(29 days)
The SJM™ Seguin annuloplasty ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.
The SJM Seguin Ring is a semi-rigid ring fabricated from an ultra-high molecular weight polyethylene core surrounded by a polyester sewing cuff, which provides a means for attaching the ring to the mitral annulus as well as a suitable surface for tissue ingrowth.
The provided document is a 510(k) summary for the SJM Seguin Annuloplasty Ring. It does not describe a study involving an AI or an algorithm-based device, nor does it provide acceptance criteria or performance data in the typical sense for such devices.
Instead, this document is a regulatory submission for a medical implant (an annuloplasty ring) and focuses on establishing substantial equivalence to a predicate device. The "performance testing" mentioned refers to non-clinical, bench-top tests of mechanical properties and biocompatibility, not a clinical study to evaluate detection accuracy, sensitivity, or specificity.
Therefore, many of the requested elements (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission for this particular device.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document lists performance characteristics that were "evaluated" but does not provide a table with specific acceptance criteria or quantitative performance results for these evaluations. It broadly states that the device is "safe and effective."
| Item | Acceptance Criteria (Not Explicitly Stated for this Device) | Reported Device Performance (Not Explicitly Stated for this Device) |
|---|---|---|
| Ring Tensile Strength | (Presumed to meet internal specifications and predicate performance) | (Evaluated, outcome inferred to be acceptable) |
| Ring Compression Strength | (Presumed to meet internal specifications and predicate performance) | (Evaluated, outcome inferred to be acceptable) |
| Suture Pullout Test | (Presumed to meet internal specifications and predicate performance) | (Evaluated, outcome inferred to be acceptable) |
| MR Safety Evaluation | (Presumed to meet relevant safety standards) | (Evaluated, outcome inferred to be acceptable) |
| Manufacturing Process Valid. | (Presumed to be validated to ensure consistent quality) | (Evaluated, outcome inferred to be acceptable) |
| Biological Evaluation | (Presumed to meet biocompatibility standards) | (Evaluated, outcome inferred to be acceptable) |
| Sterilization Parameter Eval. | (Presumed to meet sterilization efficacy standards) | (Evaluated, outcome inferred to be acceptable) |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The "tests" mentioned are non-clinical, bench-top evaluations (e.g., tensile strength, compression strength, suture pullout). These typically involve a small number of physical samples (e.g., 5-10 devices) to demonstrate consistency and compliance with engineering specifications.
- Data Provenance: Not applicable in the context of clinical studies. These are laboratory-based, non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical expert review, is not relevant for these non-clinical engineering and biological evaluations. Compliance with technical standards and internal specifications would be assessed by engineers and specialists in material science, biomechanics, and biocompatibility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in clinical studies for ambiguous cases, typically involving human readers. This document describes non-clinical tests.
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. This device is a physical annuloplasty ring, not an AI or imaging diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For non-clinical tests, "ground truth" would refer to established engineering standards, material properties, and regulatory requirements (e.g., ASTM standards for tensile strength, ISO standards for biocompatibility).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device.
{0}------------------------------------------------
16092310
SECTION 7 - 510(K) SUMMARY
Applicant Information
Submitter's Name and Address:
Contact Name
Submission Prepared
Device Information
Proprietary Name:
Common or Usual Name:
Classification:
Predicate Device:
SJM Seguin Ring model SARP-(size)
510(k) No. K014037 - cleared January 4, 2002
Device Description:
The SJM Seguin Ring is a semi-rigid ring fabricated from an ultra-high molecular weight polyethylene core surrounded by a polyester sewing cuff, which provides a means for attaching the ring to the mitral annulus as well as a suitable surface for tissue ingrowth.
Intended Use:
The SJMM Seguin annuloplasty ring is intended to be used for repair of diseased or damaged mitral heart valves that are determined by the physician to be repairable and do not require replacement.
St. Jude Medical Seguin Ring - Special 510(k)
AUG 2 7 2009
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@sjm.com
July 24, 2009
SJM Seguin Annuloplasty Ring
Semi-rigid annuloplasty ring Mitral repair ring
Class II per 21 CFR 870.3800, Annuloplasty rings
Confidential
{1}------------------------------------------------
Comparison of Required Technological Characteristics
SJM considers the SJM Seguin 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 Seguin 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 .
- Ring Compression Strength .
- Suture Pullout Test .
- . MR Safety Evaluation
- Manufacturing Process validation .
- Biological Evaluation
- Sterilization Parameter Evaluation .
Conclusion
St. Jude Medical has demonstrated that the SJM Seguin Annuloplasty ring is safe and effective for the The Seguin Ring is, with respect to intended use and technological characteristics, intended use. substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 2 7 2009
St. Jude Medical c/o Mr. Thomas Rademacher Regulatory Affairs Specialist 177 County Road B, East St. Paul, MN 55117
Re: K092310
Seguin Annuloplasty Ring Model SARP-(size), Sizes 24 mm-40 mm (even sizes) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II (two) Product Code: KRH Dated: July 24, 2009 Received: July 29, 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
{3}------------------------------------------------
Page 2 - Mr. Thomas Rademacher
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 vours.
Duna R. Vorhmer
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): K092310 Device Name: SJM Seguin Annuloplasty Ring Indications For Use:
The SJM™ Seguin annuloplasty ring is indicated for use in the repair of mitral valves that are diseased or damaged due to acquired or congenital processes.
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)
Anna R. de Sinner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K092310
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.”