STRATASIS SLING KIT

K020654 · Cook Biotech, Inc. · PAG · Apr 9, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020654
• Device Name: STRATASIS SLING KIT
• Applicant: Cook Biotech, Inc.
• Product Code: PAG · General, Plastic Surgery
• Decision Date: Apr 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STRATASISTM Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

STRATASIS Sling Kit is a sterile, single-use surgical mesh device for treating female stress urinary incontinence. The device consists of a strip of SIS (Small Intestinal Submucosa) material with TEVDEK sutures attached to each end, accompanied by two stainless steel ligature carriers. It is used by surgeons in a clinical setting to create a pubourethral sling to support the urethra, addressing urethral hypermobility or intrinsic sphincter deficiency. The device is implanted to provide mechanical support, thereby reducing incontinence symptoms and improving patient quality of life.

Clinical Evidence

Bench testing only. The device underwent a panel of tests to assess biocompatibility, disinfection, and performance characteristics, meeting all requirements.

Technological Characteristics

Device consists of SIS (Small Intestinal Submucosa) material strip with TEVDEK sutures and stainless steel ligature carriers. Sterile, single-use, surgical mesh. No software or electronic components.

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

• SUROISIS Sling (K992159)
• SIS Hernia Repair Device (K974540)
• Tension Free Vaginal Tape (K974098)

Submission Summary (Full Text)

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510(k) Premarket Notification: STRATASISTM Sling Kit

K020654

#### 9. 510(k) SUMMARY

APR = 9 2002

Submitted By: Mark Blever, President Cook Biotech Incorporated 3055 Kent Avenue West Lafayette, IN 47906 [phone]

### Device:

Trade Name: Common/Usual Name: Proposed Classification Name:

STRATASISTM Sling Kit Surgical Mesh, Urethral Sling Surgical Mesh ( PAG)

# Intended Use:

The STRATASISTM Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

### Predicate Devices:

The STRATASISTM Sling Kit is similar in terms of substantial equivalence to the following predicate devices: SUROISIS Sling (K992159) manufactured by Cook Biotech Incorporated; the SIS Hernia Repair Device (K974540) manufactured by Cook Biotech Incorporated, and Tension Free Vaginal Tape (K974098) marketed by GYNECARE.

## Device Description:

The STRATASISTM Sling Kit is composed of a strip of SIS material with TEVDEK® suture attached to each end. Two stainless steel ligature carriers are also included.

# Substantial Equivalence:

The STRATASISTM Sling Kit is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalence.

#### Discussion of Tests and Test Results:

The STRATASISTM Sling Kit was subjected to a panel of tests to assess biocompatibility, disinfection, and performance characteristics. The STRATASISTM Sling Kit met the requirements of all tests.

# Conclusions Drawn from Tests:

The STRATASISTM Sling Kit is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures are visible in the negative space within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

SEP 2 8 2012

Mr. Mark Blever President Cook Biotech, Inc. 3055 Kent Avenue WEST LAFAYETTE IN 47906

Re: K020654 Trade/Device Name: STRATASISTM Sling Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAG Dated: February 27, 2002 Received: February 28, 2002

Dear Mr. Bleyer:

This letter corrects our substantially equivalent letter of April 9, 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,

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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KO20654 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ STRATASIS™ Sling Kit

Indications For Use:

The STRATASIS™ Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K020654

OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use