(31 days)
Not Found
No
The summary describes a physical medical device (annuloplasty ring) and its mechanical properties and intended use in surgical repair. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for the repair of diseased or damaged valves, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is an annuloplasty ring used for surgical repair of heart valves. Its function is to physically support the valve, not to diagnose a condition. The "decision to undertake annuloplasty can be made only after visual analysis of the valve pathology," indicating that diagnosis happens prior to the device's use.
No
The device description clearly states it is a physical ring fabricated with silicone rubber and polyester fabric, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Attune™ Adjustable Flexible Annuloplasty Ring is a physical implant used to repair heart valves. It is surgically placed within the body and does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states it is for the "repair of a mittal or tricuspid valve." This is a surgical intervention, not a diagnostic test.
The information provided about the device's description, performance studies (tensile strength, suture pullout, etc.), and predicate device (another annuloplasty ring) all confirm its nature as a surgical implant, not an IVD.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KRH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mittal or tricuspid valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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.
1
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
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
2
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
3
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:
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.
.
4
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.