers are not given. For biocompatibility, it references "established biocompatibility results of the predicate device," implying no new animal or human testing for the subject device for biocompatibility.
- Data Provenance: The studies are described as "non-clinical testing" conducted by Intuitive Surgical, Inc. (the manufacturer). This is retrospective in the sense that it relies on existing knowledge for biocompatibility and laboratory/bench testing for performance. The location of the testing is not specified, but it's internal to the company or contracted out for specific tasks like sterilization validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving human interpretation or subjective data requiring expert consensus or ground truth establishment by human experts. It is a performance study of a physical medical device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective data. The tests are objective performance measurements against engineering specifications and industry standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging or similar applications where multiple human readers interpret cases. This document describes non-clinical performance testing of a sterilization tray.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ANSI/AAMI ST77, ISO 10993-1, ASTM D4169-09), and validated test protocols designed to assess its functional requirements, biocompatibility, and ability to withstand sterilization and handling. For sterilization efficacy, the "ground truth" is typically defined by microbial reduction levels (e.g., sterility assurance level) achieved in validated sterilization cycles.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/algorithm-based device that requires a training set.
§ 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).