MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191

K100807 · American Medical Systems, Inc. · PAH · Jun 7, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100807
• Device Name: MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
• Applicant: American Medical Systems, Inc.
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Jun 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiniArc Precise™ Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Device Story

MiniArc Precise is a single-incision sub-urethral sling system for treating female stress urinary incontinence. System comprises a sterile knitted polypropylene monofilament mesh sling and a sterile stainless steel delivery tool with a plastic handle. Modifications from predicate include self-fixating tips for snap-fit connection to the delivery tool, an actuating needle tip release mechanism, and reinforced mesh arm knitting. Used by physicians in a clinical setting to place the mesh sling under the urethra; the sling remains as a permanent implant to support weakened connective tissue until tissue in-growth occurs. The delivery tool is used to position the sling in the obturator space. The device is single-use and non-absorbable.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, animal testing, and cadaver lab testing. Bench testing verified physical properties and performance. Animal testing confirmed equivalent tissue fixation and response. Cadaver lab testing validated the surgical procedure and the 'secure connection' mechanism of the self-fixating tips. Biocompatibility was assessed per ISO 10993-1.

Technological Characteristics

Materials: Knitted polypropylene monofilament mesh. Delivery tool: Stainless steel needle with plastic handle. Energy source: None (manual). Connectivity: None. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 10993-1 (biocompatibility), ISO 11607 (packaging), 21 CFR 820 (design controls).

Indications for Use

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

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

• MiniArc® Sling System (K070065)
• MiniArc® Sling System (K071902)
• MiniArc® Sling System (K073703)

Submission Summary (Full Text)

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## 510(k) Summary As required by 21 CFR 807.92 (b)

# 510(k) Number: K100807

| Date Revised: | June 2, 2010 | JUN - 7 2010 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Information: | | |
| Submitter's Name/<br>Address | American Medical Systems, Inc.<br>10700 Bren Road West<br>Minnetonka, MN 55434-USA | |
| Owner/Operator: | American Medical Systems, Inc.<br>10700 Bren Road West<br>Minnetonka, MN 55434-USA | |
| Manufacturing Sites: | American Medical Systems, Inc.<br>10700 Bren Road West<br>Minnetonka, MN 55434-USA<br>FDA Establishment Registration Number: 2183959 | |
| | Sterigenics US, Inc.<br>7775 South Quincy Street<br>Willowbrook, IL 60527<br>FDA Establishment Registration Number: 1450293 | |

# Submission Contact Information:

| Primary Contact: | Donna M. Semlak<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternative Contact: | Melanie Hess<br>Senior Manager Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |

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#### Device(s) Information:

| Trade Name: | MiniArc Precise™ Single-Incision Sling |
|----------------------|----------------------------------------|
| Common Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, Polymeric |
| Class: | Class II / 21 CFR § 878.3300 |
| Product Code: | PAH |

#### Predicate Device:

| Device Name | Submission Number | Clearance Date |
|-----------------------|-------------------|------------------|
| MiniArc® Sling System | K070065 | March 1, 2007 |
| MiniArc® Sling System | K071902 | August 24, 2007 |
| MiniArc® Sling System | K073703 | January 20, 2008 |

#### Device Description:

The MiniArc Precise Single-Incision Sling System (MiniArc Precise) is a modification of the currently commercialized device, MiniArc Single-Incision Sling System (MiniArc), which consist of one sterile mesh sling and one sterile surgical instrument · used for sub-urethral sling placement.

The minor modifications to MiniArc for the development of the MiniArc Precise are as follows:

- Self-fixating tips on the mesh sling are for a "secure connection" (snap-fit) to 0 the delivery tool needle tip.
- Delivery tool has an actuating needle tip release mechanism for the mesh sling. ●
- Mesh slings center-length dimensions are modified and the mesh sling arms 0 are knit with reinforcement fibers.

The MiniArc Precise is available in two configurations; each configuration contains one sterile mesh sling and one sterile delivery tool. The identical delivery tool is used with both configurations. The configurations are identified by the mesh sling option, either the short center-length mesh or the long center-length mesh. The mesh sling and mesh arms material for MiniAre Precise is the same knitted polypropylene monofilament material used in the predicate, MiniArc.

MiniArc Precise uses the same surgical approach and the same mesh placement procedures as the predicate device. MiniArc. The MiniArc Precise device is for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). MiniArc Precise device is for single use only and is not to be re-sterilized.

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#### Indications for Use:

#### Existing Indications for Use:

The MiniArc Sling System (MiniArc) 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 (ISD).

