MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R

K073324 · Medtronic, Inc. · KRH · Mar 13, 2008 · Cardiovascular

Device Facts

• Record ID: K073324
• Device Name: MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
• Applicant: Medtronic, Inc.
• Product Code: KRH · Cardiovascular
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Profile 3D™ Annuloplasty Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Device Story

The Profile 3D™ Annuloplasty Ring is a surgically implanted device used for mitral valve repair. It consists of a titanium core, overmolded with silicone, and covered with polyester fabric. The ring features colored suture markers at the trigones and midpoint to assist the surgeon during implantation. The titanium core provides radiographic visualization. The device is implanted by a surgeon in the mitral position to remodel the valve annulus, correcting insufficiency or stenosis. It functions as a structural support to restore proper valve geometry, potentially improving patient cardiac function.

Clinical Evidence

Bench testing only; verification and validation studies were performed to demonstrate that modifications to the predicate device do not affect intended use or performance.

Technological Characteristics

Materials: titanium core, silicone overmold, polyester fabric cover. Form factor: Annuloplasty ring with colored suture markers for orientation. Radiographic visualization enabled by titanium core. Class II device.

Indications for Use

Indicated for patients requiring reconstruction or remodeling of pathological mitral valves to correct valvular insufficiency and/or stenosis.

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

• CG Future® Annuloplasty System, Model 638R (Ring) (K061127)

Submission Summary (Full Text)

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K073324

MAR 1 3 Zuuc

# 510(k) Summary – Medtronic Profile 3D™ Annuloplasty Ring

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CRF 807.92.

### SUBMITTER INFORMATION I.

| Company Name: | Medtronic Heart Valves (Medtronic) |
|--------------------------------------|---------------------------------------------------|
| Company Address: | 8299 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Company Phone:<br>Company Facsimile: | 763-514-6600<br>763-514-6775 |
| Contact Person: | Becky Hannack<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | November 26, 2007 |

### DEVICE IDENTIFICATION ll.

| Trade/Proprietary Name: | Profile 3D™ Annuloplasty Ring, Model 680R |
|-------------------------|-------------------------------------------|
| 21 CFR Reference: | 870.3800 |
| 21 CFR Common Name: | Ring, Annuloplasty |
| Classification: | Class II |
| Panel: | CV (74) KRH |

## III. IDENTIFICATION OF PREDICATE DEVICE

| Trade/Proprietary Name: | CG Future® Annuloplasty System, Model 638R (Ring) |
|-------------------------|---------------------------------------------------|
| 510(k) Number: | K061127 |
| 510(k) Clearance Date: | May 23, 2006 |

### IV. DEVICE DESCRIPTION

The Profile 3D™ Annuloplasty Ring, Model 680R, consists of a titanium core overmolded with silicone and covered with polyester fabric. The ring must be implanted in the mitral position. The ring is marked at three points by colored

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sutures; two markers correspond to the trigones of the mitral valve and one identifies the midpoint of the device. The device size is identified by the inside diameter of the ring at its widest point. The titanium core enables radiographic visualization of the device.

#### V. DESCRIPTION OF INTENDED USE

The Profile 3D™ Annuloplasty Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

#### SUBSTANTIAL EQUIVALENCE VI.

The Profile 3D™ Annuloplasty Ring is substantially equivalent to the predicate device, the CG Future® Annuloplasty Ring. They have the same fundamental scientific technology and intended use.

### VII. PERFORMANCE DATA

The Profile 3D™ Annuloplasty Ring was subjected to verification and validation studies. These verification/validation studies demonstrate the modifications to the predicate device are appropriate and do not affect the intended use or performance of the device.

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Public Health Service

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2008

Medtronic Heart Valves c/o Ms. Becky Hannack Regulatory Affairs Specialisty 8299 Central Avenue NE Minneapolis, MN 55432

Re: K073324

Medtronic Profile 3D™ Annuloplasty Ring, Model 680R Regulation Number: 870,3800 Regulation Name: Ring, Annuloplasty Regulatory Class: Class II (two) Product Code: KRH Dated: January 10, 2008 Received: January 11, 2008

Dear Ms. Hannack:

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.

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Page 2 - Ms. Becky Hannack

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.

Duna R. Wuchner

Image /page/3/Picture/5 description: The image shows a handwritten signature or symbol on the left side, which appears to be a stylized loop or flourish. To the right of this symbol are the letters 'B' and 'D' stacked vertically. The overall impression is that of a signature or initial, possibly from a document or piece of artwork.

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): Ko 73 32 4

Device Name: Medtronic PROFILE 3D Annuloplasty Ring, Model 680R

Indications For Use:

The PROFILE 3D Ring is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Prescription Use ਮ (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)

ver P. leclunes

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_Ko7 3324

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Profile 3D™ Annuloplasty Ring Medtronic Confidential

November 26, 2007 K07XXXXX