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

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.

AI/ML Overview

This document, K083835, is a 510(k) premarket notification for the Attune™ Adjustable Flexible Annuloplasty Ring. It aims to demonstrate substantial equivalence to a predicate device, the Tailor Annuloplasty Ring Model TARP-(size) (K014161). The focus of this document is on the physical and safety characteristics of an anulloplasty ring, not on software performance, algorithms, or AI. Therefore, most of the questions you've asked about acceptance criteria and studies related to AI or algorithm performance cannot be answered from this text.

However, I can extract information regarding the non-clinical tests performed on the device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or detailed reported device performance results. It only lists the types of performance characteristics evaluated, asserting that the device is "safe and effective for the intended use" and "substantially equivalent" to the predicate.

Characteristic Evaluated	Reported Device Performance (Summary)
Ring Tensile Strength	Substantially Equivalent to predicate, safe and effective
Suture Pullout Test	Substantially Equivalent to predicate, safe and effective
Ring Adjustability Test	Substantially Equivalent to predicate, safe and effective
Security of Final Adjustment Knot Test	Substantially Equivalent to predicate, safe and effective
MR Safety Evaluation	Substantially Equivalent to predicate, safe and effective
Manufacturing Process Validation	Substantially Equivalent to predicate, safe and effective
Biological Evaluation	Substantially Equivalent to predicate, safe and effective
Sterilization Parameter Evaluation	Substantially Equivalent to predicate, safe and effective

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes non-clinical engineering tests (e.g., tensile strength, suture pullout) rather than a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document pertains to physical device testing, not expert-adjudicated ground truth for algorithms or diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document pertains to physical device testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is not about AI-assisted diagnosis or multi-reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is not about an algorithm or software.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical tests listed, the "ground truth" would be established engineering standards, material specifications, and regulatory requirements for medical devices. For the biological evaluation, it would likely refer to biocompatibility standards. For MR Safety, it would be based on MRI compatibility guidelines and testing.

8. The sample size for the training set

Not applicable. This document is not describing an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This document is not describing an algorithm that requires a training set.

Summary

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours.

Dma R. Vahner

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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

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: (651) 756-6574 Fax: (651) 766-3049 Email: wmckelvey@sjm.com

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:

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.

Regulation Number and Section

§ 870.3800 Annuloplasty ring.

(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”