SURELIFT PROLAPSE SYSTEM
Device Facts
| Record ID | K102815 |
|---|---|
| Device Name | SURELIFT PROLAPSE SYSTEM |
| Applicant | Neomedic International |
| Product Code | OTP · Obstetrics/Gynecology |
| Decision Date | Jul 7, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5980 |
| Device Class | Class 3 |
| Attributes | Therapeutic |
Indications for Use
The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
Device Story
Surelift Prolapse System is a surgical mesh kit for transvaginal repair of anterior and posterior vaginal wall prolapse. Kit includes monofilament polypropylene mesh, PEEK anchors, stainless steel/POM anchoring handles, and passers. Mesh features six fixation points: two posterior points for sacrospinose ligaments, two middle arms for arcus tendineus, and two anterior arms for obturator foramens. Surgeon adjusts fixation points to ensure flat mesh placement and proper tension. Device used in clinical/surgical settings by physicians. Benefits include anatomical correction of prolapse through adjustable tensioning and secure fixation.
Clinical Evidence
Bench testing only. Performance testing included sterilization validation (bioburden, ETO residuals, SAL), packaging/shelf-life, biocompatibility (cytotoxicity, implantation, sensitization, genotoxicity, systemic toxicity, irritation, haemolysis, pyrogenicity), and mechanical testing (suture pullout, tensile strength, tear resistance, burst strength, stiffness, pore size, density, porosity).
Technological Characteristics
Materials: Monofilament polypropylene mesh/sutures, PEEK anchors, stainless steel AISI 303 and POM handles/passers. Mesh properties: 0.12 mm diameter, 81.87 N tensile strength, 1.12 mm pore size, 0.41 mm thickness, 41.60 g/m² density, 54.63% porosity. Sterilization: ETO. Mechanical fixation via anchors and arms.
Indications for Use
Indicated for transvaginal surgical treatment of anterior and posterior vaginal wall prolapse in adult patients.
Regulatory Classification
Identification
Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).
Predicate Devices
- AMS ELEVATE WITH INTERPRO LITE PROLAPSE REPAIR SYSTEM (K080185)
- AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM (K080185)
- GYNECARE PROLIFT +M PELVIC FLOOR REPAIR SYSTEMS (K071512)
Submission Summary (Full Text)
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| 510K AMENDMENT<br>July 6th 2011 | K102815 | SURELIFT PROLAPSE<br>SYSTEM | page 1 of 4 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------|
| 510K Summary: | JUL - 7 2011 | | |
| SUBMITTER: | Neomedic International, S.L.<br>C/ Maestrat 41-43 1º<br>08225 Terrassa (Barcelona)<br>Spain | | |
| DATE PREPARED: | September 12th, 2010 | | |
| DEVICE NAME: | Surelift Prolapse System | | |
| CLASSIFICATION NAMES: | Mesh, Surgical, Polymeric | | |
| PREDICATE DEVICES: | AMS ELEVATE WITH INTERPRO LITE PROLAPSE REPAIR<br>SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE<br>REPAIR SYSTEM<br>GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS | | |
### Device Description:
The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens.
The mesh has six fixation points (two posterior fixation points and four arms):
- Two posterior fixation points that are fixed to the sacrospinose ligaments.
- Two middle arms that are passed through the arcus tendineus.
- Two anterior arms that are passed through the anterior part of the obturator foramen.
When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.
