(59 days)
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.
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.
The provided text describes a medical device, the GMD Universal Urinary Incontinence Sling™-1011, and its substantial equivalence to predicate devices based on non-clinical studies. It does not contain information about acceptance criteria for a device's performance, nor does it detail a study that defines or proves the device meets specific performance metrics in the way the requested information (e.g., sample size for test/training sets, expert qualifications, MRMC study, standalone performance) would imply for a diagnostic or AI-driven device.
Therefore, I cannot fulfill the request as the provided text pertains to a regulatory submission for a surgical mesh device, focusing on its design modifications and substantial equivalence to existing predicate devices through bench and cadaver studies, rather than performance criteria of a device with measurable output like an AI algorithm or diagnostic tool. The document is a 510(k) summary for a physical medical implant, not a study evaluating performance of a diagnostic or decision-support system.
To answer your request, the input document would need to be a study report or regulatory submission for a device that has quantifiable performance metrics and a methodology for evaluating those metrics (e.g., an AI algorithm for image analysis).
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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.
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2000
GMD Universal Urinary Incontinence Sling-1011 TM
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 rollof extruded LDPE supplied byextrusion supplier to slingmanufacturer who cutsstamps and heat seals thatmaterial into ~16mm wideright and left sheaths | Right A 15.5mm sheath wideLDPE extrusion is cut tospecified lengths byextrusion supplier and `supplied to slingmanufacturer for assemblyinto slings. | Improved ease of sheath removal duringsling tensioning |
| Sheath Design | LDPE Sheath thickness 7microns | LDPE Sheath thicknessincreased to 16.9 microns | Improved ease of removal |
| Sheath Design | Two centrally overlappingsheaths with one of thesheaths tapered and insertedinto the other sheath, whichhas a constant width fromend to end. | Both sheaths have aconstant width from end toend. One sheath is slightlynarrower than the othersheath, which allows theoverlapping insertion. | Improved ease of removal |
| Bonding AreaDesign | The current assembly processattaches the sheath/meshsubassembly using heatshrink tube and mechanicallysqueezing the mesh andsheath into the barbs of theLDPE sleeve. The sheath Inthis process is wrappedaround the barbed end of thesleeve. The shrink tube is lefton the mesh/sheath/sleeveassembly to providemechanical grip. | Manufacture by a standardcatheter re-flow process inwhich the mesh and sheathmaterials are welded to asmooth sleeve end and theshrink tube is removed afterbeing used as amanufacturing tool. Thesleeve is the same LDPEmaterial as the 1010 sleeve(Same resin used for 1010,1011 sleeves and 1012 bullettip). | Provides a smoother bonding area andreduces the force required to pull thebonding area through tissue. Addressesuser input obtained through the postmarket surveillance process. |
| Sleeve Design | Molded LDPE sleeve in sailorblue.Proximal trocar insertion | Molded LDPE sleeve in USPClass VI Blue Colorant.Proximal trocar insertion | No material change. Colorant specifiedas USP standard. Trocar insertion pointrelocated to reduce resistance during |
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10(k) Premarket Notification
| Product Feature | Model 1010 | Model 1011- | Reason |
|---|---|---|---|
| point on the sleeve is 8 mmfrom the proximal end. | point is at the proximal endof 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.
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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
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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/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
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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
§ 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.