SHELHIGH NO-REACT BIOCUFF

K032893 · Shelhigh, Inc. · FTL · Dec 19, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032893
• Device Name: SHELHIGH NO-REACT BIOCUFF
• Applicant: Shelhigh, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery.

Device Story

Shelhigh EnCuff Patch is a cross-linked xenograft pericardium surgical mesh; treated with No-React anticalcification process; provided sterile in 2% benzyl alcohol solution. Used by surgeons in clinical settings for soft tissue reinforcement and rotator cuff repair. Acts as a non-resorbable scaffold to support tissue repair; provides tensile strength and suture retention; reapproximates well around suture holes. Benefits patient by reinforcing weakened soft tissue structures.

Clinical Evidence

Bench testing only. Device demonstrated good tensile strength, shrink temperature, and suture retention. Material is soft, pliable, and exhibits biocompatibility.

Technological Characteristics

Cross-linked xenograft pericardium; No-React anticalcification treatment; provided in 2% benzyl alcohol solution; non-resorbable scaffold; high tensile strength and suture retention.

Indications for Use

Indicated for general surgical procedures requiring reinforcement of soft tissue where weakness exists, and for reinforcement of soft tissues repaired by suture or suture anchors to the supraspinatus during rotator cuff repair surgery.

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

• Shelhigh No-React pericardial patches (K032893)

Submission Summary (Full Text)

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DEC 1 9 2003

KO32893

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December 5, 2003

## Summary of safety and efficacy Shelhigh EnCuff Patch

Applicant: Shelhigh Inc. 650 Liberty Ave, Union, NJ 07083

Contact person: Shlomo Gabbay, MD Tel: [phone] Fax [phone]

### l. Proprietary and Common Name:

Shelhigh No-React® EnCuff Patch Trade name: Common name : Surgical Mesh Classification: 878.3300 - Surgical Mesh Product Code: 79 FTM

### ll. Predicate Devices:

The Shelhigh EnCuff Patch is Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc.

### Intended Use

The Shelhigh EnCuff patch is intended for the surgical repair of soft tissue deficiencies and/or to reinforce soft tissues where weakness exists and in rotator cuff repair surgery.

### IV. Product Description

The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.

### VI. Substantial Equivalence

It is substantially equivalent to the predicate devices, having the same intended use and technological characteristics.

- VII Shelhigh EnCuff material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable. The material exhibits excellent biocompatibility, and passed the requirements of all tests
Conclusions: This device is, in respect to intended use and technological characteristics, substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Shlomo Gabbay, M.D. Medical Director Shelhigh, Inc. 650 Liberty Avenue Union, New Jersey 07083

Re: K032893

Trade/Device Name: Shelhigh No-React ® EnCuff Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: September 16, 2003 Received: September 30, 2003

Dear Dr. Gabbay:

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 - Shlomo Gabbay, M.D.

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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. 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):

Device Name:

Indications For Use:

The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.

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)

KO32823

Meriam C. Provost

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

510(k) Number .

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