MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.

K051530 · American Medical Systems, Inc. · OTN · Jul 8, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051530
• Device Name: MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195.
• Applicant: American Medical Systems, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Jul 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Monarc and BioArc TO Subfascial Hammocks are 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

Suburethral sling system for treating female stress urinary incontinence (SUI). Components include two stainless steel curved needle passers and a mesh or mesh/graft sling assembly. Used in a transobturator surgical approach. Operated by physicians in a clinical/surgical setting. The device provides mechanical support to the urethra to address hypermobility or intrinsic sphincter deficiency. The system is an alternative configuration of previously cleared predicate devices, utilizing the same surgical approach and materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

System consists of stainless steel curved needle passers and a polymeric surgical mesh or mesh/graft sling assembly. Designed for transobturator surgical approach. 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

• MonarcTM Subfascial Hammock (K023516)
• BioArcTM TO Subfascial Hammock (K040538)

Submission Summary (Full Text)

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K051530

JUL - 8 2005

| 2.6 | 510(k) Summary | 1/2 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----|
| Submitter: | American Medical Systems<br>10700 Bren Road West<br>Minnetonka, MN 55343<br>Phone: [phone]<br>Fax: [phone] | |
| Contact Person: | Denise Thompson | |
| Date Summary Prepared: | June 8, 2005 | |
| Device Common Name: | Urethral Sling, Surgical Mesh | |
| Device Trade Name: | MonarcTM, MonarcTM +, and MonarcTM C<br>Subfascial Hammocks / BioArc TOTM,<br>BioArcTM TO +, and BioArc TO - C<br>Subfascial Hammocks | |
| Device Classification Name: | Surgical Mesh, polymeric | |
| Predicate Device: | MonarcTM Subfascial Hammock, K023516<br>BioArcTM TO Subfascial Hammock, K040538 | |

### Device Description:

Device Desoription...
The Monarc and BioArc TO Subfascial Hammocks are suburethral sling procedure that rne Moharo and Blor .. orgical approach to treat stress urinary incontinence. They are uses a transoblarator ourgrout approcessions of two stainless steel curved needle passers and a mesh or mesh and graft sling assembly.

#### Indications for Use:

Indications for Ooo.
The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of I he Monaro and arra and of female stress urinary incontinence (SUI) a ouburothral hypermobility and / or intrinsic sphincter deficiency.

## Comparison to Predicate Device:

Companson to Freditore Donoot.
The Monarc and BioArc TO + and C needle passers offer physicians alternative needle The Monaro and Dio. 16 To To The needle passers are all designed for a transobturator approach.

The Indications for Use, fundamental scientific technology, surgical approach, sling placement, and materials are all the same as the predicates.

#### Supporting Information:

Supporting Informlation / validation activities reported in this Special The hisk andication substantiate equivalence to the predicate devices and did not raise any new questions of safety or efficacy.

DMC
7/8/05

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K051530

# Conclusion:

The Monarc and BioArc TO + and C Subfascial Hammock versions are substantially equivalent to their predicates with respect to intended use, technological characteristics, and performance.

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Image /page/2/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 eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is simple and recognizable, conveying the department's authority and commitment to public service.

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

SEP 2 8 2012

Ms. Denise Thompson Regulatory Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343

Re: K051530

> Trade/Device Name: Monarc +, and Moncarc C Subfascial Hammocks and the BioArc TO, BioArc To +, and BioArc TO-C Subfascial Hammocks

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: June 8, 2005 Received: June 9, 2005

Dear Ms. Thompson:

This letter corrects our substantially equivalent letter of July 8, 2005.

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,

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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100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

#### INDICATIONS FOR USE STATEMENT 1.4

510(k) Number (if known):

Device Name: AMS Monarc +, and Monarc C Subfascial Hammocks and : AMS Monarc, Monarc +, and Monaro & Cubrial +
the BioArc TO, BioArc TO +, and BioArc TO - C Subfascial Hammocks

Indications For Use:

The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of
Children TO Subfascial Art of Supela strace urinery incontinence (SUI) The Monarc and BloAte TO Sublastian Hamouth of Semale Stress urinary incontinence (SUI)
a suburethral sling for the treatment of female stress urington deficiency a suburethral sling for the treathent of lomals of lomals strency.
resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

× Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use_ (21 CFR 807 Subpart C)

: : :

<Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypt. Rurder

(Division Division of General, Restorative. and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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