CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

K103520 · Edwards Lifesciences, LLC · KRH · Jun 24, 2011 · Cardiovascular

Device Facts

• Record ID: K103520
• Device Name: CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
• Applicant: Edwards Lifesciences, LLC
• Product Code: KRH · Cardiovascular
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

Device Story

Carpentier-Edwards Physio Tricuspid annuloplasty ring (model 6200) is a prosthetic implant used during cardiac surgery to treat tricuspid valvular insufficiency. The device functions by providing structural support to the tricuspid valve annulus; it corrects annular dilatation, improves leaflet coaptation, and reinforces suture lines to prevent future dilation. It is implanted by a cardiac surgeon in an operating room setting. The device consists of a titanium core encased in a silicone sewing ring margin, covered with polyester cloth. It is a passive implantable device; it does not involve sensors, software, or active electronic components. Clinical benefit is derived from the mechanical stabilization of the valve annulus, restoring proper valve function and preventing disease progression.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included computational stress analysis, finite element analysis, tensile strength, suture retention, flexibility, ring/holder removal force, corrosion resistance, MR compatibility (ASTM F2182, F2052, F2119, F2213), comprehensive biocompatibility testing (ISO 10993-1), bioburden, pyrogen testing, packaging qualification (ISO 11607-1, ASTM D4169), and design validation by surgeons in a simulated use environment.

Technological Characteristics

Titanium core, silicone sewing ring margin, polyester cloth cover. Passive implantable ring. MR compatible per ASTM F2182, F2052, F2119, F2213. Biocompatibility per ISO 10993-1. Packaging per ISO 11607-1. Sterilization method not explicitly stated but implied by terminal sterilization requirements.

Indications for Use

Indicated for patients with tricuspid valvular insufficiency requiring correction of annular dilatation, increased leaflet coaptation, reinforcement of annular suture lines, and prevention of further annular dilatation.

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

• Edwards MC3® Tricuspid annuloplasty ring (K020864)
• Cosgrove-Edwards® annuloplasty system (K923367)
• Carpentier-Edwards® Classic® Tricuspid annuloplasty ring (K912554)

Submission Summary (Full Text)

{0}------------------------------------------------

K103520

Image /page/0/Picture/1 description: The image shows a logo with the word "Edwards" written below a square graphic. The graphic contains a large letter "E" in white, overlaid on a grid pattern. Circular designs are visible behind the letter "E" and within the grid, adding a complex, layered effect to the logo. The overall design appears to be for a company or brand named Edwards.

510(k) Summary

:

JUN 2 4 2011

| Submitter: | Edwards Lifesciences LLC |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daryl Richardson<br>Regulatory Affairs Associate<br>One Edwards Way<br>Irvine, CA 92614<br>daryl [e-mail]<br>(ph) 949-250-5036 / (fax) 949-250-3630 |
| Date Prepared: | June 15, 2011 |
| Trade Name: | Carpentier-Edwards® Physio Tricuspid™ annuloplasty ring,<br>model 6200 |
| Classification Name: | Class II, CFR 870.3800 Annuloplasty Ring, KRH |
| Predicate Device(s): | Edwards MC3® Tricuspid annuloplasty ring (K020864)<br>Cosgrove-Edwards® annuloplasty system (K923367)<br>Carpentier-Edwards® Classic® Tricuspid annuloplasty ring (K912554) |
| Device Description: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model<br>6200, is constructed of a titanium core with a silicone sewing ring<br>margin covered with a polyester cloth. |
| ·Indications for Use: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model<br>6200, is intended for use in patients with tricuspid valvular<br>insufficiency. It is intended to correct annular dilatation, increase<br>leaflet coaptation, reinforce annular suture lines, and prevent further<br>dilatation of the annulus. |
| Comparative Analysis: | It has been demonstrated that the Carpentier-Edwards Physio<br>Tricuspid annuloplasty ring, model 6200, is comparable to its predicate<br>devices in design, intended use, materials, fundamental technology<br>and principal of operation. |
| Functional/Safety Testing: | The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model<br>6200, has successfully completed design verification and validation<br>testing. The following studies were conducted:<br>Computational stress analysis |
| | |

- Finite element analysis .
Page 1 of 3

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with the letter 'E' inside a square. The letter 'E' is white and bold, and it is surrounded by a circle. The background of the square is black and white. Below the square is the word 'Edwards' in a serif font.

