Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material and design of a surgical sling and its equivalence to predicate devices, with no mention of AI or ML technology.

Therapeutic

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

Diagnostic

No

The device is a suburethral sling used for the treatment of stress urinary incontinence (SUI), which is a therapeutic purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, single-use device comprised of polypropylene knitted mesh and other physical components, indicating it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Description: The GMD Universal Urinary Incontinence Sling-1011 is a surgical implant (a suburethral sling) used to physically support the urethra to treat stress urinary incontinence. It is placed directly into the body during a surgical procedure.
Intended Use: The intended use is to treat a physical condition (stress urinary incontinence) by providing mechanical support. It does not involve testing or analyzing biological specimens.

Therefore, based on the provided information, the GMD Universal Urinary Incontinence Sling-1011 is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach. The use of the device in males and children under 18 years of age is not supported by clinical studies.

Product codes

OTN

Device Description

The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ -1011 is comprised of the same polypropylene knitted mesh as its Model 1010 and Model 1012 predicates, protected by the same disposable polypropylene sheath as its Model 1012 predicate with a disposable low density polypropylene universal sleeve at each end made of the same material and similar in design to the sleeve of its Model 1010 predicate, for attachment of the sling to GMD's reusable trocars (sold separately). Similar to both predicates, the Universal Urinary Incontinence Sling™ -- 1011 is used for inside-out / bottom-up and outside-in / top-down approaches. Similar to both predicates, 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

The use of the device in males and children under 18 years of age is not supported by clinical studies.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench and animal studies were performed on the GMD Universal Sling and previously submitted with the premarket notification cleared under K083471. Additional bench testing was performed on the modifications to the Model 1010 predicate incorporated into the Model 1011 sling. Cadaver labs were conducted on the Model 1010 predicate and submitted with K083471, on the Model 1012 predicate and submitted with K101440 and were conducted on the Model 1011 to prove the substantial equivalence of the Model 1011 to its predicates. The data demonstrates that the GMD Universal Urinary Incontinence Sling™-1011 is substantially equivalent to the predicate device(s) and that there is no change in the safety and effectiveness due to the modification.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

GMD Universal Sling (K083471), GMD Universal Sling™-1012 (K101440)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

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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PAGE 1 OF 3

GMD Universal Urinary Incontinence Sling-1011 ™

510(k) Premarket Notification

JUN 3 0 2011

Section 8: 510(k) Summary

The following information is provided as required by 21 CFR § 807.92 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

Contact:

Gail Hamilton Director, Quality Systems Generic Medical Devices, Inc. 5727 Baker Way NW. Ste. 201 Gig Harbor, WA 98332 Tel: 253-853-3582 Fax: 253-853-3589 ghamilton@gmd-us.com

Date of Submission:	May 2, 2011
Proprietary Name:	GMD Universal Urinary Incontinence Sling™-1011
Common Name:	Mesh, Surgical, Polymeric
Regulatory Class:	Class II
Product Codes:	OTN
Predicate Device(s):	GMD Universal Sling (K083471)
GMD Universal Sling™-1012 (K101440)

Device Description:

The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ -1011 is comprised of the same polypropylene knitted mesh as its Model 1010 and Model 1012 predicates, protected by the same disposable polypropylene sheath as its Model 1012 predicate with a disposable low density polypropylene universal sleeve at each end made of the same material and similar in design to the sleeve of its Model 1010 predicate, for attachment of the sling to GMD's reusable trocars (sold separately). Similar to both predicates, the Universal Urinary Incontinence Sling™ -- 1011 is used for inside-out / bottom-up and outside-in / top-down approaches. Similar to both predicates, the method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

1

2000

GMD Universal Urinary Incontinence Sling-1011 TM

K111219

Intended Use:

The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach.

The use of the device in males and children under 18 years of age is not supported by clinical studies.

Modifications Made to the Model 1010 in the Model 1011

The following table describes the changes in the Model 1010 Universal Sling that are found in the Model 1011.

