MINIARC PRO SINGLE-INCISION SLING SYSTEM

K121641 · American Medical Systems · PAH · Sep 7, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121641
• Device Name: MINIARC PRO SINGLE-INCISION SLING SYSTEM
• Applicant: American Medical Systems
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MiniArc® Pro 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 Pro is a surgical mesh system for treating female stress urinary incontinence. Device consists of a polypropylene monofilament mesh with self-fixating tips and an integrated elongation feedback system. During surgery, a delivery tool (needle) places the mesh into the obturator internus muscle. The elongation feedback system allows the surgeon to objectively measure and adjust sling tension intraoperatively; this component is removed before closing the vaginal incision. The mesh remains as a permanent implant to support the urethra. Used in clinical settings by physicians. Benefits include improved tensioning control during implantation.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including sterilization, shelf life, biocompatibility, and performance testing of the feedback system (repeatability, attachment, dimensional, removal force, stiffness). Cadaver evaluation was also conducted.

Technological Characteristics

Polypropylene Type I monofilament mesh; polycarbonate delivery tool handle; stainless steel needle with molded barb guards. Includes an elongation feedback system (polypropylene aperture, backer plate, removal suture/tab). Sterilized via ethylene oxide (EO) with SAL > 10^-6. Single-incision transobturator-like approach.

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 Precise Single-Incision Sling System (K100807)

Submission Summary (Full Text)

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

# 510(k) Number: K121641

## Date Prepared:

August 2, 2012

#### Submitter Information:

Submitter's Name/ Address:

American Medical Systems 10700 Bren Road W. Minnetonka, MN 55343

Contact Person:

Renee Mellum Sr. Regulatory Affairs Associate Tel: [phone] Fax: [phone] Renee. Mellum(a)AmericanMedicalSystems.com

Alternate Contact:

Josh Clarin Manager, Regulatory Affairs Tel: [phone] Fax: [phone] Josh. Clarin(@AmericanMedicalSystems.com

## Device Information:

Trade Name: Common Name: Classification Name:

Class: Product Code: MiniArc® Pro Single-Incision Sling System Surgical Mesh Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Single-Incision Mini-Sling Class II / 21 CFR & 878.3300 PAH

#### Predicate Device:

MiniArc Precise Single-Incision Sling System (K100807)

#### Device Description:

The MiniAre Pro Sling System is designed to treat female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is comprised of a piece of polypropylene monofilament mesh with polypropylene self-fixating tips (anchors), a mid-line mark, and elongation feedback system. The elongation feedback system is attached to the sling intraoperative adjustment/tensioning and allows for objective measurement of sling elongation during the implant procedure. The sling is intended to remain in the body as a permanent implant with the polypropylene self-fixating tips providing short-term fixation prior to tissue in-growth. The elongation feedback system is intended to be removed prior to closure of the vaginal incision. The delivery tool (needle) is designed to interface with the self-fixating tips and deliver it to the obturator internus muscle, retaining the self-fixating tip until it is selectively released by the physician.

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7 2012

SEP

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

# Indications for Use:

The MiniArc® Pro 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).

# Comparison to the Predicate Device:

The MiniArc Pro Single-Incision Sling System intended use and indication for use is identical to that of the predicate device. In addition, the MiniArc Pro Single-Incision Sling System utilizes many of the same materials, design principles and fundamental scientific technology as the predicate K100807.

| Device Characteristic | Subject Device:<br>MiniArc Pro | Predicate Device:<br>MiniArc Precise<br>K100807 |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The MiniArc Pro Single-Incision Sling<br>System is intended for the placement of a<br>sub-urethral mesh for the treatment of<br>female stress urinary incontinence (SUI)<br>resulting from urethral hypermobility<br>and/or intrinsic sphincter deficiency<br>(ISD). | The MiniArc Precise Single-Incision Sling<br>System is intended for the placement of a<br>sub-urethral mesh for the treatment of<br>female stress urinary incontinence (SUI)<br>resulting from urethral hypermobility<br>and/or intrinsic sphincter deficiency (ISD). |
| Device Design<br>Mesh Assembly:<br>• Mesh | Polypropylene, Type I monofilament | Polypropylene, Type I monofilament |
| Device Design<br>Mesh Assembly:<br>• Self-Fixating Tip | Polypropylene, Type I monofilament | Polypropylene, Type I monofilament |
| Device Design<br>Mesh Assembly:<br>• Midline Mark | Printed, Blue | Printed, Blue |
| Device Design<br>Delivery Tool:<br>• Handle | Polycarbonate with over-mold | Polycarbonate with over-mold |
| Device Design<br>Delivery Tool:<br>• Needle, material | Stainless Steel with molded barb guards | Stainless Steel with molded barb guards |
| Device Design<br>Feedback System | Polypropylene aperture, backer plate,<br>removal suture, removal tab | Not Present |
| Fundamental<br>Technology | Self fixation urethral mesh sling | Self fixation urethral mesh sling |
| Procedure | Transobturator-like approach | Transobturator-like approach |
| Packaging<br>Materials | PETG tray and Tyvek lid | PETG tray and Tyvek lid |
| Packaging<br>Configuration | Single sterile barrier configuration | Single sterile barrier configuration |

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510(k) Summary As required by 21CFR 807.92(c)

| Device Characteristic | Subject Device:<br>MiniArc Pro | Predicate Device:<br>MiniArc Precise<br>K100807 |
|-----------------------|--------------------------------|-------------------------------------------------|
| Sterilization | EO with SAL > $10^{-6}$ | EO with SAL > $10^{-6}$ |

## Summary of Non-Clinical Testing:

Bench testing was performed to support this submission. Results of the testing demonstrate that the MiniArc Pro Single-Incision Sling System meets product specification and performance requirements.

The following testing has been successfully completed:

- Sterilization .
- Shelf Life .
- Biocompatibility ●
- Performance Testing (Bench) .
- Feedback System Repeatability O
- Feedback System Attachment O
- Feedback System Dimensional O
- Feedback System Removal Force 0
- Feedback System Stiffness O
- Performance Testing (Cadaver) �
- Physician Questionnaire 0
- Cadaver Evaluation O

## Clinical Testing:

No clinical testing was performed to support this Traditional Premarket Application.

### Statement of Equivalence:

The MiniArc® Pro Single-Incision Sling System has the identical indications for use and fundamental scientific technology as the predicate device. Based on this and the design and engineering data provided in the pre-market notification, the MiniArc® Pro Single-Incision Sling System has been shown to be substantially equivalent.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

Ms. Renee Mellum Senior Regulatory Affairs Associate American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343

SEP 7 2012

Re: K121641

Trade/Device Name: MiniArc® Pro Single-Incision Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: August 3, 2012 Received: August 7, 2012

Dear Ms. Mellum:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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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 n you attp://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" (21CFR 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 K. Fisher

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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# Section 4

# 510(k) Number: TBD K121641

Device Name: MiniArc® Pro Single-Incision Sling System

# Indications for Use:

The MiniArc Pro 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).

Prescription Use X (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)

Aran Whang
(Division Sign Off)

Gastro-Renal, and 0(k) Number

MiniArc Pro Single-Incision Sling System American Medical Systems June 1, 2012

Confidential