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 < 110 cm.

AI/ML Overview

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.

Summary

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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 CordilleraSan Clemente, CA 92673
c. Telephone:Fax:	(949) 369-3890(949) 369-3891
d. Contact Person:	Mary Lou MooneyVice 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 TissueApproximation 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)

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4. DESCRIPTION OF THE DEVICE

STATEMENT OF INTENDED USE 5.

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.

COMPARISON WITH PREDICATE DEVICES 6.

The g-Cinch Suture Grasper is comparable to the g-Cath predicate device in terms of mechanism of action, technology, and materials. Both are comprised of a proximal handle and flexible body made of medical grade polymers. Both the g-Cinch Suture Grasper and the g-Cath predicate device use a distal metal snare to engage the g-Cath suture tail and apply force to advance the g-Cath cinch to approximate the g-Cath anchor pair to create a soft tissue approximation.

7. SUMMARY OF PERFORMANCE DATA

Non-clinical performance testing was conducted to ensure that the device performs as intended when used according to its instructions for use and to demonstrate equivalence to the predicate device. Testing assessed device integrity (i.e., bond joint strength), performance, biocompatibility (in accordance with ISO 10993-1) and user ergonomics. Test data showed that the device performs as intended when used according to its instructions for use. 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.

In conclusion, non-clinical performance data demonstrate that the g-Cinch device is as safe, as effective and performs as well as the g-Cath predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

USGI Medical % Ms. Mary Lou Mooney Vice President of Clinical, Regulatory and Quality 1140 Calle Cordillera San Clemente, California 92673

DEC 3 0 2010

Re: K102931

Trade/Device Name: g-Cinch Suture Grasper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW Dated: December 14, 2010 Received: December 15, 2010

Dear Ms. Mooney:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Mary Lou Mooney

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL USGI Medical Sept, 2010

510(k) Premarket Notification g-Cinch Suture Grasper

Indications for Use

DEC 3 0 2010

KID2931

510(k) Number (if known):

Device Name: g-Cinch Suture Grasper

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

Prescription Use ﮯ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krane for MXM
(Division Sign-Off)

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K102931

Page 1 of

Regulation Number and Section

§ 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.