The GMD Universal Sling is indicated for use in women as a suburethral sling for the treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The GMD Universal Sling System ™ – is a sterile, single use device for the treatment of female stress urinary incontinence. The Universal Sling is comprised of a polypropylene knitted mesh protected by a disposable polyurethane sheath with a disposable low density polypropylene universal sleeve at each end for attachment of the sling to GMD's single use or reusable trocars (sold separately). The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out / bottom-up approaches and a sleeve end trocar insertion point is for outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

AI/ML Overview

The provided text describes a 510(k) premarket application for the "GMD Universal Sling™," a medical device for treating female stress urinary incontinence. The focus of the application is to demonstrate substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance acceptance criteria through a standalone study with defined metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Use: Treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.	The GMD Universal Sling™ has the same intended use as the predicate devices Gynecare TVTTM Obturator System (K033568), Boston Scientific Lynx™ System (K081275), and Caldera Desara™ (K072456).
Technological Characteristics: Similar design and materials to predicate devices.	The GMD Universal Sling™ has similar technological characteristics to the predicate devices. Biocompatibility testing demonstrated the appropriateness of the device materials.
Mechanical & Performance Characteristics: Demonstrate similar mechanical and performance characteristics to predicate devices.	Bench and animal testing demonstrate that the GMD Universal Sling™ has similar mechanical and performance characteristics as the predicate devices.

Explanation: The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating substantial equivalence to predicate devices. This means the GMD Universal Sling™ needs to show that it is as safe and effective as the already-approved predicate devices for the specified indications. The "reported device performance" directly addresses this by stating that the new device has "the same intended use" and "similar technological characteristics," and that bench and animal studies demonstrate "similar mechanical and performance characteristics" to the predicates. Specific quantitative performance metrics or acceptance thresholds are not provided in this type of submission focused on substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, which typically relies on non-clinical (bench and animal) studies and comparison to existing predicate devices rather than a dedicated clinical "test set" to establish efficacy against specific performance criteria.
Data Provenance: The document mentions "Bench and animal studies were performed." It does not specify the country of origin for these studies or whether they were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. This type of submission does not involve human expert adjudication of a "test set" in the way a clinical study for an AI/diagnostic device would. The "ground truth" for the non-clinical studies would be based on the outcomes of the bench and animal tests against established scientific or engineering principles, or comparison to results obtained from predicate devices in similar testing.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There is no mention of a human expert adjudication process for a "test set" in the document.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical (bench and animal) studies and comparison to predicate devices, not on human reader performance with or without AI assistance.
Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study involving AI was conducted.

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

Standalone Performance: Not applicable. The GMD Universal Sling™ is a physical surgical mesh device, not an algorithm or AI-powered system, so the concept of "standalone (algorithm only)" performance does not apply.

7. The type of ground truth used

Type of Ground Truth: For the "Bench and animal studies," the ground truth would be established by the physical and biological responses observed in these studies, evaluated against engineering specifications, biocompatibility standards, and in comparison to the known performance characteristics of the predicate devices. For example, in bench testing, "ground truth" might be tensile strength measurements or material degradation rates. In animal studies, it would be biological response, inflammation levels, tissue integration, etc.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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GMD Universal Sling TM

K5g3471 Page 1 of 2

510k Premarket Application

3 2009 MAR

Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for Generic Medical Device's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor:	Generic Medical Devices, Inc. (GMD)5727 Baker Way NW. Ste. 201Gig Harbor, WA 98332
----------	--------------------------------------------------------------------------------------------

Monica Montanez MSRS, RAC, CQA Contact: Monica Montanoz and Quality Assurance Phone: 253-853-3594 Fax: (253) 853-3599 mmontanez@gmd-us.com

Date of Submission:	November 20, 2008
Proprietary Name:	GMD Universal Sling ™
Common Name:	Mesh, Surgical, Polymeric
Regulatory Class:	Class II
Product Codes:	OTN

Gynecare TVTTM Obturator System (K033568), Boston Predicate Device(s): Scientific Lynx™ System (K081275), Caldera Desara ™ (K072456)

Device Description:

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GMD Universal Sling TM

510k Premarket Applicatio

outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

Intended Use:

The GMD Universal Sling™ is intended for use in women as a suburethral sling for the treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

Comparison to Predicate Devices:

The GMD Universal Sling has the same intended use and similar technological characteristics as the predicate devices: Gynecare TVTM Obturator System (K033568), Boston Scientific Lynx™ System (K081275), Caldera Desara TM (K072456).

Non-Clinical Studies:

Bench and animal studies were performed. The data demonstrate that the GMD Universal Sling TM is substantially equivalent to the predicate device(s).

Conclusion:

The GMD Universal Sling ™ has a similar design and the same intended use as the predicates Gynecare TVTM Obturator System (K033568), Boston Scientific Lynx™ System (K081275), Caldera Desara TM (K072456). Biocompatibility testing demonstrated the appropriateness of the device materials for the proposed intended use. Bench and animal testing demonstrate that the GMD Universal Sling TM has similar mechanical and performance characteristics as the predicate device. Therefore, the GMD Universal Sling TM is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

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

Generic Medical Device, Inc. % Monica Montanez, MSRS, RAC, CQA VP Regulatory Affairs and Ouality Assurance 5727 Baker Way NW, Suite 201 GIG HARBOR WA 98332

Re: K083471 Trade/Device Name: GMD Universal SlingTM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 30, 2009 Received: February 3, 2009

Dear Ms. Montanez:

This letter corrects our substantially equivalent letter of March 3, 2009.

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 (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.

SEP 2 8 2012

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

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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 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" (21 CFR 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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fuchs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GMD Universal Sling TM

Section 4: Indications for Use Statement

510(k) Number: Device Name:

GMD Universal Sling TM

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Korone for MKM 3/3/2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083471

Page 1 of

Generic Medical Devices, Inc. November 20, 2008

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.