(228 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 8.9 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 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:
- o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
- o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
- Steris V-PRO 1 using the V-PRO/Lumen Cycle o
The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.
This document describes a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K151450) from Intuitive Surgical, Inc. The purpose of this submission is to update the Indications for Use for an existing, legally marketed predicate device (K142937) to accommodate a heavier endoscope.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative manner as one might expect for a diagnostic or AI-driven device. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its ability to accommodate a heavier endoscope and maintain sterilization efficacy.
The key performance aspect being validated is the ability of the tray to facilitate sterilization with the specified sterilizers, even with an increased maximum weight. The "acceptance criteria" can be inferred from the "Performance Data" section.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device must accommodate a maximum combined weight of 8.9 lbs (tray + endoscope). | The new Indications for Use state: "The maximum weight of tray and endoscope is 8.9 lbs." This directly addresses the weight increase. |
| Device must allow for effective sterilization of the endoscope within the specified sterilization machines/cycles with the new weight. | "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device... The testing conducted consisted of sterilization validation and bench testing, included verification testing for weight and functional specifications." This indicates that sterilization efficacy was validated for the new weight. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "sterilization validation and bench testing." It generally refers to "testing conducted."
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a US-based company (Intuitive Surgical, Inc., Sunnyvale, CA 94086), the testing would typically be conducted according to US regulatory standards and likely in a controlled laboratory environment. It is a retrospective evaluation against a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The nature of the device (sterilization tray) doesn't typically involve expert interpretation of medical images or conditions for establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical ability to hold the endoscope and allow for effective sterilization, which is assessed through laboratory testing and engineering specifications.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. For this device, the "acceptance" is based on meeting technical specifications and demonstrating equivalency through validation tests.
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
- No, an MRMC study was not done. This device is an endoscope sterilization tray, which is a physical medical device, not a diagnostic or AI-assisted system that involves human readers or interpretation of cases. Therefore, the concept of "human readers improving with AI" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- Not applicable/Not done. This device is a physical product, not an algorithm. The concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this device is based on engineering and performance specifications related to the physical dimensions of the tray, its material properties, and its ability to withstand and facilitate sterilization processes.
- Weight Capacity: The actual measured weight of the endoscope and tray against the specified maximum.
- Sterilization Efficacy: Demonstrated through validation tests that confirm the sterilizer cycles achieve the required sterility assurance level (SAL) when the endoscope is contained within the tray. This would involve standard microbiology tests, not expert consensus on medical images or pathology.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided. As there is no training set for an AI/ML algorithm, there is no ground truth established for a training set. The relevant "ground truth" for this medical device's function (sterilization and protection) is established through established scientific and engineering principles and validated testing protocols.
§ 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).