(28 days)
Not Found
No
The 510(k) summary describes a physical annuloplasty ring and its mechanical properties. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is used to repair a diseased or damaged mitral or tricuspid valve, which is a therapeutic intervention.
No
This device is an annuloplasty ring used for the repair of heart valves, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical annuloplasty ring made of silicone and polyester, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of a mitral or tricuspid valve during surgery. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (an annuloplasty ring) designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to treat a condition.
N/A
Intended Use / Indications for Use
The SJM Attune Flexible Adjustable Annuloplasty Ring is intended for mitral or tricuspid heart valve repair using conventional open heart, minimally invasive or robotic surgical techniques.
The SJM™ Attune Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease.
Product codes
KRH
Device Description
The SJM Attune Flexible Adjustable Annuloplasty Ring is a fully flexible ring fabricated from a medical grade silicone core surrounded by a polyester sewing cuff and containing a suture that will allow for adjustment after implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mitral or tricuspid valve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following performance characteristics were evaluated:
- Ring Tensile Strength ◆
- . Suture Pullout Test
- . Adjustment Suture Testing
- MR Safety Evaluation .
- Biological Evaluation
- Sterilization Parameter Evaluation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
092876
OCT 1 6 2009
SECTION 7 - 510(K) SUMMARY
Applicant Information
Contact Name
Submitter's Name and Address:
St. Jude Medical 177 County Road B. East St. Paul, MN 55117
Thomas Rademacher Regulatory Affairs Specialist St. Jude Medical 177 County Road B, East St. Paul, MN 55117 Bus: (651) 756-6473 Fax: (651) 766-3049 Email: trademacher(a)sim.com
SJM Attune Flexible Adjustable Annuloplasty
Flexible Adjustable annuloplasty ring
Mitral/Tricuspid repair ring
Annuloplasty rings
Class II per 21 CFR 870.3800,
September 15, 2009
Submission Prepared
Device Information
Proprietary Name:
Common or Usual Name:
Classification:
Predicate Device:
SJM Attune Ring model AFR-(size)
510(k) No. K083835 - cleared January 23, 2009
Device Description:
The SJM Attune Flexible Adjustable Annuloplasty Ring is a fully flexible ring fabricated from a medical grade silicone core surrounded by a polyester sewing cuff and containing a suture that will allow for adjustment after implantation.
Ring
Intended Use:
The SJM Attune Flexible Adjustable 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
SJM considers the SJM Attune 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 SJM Atture Annuloplasty Ring and the predicate device.
| Item | Equivalency |
|---|---|
| Principles of Operation | Identical |
| Product Labeling | Substantially Equivalent |
| Indications for Use | Identical |
| Physical Characteristics | Substantially Equivalent |
| Anatomical Sites | Identical |
| Target Population | Identical |
| Performance Testing | Substantially Equivalent |
| Safety Characteristics | Substantially Equivalent |
| Packaging | Identical |
| Sterilization | Identical |
| Shelf-Life | Identical |
Summary of Non-Clinical Tests
The following performance characteristics were evaluated:
- Ring Tensile Strength ◆
- . Suture Pullout Test
- . Adjustment Suture Testing
- MR Safety Evaluation .
- Biological Evaluation
- � Sterilization Parameter Evaluation
Conclusion
The additional sizes of the SJM Attune Ring are, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized depiction of a bird-like symbol, which is the department's logo. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Mr. Thomas Rademacher Regulatory Affairs Specialist 177 County Road B. East St. Paul. MN 55117
OCT 1 6 2009
Re: K092876
SJM Attune Flexible Adjustable Annuloplasty Ring Model AFR Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II (two) Product Code: KRH Dated: September 15, 2009 Received: September 18, 2009
Dear Mr. Rademacher:
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 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
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Page 2 - Mr. Thomas Rademacher
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/AboutiFDA/CentersOffices/CDRH0ffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dina R. bohner
Image /page/3/Picture/8 description: The image shows a handwritten letter 'G' in a cursive style. The letter is slightly tilted to the left and has a flowing, connected form. The stroke begins at the top, curves downward and to the left, then loops back up and around before extending downward again to form the lower part of the 'G'.
A 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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Attachment 2
Indications for Use Statement
Indications for Use
510(k) Number (if known): K 097876 Device Name: SJM™ Attune Flexible Adjustable Annuloplasty Ring Indications For Use:
The SJM™ Attune Annuloplasty Ring is indicated for use in the repair of a mitral or tricuspid valve that is diseased or damaged due to acquired or congenital valvular disease.
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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. de lanes
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_100 1 2876
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