(15 days)
The Optical Separator is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. The Optical Separator may be used with or without visualization for primary and secondary insertions.
The Optical Separator is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
The Optical Separator is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system. Traditional obturators use a blade for cutting to establish a path of entry through the several layers of tissue. The Optical Separator dilates and separates tissue along its natural fiber lines in its path of entry.
The Optical Separator will be available in sizes of 5mm, 8mm, 11mm and 12mm diameter and in lengths ranging from 55mm to 150mm.
The use of the Optical Separator, which separates tissue along its natural fibers versus cutting of tissue by traditional bladed trocars is expected to reduce trauma to vessels and the abdominal wall and minimize the risk of organ puncture. Upon removal of the trocar at the end of the procedure the separated tissue is expected to reapproximate, leaving a smaller, linear defect.
This document describes the Optical Separator, a sterile, single-use device designed to establish a path of entry for endoscopic instruments in various minimally invasive surgical procedures. The device aims to reduce trauma by dilating and separating tissue along natural fiber lines instead of cutting.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Insertion Force | N/A (Not explicitly stated, but implies meeting a threshold appropriate for intended use) | "tests to verify the insertion force" were performed. |
| Reliability | N/A (Not explicitly stated, but implies consistent function and structural integrity during use) | "tests to verify its reliability" were performed. |
| Visualization | N/A (Not explicitly stated, but implies adequate visualization during use with an endoscope) | "tests to verify... visualization during use" were performed. |
| Safety and Effectiveness | Substantial equivalence to predicate devices, and no new safety and effectiveness issues. | "The performance and functional testing demonstrated that the Optical Separator is substantially equivalent to its predicate devices and it introduces no new safety and effectiveness issues when used as instructed." |
2. Sample Size and Data Provenance for Test Set
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is general "performance and functional testing" rather than a clinical study with a defined test set of patient data.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth as this was not a study involving diagnostic interpretation or subjective assessment. The testing described focuses on mechanical and functional performance characteristics of the device.
4. Adjudication Method for Test Set
No adjudication method is mentioned as there was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or mentioned. This device is a surgical instrument, not a diagnostic imaging aid that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was performed or mentioned. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for assessing the device's performance was based on:
- Engineering specifications and standards: Implicit in the "tests to verify insertion force," "reliability," and "visualization."
- Comparison to predicate devices: The primary ground truth for regulatory approval was demonstrating "substantial equivalence" to existing, legally marketed predicate devices (EndoPath Optiview Optical Surgical Obturator and Applied Medical Dilating Tip Obturator). This implies that the performance of the predicate devices served as a benchmark for safety and effectiveness.
8. Sample Size for Training Set
The concept of a "training set" is not applicable here as this is a physical medical device undergoing performance and functional testing, not a machine learning algorithm.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set mentioned for this type of 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.