(138 days)
The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:
STERRAD 100NX sterilization system using the Express cycle
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 tray and endoscope is 7.7 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 thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Steroscope Sterilization Tray is designed to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle), and the following Steris low temperature hydrogen peroxide gas sterilization systems:
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 Endoscope Sterilization Tray is the same tray previously cleared for sterilizing the endoscopes in STERRAD sterilizers. The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability.
Based on the provided text, the document is a 510(k) premarket notification for an Endoscope Sterilization Tray. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new, innovative device (like an AI algorithm).
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, effect size of human improvement with AI, standalone performance, training set details) is not applicable to this document, as it is related to the validation of a medical device involving software or AI, particularly for diagnostic or interventional tasks.
The document discusses the performance data in terms of sterilization validation and limits of reuse testing for the sterilization tray, demonstrating its functionality and safety. The acceptance criteria here are related to ensuring the tray effectively facilitates sterilization and maintains its integrity over multiple uses, making it equivalent to the predicate device.
Here's an attempt to extract relevant information and explain why other parts of your prompt are not present in this document:
Acceptance Criteria and Device Performance (as inferred from the document)
The core "acceptance criteria" for this device, as per a 510(k) pathway, is to demonstrate substantial equivalence to a predicate device. This is achieved by showing that the subject device is as safe and effective, and performs at least as safely and effectively, as the predicate.
For a physical device like a sterilization tray, this typically involves demonstrating:
- Ability to encase and protect the endoscope: This is a fundamental design function.
- Compatibility with specified sterilization systems/cycles: The primary focus of this 510(k) is to expand compatibility to additional Steris V-PRO systems.
- Maintenance of structural integrity and functionality over multiple uses (limits of reuse): Ensuring the tray remains effective after repeated sterilization cycles.
- Cleaning effectiveness: Ensuring the tray can be adequately cleaned.
- Biocompatibility: Ensuring the materials are safe for use in a medical context.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Summary from Document) |
|---|---|
| Material and Design Equivalence: The device should have the same design, materials, and manufacturing processes as the predicate device to support substantial equivalence. | "The subject Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the predicate Intuitive Surgical Endoscope Sterilization Tray (K133942) in design, materials, and technological characteristics." |
| "The subject device design, materials and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K142937)." (Note: there seems to be a typo here, K142937 is the subject device, K133942 is the predicate, but the intent is clear). | |
| Functional Equivalence & Compatibility with Sterilization: The device must effectively encase, protect, and be compatible with the specified sterilization systems/cycles. | The primary purpose of this 510(k) is to extend compatibility to new sterilization systems: "The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability." |
| The "Performance Data" states: "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." | |
| Sterilization Validation: The tray must allow for effective sterilization of the enclosed endoscope when used with the specified sterilizers. | "The testing conducted consisted of sterilization validation and limits of reuse testing..." (Specific performance results for sterilization efficacy are not detailed in this summary, but are implied to be satisfactory for substantial equivalence). |
| Limits of Reuse: The tray must maintain its integrity and performance over its intended lifespan/number of uses. | "...and limits of reuse testing..." (Specific results not detailed, but implied to meet requirements for substantial equivalence). |
| Cleaning and Biocompatibility: The device should remain cleanable and biocompatible. | "...cleaning, and biocompatibility testing were not repeated as the subject device design, materials and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K142937)." (Again, K133942 is the predicate. The performance is inferred from identity to the predicate, which presumable passed these tests). |
| Dimensional Measurements & Functional Verification: The device must meet its design specifications for size and basic functionality. | "...dimensional measurements, functional verification..." (These were part of the testing carried out previously for the predicate device, not re-done for this submission due to identical design). |
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. For a physical device like this, test samples would be units of the sterilization tray itself subjected to various tests.
- Data Provenance: The tests would have been performed in a laboratory setting by the manufacturer (Intuitive Surgical, Inc.). The document doesn't specify if the testing was retrospective or prospective in the sense of clinical studies, but it would be prospective lab testing for device validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic performance (e.g., radiology images). The "ground truth" for a sterilization tray is its measurable physical performance and its ability to facilitate sterilization, which is determined through engineering and microbiology testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method is applicable for the validation of this type of device.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is not an AI software and does not involve human readers for diagnostic interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be established by:
- Standardized sterilization efficacy tests: e.g., using biological indicators or thermocouples to verify sterility within the tray after a cycle.
- Mechanical and material property tests: e.g., stress testing, dimensional stability measurements, visual inspection for damage after reuse cycles.
- Biocompatibility standards: Confirmation that materials meet established safety standards.
- The "ground truth" for this device's performance would be established by:
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The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- N/A. Since there is no training set, this is not applicable.
§ 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).