SHELHIGH BIORING

K023940 · Shelhigh, Inc. · KRH · Jun 4, 2003 · Cardiovascular

Device Facts

• Record ID: K023940
• Device Name: SHELHIGH BIORING
• Applicant: Shelhigh, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Jun 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.

Device Story

The Shelhigh BioRing is an annuloplasty ring used in cardiac surgery to reinforce the mitral valve. It consists of a circular polyester ring covered with No-React processed pericardium. The device is implanted by a surgeon during mitral valve repair procedures. It provides structural support to the valve annulus, aiming to restore proper valve function and benefit patients with mitral valve disease. The materials are biocompatible, non-toxic, non-hemolytic, and non-pyrogenic.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and biocompatibility testing.

Technological Characteristics

Circular ring composed of polyester material covered with No-React processed pericardium. Biocompatible, non-toxic, non-hemolytic, and non-pyrogenic materials. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring repair of the human cardiac mitral valve due to acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring.

Regulatory Classification

Identification

An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”

Predicate Devices

• AnnuloFlex
• Duran Flexiable Ring
• Shelhigh No-React pericardial Patch

Submission Summary (Full Text)

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K023940

JUN - 4 2003

510(K) Summary Class Shelhigh BioRing

# Proprietary and Common Name:

Shelhigh BioRing™ Trade name: Common name : Annuloplasty Ring

## Predicate Devices

AnnuloFlex, Duran Flexiable Ring,and Shelhigh No-React pericardial Patch.

## Intended Use

The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve.

# Product Description

The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.

# Substantial Equivalence

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

Shelhigh BioRing™ material exhibits good tensile strength, and suture retention. The materials used in the manufacture of the BioRing™ are non-toxic, non-hemolytic, and non-pyrogenic. The materials exhibit excellent biocompatibility, and passed the requirments 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2003

Shelhigh, Inc c/o Shlomo Gabbay, M.D. Chief Scientific Advisor P.O. Box 884 Millburn, NJ 07041

Re: K023940

Trade Name: Shelhigh BioRingTM Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: 74 KRH Dated: November 6, 2003 Received: November 26, 2002

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.

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Page 2 - Shlomo Gabbay, M.D.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

N. Dale Tuttle

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known):

Device Name: Shelhigh BioRing™ Indications For Use:

> The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use

Ov

Over-The-Counter Use

(Per 21 CFR 801.109)

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(Optional Format 1-2-96)

N.Oelam

510(k) Number