### Proposed Indications for Use:

There are no changes to the existing indications for use with the exception of the device name, as shown below:

The MiniArc Precise™ Single-Incision 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(ISD).

#### Comparison to Predicate Device:

The proposed MiniArc Precise and the predicate device, MiniArc, consist of one sterile mesh sling and one sterile surgical instrument (needle passer or deliver tool).

The MiniArc Precise and MiniArc devices are intended for the placement of a suburethral mesh sling under the female urethra, with self-fixating tips in the right and left obturator. The mesh sling is placed with the use of a surgical instrument. The surgical instrument is a stainless steel curved needle with an attached plastic handle. The tip portion of surgical instrument is configured to allow for secure connection and placement of the mesh sling. The mesh sling is a piece of knitted polypropylene mesh with self-fixating tips at each end. The mesh sling is intended to remain in the body as a permanent implant and is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.

These device systems are for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (1SD). These devices are for single use and are not to be re-sterilized.

- The MiniArc Precise has the same intended use, same implant materials, and same . • sterilization methods. The MiniArc Precise also uses similar manufacturing processes and similar delivery tool materials/characteristics to the predicate device, MiniArc.
## Summary of Non-Clinical Testing / Statement of Substantial Equivalence

The non-clinical testing included the assessment of the MiniArc Precise physical properties; ability to achieve its intended use; and substantial equivalence to the MiniArc predicate device.

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- Bench testing confirmed the product performance of the MiniArc Precise to be . suitable for its intended use: the same intended use as the predicate device.
- Animal testing confirmed the tissue fixation and tissue response is equivalent ● to the predicate device.
- Cadaver lab testing confirmed the surgical procedure, using the "secure ● connection" self-fixating tips to the delivery tool needle, is the equivalent to the predicate device.
- Biocompatibility assessment ensured the MiniArc Precise materials are ● biocompatible based on the similarity of the materials to the predicate device.

The following table is a summary of non-clinical testing conducted in accordance to industry standards/regulations:

| Test | Industry Standards |
|---------------------|------------------------------------------------------------------------------------------------------------------|
| Design Verification | Quality System Requirements FDA 21 CFR Part 820.20 EN ISO<br>13485: 2003; Design Controls FDA 21 CFR Part 820.30 |
| Device Performance | Quality System Requirements FDA 21 CFR Part 820.20 EN ISO<br>13485: 2003; Design Controls FDA 21 CFR Part 820.30 |
| Animal Model | FDA 21 CRR: Part 58 Good Laboratory Practice Regulations |
| Packaging | ISO 11607: 2006 Part 1 and Part 2: Packaging for Terminal<br>Sterilized Medical Devices |
| Shelf Life | ISO 11607: 2006 Part 1, 6.4 Stability Testing |
| Biocompatibility | ISO 10993-1: 2009 Biological Evaluation of Medical Devices. |
| Sterilization | ISO 11135: Medical Devices - Validation and Routine Control of<br>Ethylene Oxide Sterilization and EN ISO 13485. |

The proposed MiniArc Precise device performance, intended use and fundamental scientific technology remain unchanged from the predicate device. The proposed modifications do not change the mesh fixation mechanism found in the predicate device, MiniArc. The tissue fixation element fixates the mesh until tissue in-growth occurs through the pores of the mesh. The mesh sling will still be used as a supporting framework in areas where the connective tissue has weakened or ruptured. The mesh sling, with self-fixating tips, is intended to remain in the body as a permanent implant.

American Medical Systems considers the MiniArc Precise product performance to be significantly equivalent to the predicate device, MiniArc, because there are no changes to the product performance specifications; device intended use; or device functional scientific technology.

### Conclusion

The above non-clinical testing for the MiniArc Precise demonstrates product performance to be substantially equivalent and demonstrates that it is as safe and effective as the predicate device. MiniArc.

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

American Medical Systems, Inc. % Ms. Donna Semlak Senior Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55434

SEP 2 8 2012

Re: K100807

Trade/Device Name: MiniArc Precise™ Single-Incision Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: April 23, 2010 Received: April 26, 2010

Dear Ms. Semlak:

This letter corrects our substantially equivalent letter of June 7, 2010.

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. 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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K100807
p. 1. f 1

Indications for Use Statement

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Name of Devices:

Indications for Use:

MiniArc Precise™ Single-Incision Sling System

The MiniArc Precise™ Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Prescription Use X (Part 21 CFR 801 Subpart D)

## AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

Daniel Kione for MKCM

(Division Slyn-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K100807

Trade Secret/Confidential

American Medical Systems