(315 days)
The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions.
The Veins dissector (stripper) is used for the blunt preparation of tubular structures. specifically for the free-preparation of vessels, e.g. the vein saphena magma.
The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.
The Instruments for endoscopic subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Beins (ESDP) consists of operating telescopes, endoscopic operating tubes, laser guide, hook knife, various monopolar and bipolar grasping forceps and scissors, and veins dissector (stripper).
Here's an analysis of the provided information regarding the acceptance criteria and study for the device:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific, quantifiable acceptance criteria or performance metrics reported for the device. The submission explicitly states:
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Data | Not applicable (no specific criteria defined) | "Performance data not generated." |
| Clinical Tests | Not applicable (no specific criteria defined) | "No clinical tests performed." |
The document concludes with a general statement on design and testing for safety and effectiveness, but this doesn't constitute quantifiable performance data against predefined criteria.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. No test set was used for performance evaluation, as "performance data not generated" and "no clinical tests performed."
- Data Provenance: Not applicable, as no data was generated or used for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No ground truth was established as no test set or performance evaluation was conducted.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used.
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
- MRMC Study: No. The document explicitly states "No clinical tests performed" and "Performance data not generated." This device is from 1998, well before the widespread use and regulatory expectation of AI-assisted device studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. The document explicitly states "No clinical tests performed" and "Performance data not generated." This device is not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No ground truth was established as no test set or performance evaluation was conducted.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. This device is not an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
Based on the provided 510(k) summary, there was no study conducted to explicitly prove the device meets pre-defined acceptance criteria through performance data or clinical trials. The submission relies on demonstrating substantial equivalence to existing predicate devices.
The document states:
- "Performance data not generated."
- "No clinical tests performed."
- "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement from the manufacturer, not indicative of a specific study proving it.)
- "The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf and competitors."
The FDA's letter concurs with the substantial equivalence claim, allowing the device to be marketed. This means the device was cleared because it was deemed as safe and effective as a legally marketed predicate device, primarily based on its technological characteristics and intended use, rather than new performance data or clinical studies generated for this specific submission.
§ 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.