MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM

K070846 · Prosurg, Inc. · FTL · Jul 2, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070846
• Device Name: MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
• Applicant: Prosurg, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroentrological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.

Device Story

MiniSling is an implantable polymer sling and surgical mesh system with modular self-anchoring fixation ends. Used by surgeons in clinical settings for pelvic floor repair and SUI treatment. System includes a single-use, universal introducer with a notched tip, available in straight, curved, malleable, or detachable configurations. Introducer facilitates delivery of T-anchors and split-anchors into soft tissue; allows intra-operative adjustment of anchor and sling position. Quick-connect/disconnect mechanism enables precise placement. Device provides mechanical support to weakened soft tissue; benefits patients by correcting urethral hypermobility or prolapse with minimal discomfort. Clinical decision-making relies on surgeon's assessment of patient anatomy and procedure requirements.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated tensile strength and breakage force equal to or greater than predicate devices. Tissue fixation anchor pull force testing showed an average of >4000 Gms during initial implantation.

Technological Characteristics

Polymer sling and surgical mesh with modular self-anchoring fixation ends (T-anchors and split-anchors). Includes universal introducer (straight, curved, malleable, detachable). Mechanical fixation principle. Sterilized for single use.

Indications for Use

Indicated for treatment of Stress Urinary Incontinence (SUI) due to urethral hypermobility or intrinsic sphincter deficiency (ISD), and for soft tissue reinforcement in urological, gynecological, uro-gynecological, or gastroenterological procedures, including prolapse repair and pelvic floor reconstruction.

Regulatory Classification

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.

Predicate Devices

• BioSling - Bioabsorbable Sling & Surgical Mesh (K010533)
• Zippere - bioabsorbable / Non-Absorbable Polymer Sling & Mesh (K030631)
• AMS-Smart Sling System & pelvic Floor Repair System (K063713)
• Gynecare - TVT Secure System & Pelvic Floor Repair System (K052401)

Submission Summary (Full Text)

{0}------------------------------------------------

K070846

# 510K Summary of Safety & Effectiveness

## MiniSling™ - Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System

Company:

Contact:

Prosurg, Inc 2193 trade Zone blvd San Jose CA 95131

Ashvin Desai , Mgr Regulatory Affairs Tel: [phone]

Date Preparaed: June 26, 2007

Device Name: MiniSling™ - Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System

Predicated Devices: BioSling - Bioabsorbable Sling & Surgical Mesh (Ref: K 010533) Zippere - bioabsorbable / Non-Absorbable Polymer Sling & Mesh (Ref: K 030631) AMS-Smart Sling System & pelvic Floor Repair System (Ref K 063713) Gynecare - TVT Secure System & Pelvic Floor Repair System ( K 052401)

## Device Description:

The MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Single use, universal introducer device with notched tip design, compatible with Fixed, Adjustable and Snap-On modular self anchoring fixation ends of urethral sling and surgical mesh. The Introducer tip can be attached to slot in the fixation anchor for quick connect & disconnect for easy delivery of urethral sling and surgical mesh into target soft tissue. The position of Fixation anchors and sling can also be adjusted intra-operatively using introducer. The T anchors and Split anchors can be delivered in to soft tissue using, modified needle device with ease and minimum discomfort to the patient. The introducer device is available in straight, curved malleable and detachable configuration in various length and curvature to meet physician's preference, patient's anatomy & surgical procedure requirements.

# Indications for Use:

MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroentrological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.

{1}------------------------------------------------

Page ② of ②

#### Comparison of technological Characteristics:

The Mini-Sling - Adjustable Polymer Sling & Surgical Mesh with Self-anchoring System is a modification of the currently marketed BioSling and Zippere Urethral Sling and Surgical Mesh used for pelvic floor support. While it represents s a refinement to the predicate systems, the overall technology and the intended use of the both system are identical. Both predicate and proposed systems are designed for treatment of female Strees Urinary Incontinence (SUI) disorders and pelvic floor repair and reconstruction surgery. The materials, manufacturing methods, packaging and sterilization process used are also identical.

#### Performance Data:

Preclinical testing was performed to ensure that the Urethral Slings and Surgical mesh products performs as intended when used according to the instructions for use. Laboratory product testing has indicated that the urethral Sling and Surgical mesh devices has demonstrated satisfactory performance for its intended applications. Mechanical testing of the devices also demonstrated that the tensile strength and breakage force are equal or more than the predicated devices and are satisfactory for its intended use. The average pull force of tissue fixation anchor is more than 4000 Gms, during initial implantation stage.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Prosurg, Inc % Mr. Ashvin Desai Manager, Regulatory Affairs 2193 Trade Zone Boulevard San Jose, California 95131

JUL - 2 2007

Re: K070846

Trade/Device Name: MiniSling" Adjustable Polymer Sling & Surgical Mesh with Self Anchoring System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: May 31, 2007 Received: June 05, 2007

Dear Mr. Desai:

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 application (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 such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Ashvin Desai

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours. Mark N. Melkerson Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K070846

Device Name: MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System

Indications for Use:

MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI ) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number

Page 1 of 1

16070846