CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200

K083470 · Edwards Lifesciences, LLC · KRH · Jan 23, 2009 · Cardiovascular

Device Facts

• Record ID: K083470
• Device Name: CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
• Applicant: Edwards Lifesciences, LLC
• Product Code: KRH · Cardiovascular
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Carpentier-Edwards Physio II Annuloplasty Ring is intended for the correction of mitral valve Insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve. The Carpentier-Edwards Physio if Annuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion. The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole. The decision to undertake annuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae. The remodeling annuloplasty technique with a Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, may be used in all acqured or congental mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue. For Type I mitral insufficiencies with no subvalvular lesions and normal vaivular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repar in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III imitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy.

Device Story

Carpentier-Edwards Physio II Annuloplasty Ring (Model 5200) is a prosthetic implant used during mitral valve repair surgery. Device functions as a remodeling tool to support the mitral annulus, maintaining physiologic shape and motion throughout the cardiac cycle. It promotes valve coaptation during systole and hemodynamics during diastole. Implanted by cardiac surgeons in an operating room setting. Device provides structural support to the fibrous mitral annulus in cases of dilatation or deformation. Benefits include preservation of the natural valve and restoration of valve integrity.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Constructed of cobalt-chromium alloy and polyester film bands; silicone sewing ring margin covered with polyester cloth. Ring form factor designed for mitral annular remodeling. Non-electronic, mechanical implant.

Indications for Use

Indicated for patients with acquired or congenital mitral insufficiency or mixed mitral insufficiency and stenosis requiring repair rather than valve replacement. Contraindicated in severe congenital malformations (e.g., AV canal, hypoplastic commissures) or severe degenerative valvular diseases with considerable excess tissue.

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

• Carpentier-Edwards Physio™ Annuloplasty Ring (K926138)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letter 'E' in a stylized font, superimposed on a background of circles and squares. The letter 'E' is white, while the background is black. Below the logo, the word 'Edwards' is written in a serif font.

K083470 JAN 2 3 2009

## 510(k) Summary

| Submitter | Edwards Lifesciences LLC |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Erica A Walters<br>Regulatory Affairs Associate<br>[e-mail]<br>(ph) 949-250-2438<br>(fax) 949-250-3630 |
| Date Prepared | November 20, 2008 |
| Trade Name | Carpentier-Edwards Physio II™ Annuloplasty Ring,<br>Model 5200 |
| Classification Name | Class II, CFR 870 3800 Annuloplasty Ring, KRH |
| Predicate Device(s) | Carpentier-Edwards Physio™ Annuloplasty Ring<br>(K926138) |
| Device Description | The Carpentier-Edwards Physio II annuloplasty ring,<br>model 5200, is constructed of cobalt-chromium<br>alloy/polyester film bands with a silicone sewing ring<br>margin covered with a polyester cloth |
| Indications for Use | The Carpentier-Edwards Physio II annuloplasty ring,<br>model 5200, is intended for the correction of mitral<br>valvular insufficiency where the lesions are not so severe<br>as to require total valve replacement |
| Comparative Analysis | It has been demonstrated that the Carpentier-Edwards ,<br>Physio II annuloplasty ring, model 5200, is comparable to<br>its predicate device in design, intended use, materials,<br>and principal of operation |
| Functional/Safety Testing | The Carpentier-Edwards Physio II annuloplasty ring,<br>model 5200, has successfully completed design<br>verification testing |
| Conclusion. | The Carpentier-Edwards Physio II annuloplasty ring,<br>model 5200, is substantially equivalent to its predicate<br>device |

ﻟﺴﻴﺎﺭ ﺍ

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edwards Lifesciences, LLC Erica A Walters Regulatory Affairs Associate One Edwards Way Irvine CA 92614

JAN 23 2009

Re K083470

Trade/Device Name Carpentier-Edwards Physio II annuloplasty ring, model 5200 Regulation Number 21 CFR 870 3800 Regulation Name Annuloplasty ring Regulatory Class Class II Product Code KRH Dated November 20, 2008 Received November 24, 2008

t,

Dear Ms Walters

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 adulteratıon

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

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 buhner

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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## Indications for Use

510(k) Number (if known)

Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200 Device Name

Indications For Use

The Carpentier-Edwards Physio II Annuloplasty Ring is intended for the correction of mitral valve Insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve

The Carpentier-Edwards Physio if Annuloplasty Ring is intended to meet the challenges of modern valvuloplasty by maintaining the physiologic annular shape and motion The annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle, thereby maintaining coaptation and valve integrity in systole while permitting good hemodynamics in diastole

The decision to undertake annuloplasty can be made only after visual analysis of the lesion present The most favorable conditions for annuloplasty using a prosthetic ring are a combination of the distended natural valve ring associated with supple valve cusps and normal chordae tendineae

The remodeling annuloplasty technique with a Carpentier-Edwards Physio II Annuloplasty Ring, Model 5200, may be used in all acqured or congental mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus, with the exception of severe congenital malformations (e g , AV canal or hypoplastic commissures) or severe degenerative valvular diseases where there is considerable excess tissue

For Type I mitral insufficiencies with no subvalvular lesions and normal vaivular movements, this ring technique used alone is sufficient However, the ring technique must be associated with mitral valvuloplasty repar in Type II insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae or papillary muscle and in Type III imitation of valvular movements due to fusion of the commissures or chordae, or chordal hypertrophy

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Holmes

(Division Sign-Off)
Division of Cardiovascular Devices

umber K083470

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