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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary

(As required by 21 CFR 807.92)

FEB 1 4 1997

Submitter Information A.

St. Jude Medical Division (SJMD) Submitter's Name:

Address:

St. Jude Medical. Inc. One Lillehei Plaza St. Paul. MN 55117

Jonas A. Runquist Contact Person:

(612) 483-2000 Telephone Number:

Submission Prepared: March 28, 1996
B. Device Information

Proprietary Name:

Common or Usual Name:

Valvuloplasty Ring Mitral Valve Support Ring

Annuloplasty Ring

Classification Name: Pre-amendment Class lll CFR $870.3800 Cardiovascular Prosthetic Devices, Annuloplasty Ring

Predicate Device:

St. Jude Medical considers the Seguin Annuloplasty ring to be "substantially equivalent" to the Carpentier-Edwards Physio™ annuloplasty ring manufactured by Baxter Healthcare Corporation. The Physio annuloplasty ring was previously found by the Food and Drug Administration to be substantially equivalent to the Carpentier-Edwards ring which was marketed prior to May, 1976.

SJM® Sequin Annuloplasty Ring Model SAR-M

Annuloplasty Ring Device Description: Sequin The is a semi-rigid ring fabricated from an annuloplasty ultra-high molecular weight polyethylene (PE) core surrounded by

510(K) Summary Seguin Annuloplasty Ring

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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 Seguin Annuloplasty Ring is indicated for use in Intended Use: 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.

C. Comparison of Required Technological Characteristics

SJM considers the Seguin Annuloplasty Ring substantially equivalent in general configuration, function and intended use to the Carpentier-Edwards Physio™ annuloplasty ring. The table below addresses equivalency characteristics for the Sequin Annuloplasty Ring and the Physio™ annuloplasty ring. Each equivalency characteristic is then further addressed.

	Characteristic	Equivalency
a.	Product Labeling	Substantially Equivalent
b.	Intended Use	Identical
c.	Physical Characteristics	Substantially Equivalent
d.	Anatomical Sites	Identical
e.	Target Population	Identical
f.	Performance Testing	Substantially Equivalent
g.	Safety Characteristics	Substantially Equivalent

Product Labeling

Product labeling provided with the Seguin Annuloplasty Ring and the Physio™ annuloplasty ring are substantially equivalent as both devices provide similar Indications for Use, contraindications, warnings, precautions, etc.

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Intended Use

The intended use for the Seguin Annuloplasty Ring and the Physio™ annuloplasty ring are identical. Both devices are intended for the repair of diseased or damaged mitral valves determined by the Physician to be repairable.

Physical Characteristics

The physical characteristics of the Seguin Annuloplasty ring and the Physio™ annuloplasty ring are substantially equivalent as both devices are kidney shaped to match the mitral heart annulus. Both devices utilizes a core that provides a combination of flexibility and rigidity. The Sequin Annuloplasty Ring utilizes a polymer core and the Physio™ annuloplasty ring utilizes a core of metal bands to provide the semi-flexible properties. Both devices are covered in polyester fabric providing a means to attach the device to the heart annulus. The Seguin annuloplasty ring is available in mitral sizes 26mm - 40mm and the Physio™ annuloplasty ring is available in mitral sizes 24mm - 40mm. Both devices utilize a set of sizing obturators to select the proper size of prosthesis.

Anatomical Sites

Both the Seguin Annuloplasty Ring and the Physio™ annuloplasty ring are intended for use in the mitral valve.

Target Population

The target population for the Sequin Annuloplasty Ring and the Physio™ annuloplasty ring are identical. Both devices are targeted for patients of all ages, etc. with diseased or damaged mitral valves caused by acquired congenital processes resulting in mitral insufficiency and or stenosis.

Performance Testing

Performance testing on the Seguin Annuloplasty Ring has demonstrated that the prosthesis is substantially equivalent to the Physio™ annuloplasty ring. Animal testing (and clinical evaluations) have clearly demonstrated that the Seguin Annuloplasty Ring, like the Physio™ annuloplasty ring is capable of adequately repairing diseased or damaged mitral valves.

Safety Characteristics

Safety testing on the Sequin Annuloplasty Ring has demonstrated that the prosthesis is substantially equivalent to the Physio™ annuloplasty ring. [n-vitro testing has illustrated that the Sequin Annuloplasty Ring, like the Physio™ annuloplasty ring is capable of withstanding stresses without failure well beyond those that may be experience in-yive. Biocompatibility testing has also established that the Seguin ring like the Physio™ annuloplasty ring, is biocompatible and non-toxic.

510(K) Summary Seguin Annuloplasty Ring

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D. Summary of Nonclinical Tests

The following outlines the testing performed to demonstrate substantial equivalence to the Physio™ annuloplasty ring.

Evaluation of the mitral annulus to examine deflections of the Seguin 1. Annuloplasty Ring based on literature references.

