The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (USGI g-Prox Endoscopic Grasper) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study proving performance against acceptance criteria in the context of AI or advanced analytical devices. As such, most of the requested information (related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not available or applicable to this type of submission.

The relevant information from the document is summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use	Device performs as intended for tissue grasping and mobilization in minimally invasive procedures.
Technology	Comparable to predicate devices.
Materials	Comparable to predicate devices.
Safety & Effectiveness	Deemed substantially equivalent to predicate devices, implying similar safety and effectiveness profiles.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing was conducted to ensure that the modified device performs as intended." However, it does not specify the sample size, type of data (e.g., in vitro, ex vivo, in vivo), country of origin, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a surgical instrument, and its performance is evaluated through bench testing and comparison to predicate devices, not typically through expert-established ground truth in the context of diagnostic or analytical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document refers to "Bench testing," but provides no details on adjudication methods.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a surgical instrument, not an AI-assisted diagnostic or analytical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For bench testing, the "ground truth" would likely be engineering specifications, material properties, and functional performance benchmarks (e.g., grasping force, durability, tissue damage assessment), rather than clinical ground truth like pathology or expert consensus. No specific type is mentioned.

8. The sample size for the training set

Not applicable. The device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. The device is not an AI algorithm requiring a training set.

Summary

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USGI Medical Special 510(k) Device Modification USGI g-Prox Endoscopic Grasper

K093018
page 1/2

OCT - 7 2009

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

SUBMITTER INFORMATION 1.

a. Company Name:

b. Company Address:

USGI Medical

1140 Calle Cordillera San Clemente, CA 92673

c. Telephone: (949) 369-3890 Fax:
d. Contact Person:

(949) 369-3891

Mary Lou Mooney Vice President of Clinical, Regulatory & Quality

e. Date Summary Prepared: September 3, 2009

2. DEVICE IDENTIFICATION

con is 1. ing submittee. g-Prox Endoscopic Grasper a. Trade/Proprietary Name:

b. Common Name:

c. Classification Name:

Grasper
Medical

cologic laparoscope and accessories, 884.1720

IDENTIFICATION OF PREDICATE DEVICES 3.

g-Prox Endoscopic Grasper

Mooney
USGI Medical
(K061276)dent of Clinica!,
regulators & Quality

g-1 rux Endoscopie ( rasper

.
. Columbia 376

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USGI Medical Special 510(k) Device Modification USGI g-Prox Endoscopic Grasper

4. DESCRIPTION OF THE DEVICE

5. STATEMENT OF INTENDED USE

The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.

6. COMPARISON WITH PREDICATE DEVICES

The g-Prox Endoscopic Grasper is comparable to the predicate devices in terms of intended use, technology, and materials.

Bench testing was conducted to ensure that the modified device performs as intended when used according to its instructions for use.

ing angle in ortherelades a haman dant can accept the groch in volk circle Catheter and other small diameter instruments.

has a mechanism to vary a

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..

sa findose whe brush in considerable in the predicate devices in terms

16 1 in Ted

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

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

OCT - 7 2009

Re: K093018

Trade/Device Name: g-Prox Endoscopic Grasper Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, GDW, HET Dated: September 3, 2009 Received: September 8, 2009

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.

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.

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

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Page 2 - Ms. Kirsten H. Paulson

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Mark McMillan

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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USGI Medical Special 510(k) Device Modification USGI g-Prox Endoscopic Grasper

Indications for Use

510(k) Number (if known): K093018

Device Name: g-Prox Endoscopic Grasper

Indications For Use:

The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.

Prescription Use (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)

:ございし minimally Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krane for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093018

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Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.