MODIFICATION TO SPARC SLING SYSTEM

K021263 · American Medical Systems, Inc. · OTN · May 15, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021263
• Device Name: MODIFICATION TO SPARC SLING SYSTEM
• Applicant: American Medical Systems, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPARC™ Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

SPARC™ Sling System is a sterile, single-use surgical kit for treating female stress urinary incontinence. Kit includes two stainless steel curved needle passers and a polypropylene monofilament mesh sling (1.1 cm x 50 cm) with a central tensioning suture and protective plastic sheaths. Dilating connectors attach the mesh to needle passers for placement. Used by surgeons in clinical settings to position the sling suburethrally. Device provides mechanical support to the urethra to restore continence. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarity to predicate devices.

Technological Characteristics

Materials: Polypropylene monofilament mesh, stainless steel needle passers. Dimensions: 1.1 cm width x 50 cm length mesh. Principle: Mechanical suburethral support. Sterilization: Sterile, single-use kit.

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

• SPARC™ Sling System (K011251)
• SPARC™ Sling System (K013351)
• SPARC™ Sling System (K020663)

Submission Summary (Full Text)

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MAY 1 5 2002

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AMERICAN MEDICAL SYSTEMS

## 510(k) SUMMARY

| Submitter's Name: | American Medical Systems, Inc. |
|------------------------------|---------------------------------------------------|
| Address: | 10700 Bren Road West<br>Minnetonka, MN 55343 |
| Tel: | 952-930-6120 |
| Fax: | 952-930-6496 |
| Contact Person: | Mark McIntyre |
| Date of Summary Preparation: | April 19, 2002 |
| Device Common Name: | Surgical Mesh, Sling, Urethral Sling |
| Device Trade Name: | SPARC™ Sling System |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | SPARC™ Sling System - K011251, K013351<br>K020663 |

## Device Description

The SPARC™ Sling System as currently marketed is a sterile, single use procedure kit consisting of:

- Two stainless steel, curved, 22-cm long, needle passers (also called insertion . tools).
- One piece of AMS Polypropylene sling mesh with attached dilating . connectors. The AMS Polypropylene sling mesh is constructed of polypropylene monofilament that is precut to 1.1 cm width x 50cm length. A fixed blue polypropylene tensioning suture runs through the middle of the sling mesh. Two plastic sheaths that overlap in the center of the sling mesh, cover the sling mesh and protect it during placement.

Dilating connectors are attached to either end of the plastic sheaths. The dilating connectors are used to attach to the vaginal ends of the SPARC™ needle passers during the procedure to facilitate sling placement.

- In K013355, two blue colored plastic cystoscopy aids are included in the kit in ● order to facilitate cystoscopic viewing of the bladder. The use of these cystoscopy aids is optional. The proposed device that is the subject of this 510k will not include the cystoscopy aids.

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

Mr. Mark McIntyre Director, Regulatory Affairs and Biostatistics American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

SEP 2 8 2012

Re: K021263 Trade/Device Name: SPARCTM Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 19, 2002 Received: April 22, 2002

Dear Mr. McIntyre:

This letter corrects our substantially equivalent letter of May 15, 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 intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonton 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, FTDA 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. Rooks

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 ENCLOSURE '

Ko2/263

510(k) Number:

Device Name:

SPARC™ Sling System

Indications for Use:

The SPARC™ Sling System is intended for the placement of a The SFARO - Oling for the treatment of female stress urinary incontinence (SUI) 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) (Division Sign-off) Division of General and Restorative Devices

> > 510(k) Number _

Prescription Use (Per 21 CFR801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

miriam (

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

510(k) Number -