← Product Code [KRH](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH) · K092876 # SJM ATTUNE ANNULOPLASTY RING (K092876) _St Jude Medical · KRH · Oct 16, 2009 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K092876 ## Device Facts - **Applicant:** St Jude Medical - **Product Code:** [KRH](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH.md) - **Decision Date:** Oct 16, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.3800 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## 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. ## Device Story SJM Attune Flexible Adjustable Annuloplasty Ring is a surgical implant for mitral or tricuspid valve repair. Device consists of medical-grade silicone core, polyester sewing cuff, and integrated adjustment suture. Implanted during open heart, minimally invasive, or robotic surgery by cardiac surgeons. Suture allows for post-implantation adjustment of ring geometry to optimize valve function. Device provides structural support to diseased or damaged heart valves; benefits include restoration of valve competence and improved hemodynamic function. ## Clinical Evidence Bench testing only. Performance characteristics evaluated included ring tensile strength, suture pullout testing, adjustment suture testing, MR safety evaluation, biological evaluation, and sterilization parameter evaluation. ## Technological Characteristics Medical-grade silicone core; polyester sewing cuff; integrated adjustment suture. Flexible, adjustable ring design. Sterilization method identical to predicate. Class II device (21 CFR 870.3800). ## Regulatory 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 - SJM Attune Ring model AFR-(size) ([K083835](/device/K083835.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. {1}------------------------------------------------ ## 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K092876](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRH/K092876) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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