- Tensile strength .
- Suture retention .
- . Flexibility
- Ring / Ring holder removal force .
- Corrosion resistance .
- Magnetic resonance compatibility (RF heating, image artifact, . displacement force, induced torque)
- Biocompatibility (percent inhibition of cell growth, medium . eluate method - cytotoxicity, blood compatibility, complement activation, gene mutation assay, chromosomal aberration effect assay, agar overlay - cytotoxicity, DNA damage / effects assay, Mouse systemic injection - systemic toxicity, rabbit pvrogen - systemic toxicity, rabbit intracutaneous reactivity, guinea pig maximization, rabbit intramuscular implantation sub-chronic and chronic evaluations)
- Relative resistance evaluation and comparison for sterilization .
- . Bioburden
- Limulus amebocyte lysate pyrogen testing .
- Packaging qualification (visual inspection, sterile barrier . integrity, dye leak, burst)
- Shelf-life assessments of packaging and product components .
- Design validation by surgeons in simulated use environment .

Standards used in support of the application

See the attached table

Conclusion:

The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is substantially equivalent to its predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo with the word "Edwards" written below a square graphic. The graphic contains a white letter "E" superimposed over a grid pattern and circular shapes. The letter "E" is stylized and appears to be partially obscured by the circular elements within the square.

# Utilization of Standards

| Standard No. | Standard Title |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO<br>10993-1:2009 | Biological evaluation of medical device -<br>Part 1: Biological Testing |
| ASTM<br>F2182:2009 | Standard Test Method for Measurement<br>of Radio Frequency Induced Heating<br>Near Passive Implants During Magnetic<br>Resonance Imaging |
| ASTM<br>F2052:2006 | Standard Test Method for Measurement<br>of Magnetically Induced Displacement<br>Force on Medical Devices in the<br>Magnetic Resonance Environment |
| ASTM<br>F2119:2007 | Standard Test Method for Evaluation of<br>MR Image Artifacts from Passive<br>Implants |
| ASTM<br>F2213:2006 | Standard Test Method for Measurement<br>of Magnetically Induced Torque on<br>Medical Devices in the Magnetic<br>Resonance Environment |
| BS EN ISO<br>11607-1:2009 | Packaging for Terminally Sterilized<br>Medical Devices, Part 1: Requirements<br>for Materials, Sterile Barrier Systems<br>and Packaging Systems (ISO 11607-<br>1:2006) |
| ASTM<br>D4169:2005 | Standard Practice for Performance<br>Testing of Shipping Containers and<br>Systems |
| ISO<br>14971:2007 | Medical Devices - Application of risk<br>management to medical devices |

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top and left side of the circle. The eagle is composed of three curved lines that form the body and wings, and a smaller curved line that forms the head and beak.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Edwards Lifesciences, LLC c/o Mr. Daryl Richardson Regulatory Affairs Associate One Edwards Way Irvine, CA 92614

JUN 2 4 2011

Re: K103520

Carpentier-Edwards™ Physio Tricuspid™ Annuloplasty Ring, Model 6200 Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH Dated: June 22, 2011 Received: June 23, 2011

Dear Mr. Richardson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

{4}------------------------------------------------

### Page 2 - Mr. Daryl Richardson

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

R. D. Hinderaker, M.D.

Bram D. Auckerman, M.D. Director) Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): 《103520

Device Name: Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200

Indications for Use:

The Carpentier-Edwards Physio Tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid valvular insufficiency. It is intended to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

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

Over-The-Counter Use: [] (Part 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)

Signature

yascular Devices 510(k)

Page 1of 1