ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR

K072655 · Genesee Biomedical, Inc. · KRH · Oct 23, 2007 · Cardiovascular

Device Facts

• Record ID: K072655
• Device Name: ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
• Applicant: Genesee Biomedical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Oct 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral annulus and restrict expansion of the annulus.

Device Story

The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring is an implantable device used during mitral valve repair surgery. It consists of a braided polyester body with an MP35N wire stiffener and spring mechanism to provide structural support to the atrioventricular annulus. The device is radiopaque and available in multiple sizes. It is implanted by a surgeon in an operating room setting to stabilize the annulus and restrict its expansion, thereby supporting the natural valve structure and potentially improving long-term valve function for the patient.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including LAL, sterility validation, Class VI biocompatibility testing, and mechanical testing of the ring and its components.

Technological Characteristics

Implantable semi-rigid ring; materials include braided polyester, MP35N wire, and MP35N spring/coupler; radiopaque; sterilized via gamma radiation; supplied on a disposable holder in Tyvek/Polymylar pouches.

Indications for Use

Indicated for patients undergoing surgical repair of diseased or damaged mitral valves where valve preservation is determined appropriate by the surgeon.

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

• Sculptor® Semi-Rigid Mitral Annuloplasty Ring Model 605M (K905175)

Submission Summary (Full Text)

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K072655

# 007 23 2007

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Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

- 1. Device Name:
Trade Name: ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring Model 800SR

Common Name(s): Annuloplasty Ring

Classification Name(s): Ring, Annuloplasty

## 2. Establishment Name & Registration Number:

Genesee Biomedical, Inc. Name: Number: 1723241

# 3. Classification(s):

Class II Device Class: Classification Panel: Cardiovascular Devices Panel Product Code(s): KRH

# 4. Equivalent Predicate Device:

Genesee Biomedical Inc's. Sculptor® Semi-Rigid Mitral Annuloplasty Ring Model 605M (K905175). Equivalence can be seen in the design, material composition, surgical technique and intended use.

# 5. Device Description:

The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are implantable, Semi-Rigid, annular rings. The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral valve repair. The body of the ring is made of flat braided Polyester. The ring contains an MP35N wire stiffener in the lateral and posterior segments. The wire stiffener is contained within a closecoiled MP35N spring, the two ends of which are joined together by a miniature MP35N coupler in the mid-anterior segment. The entire circumferential of the annuloplasty ring is radiopaque. The rings are available in the following six sizes: 24mm, 26mm, 28mm, 30mm, 32mm, 36mm, 36mm and 40mm. The size refers to the lateral diameter of the stiffener band.

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## 6. Packaging:

The ATS SIMULUSTM Semi-Rigid Mitral Annuloplasty Ring is supplied STERILE (sterilized by gamma radiation) and non-pyrogenic, mounted on a disposable holder, packaged in inner and outer Chevron style Tyvek/Polymylar peel pouches. The ring will remain sterile until at least the expiration date provided the package is unopened and undamaged.

### 7. Indications for Use:

The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the natural annulus and restrict expansion of the annulus

### 8. Testing Summary:

Testing included LAL, Sterility Validation, and Class VI Biocompatibility tests on the predicate device. Mechanical testing was carried out on complete modified rings and ring components. All test results were satisfactory.

### 9. Applicant Name & Address:

John T. M. Wright, Ph.D. Genesee Biomedical, Inc. 1308 So Jason Street, Denver, CO 80223 Phone [phone] extension 111 [phone] Fax Email [e-mail]

#### 10. Registration Number:

1723241

#### 11. Company Contact:

John Wright, Ph.D. Genesee Biomedical, Inc.

#### 12. Submission Correspondent:

John T. M. Wright, Ph D. Chief Executive Officer Genesee Biomedical, Inc.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2007

Genesee Biomedical, Inc c/o John T. M. Wright Ph.D Chief Executive Officer 1308 S. Jason Street Denver, CO 80223-3408

Re: K072655

ATS Simulus TM Semi-Rigid Mitral Annuloplasty Ring Model 800SR Regulation Number: 21 CFR 870.3800 Regulation Name: Ring, Annuloplasty Regulatory Class: Class II (two) Product Code: KRH Dated: September 12, 2007 Received: September 24, 2007

Dear Dr. Wright:

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 - Dr. John T. M. Wright

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]. 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/industry/support/index.html.

Sincerely yours,

R. bochner

A 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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Kon2655 510(k) Number :_

ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Ring Model 800SR Device Name(s):

# Indications For Use:

The ATS SIMULUS™ Semi-Rigid Mitral Annuloplasty Rings Model 800SR are for use in those patients undergoing surgery of diseased or damaged mitral valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty rings provide support for the mitral annulus and restrict expansion of the annulus.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional format 1-2-96)

una D. Verdennes

(Division Si - Off) Division of Cardiovascular Devices

510(K) Number_K072655