(87 days)
The g-Cinch is intended for use with the g-Cath Tissue Anchor Delivery Catheter for suture grasping and cinching of g-Cath Tissue Anchors
The g-Cinch Suture Grasper is a sterile, single patient use device used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for grasping and cinching g-Cath Tissue Anchors. It is comprised of a proximal polycarbonate/ABS handle, flexible shaft made of medical grade polymers and a distal metal snare. It has a nominal working length of 159 cm and can be introduced through either an endoscopic access device or endoscope with a > 2.8 mm nominal channel diameter and working length of
Here's an analysis of the provided text regarding the g-Cinch Suture Grasper, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Integrity (Bond joint strength) | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Performance (as intended) | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Biocompatibility | Met ISO 10993-1 requirements. |
| User Ergonomics | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Equivalence to Predicate Device (g-Cath) | "Test data also showed that the g-Cinch met the same acceptance criteria as the g-Cath predicate device, and thereby demonstrated equivalent safety and performance to the predicate device." |
Study Information:
The provided document describes a non-clinical performance testing study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the non-clinical performance testing. It refers generally to "Test data."
- Data Provenance: The study was a non-clinical performance testing and therefore did not involve human subjects or patient data. It describes internal testing conducted by USGI Medical.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was a non-clinical engineering/performance study, not a study evaluating diagnostic accuracy or requiring expert-established ground truth in the traditional sense of clinical or image-based studies. The "ground truth" would be the engineering specifications and performance standards.
4. Adjudication Method for the Test Set
- Not applicable. As a non-clinical engineering performance study, there was no need for expert adjudication of results. Performance was measured against predefined engineering and material specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not conducted as this was a non-clinical device performance study, not a clinical study involving human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a mechanical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- The "ground truth" for this non-clinical study was based on engineering specifications, material properties, and predefined performance standards for the device itself and its predicate (g-Cath Tissue Anchor Delivery Catheter). For example, bond joint strength would have objective measurement criteria.
8. The Sample Size for the Training Set
- Not applicable. This was a physical device performance study, not an AI/algorithm study that involves "training sets."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As this was not an AI/algorithm study, there was no training set or ground truth established for a training set.
§ 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.