(169 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 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 the 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 (P/N: 400490) 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 intended for use to encase and protect compatible da Vinci Xi endoscopes (Model #'s 470026, 470027) during the transport and sterilization process.
The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight; it is the same tray as no changes were made to these parameters.
This document is a 510(k) premarket notification for an Endoscope Sterilization Tray (K180964). It asserts substantial equivalence to a previously cleared predicate device (K170640). The core argument is that the subject device is identical to the predicate device in design, materials, and manufacturing processes, with only a minor change to the reprocessing instructions related to where specific endoscope model numbers are referenced.
Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria is largely absent because the submission relies on a claim of identity to a previously cleared device, not new performance data.
Here's an attempt to fill in the requested information based on the provided text, with many fields indicating "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Status |
|---|---|---|
| Functional Equivalence | Device design, materials, dimensions, and weight must be identical to the predicate device. | The subject Endoscope Sterilization Tray (P/N: 400490) and predicate tray (K170640) are identical in terms of design, materials, dimensions and weight. The document explicitly states "it is the same tray as no changes were made to these parameters." |
| Indications for Use (IFU) | Intended use must be for encasing and protecting compatible da Vinci Xi endoscopes for sterilization in specified machines/cycles. | The IFU specifies use for compatible da Vinci Xi endoscopes for sterilization in: STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle), Steris V-PRO maX (Non Lumen, Flexible, or Lumen cycles), Steris V-PRO 1 Plus (Non Lumen or Lumen cycles), and Steris V-PRO 1 (V-PRO/Lumen cycle). |
The only change made from the predicate's IFU was the removal of specific da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) from the IFU Statement. These model numbers are now referenced within the reprocessing instructions to clarify usage. The device is still explicitly stated to be used only with these specific da Vinci Xi Endoscope models. |
| Sterilization Process | Compatibility with specified sterilization machines/cycles and maintained effectiveness of the sterilization process. | "Additionally there are no changes to the sterilization process parameters between the subject device and the predicate device; therefore sterilization validation testing was not repeated." This implies that the previous validation for the predicate device is considered applicable. |
| Cleaning | Device must be cleanable. | "Cleaning...testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data. |
| Biocompatibility | Materials used in the device must be biocompatible. | "Biocompatibility...testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data. |
| Bench Testing | Device performance and protection capabilities must be demonstrated through bench testing. | "Bench testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data. |
| Physical/Chemical Properties | Physical/chemical properties must be identical to the predicate device. | "The physical/chemical properties of the subject device are identical to the predicate device, since there are no changes to the tray features and materials." |
Regarding the study that proves the device meets the acceptance criteria:
The provided document does not describe a new study to demonstrate that the subject device (K180964) meets specific acceptance criteria. Instead, it relies entirely on the assertion of substantial equivalence to a previously cleared predicate device (K170640). The fundamental premise is that because the device itself is identical to the predicate (same design, materials, weight, manufacturing processes), and the only change is in the documentation (where specific model numbers are referenced), no new performance testing (cleaning, biocompatibility, sterilization validation, bench testing) was deemed necessary.
Therefore, the "study" is effectively the original substantial equivalence determination for the predicate device (K170640), which would have included such testing. This current submission leverages that prior clearance.
Additional Requested Information (based on provided text):
2. Sample size used for the test set and the data provenance:
- Sample Size: Not Applicable / Not Provided (no new testing performed for this submission)
- Data Provenance: Not Applicable / Not Provided (no new testing performed)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not Applicable / Not Provided (no new testing performed and no ground truth establishment relevant to this specific submission)
- Qualifications of Experts: Not Applicable / Not Provided
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided (no new testing performed)
5. 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:
- Not Applicable / Not Provided. This device is a physical sterilization tray, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This device is a physical sterilization tray, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided. For the predicate device, the ground truth would have been established through validated sterilization efficacy, cleaning efficacy, and biocompatibility testing according to relevant standards.
8. The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. This is not an AI/machine learning 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).