Product Feature	Model 1010	Model 1011	Reason
Sheath Design	470mm wide, 300m long roll
of extruded LDPE supplied by
extrusion supplier to sling
manufacturer who cuts
stamps and heat seals that
material into ~16mm wide
right and left sheaths	Right A 15.5mm sheath wide
LDPE extrusion is cut to
specified lengths by
extrusion supplier and `
supplied to sling
manufacturer for assembly
into slings.	Improved ease of sheath removal during
sling tensioning
Sheath Design	LDPE Sheath thickness 7
microns	LDPE Sheath thickness
increased to 16.9 microns	Improved ease of removal
Sheath Design	Two centrally overlapping
sheaths with one of the
sheaths tapered and inserted
into the other sheath, which
has a constant width from
end to end.	Both sheaths have a
constant width from end to
end. One sheath is slightly
narrower than the other
sheath, which allows the
overlapping insertion.	Improved ease of removal
Bonding Area
Design	The current assembly process
attaches the sheath/mesh
subassembly using heat
shrink tube and mechanically
squeezing the mesh and
sheath into the barbs of the
LDPE sleeve. The sheath In
this process is wrapped
around the barbed end of the
sleeve. The shrink tube is left
on the mesh/sheath/sleeve
assembly to provide
mechanical grip.	Manufacture by a standard
catheter re-flow process in
which the mesh and sheath
materials are welded to a
smooth sleeve end and the
shrink tube is removed after
being used as a
manufacturing tool. The
sleeve is the same LDPE
material as the 1010 sleeve
(Same resin used for 1010,
1011 sleeves and 1012 bullet
tip).	Provides a smoother bonding area and
reduces the force required to pull the
bonding area through tissue. Addresses
user input obtained through the post
market surveillance process.
Sleeve Design	Molded LDPE sleeve in sailor
blue.
Proximal trocar insertion	Molded LDPE sleeve in USP
Class VI Blue Colorant.
Proximal trocar insertion	No material change. Colorant specified
as USP standard. Trocar insertion point
relocated to reduce resistance during

2

10(k) Premarket Notification

Product Feature	Model 1010	Model 1011-	Reason
	point on the sleeve is 8 mm
from the proximal end.	point is at the proximal end
of the sleeve	sling assembly positioning.

Comparison to Predicate Devices:

The GMD Universal Urinary Incontinence Sling™-1011 has the same intended use and similar technological characteristics as the predicate devices: GMD Universal Sling™-1010 (K083471) and GMD Universal Sling™-1012 (K101440). The GMD Universal Urinary Incontinence Sling™-1011 is equivalent to the predicates.

Non-Clinical Studies:

Bench and animal studies were performed on the GMD Universal Sling and previously submitted with the premarket notification cleared under K083471. Additional bench testing was performed on the modifications to the Model 1010 predicate incorporated into the Model 1011 sling. Cadaver labs were conducted on the Model 1010 predicate and submitted with K083471, on the Model 1012 predicate and submitted with K101440 and were conducted on the Model 1011 to prove the substantial equivalence of the Model 1011 to its predicates. The data demonstrates that the GMD Universal Urinary Incontinence Sling™-1011 is substantially equivalent to the predicate device(s) and that there is no change in the safety and effectiveness due to the modification.

Conclusion:

The GMD Universal Urinary Incontinence Sling™-1011 has a similar design and the same intended use as the predicates GMD Universal Sling ™-Model 1010 (K083471) and GMD Universal Sling™-1012 (K101440). Biocompatibility testing and the current knowledge of the material provided by scientific literature demonstrated the appropriateness of the device materials for the proposed intended use. Bench and cadaver lab testing demonstrates that the GMD Universal Urinary Incontinence Sling™-1011 has similar mechanical and performance characteristics as the predicate devices as described in Section 13. Therefore, the GMD Universal Urinary Incontinence Sling™-1011 is substantially equivalent.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Generic Medical Devices Inc. % Mr. Jeff Morgan Principle Consultant JWM Associates LLC P.O. Box 818 OCEAN SHORES WA 98569

SEP 2 8 2012

Re: K11219 Trade/Device Name: GMD Universal Urinary Incontinence SlingTM-101 1 Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: May 2, 2010 Received: May 4, 2011

Dear Mr. Morgan:

This letter corrects our substantially equivalent letter of June 30, 2011.

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.

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

4

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Perkins

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

5

Section 6: Indications for Use Statement

KIII219 510(k) Number:

Device Name: GMD Universal Urinary Incontinence Sling™-1011

Indications for Use:

The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach.

The use of the device in males and children under 18 years of age is not supported by clinical studies.

Prescription Use 区

AND/OR

Over-The-Counter Use []

(Part 21 CFR 801 Subpart D)

(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)

Herbert Hoover

ve. Gastro-Renal, and