SIIS#1 TISSUE SUSPENSION SYSTEM

K020705 · Tag Medical Products · OTN · Apr 26, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020705
• Device Name: SIIS#1 TISSUE SUSPENSION SYSTEM
• Applicant: Tag Medical Products
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SiiS#1 Bladder-Neck Suspension Device is a sterile, single-use device intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting form urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Bladder-Neck Suspension Device Inserter, and Sling Locator are provided and are intended to facilitate the placement of the SiiS#1 Bladder-Neck Suspension Device.

Device Story

SiiS#1 Tissue Suspension System is a sterile, single-use pubourethral sling for stress urinary incontinence treatment. Device consists of undyed polyester tubular mesh (approx. 6mm x 305mm) with toggle anchors and a secondary sliding mesh (80mm) connected via sliding locks. System includes a stainless steel/anodized aluminum needle inserter for passing anchors through rectus fascia and a polyacetal reusable sling locator for positioning. Surgeon uses inserter to place mesh; sliding locks allow intraoperative adjustment of sling length to achieve desired tension. Device provides mechanical support to urethra. Benefits include correction of urethral hypermobility or intrinsic sphincter deficiency. Used in clinical/surgical settings by physicians.

Clinical Evidence

Bench testing only. Cadaver testing performed to evaluate pull-out force, demonstrating performance exceeding that of the predicate device.

Technological Characteristics

Materials: Undyed polyester tubular mesh (knitted filaments of extruded polyester strands), stainless steel inserter with anodized aluminum handle, polyacetal sling locator. Dimensions: Mesh 6mm x 305mm, sliding mesh 80mm. Principle: Mechanical pubourethral support via sling. Sterilization: Sterile, single-use.

Indications for Use

Indicated for female patients with stress urinary incontinence (SUI) caused by urethral hypermobility and/or intrinsic sphincter deficiency.

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

• Tension Free Vaginal Tape (TVT) System

Submission Summary (Full Text)

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K020705 page 1 of 2

## SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary in formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

| New Device Name: | SiiS#1 Tissue Suspension System |
|------------------------|-------------------------------------------|
| Predicate Device Name: | Tension Free Vaginal Tape (TVT)<br>System |

The SiiS#1 Tissue Suspension Device is a sterile single use device, consisting of Device one piece of undyed polyester tubular mesh approximately 6 mm diameter x 305 Description mm long (.250 x 12 inches) with both ends terminating in toggle type tissue The anchors and part of the mesh are held within a long needle inserter. anchors. Attached to the mesh creating a secondary sling is a sliding mesh approximately 80 mm long connected to the longer mesh with sliding locks. The sliding locks are advanced with the sling locator to shorten the length of the sling until desired length is achieved. Polyester tubular mesh is constructed of knitted filaments of extruded polyester strands identical in composition to that used in polyester non-absorbable surgical suture. The material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.

> The SiiS#1 Inserter is provided sterile and single use. The inserter is made of stainless steel with an anodized aluminum handle. The tip of the inserter is constructed to accept the toggle anchors and part of the tubular mesh. The inserter is intended to facilitate the passage of the toggle anchors through the rectus fascia below the abdominal skin.

> The SiiS#1 Reusable Sling Locator is provided sterile and single use. The locator is made of polyacetal or equivalent and is intended to facilitate the position of the sliding sling on the longer suspender. It is connected and fixed to the longer suspender and interfaces with the sliding sling adjustment locks.

- The SiiS#1 Device is intended to be used as a pubourethral sling for treatment of Intended Use Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency,
Indications (from labeling): The SiiS#1 device is intended to be used as a Indications pubourethral sling for treatment of stress urinary incontinence (SUI), for female Statement urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Inserter, Sling Locater and Urethral Probe are available and intended to facilitate placement of the SiiS#1 device.

Technologically both the new device and predicate device are the same (i.e., both Technological are meshes that provide pubourethral support). Additionally, both devices utilize Characteristics accessories for use in the surgical procedure. Any differences between the devices do not raise new questions of safety and effectiveness.

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K020705 page 2 of 2

| Performance<br>Data | Cadaver testing has shown that the SiiS#1 has a pull-out force that is well over that<br>of the predicate device. Cadaver test data is provided in Attachment # 5. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions | Based on the 510(k) summaries and the 510(k) statements (21 CFR 807) and the<br>information provided herein, we conclude that the modified device is substantially<br>equivalent to the existing legally marketed device under the Federal Food, Drug<br>and Cosmetic Act. |
| Contact | Dan Moor, Chief Engineer, T..A.G. Medical Products LTD, Kibbutz Gaaton 25130,<br>Israel |
| Date | 02/01/02 |

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

Mr. Dan Moor Chief Engineer T.A.G. Medical Products LTD. Kibbuts Gaaton ISRAEL 25130

SEP 2 8 2012

Re: K020705 Trade/Device Name: SiiS#1 Tissue Suspension System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: February 4, 2002 Received: March 4, 2002

Dear Mr. Moor:

This letter corrects our substantially equivalent letter of April 26, 2002.

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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510(k) Number (if known): ____K020705

Device Name: SiiS#1 Tissue Suspension System

Indications for Use:

The SiiS#1 Bladder-Neck Suspension Device is a sterile, single-use device intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting form urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Bladder-Neck Suspension Device Inserter, and Sling Locator are provided and are intended to facilitate the placement of the SiiS#1 Bladder-Neck Suspension Device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use

or

Over-The- Counter Use

Miriam C. Provost

ision Sion-Off Division of General, Restorative and Neurological Devices

(Optional Format 1-2-96)

510(k) Number K020705

TRADITIONAL 510(k) SiiS#1

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