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510(k) Data Aggregation
(319 days)
The Seguin Annuloplasty Ring is indicated for use in repair of diseased or damaged mitral heart valves that are determined by the Physician to be repairable and do not require replacement. The Seguin Annuloplasty Ring provides support to the mitral heart valve restricting expansion of the annulus.
The Seguin is a semi-rigid annuloplasty ring fabricated from an ultra-high molecular weight polyethylene (PE) core surrounded by a custom Dialine® polyester sewing ring. The PE core is covered with a knitted polyester material providing a means for attaching the ring to the heart annulus as well as a suitable surface for tissue ingrowth.
The provided text describes the 510(k) Summary for the St. Jude Medical (SJM) Seguin Annuloplasty Ring, which is intended for use in the repair of diseased or damaged mitral heart valves. The summary aims to demonstrate substantial equivalence to the predicate device, the Carpentier-Edwards Physio™ annuloplasty ring.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it frames the "acceptance" as demonstrating substantial equivalence to the predicate device. The performance is reported by stating that the Seguin Annuloplasty Ring has similar or substantially equivalent characteristics and performance to the Physio™ annuloplasty ring.
| Characteristic / Test | Acceptance Criteria (Implicit) | Reported Device Performance (Seguin Annuloplasty Ring) |
|---|---|---|
| Product Labeling | Substantially Equivalent to Predicate Device | Similar Indications for Use, contraindications, warnings, precautions, etc., as the Physio™ annuloplasty ring. |
| Intended Use | Identical to Predicate Device | Identical to the Physio™ annuloplasty ring: repair of diseased or damaged mitral valves determined by Physician to be repairable. |
| Physical Characteristics | Substantially Equivalent to Predicate Device (kidney-shaped, core for flexibility/rigidity, covered in polyester fabric, similar size range) | Kidney-shaped, polymer core for flexibility/rigidity, covered in knitted polyester material. Available in 26mm-40mm (Physio™: 24mm-40mm). Utilizes sizing obturators. |
| Anatomical Sites | Identical to Predicate Device | Intended for use in the mitral valve, identical to the Physio™ annuloplasty ring. |
| Target Population | Identical to Predicate Device | Identical to the Physio™ annuloplasty ring: patients of all ages with diseased or damaged mitral valves. |
| Performance Testing | Substantially Equivalent to Predicate Device | Demonstrated capability of adequately repairing diseased or damaged mitral valves, similar to the Physio™ annuloplasty ring. |
| Safety Characteristics | Substantially Equivalent to Predicate Device | Capable of withstanding stresses well beyond in-vivo experience, biocompatible, and non-toxic, similar to the Physio™ annuloplasty ring. |
| Evaluation of Mitral Annulus (Deflections) | Expected orifice reduction between 2.9% (rigid) and 10% (flexible) for severe cardiac cycle. | Expected orifice reduction between 10% and 2.9% during severe cardiac cycle, similar to semi-rigid predicate. |
| Theoretical Failure Analysis (Stress Magnitudes) | Worst case physiological loads < half the force required to yield the PE core. | Worst case physiological loads < half the force required to yield the Ultra High Molecular Weight polyethylene core. |
| Theoretical Failure Analysis (Stress Location) | Safe stress locations (implicit) | Addressed structural stress locations. |
| Physical Testing (Compressive Failure) | Force required to reduce area by 10% does not result in damage or compromise performance. | The 26mm ring (worst case) requires the greatest load to reduce orifice by 10% without damage or compromise. Larger rings require less load. |
| Physical Testing (Tensile Failure) | Yield strength and ultimate tensile strength well above expected in-vivo stresses. | Yield strength and ultimate tensile strength are extremely high and well above expected in-vivo stresses. |
| Physical Testing (Suture Pull Out) | Suture pull force exceeds expected in-vivo forces, with seam stronger than fabric. | Hand sewn seam is stronger than the fabric; fabric strength far exceeds forces expected in-vivo. |
| Biocompatibility Testing | Pass (for all listed tests) | All listed tests (USP Systemic Injection, Implantation, Mutagenicity, Intracutaneous, Sensitization, Pyrogen, Subchronic Toxicity) Passed. |
| Long-Term Animal Testing | Absence of excessive stenosis, regurgitation, structural failure, and good healing characteristics. | All results from the animal study were considered excellent; similar performance to the Physio™ annuloplasty ring. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Nonclinical Tests (Theoretical and Physical Testing): Not explicitly stated as "sample size" in the conventional sense. The "test set" here refers to the device itself or components:
- Evaluation of the mitral annulus: Based on literature references (not a test on a device sample).
- Theoretical Failure Analysis: Computational Structural Analysis on the device design.
- Physical Testing (Compressive, Tensile, Suture Pull-out): Performed on "the Seguin Annuloplasty Ring." It specifies the 26mm ring as representing "worst-case conditions," implying multiple sizes were tested or considered. No specific number of rings tested is mentioned.
- Biocompatibility Testing: Performed on "the Seguin Annuloplasty Ring" materials. The tests themselves have their own sample sizes (e.g., number of animals for in-vivo tests like implantation, systemic injection, sensitization, pyrogen; cell cultures for mutagenicity). These specific internal sample sizes are not provided in the summary.
- Long-Term Animal Testing: "Animals were monitored." No specific number of animals is stated.
- Data Provenance:
- Nonclinical Tests: Conducted by St. Jude Medical Division (SJM).
- Biocompatibility Testing: Conducted at ViroMed Laboratories in Minneapolis, MN, under GLP per 21 CFR Part 58.
- Dialine Polyester Fabric Testing: Performed by an outside expert and published in a scientific journal (King, et. al., Journal of Biomedical Materials Research, 1995).
- Long-Term Animal Testing: Conducted by SJM.
- Retrospective/Prospective: All tests described are prospective in nature, performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- No "ground truth" establishment in the typical clinical study sense. The tests performed are engineering, material, and animal studies.
- Biocompatibility Testing: Conducted by ViroMed Laboratories (a contract lab). Not specified if external experts established ground truth, but the tests follow established protocols (USP standards, Ames Assay, etc.).
- Dialine Polyester Fabric Testing: Performed by "an outside expert" and published in a scientific journal, implying peer review validating the data.
- Animal Testing: Ex-plant evaluations included "complete macroscopic, microscopic and histological examinations." While not explicitly stated, this usually involves veterinary pathologists or scientists evaluating the findings. No specific number or qualifications are given for these evaluators.
4. Adjudication Method for the Test Set:
- Not applicable. This document describes non-clinical and animal testing for device equivalence, not human clinical trials requiring adjudication of outcomes or diagnoses.
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:
- Not applicable. This is a medical device for valve repair, not an AI/imaging diagnostic tool. There is no mention of AI, human readers, or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to medical device testing, not AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Nonclinical Tests: Engineering principles, material science properties, and established physiological load values from literature (for theoretical analysis), and measurable physical properties for physical testing (e.g., force, deflection, tensile strength).
- Biocompatibility Testing: Standardized biological assays and animal responses as per USP and other established protocols.
- Long-Term Animal Testing: Macroscopic, microscopic, and histological examinations of explanted rings and surrounding tissue; observation of animal health/complications (e.g., stenosis, regurgitation). This involves pathology and observation of outcomes in animals.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device's non-clinical testing for substantial equivalence. This is not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
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