EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900

K020864 · Edwards Lifesciences, LLC · KRH · Apr 17, 2002 · Cardiovascular

Device Facts

• Record ID: K020864
• Device Name: EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
• Applicant: Edwards Lifesciences, LLC
• Product Code: KRH · Cardiovascular
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edwards MC3 Tricuspid Annuloplasty System, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

Device Story

The Edwards MC3 Tricuspid Annuloplasty System (Model 4900) is a surgical implant used to treat tricuspid annular dilatation. The system consists of a rigid, titanium alloy annuloplasty ring and a template/lanyard assembly (holder) used during implantation. The ring features a sewing margin composed of silicone rubber covered with polyester velour cloth. The device is implanted by a surgeon during cardiac surgery to reinforce the tricuspid annulus, thereby increasing leaflet coaptation and preventing future dilatation. It functions as a mechanical support structure for the heart valve annulus.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design verification testing.

Technological Characteristics

The device is a rigid annuloplasty ring constructed of titanium alloy. The sewing margin consists of silicone rubber covered with polyester velour cloth. It is a mechanical implant provided in various sizes (26-36 mm). No software, energy source, or electronic components are involved.

Indications for Use

Indicated for patients requiring correction of tricuspid annular dilatation, reinforcement of annular suture lines, and prevention of further annular dilatation to improve leaflet coaptation.

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

• Cosgrove-Edwards™ Annuloplasty System (K923367)

Submission Summary (Full Text)

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K020864

## 510(k) Summary

| Submitter: | Edwards Lifesciences LLC |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Susan Reynolds, Regulatory Affairs Associate |
| Date Prepared: | March 15, 2002 |
| Trade Name: | Edwards MC3 Tricuspid Annulplasty System |
| Classification Name: | Class II, CFR 870.3800 Annuloplasty Ring, 74 KRH |
| Predicate Device: | Cosgrove-Edwards™ Annuloplasty System (K923367) |
| Device Description: | The Edwards MC3 Tricuspid Annuloplasty System,<br>Model 4900, consists of two primary components; the<br>implantable annuloplasty ring and the template/lanyard<br>assembly (or holder).<br>The implantable annuloplasty ring is constructed of<br>titanium alloy and has a sewing ring margin that<br>consists of a layer of silicone rubber, covered with<br>polyester velour cloth sewn with a single seam. |
| Indications for Use: | The Edwards MC3 Tricuspid Annuloplasty System, is<br>intended for use in patients to correct annular dilatation,<br>increase leaflet coaptation, reinforce annular suture<br>lines, and prevent further dilatation of the annulus. |
| Comparative Analysis: | It has been demonstrated that the Edwards MC3<br>Tricuspid Annuloplasty System is comparable to the<br>predicate device in design, intended use, materials, and<br>principal of operation. |
| Functional/Safety Testing: | The Edwards MC3 Tricuspid Annuloplasty System has<br>successfully completed design verification testing. |
| Conclusion: | The Edwards MC3 Tricuspid Annuloplasty System is<br>substantially equivalent to the predicate device. |

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Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edwards Lifesciences, LLC c/o Ms. Susan Reynolds Regulatory Affairs Associate One Edwards Way Irvine. CA 92614

# APR 1 7 2002

Re: K020864

Trade/Device Name: Edwards® MC3 Tricuspid Annuloplasty System, Model 4900, sizes 26, 28, 30, 32, 34, and 36 mm Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: March 15, 2002 Received: March 18, 2002

Dear Ms. Reynolds:

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.

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

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## Page 2 - Ms. Susan Reynolds

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 007), accesses (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) rms loket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 01 - 11 - 11 - 11 - 11 - 11 - 10 - 11 - 10 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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 Oivision 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,

Dea Tell

onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Edwards MC3 Tricuspid Annuloplasty System

Indications for Use:

The Edwards® MC3 Tricuspid Annuloplasty System is intended for use in patients to correct annular dilatation, increase leaftet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

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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)

**Division of Cardiovascular & Respiratory Devices**
510(k) Number K020564