(50 days)
The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW Technology has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Medline ReNewal Reprocessed ENDOPATH XCEL Universal Trocar Stability Sleeve with OPTIVIEW Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology devices are sterile, single-patient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments that are 5-mm in diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an integrated seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation. The trocars contain OPTIVIEW Technology that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.
This document describes a substantial equivalence determination for a reprocessed medical device, the Medline Renewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria as typically found in an AI/ML medical device submission.
Instead, this submission focuses on demonstrating that the reprocessed device is "substantially equivalent" to an already legally marketed predicate device (Ethicon ENDOPATH XCEL Trocar with OPTIVIEW Technology). The performance testing outlined is to show that the reprocessed device maintains the same functional characteristics as the predicate device after reprocessing.
Therefore, many of the requested categories for AI/ML device studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, effect size) are not applicable to this type of traditional medical device submission.
Here's an attempt to extract relevant information given the context of a reprocessed traditional medical device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and results in the format typically seen for AI/ML performance. Instead, it lists various functional performance studies and concludes that the reprocessed device was "found to be substantially equivalent" to the predicate. The "acceptance criteria" for a reprocessed device are generally that its performance characteristics (functional, cleaning, biocompatibility, sterilization) meet or exceed those of the original device or established standards, ensuring safety and effectiveness are maintained post-reprocessing.
| Test Category | Reported Device Performance (Medline ReNewal Reprocessed ENDOPATH XCEL Trocar) | "Acceptance Criteria" (Implied from comparison to Predicate Device) |
|---|---|---|
| Functional Performance | Functional characteristics must be substantially equivalent to the predicate device. | |
| Seal Leakage | Performance found to be substantially equivalent to the predicate device. | Pressure and fluid leakage rates must be comparable to or meet the performance of the predicate device. |
| Seal Drag | Performance found to be substantially equivalent to the predicate device. | Insertion/withdrawal force must be comparable to the predicate device to ensure smooth instrument passage. |
| Surface Roughness | Performance found to be substantially equivalent to the predicate device. | Surface finish must be comparable to the predicate device to prevent tissue damage and facilitate instrument use. |
| Endoscope Smudge | Performance found to be substantially equivalent to the predicate device. | Ability to reduce/prevent endoscope smudging (as intended by OPTIVIEW Technology) must be comparable to the predicate device. |
| Visualization | Performance found to be substantially equivalent to the predicate device. | Visual clarity and obstruction prevention for endoscope use, comparable to the predicate device. |
| Cleaning | Post-reprocessing, the device must be free from harmful levels of contaminants and visually clean. | |
| Protein and Carbohydrates | Residual levels met acceptance criteria. | Residual protein and carbohydrate levels must be below specified safety thresholds. |
| Visual Inspection | Visually clean. | No visible soil, debris, or damage. |
| Cleaning Performance Qual. | Performance met acceptance criteria. | Validated cleaning process effectively removes contaminants. |
| Biocompatibility | Must be non-toxic and non-irritating, comparable to a new device. | |
| Cytotoxicity (direct & indirect) | Met acceptance criteria. | No significant cytotoxic effects. |
| Irritation (whole device) | Met acceptance criteria. | No significant irritation. |
| Sensitization (whole device) | Met acceptance criteria. | No significant sensitization. |
| Pyrogenicity (direct & indirect) | Met acceptance criteria. | No significant pyrogenic response. |
| Acute Systemic Toxicity | Met acceptance criteria. | No significant acute systemic toxicity. |
| (direct & indirect) | ||
| Sterilization & Packaging | Device must be sterile and maintain sterility until use, with acceptable residual sterilant levels. | |
| Bioburden Enumeration Testing | Met acceptance criteria. | Bioburden levels must be within acceptable limits for sterilization validation. |
| Ethylene Oxide & ECH Residuals | Met acceptance criteria. | Ethylene Oxide (EtO) and Ethylene Chlorohydrin (ECH) residuals must be below specified safety limits. |
| Product Stability | Met acceptance criteria. | The device must maintain its functional integrity and sterility over its stated shelf life after reprocessing and packaging. |
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text for each test. The document mentions "the proposed device" and "the predicate device" which implies comparative testing was conducted using a sufficient number of units to establish statistical equivalence for each functional and material characteristic.
- Data Provenance: The studies were conducted by Medline ReNewal as part of their 510(k) submission for a reprocessed device. This is prospective testing performed to support the regulatory submission. The country of origin of the data is implied to be the US, where Medline ReNewal is based and operates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. For this type of traditional medical device, "ground truth" is established through engineering and scientific testing against defined specifications, industry standards, and comparison with the predicate device's known performance, rather than expert consensus on medical images or clinical outcomes.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation of data is being evaluated. For device performance testing, results are typically objective measurements (e.g., leakage rate, residual chemical levels) compared against defined criteria.
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
This is not applicable. This submission concerns a traditional reprocessed surgical instrument, not an AI/ML device. Therefore, no MRMC study, AI assistance evaluation, or effect size related to human reader improvement is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the functional and material tests:
- Engineering Specifications: Performance against predefined engineering and material specifications.
- Industry Standards: Compliance with relevant ISO, ASTM, or other industry standards (e.g., for biocompatibility, sterility).
- Predicate Device Performance: Direct comparison of measurements and characteristics to the performance of a new (un-reprocessed) predicate device. For example, a leakage test result on the reprocessed device would be compared to the leakage test result on the original device.
8. The sample size for the training set
This is not applicable. This is a traditional medical device, not an AI/ML device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a traditional medical device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.