# Description of material components and physical properties:
| Component | Material |
|------------------------------------|---------------------------------|
| Monofilament polypropylene mesh | Polypropylene monofilament |
| Monofilament polypropylene sutures | Polypropylene monofilament |
| Anchors | PEEK |
| Anchoring Handle | Stainless steel AISI 303<br>POM |
| Passers | Stainless steel AISI 303<br>POM |
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| 510K AMENDMENT<br>July 6th 2011 | K102815 | SURELIFT PROLAPSE<br>SYSTEM |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Component | Properties | |
| Monofilament polypropylene mesh | Knitted mesh<br>Monofilament diameter = 0,12 mm<br>Tensile break strength = 81,87 Newton<br>Pore size = 1,12 mm<br>Thickness = 0,41 mm<br>Density = 41,60 g/m²<br>Porosity = 54,63 % | |
| Monofilament polypropylene sutures | USP 0 | |
| Anchors | Diameter: 3 mm<br>Length: 7 mm | |
| Anchoring Handles | Anchoring Handle tube diameter = 6 mm<br>Anchoring Handle tube length = 204 mm | |
| Passers | Passers diameter = 4 mm | |
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| 510K AMENDMENT<br>July 6th 2011 | K102815. | SURELIFT PROLAPSE<br>SYSTEM |
|---------------------------------|----------|-----------------------------|
|---------------------------------|----------|-----------------------------|
### Predicate Devices:
The following two devices have been previously cleared by the FDA in the following 510(K)
| Device | 510 (K)<br>document<br>number | Date Cleared | Indications |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------|-------------------------------|
| AMS ELEVATE WITH INTERPRO LITE<br>PROLAPSE REPAIR SYSTEM, AMS<br>ELEVATE WITH INTEXEN LP PROLAPSE<br>REPAIR SYSTEM | K080185 | April 10 2008 | Pelvic Floor<br>Repair System |
| GYNECARE PROLIFT +M* PELVIC<br>FLOOR REPAIR SYSTEMS | K071512 | May 15 2008 | Pelvic Floor<br>Repair System |
#### Intended Use:
The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
## Technological Characteristics comparison:
The Surelift prolapse system and the two predicate devices are substantially equivalent:
The two predicate devices are intended for pelvic floor prolapse repair.
The two predicate devices use monofilament polypropylene mesh and have multi-arm design for mesh adjustment and fixation.
The two predicate devices include accessories to aid in mesh placement.
One of the predicate devices (AMS) uses anchors to fixate the mesh to the sacrospinose ligament. The two predicate devices are sterilized by ETO.
There are differences compared to the predicate devices:
- 1. The design of the arms is different: The Surelift has six fixation points (two posterior fixation points and four arms), the AMS Elevate has four fixation points (two posterior fixation points and two arms) and the Prolift has four fixation points (four arms). Surelift fixation points: two posterior fixation points (sacrospinose ligament), two medium arms (Arcus tendineus) and two anterior arms (anterior obturator foramen). AMS Elevate fixation points: two posterior fixation points (Sacrospinose ligament) and two anterior arms (anterior obturator foramen). Prolift fixation points: two medium arms (Arcus tendineus) and two anterior arms (anterior obturator foramen).
- 2. The anchor material of the AMS Elevate is polypropylene, and the anchor material of the Surelift is PEEK.
The differences between the three devices do not raise new questions on the safety and effectiveness. We consider the proposed device is substantially equivalent to the predicate devices.
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| 510K AMENDMENT<br>July 6th 2011 | K102815 * | SURELIFT PROLAPSE<br>SYSTEM |
|---------------------------------|-----------|-----------------------------|
|---------------------------------|-----------|-----------------------------|
Performance tests:
| 2<br>Performance test | Test description |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Bioburden<br>Ethylene oxide residuals<br>Ethylene chlorohydrins residuals<br>Sterility assurance level (SAL) determination |
| Packaging | Expiration dating test |
| Biocompatibility | Cytotoxicity<br>Implantation<br>Sensitization with polar and non-polar extract<br>Genotoxicity<br>Acute systemic toxicity<br>Irritation<br>Haemolysis<br>Extractable metallic ions<br>Pyrogen test |
| Mechanical tests | Suture pullout strength<br>Tensile break strength at break<br>Tear resistance<br>Burst strength<br>Stiffness<br>Pore size<br>Thickness<br>Density<br>Porosity<br>Prolapse anchor-mesh strength<br>Prolapse arm tensile strength |
Results of verification testing indicate that the product meets the established performance requirements and standards.
## Conclusions:
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the proposed device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neomedic International S.L. c/o Jeffrey R. Shideman, Ph.D. President International Medical Products Corporation 7307 Glouchester Drive EDINA MN 55435
SEP 2 8 2012
Re: K102815 Trade Name: Surelift Prolapse System Regulation Number: 21 CFR 8878.3300 Regulation Name: Surgical Mesh Regulation Class: II Product Code: OTP Dated: June 28, 2011 Received: June 30, 2011
Dear Dr. Shideman:
This letter corrects our substantially equivalent letter of July 7, 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 (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/CDRH0ffices/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. Civiletti
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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Indications for Use
510(k) Number (if known): K102815
Device Name: SURELIFT PROLAPSE SYSTEM
Indications for Use:
The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
Prescription Use X (Part 2) 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
Tom M. Whig
