ULTRAPRO PLUG

K070224 · ETHICON, Inc. · FTL · Apr 17, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070224
• Device Name: ULTRAPRO PLUG
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.

Device Story

ULTRAPRO Plug is a sterile, partially absorbable surgical mesh implant; consists of a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. Used in open surgical repair of groin hernia defects to fill and reinforce tissue. Implanted by surgeons in an operating room setting. Device provides mechanical support to hernia site; absorbable and nonabsorbable polymer composition facilitates tissue integration and repair. Benefits include reinforcement of inguinal hernia defects during open surgical procedures.

Clinical Evidence

No clinical data. Biological reactivity assessed per ISO 10993-1. Functional performance verified via bench and animal testing.

Technological Characteristics

Partially absorbable surgical mesh; composed of nonabsorbable and absorbable polymers. Form factor includes a thermoformed 3D plug and a flat, preshaped onlay patch. Sterilized. Materials assessed for biological reactivity per ISO 10993-1.

Indications for Use

Indicated for open repair of groin hernia defects in patients requiring surgical reinforcement of hernia sites.

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

• ULTRAPRO Mesh (K033337)
• BARD Mesh PerFix Plug (K922916)

Submission Summary (Full Text)

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K070224

# Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

#### Submitted by:

Bryan A. Lisa Sr. Regulatory Affairs Associate ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

APR 1 7 2007

# Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (FTL)

#### Trade Name:

ULTRAPRO* Plug

## Predicate Devices:

ULTRAPRO* Mesh (ETHICON, Inc.) - K033337 BARD Mesh PerFix Plug (Davol, Inc.) - K922916

#### Statement of Intended Use:

ULTRAPRO Plug is a partially absorbable device used to fill and reinforce inguinal hernia defects. ULTRAPRO Plug is indicated for open repair of groin hernia defects.

## Device Description:

The ULTRAPRO Plug device is composed of two sterile components: a thermoformed, three-dimensional plug and a flat, preshaped onlay patch. The ULTRAPRO Plug device is indicated for the open repair of groin hernia defects.

## Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a sterile, mesh implant intended for the repair of hernia defects. The proposed device is made of nonabsorbable and absorbable polymers, which are identical to those found in ULTRAPRO Mesh, currently marketed by ETHICON, Inc.

#### Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements.

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K070224

BAL-2007-001

22

# Conclusions:

Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

.

:

* Trademark of ETHICON, Inc.

#### 510(K) SUMMARY

.. .

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon, Inc. % Mr. Bryan A. Lisa Sr. Regulatory Affairs Associate Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

APR 1 7 2007

Re: K070224

Trade/Device Name: ULTRAPRO* Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2007 Received: April 9, 2007

Dear Mr. Lisa:

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.

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 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); 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,

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Page 2 - Mr. Bryan A. Lisa

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Pete O Rum

Mark N. Melkerson
Director

m
D&P Dir
4/1/09

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K870224

Device Name: ULTRAPRO* Plug

Indications for Use:

ULTRAPRO Plug is indicated for open repair of groin hernia defect

hernia defects.

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

*Trademark.

510(k) Number

(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)