ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF

K052565 · Genesee Biomedical, Inc. · KRH · Nov 17, 2005 · Cardiovascular

Device Facts

• Record ID: K052565
• Device Name: ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF
• Applicant: Genesee Biomedical, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid 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 or tricuspid annulus and restrict expansion of the annulus.

Device Story

Implantable, fully flexible, braided polyester annuloplasty ring; provides structural support to mitral or tricuspid annulus; restricts annular expansion. Used during cardiac valve repair surgery; implanted by surgeons. Features circumferential flexible radiopaque marker for visualization. Available in sizes 23-35 mm; includes green trigone markers for orientation. Supplied sterile via gamma radiation.

Clinical Evidence

Bench testing only. Included LAL testing, sterility validation, Class IV biocompatibility testing, and mechanical testing on complete rings and components. All results satisfactory.

Technological Characteristics

Braided polyester annuloplasty ring; fully flexible; circumferential radiopaque marker; green trigone markers at 120 degrees. Sizes: 23-35 mm. Sterilization: Gamma radiation.

Indications for Use

Indicated for patients undergoing mitral or tricuspid valve repair surgery 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

• PTI Annuloplasty Ring (K905175), now known as the Genesee BioMedical, Inc. Sculptor® Annuloplasty Ring

Submission Summary (Full Text)

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# NOV 1 7 2005

Ps 1 of 2

| 510(k) Summary Information<br>Premarket Notification, Section 510(k) | Genesee Biomedical, Inc.<br>JUNE 27, 2005 |
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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

#### 1. Device Name:

Trade Name: ATS SIMULUS Annuloplasty Ring Model 700FF

Common Name(s): Annuloplasty Ring

Classification Name(s): Ring, Annuloplasty

#### 2. Establishment Name & Registration Number:

Name: Genesee Biomedical, Inc. Number: 1723241

#### 3. Classification(s):

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

#### 4. Equivalent Predicate Device:

K905175, PTI Annuloplasty Ring (Sterile), Now called the Genesee BioMedical, Inc. Sculptor® Annuloplasty Ring.

Equivalence can be seen in the design, material composition, surgical technique and intended use.

#### 5. Device Description:

The ATS SIMULUS Annuloplasty Rings are implantable, fully flexible, annular rings (Figure 1). The rings reduce and stabilize the atrioventricular annulus in patients undergoing mitral or tricuspid valve repair. The body of the ring is made of braided Polyester. The ring contains a circumferential flexible radiopaque marker. The entire circumference of the ring is radiopaque.

The annuloplasty rings and accessories are designed as an integrated system to ease implantation. Malleable stems connects the double ended sizers to their handle

The rings are available in the following sizes: 23 mm, 27 mm, 31 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the ring. Green trigone markers are spaced at 120° from the radial seam, which is located midpoint of the posterior segment.

#### 6. Packaging:

The ATS SIMULUS Annuloplasty Rings are supplied STERILE (sterilized by gamma radiation) and nonpyrogenic, packaged in inner and outer blister trays with peelable lids. Each ring is mounted on a disposable holder. The rings will remain sterile until at least the expiration date provided the package is unnened and undamaged.

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K052565

B 2 or 2

#### 7. Indications for Use:

The ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid 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 or tricuspid annulus and restrict expansion of the annulus

### 8. Testing Summary:

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

#### Applicant Name & Address: 9.

John T. M. Wright, Ph.D. Genesee Biomedical, Inc. 1308 So Jason Street, Denver, CO 80223 Phone [phone] extension 111 Fax [phone] Email jwright@geneseebiomedical com

- 10. Registration Number:
1723241

### Company Contact: 11.

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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NOV 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052565

ATS SIMULUS Annuloplasty Ring Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (Two) Product Code: KRH Dated: November 14, 2005 Received: November 15, 2005

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. Iisting 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 - John T. M. Wright, Ph.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 (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. 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,

Donna R. Vichner

GA 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

510(k) Number : K052565

ATS SIMULUS Annuloplasty Ring Device Name(s):

# Indications For Use:

The ATS SIMULUS Annuloplasty Rings are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid 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 or tricuspid annulus and restrict expansion of the annulus.

Prescription Use ________X Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna Lachner

(Division Sign-Off) (Division Olgh-div)
Division of Cardiovascular Devices

510(k) Number k 152565

(Per 21 CFR 801.109)

(Optional format 1-2-96)