(28 days)
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.
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.
This submission (K092876) describes the SJM Attune Flexible Adjustable Annuloplasty Ring, which is a fully flexible ring for mitral or tricuspid heart valve repair. The submission focuses on demonstrating substantial equivalence to a predicate device (SJM Attune Ring, K083835) and primarily relies on non-clinical performance testing.
1. A table of acceptance criteria and the reported device performance
The provided document details that the SJM Attune Flexible Adjustable Annuloplasty Ring was found to be substantially equivalent to its predicate device (K083835) based on a comparison of technological characteristics and non-clinical performance testing. The specific acceptance criteria and detailed performance results from these tests are not provided in this 510(k) summary. The document lists the types of tests performed but does not quantify the results or state the specific criteria for acceptance for each.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied as meeting equivalence) |
|---|---|
| Ring Tensile Strength requirements | Performance deemed substantially equivalent to predicate |
| Suture Pullout Test requirements | Performance deemed substantially equivalent to predicate |
| Adjustment Suture Testing requirements | Performance deemed substantially equivalent to predicate |
| MR Safety Evaluation requirements | Performance deemed substantially equivalent to predicate |
| Biological Evaluation requirements | Performance deemed substantially equivalent to predicate |
| Sterilization Parameter Evaluation requirements | Performance deemed substantially equivalent to predicate |
| Manufacturing and Design specifications | Substantially equivalent to predicate |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes used for the non-clinical tests (Ring Tensile Strength, Suture Pullout Test, etc.). It also does not mention the data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically not applicable to non-clinical bench or laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study involved non-clinical performance testing (bench testing) and not studies requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method for the test set
This information is not applicable as the study involved non-clinical performance testing and not studies requiring adjudication of output.
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
No such study was conducted or mentioned in this 510(k) submission. The device is an annuloplasty ring for heart valve repair, not an AI diagnostic or assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was conducted. The device is a physical medical implant.
7. The type of ground truth used
This information is not applicable as the studies were non-clinical performance tests, not clinical studies requiring a ground truth (e.g., pathology, expert consensus). The "ground truth" for the non-clinical tests would be the established engineering/performance standards and the characteristics of the predicate device.
8. The sample size for the training set
This information is not applicable as the device is a physical medical implant, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical implant, not an AI/machine learning model.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
Page 1 of
§ 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.”