BIOARC SP SLING KIT

K030123 · American Medical Systems, Inc. · OTN · Feb 6, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030123
• Device Name: BIOARC SP SLING KIT
• Applicant: American Medical Systems, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Feb 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

BioArc SP Sling Kit is a sterile, single-use surgical kit for treating female stress urinary incontinence. Kit includes two stainless steel curved needle passers and two polypropylene sling Y-meshes. One end of the Y-mesh features a clamp for attaching a physician-selected biologic tissue graft; the opposite end has a dilating connector that attaches to the needle passer to facilitate placement. A fixed polypropylene tensioning suture runs through the mesh, which is protected by a plastic sheath during insertion. Used in a clinical setting by a physician; the device utilizes the same suprapubic surgical approach as the predicate SPARC system. The sling provides mechanical support to the urethra to restore continence.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Polypropylene (sling mesh, tensioning suture), stainless steel (needle passers), plastic (sheath). Design: Y-shaped mesh with dilating connector and graft clamp. Energy source: None (mechanical). Connectivity: None. 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

• SPARC™ Sling System (K011251, K013355, K020663, K021263)

Submission Summary (Full Text)

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KC30123

AMERICAN MEDICAL SYSTEMS

# 510(k) SUMMARY

| Submitter's Name: | American Medical Systems, Inc. FEB 06 2003 |
|------------------------------|-------------------------------------------------------------|
| Address: | 10700 Bren Road West<br>Minnetonka, MN 55343 |
| Tel: | 952-933-4666 |
| Fax: | 952-930-6496 |
| Contact Person: | David Worrell |
| Date of Summary Preparation: | January 13th, 2003 |
| Device Common Name: | Surgical Mesh, Sling, Urethral Sling |
| Device Trade Name: | BioArc SP™ Sling Kit |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | SPARC™ Sling System - K011251, K013355,<br>K020663, K021263 |

#### Device Description

The BioArc SP Sling Kit is a sterile, single use procedure kit consisting of two stainless steel. 22cm curved needle passers (also called insertion tools) and two AMS Polypropylene sling Y-mesh. At one end of the sling Y-mesh, a clamp is attached by polypropylene suture to each leg of the "Y". The clamp is used for suturing a tissue graft to the sling Y-mesh. A dilating connector is attached to the opposite end of the sling Y-mesh. The dilating connector secures to the keyed end of the BioArc SP needle passer during the procedure to facilitate sling placement. A fixed polypropylene tensioning suture runs through the middle of each sling Y-mesh. A plastic sheath covers each sling Y-mesh and protects it during placement. The same suprapubic approach used to place the SPARC sling mesh is used to place the BioArc SP sling Y-mesh.

#### Indications for Use

The BioArc SP Sling Kit is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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K030123

### AMERICAN MEDICAL SYSTEMS

# Comparison to Predicate Device

The fundamental scientific technology of the BioArc SP Y-mesh and needle passers is unchanged from the predicate device(s). The primary change to the addition of the "Y" to one end of the sling mesh. The Y-end allows the physician to suture biologic graft material of their choice between the two pieces of 1.1cm x 22cm sling Y-mesh. The needle passers used with BioArc SP sling Y-mesh are the same as the ones used with SPARC sling mesh. BioArc SP sling Y-mesh uses the same suprapubic approach and surgical procedure for placement as the SPARC sling mesh.

#### Supporting Information

A risk analysis for the BioArc SP and the verification and validation activity reported in this Special 510(k) application substantiate equivalence to the predicate and did not raise any new questions of safety or effectiveness.

### Conclusion

The BioArc SP Sling Kit is substantially equivalent to the predicate with respect to intended use, technological characteristics and performance.

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

Mr. David Worrell Sr. Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

SEP 28 202

Re: K030123 Trade/Device Name: BioArc SP™ Sling Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: January 13, 2003 Received: January 14, 2003

Dear Mr. Worrell:

This letter corrects our substantially equivalent letter of February 6, 2003.

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/ResourcesforYou/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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## INDICATIONS FOR USE ENCLOSURE

| 510(k) Number: | K434123 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | BioArc™ SP Sling Kit |
| Indications for Use: | The BioArc™ SP Sling Kit is intended for the placement of a pubourethral sling 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 C. Provost

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

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