VICRYL * MESH BAG

K051701 · ETHICON, Inc. · FTL · Sep 29, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051701
• Device Name: VICRYL * MESH BAG
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).

Device Story

VICRYL Mesh Bag consists of polyglactin 910 mesh, a synthetic absorbable copolymer, preshaped to fit kidney, spleen, or liver; integrated VICRYL sutures threaded along mesh periphery facilitate organ support. Device provides temporary structural support to solid organs; used by surgeons in clinical settings. Material is inert, nonantigenic, and nonpyrogenic, eliciting minimal tissue reaction during absorption. Benefit includes simplified application for organ containment or support compared to standard mesh.

Clinical Evidence

No clinical data. Substantial equivalence is supported by performance data from the predicate device.

Technological Characteristics

Material: Polyglactin 910 (synthetic absorbable copolymer of glycolide and lactide). Form: Preshaped mesh with integrated VICRYL sutures. Principle: Mechanical support for solid organs. Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for temporary wound or solid organ support of the kidney, liver, or spleen.

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

• VICRYL Mesh

Submission Summary (Full Text)

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KOS1701

# SEP 2 9 2005

#### SUMMARY OF SAFETY AND EFFECTIVENESS

# 510(k) 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. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

NEW DEVICE NAME: VICRYL* Mesh Bag

PREDICATE DEVICES NAME: VICRYL Mesh

#### Device Description

VICRYL Mesh Bag consists of a VICRYL Mesh adapted to the form and size of kidney, spleen, or liver and tied with VICRYL sutures (dyed and undyed).

The integrated strands of VICRYL sutures are threaded along the periphery of the mesh, which facilitates its use as organ support for the kidney, spleen, or liver. The VICRYL Mesh is prepared from polyglactin 910, a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic acid and lactic acids. The mesh is prepared from uncoated, undyed fiber identical in composition to that used in VICRYL (polyglactin 910) synthetic absorbable suture, which has been found to be inert, nonantigenic, and nonpyrogenic and to elicit only a milc tissue reaction during absorption.

#### Intended Use

VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).

#### Indications Statement

VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).

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#### Technological Characteristics

VICRYL Mesh Bag has similar technological characteristics as the predicate device. The VICRYL Mesh Bag is essentially VICRYL Mesh that has been preshaped to specific sizes to facilitate its application.

#### Performance Data

Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended.

#### Conclusions

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act.

### Contact

Jennifer Paine Manager, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 908-218-3323

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2005

Ms. Jennifer M. Paine, M.S. Manager, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876

Rc: K051701

Trade/Device Name: VICRYI Mesh Bag Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 26, 2005 Received: August 29, 2005

Dear Ms. Paine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became of one device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 28, 1976. the enactment date of the Medical Device Amendments, or to commerce pror co may 2011-11-11 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 1 ou may outrols 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 may be sabyeet to back at 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 hat 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 or any I 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 form in the qualify by over provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Jennifer M. Paine, M.S.

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to begin manisting your device of your device to a legally premits tourneadon. The PIPA mainig of cation 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 advice for your do november 10 - 11 5. Also, please note the regulation entitled, Colliact the Office of Complance at (21 t ) stiffication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millersen

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

Enclosure

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# KOS1701

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VICRYL Mesh Bag

Indications for Use:

VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).

#### AND/OR Over-The-Counter Use _ Prescription Use X . (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkman

(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices man 510(k) Number_ KOS1701