(83 days)
The intended use of the New Device is to establish a path of entry for minimally invasive instruments.
The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve has applications in abdominal, thoracic and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The obturator can be used without visualization for primary and secondary insertions.
The ENDOPATH® OPTIVIEW™ Optical Obturator and Sleeve consists of two main components: an obturator with an optical element and a trocar sleeve.
The optical obturator provides visualization of tissue as it passes through each layer by dilating and separating the tissue along its path of entry.
The sleeve component has sealing capability to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through the trocar sleeve during a surgical procedure
The ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve shall be provided in a variety of size sleeves from 3mm to 12mm in diameter and 65mm to 155mm in length.
The sleeve component of the device will be supplied with or without a stopcock for insufflation, with seals to maintain pneumoperitoneum as instruments are passed through the trocar sleeve, with or without a desufflation lever, and with or without stability threads for additional retention of the sleeve while it is in tissue.
The provided document describes the acceptance criteria and study for the ENDOPATH® OPTIVIEW™ Optical Surgical Obturator and Sleeve.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from "Performance data" section) | Reported Device Performance (from "Performance data" section) |
|---|---|
| Mating the obturator with the sleeve | Acceptable performance |
| Insertion into the operative cavity with or without visualization | Acceptable performance |
| Removal of the obturator from the sleeve | Acceptable performance |
| Security of the sleeve in tissue | Acceptable performance |
| Maintenance of pneumoperitoneum of the operative space | Acceptable performance |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed." It does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The evaluations are described as "pre-clinical laboratory evaluations," suggesting they were conducted in a controlled lab setting rather than with human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth or their qualifications for the pre-clinical laboratory evaluations. The evaluations focused on objective device performance metrics rather than subjective assessment requiring expert consensus.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. Given the pre-clinical laboratory nature of the evaluations, an adjudication process involving multiple human observers would typically not be required for the specified performance metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The document describes pre-clinical laboratory evaluations of the device's functional performance, not a study comparing human readers' performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was done in the sense that the evaluations focused solely on the device's functional performance in a laboratory setting. There is no mention of an algorithm, as this is a physical surgical device, not a software or AI product. The "pre-clinical laboratory evaluations" represent this standalone assessment of the device's capabilities.
7. Type of Ground Truth Used
The ground truth used was based on the designed functionality and expected physical performance of the device in pre-clinical laboratory settings. This would involve quantifiable measurements and observations of the device's mechanical integrity (mating, removal), interaction with mock tissue (insertion, security of sleeve), and maintenance of a sealed environment (pneumoperitoneum). It is not expert consensus, pathology, or outcomes data in the traditional sense, but rather adherence to engineering and functional specifications.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is a physical medical device, not an AI or machine learning model that requires a training set. The "pre-clinical laboratory evaluations" are for testing the device, not for training it.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this physical 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.