(86 days)
The intended use of the ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve is to establish a path of entry for endoscopic instruments.
The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has applications in abdominal, gynecologic, and thoracic minimally invasive surgical procedures as well as endoscopic surgery of superficial veins and fascia of the lower extremities to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The trocar may be used without visualization for primary and secondary insertions.
The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve consists of an obturator and a 5mm, 11mm, or 12mm sleeve.
The clear, tapered optical element, when used with an endoscope, provides visibility of individual tissue layers during insertion. The blunt tip maysupplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve has a sealing range that accommodates appropriately sized instruments. The obturator accommodates an appropriately sized zero degree endoscope. There are two obturator ergonomic options: O designated codes without a handle, and H designated codes with an integral pistol grip handle which aids in the insertion of the device.
The provided text describes a 510(k) summary for the ENDOPATH® OPTIVIEW® Optical Surgical Obturator and Sleeve. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving device acceptance criteria cannot be extracted from this document, as the document's purpose is different.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance |
|---|---|
| Mating obturator with sleeve | Acceptable performance |
| Insertion into operative cavity (with/without visualization) | Acceptable performance |
| Removal of obturator from sleeve | Acceptable performance |
| Security of sleeve in tissue | Acceptable performance |
| Maintenance of pneumoperitoneum | Acceptable performance |
Reasoning: The "Performance data" section states, "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. These studies demonstrated acceptable performance to the predicate device in mating the obturator with the sleeve, insertion into the operative cavity with or without visualization, removal of the obturator from the sleeve, security of the sleeve in tissue, and maintenance of pneumoperitoneum of the operative space." This implies that the 'acceptable performance to the predicate device' for these specific functions served as the acceptance criteria for those tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified.
- Data provenance: "Pre-clinical laboratory evaluations." The country of origin and whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The document does not describe studies involving expert-established ground truth. The "performance data" describes pre-clinical laboratory evaluations against a predicate device, which typically involves engineering or technical assessment rather than expert evaluation of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as it relates to expert review.
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 an AI device. No MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" implicitly used was the performance of the legally marketed predicate device. The study aimed to show "acceptable performance to the predicate device" across several functional aspects.
8. The sample size for the training set
- Not applicable. This is not an AI device, so there is no concept of a training set as would be used in machine learning. If this refers to samples used in general pre-clinical testing, it is not specified.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI 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.