ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR

K083835 · St Jude Medical · KRH · Jan 23, 2009 · Cardiovascular

Device Facts

• Record ID: K083835
• Device Name: ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
• Applicant: St Jude Medical
• Product Code: KRH · Cardiovascular
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Attune™ Adjustable Flexible Annuloplasty Ring is intended for mitral or tricuspid heart valve repair using conventional open heart, minimally invasive or robotic surgical techniques.

Device Story

The Attune™ Adjustable Flexible Annuloplasty Ring is a surgical implant used during open heart, minimally invasive, or robotic valve repair procedures. It consists of a flexible medical-grade silicone rubber core encased in polyester fabric, featuring an integrated suture that allows the surgeon to adjust the ring's size post-implantation to optimize valve function. The device is implanted by a cardiac surgeon to support the annulus of a diseased or damaged mitral or tricuspid valve. By providing structural support and allowing for intraoperative or post-implantation adjustment, the ring helps restore proper valve coaptation, potentially improving patient outcomes by correcting valvular regurgitation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including ring tensile strength, suture pullout, ring adjustability, security of final adjustment knot, MR safety evaluation, manufacturing process validation, biological evaluation, and sterilization parameter evaluation.

Technological Characteristics

Flexible annuloplasty ring; medical-grade silicone rubber core; polyester fabric covering; integrated adjustment suture. Device is intended for surgical implantation. Sterilization parameters evaluated.

Indications for Use

Indicated for repair of mitral or tricuspid valves diseased or damaged due to acquired or congenital valvular disease. Requires surgeon determination of repairability via visual analysis. For use by trained surgeons only.

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

• Tailor Annuloplasty Ring Model TARP-(size) (K014161)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The text is in all capital letters and is written in a simple, sans-serif font.

FEB 1 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Mr. William McKelvey Senior Regulatory Affairs Specialist 177 East County Road B, East St. Paul, MN 55117

Re: K083835

Attune™ Adjustable Flexible Annuloplasty Ring Model AFR Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty Ring Regulatory Class: Class II (two) Product Code: KRH Dated: December 22, 2008 Received: December 23, 2008

Dear Mr. McKelvey:

This letter corrects our substantially equivalent letter of January 23, 2009.

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 (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 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 - Mr. William McKelvey

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 (OS) 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 continue 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/cdrl/dsma/dsmamain.html

Sincerely yours.

Dma R. Vahner

Image /page/1/Picture/6 description: The image contains a handwritten scribble. The scribble appears to be a series of connected, curved lines, possibly resembling a stylized signature or a doodle. The lines vary in thickness and direction, creating a somewhat chaotic and abstract design.

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

# U.S. Food and Drug Administration - Center for Devices and Radiological Health

Page 2011 Coffee 1 1

510(k) Number (if known):K083835

Device Name: Attune™ Adjustable Flexible Annuloplasty Ring

## Indications For Use

The Attune™ Adjustable Flexible Annuloplasty Ring is indicated for use in the repair of a mittal or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease. It is the responsibility of the surgeon to determine that the valve is repairable. The decision to undertake annuloplasty can be made only after visual analysis of the valve pathology. Only surgeons who have received appropriate training should perform valve repair using the Attune™ Adjustable Flexible Annuloplasty Ring

x 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)

sunner R. Juli

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K083835

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## 510(K) SUMMARY

(as required by 21 CFR 807.92)

#### A. Submitters Information

Submitter's Name and Address:

Contact Name

St. Jude Medical 177 County Road B. East St. Paul, MN 55117

William McKelvey, RAC Sr. Regulatory Affairs Specialist St. Jude Medical 177 County Road B, East St. Paul, MN 55117 Bus: [phone] Fax: [phone] Email: [e-mail]

Submission Prepared

December 22, 2008 Amendment January 16, 2009

B. Device Information

Proprietary Name:

Common or Usual Name:

Attune™ Adjustable Flexible Annuloplasty Ring model AFR-(size)

Adjustable Flexible Annuloplasty ring, Mitral/Tricuspid Repair Ring

Classification:

Class II per 21 CFR 870.3800. Annuloplasty rings

### Predicate Device:

Tailor Annuloplasty Ring Model TARP-(size) - 510 (k) K014161

## Device Description:

The Attune™ Adjustable Flexible Annuloplasty Ring is a fully flexible ring fabricated with a medical grade silicone rubber core surrounded by polyester fabric and containing a suture that will allow adjustment after implantation.

## Intended Use:

The Attune™ Adjustable Flexible Annuloplasty Ring is intended for mitral or tricuspid heart valve repair using conventional open heart, minimally invasive or robotic surgical techniques.

.

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#### Comparison of Required Technological Characteristics C.

St. Jude Medical considers the Attune™ Adjustable Flexible Annuloplasty Ring to be substantially equivalent in technological characteristics (e.g. design and materials) and intended use to the predicate device. The table below is a comparison of the equivalency characteristics between the Attune™ Adjustable Flexible Annuloplasty Ring and the predicate device.

| Characteristic | Equivalency |
|-----------------------------|--------------------------|
| a. Product Labeling | Substantially Equivalent |
| b. Indications for Use | Identical |
| c. Physical Characteristics | Substantially Equivalent |
| d. Anatomical Sites | Identical |
| e. Target Population | Identical |
| f. Performance Testing | Substantially Equivalent |
| g. Safety Characteristics | Substantially Equivalent |

#### D. Summary of Non-Clinical Tests

The following performance characteristics were evaluated;

- Ring Tensile Strength ●
- Suture Pullout Test ●
- Ring Adjustability Test
- . Security of Final Adjustment Knot Test
- . MR Safety Evaluation
- Manufacturing Process validation
- . Biological Evaluation
- Sterilization Parameter Evaluation .

## Conclusion

St Jude Medical has demonstrated that the Attune™ Adjustable Flexible Annuloplasty Ring is safe and effective for the intended use. The Attune™ Adjustable Flexible Annuloplasty Ring is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.