REPLICATION MEDICAL VESSEL GUARD

K082782 · Replication Medical, Inc. · OMR · Apr 2, 2009 · Cardiovascular

Device Facts

• Record ID: K082782
• Device Name: REPLICATION MEDICAL VESSEL GUARD
• Applicant: Replication Medical, Inc.
• Product Code: OMR · Cardiovascular
• Decision Date: Apr 2, 2009
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.

Device Story

EnGuard Vessel Guard is a biocompatible implantable device used as a cover for vessels during anterior vertebral surgery. It is designed to provide a protective barrier for vascular structures. The device is available in multiple sizes. It is intended for use by surgeons in an operating room setting. The device is placed over vessels to provide coverage; it does not claim to reduce post-operative adhesion formation. Clinical benefit is derived from its function as a protective vessel cover.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed material suitability for long-term implantation. Suture pullout testing demonstrated mechanical equivalence to predicate devices. No clinical data provided.

Technological Characteristics

Biocompatible material; implantable vessel cover; available in multiple sizes; mechanical fixation via sutures.

Indications for Use

Indicated for use as a cover for vessels following anterior vertebral surgery.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• PRECLUDE Vessel Guard (K061727)
• PRECLUDE IMA Sleeve (K960532)

Submission Summary (Full Text)

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## Replication Medical Vessel Guard 510(k) Summary K082782

APR - 2 2009

| Device Manufacturer: | Replication Medical, Inc.<br>7 Clarke Drive<br>Cranbury, NJ 08512 | |
|----------------------|-------------------------------------------------------------------|--|
| Submission Date: | September 11, 2008 | |
| Contact Person: | Ann Prewett<br>Tel: [phone] Fax: [phone] | |
| Proprietary Name: | Replication Medical Vessel Guard | |
| Common Name: | Vessel Guard | |
| Device Class: | Class III | |
| Product Codes: | MFX | |

## Device Description and Intended Use:

The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.

### Technological Characteristics

The Replication Medical Vessel Guard is similar to legally marketed devices as listed below in that they share similar indications for use and incorporate similar technological characteristics. Biocompatibility testing was conducted and the testing indicated that the material is suitable for long term implantation. Suture pullout testing was also performed and the testing confirmed that the Vessel Guard is equivalent to predicate devices.

### Substantial Equivalence Information:

| Trade/Proprietary Name | Manufacturer | 510(K) # | Clearance Date |
|------------------------|-----------------------------|----------|----------------|
| PRECLUDE Vessel Guard | W.L. Gore & Associates, Inc | K061727 | 8/7/2006 |
| PRECLUDE IMA Sleeve | W.L. Gore & Associates, Inc | K960532 | 5/23/1996 |

The Replication Medical Vessel Guard is similar to the devices listed in the table below.

The safety and effectiveness of Vessel Guard is based upon the determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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" arranged in a circle around the eagle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2009

Replication Medical Inc. c/o M Squared Associates, Inc. 901 King Street Suite 200 Alexandria, VA 22314 Attn: Mr. Marcos Velez-Duran

Re: K082782

Trade Name: EnGuard™ Vessel Guard Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: II Product Code: OMR Dated: February 24, 2009 Received: February 25, 2009

Dear Mr. Velez-Duran:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section-513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling and any promotional materials:

The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established.

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Furthermore, the indication for use as a cover for vessels following anterior vertebral r urthermore, the mersanntly displayed in all labeling, including pouch box, and carton sures, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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 (1 will) with and be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Jour device TDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does r loase of 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 I vartal 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276your device (2) OF R Party of regulation entitled, "Misoranding by reference to premarket of 20. "Thise note the the regard". You may obtain other general information on your

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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,

Christy Foreman for

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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Page 4 - Mr. Marcos Velez-Duran

# Indications for Use

510(k) Number (if known):_K082782

Device Name: EnGuard™ Vessel Guard

Indications For Use: The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.

Prescription Use _ V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

R. v. Ames

summer (Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices K08278

510(k) Number.