(88 days)
Intended for use in Endoscopic Saphenous Vein harvesting procedures.
The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical. For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm. The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.
This document is a 510(k) premarket notification for a medical device called the "Henke Sass Wolf Saphenous Vein Laparoscope." It's primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for an AI-powered device.
Therefore, many of the requested sections about AI-specific criteria, studies, and ground truth are not applicable to this document. I will extract the information that is present concerning safety and effectiveness testing.
Acceptance Criteria and Study for the Henke Sass Wolf Saphenous Vein Laparoscope
This submission is for a conventional medical device, a laparoscope, and not an AI-powered device. As such, the "acceptance criteria" and "device performance" are related to established safety and performance standards for such physical medical instruments, rather than AI model metrics. The study focuses on demonstrating compliance with these standards and substantial equivalence to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Conducted | Reported Device Performance |
|---|---|
| Electrical Safety: | |
| EN 60601-1-1 | Successfully met requirements |
| EN 601-2-10 | Successfully met requirements |
| Electromedical System: | |
| EN 60601-1-1 | Successfully met requirements |
| Substantial Equivalence: | |
| Equivalence in Intended Use | Substantially equivalent to Stryker Saphenous Vein Harvest Laparoscope and compatible with Ethicon's Subcu-Retractor. Can also substitute for HSW 5mm Laparoscope (K941967). |
| Equivalence in Materials | Identical to existing HSW 5mm Laparoscopes. |
| Equivalence in Modes of Construction | Identical to existing HSW 5mm Laparoscopes. |
| Equivalence in Optical Performance | Identical to existing HSW 5mm Laparoscopes. |
| Equivalence in Safety | Identical to existing HSW 5mm Laparoscopes. |
| Differences (Working Length, Angle of View) | Modified working length to 300mm and angle of view, but materials and basic design are identical to existing HSW 5mm Laparoscopes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a "test set" as would be used for AI/software. The testing mentioned (Electrical Safety, Electromedical System) would involve testing of physical device prototypes or production samples. The substantial equivalence argument relies on comparison to known predicate devices already on the market.
- Data Provenance: Not applicable in the context of data for an AI model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as this is a submission for a physical medical device, not an AI or diagnostic application that would require expert-established ground truth on a test set of data.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, this type of study is typically done for diagnostic imaging or AI systems where human reader performance is a key metric. This is a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" here is compliance with established safety standards (EN 60601-1-1, EN 601-2-10) and physical attributes (materials, construction, optical performance, safety) matching a known, legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.