POPMESH

K053424 · Caldera Medical, Inc. · FTL · Feb 22, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053424
• Device Name: POPMESH
• Applicant: Caldera Medical, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route. POPmesh™ is a prescriptive device and should only be used by a licensed physician.

Device Story

POPmesh is a non-absorbable surgical mesh constructed from knitted monofilaments of extruded polypropylene. Device provides support for fascial deficiencies; used in abdominal wall hernia repair (inguinal, femoral, incisional) and uterovaginal prolapse. Warp-knit construction allows cutting into desired shapes/sizes without unraveling; maintains isotropic properties, strength, flexibility, and durability. Supplied sterile for use by licensed physicians in open, laparoscopic, or vaginal surgical procedures. Device acts as a permanent implant to reinforce tissue and manage stresses encountered in the body.

Clinical Evidence

Bench testing only. Biocompatibility and physical testing performed in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.

Technological Characteristics

Non-absorbable polypropylene monofilament mesh; warp-knit construction; isotropic properties; sterile; Class II device per 21 CFR 878.3300.

Indications for Use

Indicated for patients requiring surgical repair of abdominal wall hernias (inguinal, femoral, incisional), uterovaginal prolapse, and other fascial deficiencies requiring support material. For use by licensed physicians in open, laparoscopic, or vaginal procedures.

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

• Minimesh® Polyproylene Mesh (K041362)
• Prolene® (K001122)
• Vypro® II (K002672)

Submission Summary (Full Text)

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

Caldera Medical, Inc. POPmesh 510(K)

K05 3424
Page 1 of 2

# FEB 2 2 2006

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTED BY: | Caldera Medical, Inc.<br>28632 Roadside Drive, Suite 260<br>Agoura Hills, CA 91301 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Marla Kengen |
| DATE PREPARED: | October 12, 2005 |
| CLASSIFICATION: | Polymeric Surgical Mesh (Product Code FTL) is a Class II<br>device per 21 CFR 878.3300 |
| COMMON NAME: | Polymeric Surgical Mesh |
| PROPRIETARY NAME: | POPmeshTM |
| PREDICATE DEVICES: | K041362 Minimesh® Polyproylene Mesh<br>(Mpathy Medical Devices Limited)<br>K001122 Prolene® (Ethicon , Inc.)<br>K002672 Vypro® II (Ethicon, Inc.) |
| DEVICE<br>DESCRIPTION: | POPmeshTM is a non-absorbable polypropylene mesh<br>constructed from knitted monofilaments of extruded<br>polypropylene. |
| | POPmeshTM is constructed using a warp- knit process to a<br>unique design that permits the mesh to be cut into any desired<br>shape or size without unraveling. |
| | It maintains excellent isotropic properties arising from its<br>knitted construction. |
| | POPmeshTM has the necessary strength, flexibility, durability<br>and surgical adaptability. These properties permit the correct<br>adaptation to the various stresses encountered in the body. |
| | The device is supplied sterile. |

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

#### Caldera Medical, Inc. POPmesh 510(K)

510(k)

K053424
page 2 of 2

#### 510(k) SUMMARY OF SAFETY & EFFECTIVENESS cont.

POPmesh™ may be used for the repair of abdominal wall hernia, INTENDED USE: including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

> POPmesh™ is a prescriptive device and should only be used by a licensed physician.

POPmesh™ has the same indications as its predicate device, Minimesh, Mpathy Corp.

The patient contact materials used in this device are the same TESTING: materials as the predicate detailed. Polypropylene has a long history of biocompatibility.

> Testing has been performed on the POPmesh™ for biocompatibility as well as appropriate physical testing as outlined in the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

Caldera Medical, Inc. c/o Ms. Marla Kengen Project Leader 28632 Roadside Drive, Suite 260 Agoura Hills, California 91301

Re: K053424

Trade/Device Name: Caldera Medical, Inc. POPmesh™M Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 27, 2006 Received: January 31, 2006

Dear Ms. Kengen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to ttg ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . conninered prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrolore, mains of the Act include requirements for annual registration. listing of general controll provisive, 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 such additional controls. Existing major regulations affecting your device n may be sucjoet to basil 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 i least of advised that I Drivisation that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any it ederal statutes and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITC Fatt 6075, accems (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 - Ms. Kengen

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to organ maining of substantial equivalence of your device to a legally promative notification."> > results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrice for your 240) 276-0115. Also, please note the regulation entitled, Comact the Office of Complains and (E+) notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

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

Enclosure

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

### Caldera Medical, Inc. POPmesh 510(K)

## Indications for Use

510(k) Number: *K053424*

Device Name: Caldera Medical, Inc. POPmesh™

Indications for Use:

POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require temoral, and the sional decrovagnial processo and consection of procedures of for repair by the vaginal route.

AND/OR X ___ Prescription Use (Part 21 CFR 801 Subpart D)

()ver-The-Counter Use (21 CFR 807 Subpart C )

(PLEASE DO NOT WRITE BELOW THIS) LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Device Evaluation (ODE) Concurrence of C

> > (Division Sign-Division of General, Restorative, and Neurological Devices

| 510(k) Number | k053424 |
|---------------|---------|
|---------------|---------|

Page 28

Confidential