ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

K992056 · Sulzer Carbomedics, Inc. · KRH · Oct 12, 1999 · Cardiovascular

Device Facts

• Record ID: K992056
• Device Name: ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
• Applicant: Sulzer Carbomedics, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Oct 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AnnuloFlex annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Device Story

AnnuloFlex Annuloplasty System is a flexible ring used in mitral valve repair; implanted in the mitral position to reinforce valve structure. Device consists of an annuloplasty ring and a holder assembly; used with separate instrumentation for sizing and implantation. Surgeon-operated in a clinical/surgical setting. Flexible design allows for partial or complete ring implantation based on surgeon preference and patient condition. Benefits include structural reinforcement of the mitral valve, potentially avoiding full valve replacement. Output is the physical ring itself, which provides mechanical support to the valve annulus.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed materials are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical testing included suture retention analysis, demonstrating that the sewing ring fabric is comparable to fabrics used in vascular prostheses.

Technological Characteristics

Flexible annuloplasty ring; includes holder assembly. Materials are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical properties include suture retention comparable to vascular prostheses. No software or electronic components.

Indications for Use

Indicated for patients requiring mitral valve repair due to acquired or congenital disease, or replacement of a previously implanted annuloplasty ring. Contraindicated if visual inspection indicates the valve is not repairable and requires replacement.

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

• Sulzer Carbomedics® AnnuloFlo™ Annuloplasty Ring
• Medtronic Duran Flexible Ring
• Baxter Cosgrove-Edwards Ring

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "SULZER MEDICA" in a bold, sans-serif font. Above the text, there is a handwritten number "1992056". The text is the name of a company in the medical field. The image is likely a logo or a document header.

## OCT 1 2 1999

### Sulzer Carbomedics Inc.

1300 East Anderson Lane Austin, Texas 78752-1793

Phone [phone] FAX [phone] WATS [phone] (US and Canada)

### 510(k) SUMMARY

per 21 CFR §807.92

| Submitter | Contact |
|--------------------------|-----------------------------------|
| Sulzer Carbomedics Inc. | Robert M. Wolfarth, CQA |
| 1300 East Anderson Lane | Regulatory Affairs Specialist |
| Austin, Texas 78752-1793 | Telephone: [phone] |
| | Facsimile: [phone] |
| | E-mail: [e-mail] |

| Date of Summary: | May 28, 1999 |
|-------------------|---------------------------------|
| Common Name: | Annuloplasty Ring |
| Proprietary Name: | AnnuloFlex™ Annuloplasty System |

Description of Device: The AnnuloFlex™ Annuloplasty System consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral position. A complete set of instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.

Statement of Intended Use: The AnnuloFlex™ System is intended for use in the repair of the human cardiac mitral valve.

Technological Comparison: The AnnuloFlex™ Annuloplasty Ring is a flexible annuloplasty ring which can be implanted either as a partial or complete ring, according to the surgeon's preference and/or patient condition. For purposes of this submission, the AnnuloFlex™ Annuloplasty Ring was compared to the following predicate devices:

- Sulzer Carbomedics® AnnuloFlo™ Annuloplasty Ring: rigid ring with nearly identical � materials, identical manufacturing process, and identical function
- Medtronic Duran Flexible Ring: flexible complete ring with identical function �
- Baxter Cosgrove-Edwards Ring: flexible partial ring with identical function �

Testing: Material biocompatibility testing has been completed that supports that the materials used in the manufacture of the AnnuloFlex "are non-toxic, non-hemolytic, and non-pyrogenic. Mechanical testing for the AnnuloFlex" annuloplasty ring includes suture retention testing and demonstrated that the sewing ring fabric is comparable to fabrics used in vascular prostheses. Testing demonstrated that the AnnuloFlex" Annuloplasty Ring is substantially equivalent to the predicate devices for repair of the mitral valve.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

# OCT 1 2 1999

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert M. Wolfarth Regualtroy Affairs Specialist Sulzer Medica Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793

Re: K992056 Sulzer Cardomedics® AnnuloFlex™ Annuloplasty System Requlatory Class: III (Three) Product Code: 74 KRH Dated: June 17, 1999 Received: June 18, 1999

#### Dear Mr. Wolfarth:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval) , 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Robert M. Wolfarth

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number:

K992056

· Device Name:

AnnuloFlex System

Indications for Use:

The AnnuloFlex annuloplasty ring is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.

Beete L. Campbell
Division Sign Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K992056

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109 OR

Over-The-Counter Use

(Optional Format 1-2-96)