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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Surelift Prolapse System, based on the provided 510(k) amendment:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific clinical safety and effectiveness through a dedicated clinical performance study with detailed acceptance criteria measured against clinical outcomes. The "performance tests" listed are primarily related to material properties, sterilization, and biocompatibility, ensuring the device meets established standards for medical devices of its type.

Acceptance Criteria Category	Specific Test/Property	Reported Device Performance
Material Properties	Monofilament diameter (mesh)	0.12 mm
	Tensile break strength (mesh)	81.87 Newton
	Pore size (mesh)	1.12 mm
	Thickness (mesh)	0.41 mm
	Density (mesh)	41.60 g/m²
	Porosity (mesh)	54.63 %
	Suture size	USP 0
	Anchor diameter	3 mm
	Anchor length	7 mm
	Anchoring Handle tube diameter	6 mm
	Anchoring Handle tube length	204 mm
	Passers diameter	4 mm
Mechanical Strength	Suture pullout strength	Meets established performance requirements and standards
	Tensile break strength at break	Meets established performance requirements and standards
	Tear resistance	Meets established performance requirements and standards
	Burst strength	Meets established performance requirements and standards
	Stiffness	Meets established performance requirements and standards
	Prolapse anchor-mesh strength	Meets established performance requirements and standards
	Prolapse arm tensile strength	Meets established performance requirements and standards
Sterilization	Bioburden	Meets established performance requirements (sterilized by ETO)
	Ethylene oxide residuals	Meets established performance requirements and standards
	Ethylene chlorohydrins residuals	Meets established performance requirements and standards
	Sterility assurance level (SAL) determination	Meets established performance requirements and standards
Packaging	Expiration dating test	Meets established performance requirements and standards
Biocompatibility	Cytotoxicity	Meets established performance requirements and standards
	Implantation	Meets established performance requirements and standards
	Sensitization with polar and non-polar extract	Meets established performance requirements and standards
	Genotoxicity	Meets established performance requirements and standards
	Acute systemic toxicity	Meets established performance requirements and standards
	Irritation	Meets established performance requirements and standards
	Haemolysis	Meets established performance requirements and standards
	Extractable metallic ions	Meets established performance requirements and standards
	Pyrogen test	Meets established performance requirements and standards

Study that Proves Device Meets Acceptance Criteria:

The document describes a series of "Performance tests" that were conducted to demonstrate the device meets established performance requirements and standards.

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

The document does not specify sample sizes for any of the individual performance tests (e.g., number of meshes tested for tensile strength, number of anchors for pullout strength). It also doesn't mention data provenance regarding country of origin or whether the data was retrospective or prospective. These types of tests are typically conducted in a laboratory setting using manufactured samples.

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

This information is not applicable in this context. The "performance tests" relate to physical, chemical, and biological properties, not clinical diagnostic accuracy or interpretation requiring expert consensus on a test set. The ground truth for these tests is based on objective measurements and adherence to recognized standards.

4. Adjudication Method for the Test Set:

This information is not applicable. The performance tests are objective measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The submission is for a surgical implant (Surelift Prolapse System), not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

No, a standalone performance study in the context of an algorithm's performance was not done. This device is a surgical mesh kit, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests described is based on:

Objective measurements: For physical properties like dimensions, tensile strength, pore size, etc.
Established standards and regulations: For sterilization (e.g., SAL), biocompatibility (e.g., ISO standards for cytotoxicity, irritation), and other performance requirements.

8. Sample Size for the Training Set:

This information is not applicable. The device is a surgical mesh kit, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

Summary

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510K AMENDMENTJuly 6th 2011	K102815	SURELIFT PROLAPSESYSTEM	page 1 of 4
510K Summary:	JUL - 7 2011
SUBMITTER:	Neomedic International, S.L.C/ Maestrat 41-43 1º08225 Terrassa (Barcelona)Spain
DATE PREPARED:	September 12th, 2010
DEVICE NAME:	Surelift Prolapse System
CLASSIFICATION NAMES:	Mesh, Surgical, Polymeric
PREDICATE DEVICES:	AMS ELEVATE WITH INTERPRO LITE PROLAPSE REPAIRSYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSEREPAIR SYSTEMGYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS

Device Description:

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 303POM
Passers	Stainless steel AISI 303POM

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510K AMENDMENTJuly 6th 2011	K102815	SURELIFT PROLAPSESYSTEM
Component	Properties
Monofilament polypropylene mesh	Knitted meshMonofilament diameter = 0,12 mmTensile break strength = 81,87 NewtonPore size = 1,12 mmThickness = 0,41 mmDensity = 41,60 g/m²Porosity = 54,63 %
Monofilament polypropylene sutures	USP 0
Anchors	Diameter: 3 mmLength: 7 mm
Anchoring Handles	Anchoring Handle tube diameter = 6 mmAnchoring Handle tube length = 204 mm
Passers	Passers diameter = 4 mm

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510K AMENDMENTJuly 6th 2011	K102815.	SURELIFT PROLAPSESYSTEM
---------------------------------	----------	-----------------------------

Predicate Devices:

The following two devices have been previously cleared by the FDA in the following 510(K)

Device	510 (K)documentnumber	Date Cleared	Indications
AMS ELEVATE WITH INTERPRO LITEPROLAPSE REPAIR SYSTEM, AMSELEVATE WITH INTEXEN LP PROLAPSEREPAIR SYSTEM	K080185	April 10 2008	Pelvic FloorRepair System
GYNECARE PROLIFT +M* PELVICFLOOR REPAIR SYSTEMS	K071512	May 15 2008	Pelvic FloorRepair System

Intended Use:

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).
1. 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 AMENDMENTJuly 6th 2011	K102815 *	SURELIFT PROLAPSESYSTEM
---------------------------------	-----------	-----------------------------

Performance tests:

2Performance test	Test description
Sterilization	BioburdenEthylene oxide residualsEthylene chlorohydrins residualsSterility assurance level (SAL) determination
Packaging	Expiration dating test
Biocompatibility	CytotoxicityImplantationSensitization with polar and non-polar extractGenotoxicityAcute systemic toxicityIrritationHaemolysisExtractable metallic ionsPyrogen test
Mechanical tests	Suture pullout strengthTensile break strength at breakTear resistanceBurst strengthStiffnessPore sizeThicknessDensityPorosityProlapse anchor-mesh strengthProlapse 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:

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

Regulation Number and Section

§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.

(a)
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).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.