GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

• K Number: K083471
• Device Name: GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
• Manufacturer: GENERIC MEDICAL DEVICE, INC.
• Date Cleared: 2009-03-03 ( 99 days)
• Product Code: OTN
• Regulation Number: 878.3300

Intended Use

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.

Predicate Devices

K033568, K081275, K072456

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and surgical placement of a mesh sling, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is indicated for the treatment of stress urinary incontinence, which is a medical condition.

Diagnostic

No

The device description indicates that the GMD Universal Sling is a surgical implant used for treating stress urinary incontinence, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, single-use device comprised of a polypropylene knitted mesh and other physical components, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the surgical treatment of stress urinary incontinence by implanting a suburethral sling. This is a surgical procedure performed on the patient's body.
• Device Description: The device is a sterile, single-use surgical implant made of polypropylene mesh. It is designed to be physically placed within the body.
• Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not involve the analysis of any biological samples.

Therefore, the GMD Universal Sling is a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

OTN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

women

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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. 201
Gig Harbor, WA 98332 |

----------	--------------------------------------------------------------------------------------------

Monica Montanez MSRS, RAC, CQA Contact: Monica Montanoz and Quality Assurance Phone: [phone] Fax: [phone] [e-mail]

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:

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

:

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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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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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:

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.

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

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Generic Medical Devices, Inc. November 20, 2008