REFINE LIFT SYSTEM

K083102 · Alure Medical, Inc. · FTL · May 11, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083102
• Device Name: REFINE LIFT SYSTEM
• Applicant: Alure Medical, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.

Device Story

Refine™ Support System comprises non-absorbable surgical mesh and suture anchor; delivery system included. Used for reinforcement of soft tissue during plastic or reconstructive surgical procedures. Device provided sterile for single use. Operates as mechanical implant to provide structural support to soft tissue. Clinical benefit derived from reinforcement of tissue sites. No software or electronic components involved.

Clinical Evidence

Bench testing and cadaver evaluations performed to substantiate performance requirements and user needs. No clinical trial data provided.

Technological Characteristics

Non-absorbable polymeric surgical mesh and suture anchor. Single-use, sterile delivery system. Mechanical implant design consistent with existing 21 CFR 878.3300 surgical meshes.

Indications for Use

Indicated for reinforcement of soft tissue in plastic or reconstructive procedures. Patient population not specified.

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

• SupraMesh EXTRATM (K080216)
• INFINIT Mesh (K081069)
• Prolene™ Soft (polypropylene) Mesh (K001122)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

MAY 11 2009

| General Information | |
|--------------------------------------|----------------------------------------------------------------|
| Submitter/Manufacturer Name/Address: | Alure Medical, Inc.<br>2445 Impala Drive<br>Carlsbad, CA 92010 |
| Alternate Manufacturing Location: | Alure Medical, Inc.<br>3637 Westwind Blvd., Suite B |

Establishment Registration Number:

Contact Person:

Phone Number:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

Santa Rosa, CA 95403

Not Available

Jasper Benke

[phone]

October 17, 2008

Refine™ Support System

Surgical Mesh

Mesh, Surgical, Polymeric, (21 CFR 878.3300, Product Code FTL)

## Predicate Device Information

K080216 SupraMesh EXTRATM K081069 INFINIT Mesh K001122 Prolene™ Soft (polypropylene) Mesh

### Product Description

The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant consists of a mesh and suture anchor. The device and the delivery system are delivered sterile and are for single use only.

### Intended Use

The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.

#### Substantial Equivalence

## Indications

Indications for use of the Refine™ Support System are similar to those of the predicate devices and have been substantiated by performance evaluations and comparison studies.

{1}------------------------------------------------

K083102 Page 2/2

## Technological Characteristics

In establishing substantial equivalence to the predicate devices, Alure Medical evaluated the materials, technology, and specifications of the subject and predicate devices. The technological characteristics are similar to many non-absorbable, implantable devices used in the reinforcement of soft tissue.

## Performance

The Refine™ Support System is considered substantially equivalent in performance to the predicate devices. The device conforms to specifications and meets clinical user needs and intended uses. Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance.

## Summary of Safety and Effectiveness

Indications for use, technological characteristics, and performance evaluations of the Refine™ Support System show that the device is substantially cquivalent to the predicate devices. Any differences arc minor and do not raise any additional concerns regarding safety or effectiveness of the device.

#### CONFIDENTIAL - Alure Medical, Inc.

H

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font.

Public Health Service

11 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alure Medical Inc. % Mr. Jasper Benke Director, Regulatory Affairs, Quality Assurance & Clinical Affairs 2445 Impala Drive Carlsbad, California 92010

Re: K083102

Trade/Device Name: Refine™ Support System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 7, 2009 Received: May 8, 2009

Dear Mr. Benke:

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 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 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.

{3}------------------------------------------------

Page 2 - Mr. Jasper Benke

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

For D. Whinn

Mark N. Melkerson Division of General, Restorativ and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number:

K083102

Device Name:

Refine™ Support System

Indications for Use:

The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.

Prescription Use × (Part 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)

Daniel Keane for mxm

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

510(k) Number K053102