ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC

K052899 · Genesee Biomedical, Inc. · KRH · Nov 17, 2005 · Cardiovascular

Device Facts

• Record ID: K052899
• Device Name: ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
• 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 Genesee BioMedical ATS SIMULUS 700FC Annuloplasty Bands 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 bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Device Story

Implantable, fully flexible, braided polyester annuloplasty band; used to stabilize/reduce atrioventricular annulus during mitral or tricuspid valve repair. Features circumferential radiopaque marker for visualization; green trigone markers for orientation. Available in sizes 23-35 mm. Supplied sterile via gamma radiation. Implanted by surgeons in clinical/OR settings. Provides structural support to annulus; restricts pathological expansion; facilitates valve repair. Integrated system includes double-ended sizers with malleable stems for implantation ease.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including LAL testing, sterility validation, and Class IV biocompatibility testing on the predicate device. Mechanical testing performed on modified bands and components; all results satisfactory.

Technological Characteristics

Braided polyester body; circumferential flexible radiopaque marker; green trigone markers. Sizes: 23-35 mm (inner diameter). Sterilization: Gamma radiation. Class II device. Standalone implant.

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 (Sterile), now called the Genesee BioMedical, Inc. Sculptor Annuloplasty Ring (K905175)

Submission Summary (Full Text)

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K\$\phi\$52899

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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>510(k) Summary Information | Genesee BioMedical, Inc. |
| Premarket Notification, Section 510(k) | JUNE 28, 2005 |
| | |

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

#### Device Name: 1.

ATS SIMULUS FC Annuloplasty Band Model 700FC Trade Name:

Common Annuloplasty Ring Name(s):

Classification Ring, Annuloplasty Name(s):

# Establishment Name & Registration Number: 2.

Genesee BioMedical, Inc. Name: 1723241 Number:

# Classification(s): 3.

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

# Equivalent Predicate Device: 4

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

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

The bands are available in the following sizes: 23 mm, 27 mm, 29 mm, 31 mm, 33 mm and 35 mm. The size refers to the inner diameter of the band. Green trigone markers are spaced at 120° from the midpoint of the posterior segment, which is also indicated by a green marker.

#### Packaging: 6.

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

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K052899

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# Indications for Use: 7.

The ATS SIMULUS FC Annuloplasty Bands 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 bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus

# Testing Summary: 8.

Testing included LAL, Sterility Validation, Class IV Biocompatability tests on the predicate device. Mechanical testing was carried out on complete modified bands and band 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 [phone] Fax Email [e-mail]

# 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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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized image of three human figures, representing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2005

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

# Re: K052899

ATS SIMULUS FC Annuloplasty Band Model 700FC Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (Two) Product Code: KRH Dated: October 12, 2005 Received: October 14, 2005

# Dear Dr. Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in ind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prior to rial) 2011-07-2014 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 I ou may, increre, mains 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 - 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.

Dummer R. Viener

1 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 : | K052899 |
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Device Name(s): ATS SIMULUS Annuloplasty Band

# Indications For Use:

The Genesee BioMedical ATS SIMULUS 700FC Annuloplasty Bands 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 bands provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Prescription Use __ X ________________________________________________________________________________________________________________________________________________________ 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)

Donna himes

(Division Sign-Off) Division of Cardiovascular Devices

K652899 510(K) Number_