(87 days)
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or functionalities.
No
The device is described as an accessory used for grasping and cinching tissue anchors during medical procedures, not directly for treating a disease or condition.
No
The device description states it is used for "suture grasping and cinching of g-Cath Tissue Anchors," which is a mechanical function, not diagnostic. There are no mentions of image processing, AI, or any diagnostic capabilities.
No
The device description explicitly states it is comprised of physical components like a handle, flexible shaft, and metal snare, indicating it is a hardware device.
Based on the provided information, the g-Cinch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "suture grasping and cinching of g-Cath Tissue Anchors" in conjunction with a delivery catheter. This is a mechanical action performed in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical device with a handle, shaft, and snare designed for manipulating sutures and anchors within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used to examine specimens outside the body to provide information about a person's health.
Therefore, the g-Cinch is a surgical accessory used during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OCW
Device Description
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
§ 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.
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K102931 p. I of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 3 0 2010 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
1. SUBMITTER INFORMATION
| a. Company Name: | USGI Medical |
|---|---|
| b. Company Address: | 1140 Calle Cordillera |
| San Clemente, CA 92673 | |
| c. Telephone: | |
| Fax: | (949) 369-3890 |
| (949) 369-3891 | |
| d. Contact Person: | Mary Lou Mooney |
| Vice President of Clinical, | |
| Regulatory & Quality | |
| e. Date Summary Prepared: | December 29, 2010 |
| DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | g-Cinch™ Suture Grasper |
| b. Common Name: | Endoscopic Tissue |
| Approximation Device |
c. Classification Name:
Endoscope and accessories, 876.1500
3. IDENTIFICATION OF PREDICATE DEVICES
| g-Cath Tissue Anchor Delivery Catheter | USGI Medical
(K061276) |
|-------------------------------------------|---------------------------|
| Endosuture System Endo-Holder Knot Pusher | Ethicon
(K963329) |
1
4. DESCRIPTION OF THE DEVICE
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