A thorough review of the literature was performed to obtain estimates for physiological loads that may be placed on a cardiovascular prosthesis such as an annuloplasty ring in-vivo. The literature indicates that a worst case physiological load may be approximately 1.8 Lbs. and 200 mm Hg. The literature states that the maximum orifice reduction based on these loads is approximately 10% for a flexible annuloplasty ring, and 2.9% for a rigid annuloplasty ring. SJM utilized the 10% value for the flexible ring as the worst case condition in evaluating structural integrity of the Sequin Annuloplasty Ring. In reality, the Seguin Annuloplasty Ring like the Physio™ annuloplasty ring is a semi-rigid prosthesis and would be expected to have an orifice reduction of between 10% and 2.9% during a severe cardiac cycle.

2. Theoretical failure analysis

Stress magnitudes a.

Stress location b.

The Computational Structural Analysis addressed the structural stress magnitudes and stress locations on the Seguin Annuloplasty Ring. The results of this testing demonstrated that the expected worst case physiological loads based on literature references are less than half the force required to yield the Ultra High Molecular Weight polyethylene core of the Seguin Annuloplasty Ring. This testing has demonstrated that the Sequin Annuloplasty Ring has similar safety characteristics as the Physio™ annuloplasty ring.

3. Physical testing

Compressive failure mechanism based on theorotical loads and a. deflections

Compressive testing was designed to demonstrate that the force required to reduce the area of the Seguin Annuloplasty Ring by 10% (representing extreme conditions) did not result in damage or compromise the performance of the prosthesis. Data

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indicates that the 26mm ring (smallest) represents worst case conditions as it requires the greatest load to reduce the orifice of the ring by 10%. Decreased loads are required to achieve the 10% orifice reduction for the larger ring sizes.

Tensile failure mechanism based on theoretical loads and deflections b.

Tensile tests were performed to illustrate that the yield strength and the ultimate tensile strength of the Sequin Annuloplasty Ring are extremely high and are well above expected in-vivo stresses.

Suture pull out tests C.

The suture pull out test was designed to evaluate the potential of ring dehiscence with the Sequin Annuloplasty Ring as a result of sewing ring fabric failure. These tests investigated the strength of the hand sewn seam on the sewing ring as well as the tensile strength of the fabric. The strength of the sewing ring seam and fabric were evaluated by placing sutures through the sewing cuff and performing tensile or pull tests. This testing demonstrated that the hand sewn seam is stronger than the fabric as all sutures tore the fabric before failure of the seam occurred. The study also demonstrated that the strength of the fabric far exceeds the forces expected in-vivo.

The physical testing performed on the Sequin Annuloplasty Ring has demonstrated that it has similar safety characteristics as the Physio™ annuloplasty ring.

4. Biocompatibility testing

The materials used for the Seguin Annuloplasty Ring have an extensive clinical history with no adverse biocompatible response. The tests performed and the results are as follows:

Test	Result
USP Systemic Injection	Pass
USP Implantation (14 day) - Ultra High Molecular Weight Polyethylene	Pass
USP Implantation (14 day) - Polyester Fabric	Pass
Salmonella Mutagenicity Plate Assay (Ames Assay)	Pass
USP Intracutaneous Test	Pass
Guinea Pig Delayed Contact Sensitization Test(Extracted in Cottonseed Oil)	Pass
Guinea Pig Delayed Contact Sensitization Test(Extracted in Sodium Chloride)	Pass

Sequin Annuloplasty Rina

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USP Rabbit Pyrogen Test	Pass
Subchronic Toxicity with Histopathology (14 day)	Pass

The biocompatibility tests were conducted at ViroMed Laboratories in Minneapolis MN. and were performed under Good Laboratory Practices per 21 CFR Part 58.

In addition to the biocompatibility tests performed above, physical testing, and animal implant tests were performed on Dialine polyester fabric by an outside expert. This testing was published in a scientific journal. ( King, et. al: Evaluating the Dialine Vascular Prosthesis knitted from an alternative source of polvester varns Journal of Biomedical Materials Research, Vol 29, 595-610 (1995)). The results of these tests demonstrated that the Dialine polyester fabric was essentially equivalent to Dupont based (Dacron®) polyester fabrics in terms of physical, and tissue response characteristics.

Long term animal testing 5.

Surgical handling characteristics a.
In-vivo performance ﻗ
- Tissue in-growth properties i
- Macroscopic evaluations u
- -Histological examinations

Animal testing on the Seguin Annuloplasty Ring was designed to evaluate the performance of the prosthesis in-vivo for up to two years. Animals were monitored for evidence of excessive stenosis, regurgitation or other complications. Following explant, the annuloplasty rings were subjected to complete macroscopic, microscopic and histological examinations to access the prosthesis for evidence structural failure and to evaluate healing characteristics. All results from the animal study were considered excellent.

The animal testing has demonstrated that the performance of the Seguin Annuloplasty Ring is similar to the Physio™ annuloplasty ring.

Regulation Number and Section

§ 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.”