(319 days)
Carpentier-Edwards Physio™ annuloplasty ring
Carpentier-Edwards Physio™ annuloplasty ring
No
The summary describes a physical medical device (annuloplasty ring) and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is implanted to repair diseased or damaged mitral heart valves, which is a therapeutic intervention.
No
The device is an annuloplasty ring used for repairing the mitral heart valve, not for diagnosis. Its purpose is to provide structural support, not to identify or determine a disease state.
No
The device description clearly states it is a physical annuloplasty ring fabricated from materials like polyethylene and polyester, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Seguin Annuloplasty Ring is a physical implant designed to repair and support the mitral heart valve within the body. It is a surgical device, not a diagnostic test performed on a sample outside the body.
The description clearly indicates it's a medical device used in a surgical procedure to treat a structural problem with the heart valve.
N/A
Intended Use / Indications for Use
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.
Product codes
CFR §870.3800
Device Description
The Seguin is a semi-rigid 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mitral heart valves
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
-
Evaluation of the mitral annulus to examine deflections of the Seguin Annuloplasty Ring based on literature references.
Purpose: To obtain estimates for physiological loads that may be placed on a cardiovascular prosthesis such as an annuloplasty ring in-vivo.
Key Results: Literature indicates that a worst case physiological load may be approximately 1.8 Lbs. and 200 mm Hg. 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. -
Theoretical failure analysis
Purpose: To address structural stress magnitudes and stress locations on the Seguin Annuloplasty Ring.
Key Results: 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. Demonstrated similar safety characteristics as the Physio™ annuloplasty ring. -
Physical testing
a. Compressive failure mechanism based on theoretical loads and deflections
Purpose: 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.
Key Results: The 26mm ring (smallest) represents worst case conditions, requiring the greatest load to reduce the orifice by 10%. Decreased loads required for larger ring sizes.
b. Tensile failure mechanism based on theoretical loads and deflections
Purpose: To illustrate that the yield strength and the ultimate tensile strength of the Seguin Annuloplasty Ring are extremely high and are well above expected in-vivo stresses.
Key Results: Yield and ultimate tensile strength are well above expected in-vivo stresses.
c. Suture pull out tests
Purpose: To evaluate the potential of ring dehiscence with the Seguin Annuloplasty Ring as a result of sewing ring fabric failure.
Key Results: The hand sewn seam is stronger than the fabric; sutures tore the fabric before seam failure. Strength of the fabric far exceeds forces expected in-vivo.
Conclusion: Physical testing demonstrated similar safety characteristics as the Physio™ annuloplasty ring.
- Biocompatibility testing
Purpose: To demonstrate biocompatibility of the materials.
Study Type: In-vitro tests and animal implant tests.
Results:
- 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
- USP Rabbit Pyrogen Test: Pass
- Subchronic Toxicity with Histopathology (14 day): Pass
Data Source: ViroMed Laboratories in Minneapolis MN, performed under Good Laboratory Practices per 21 CFR Part 58.
Additional: Dialine polyester fabric evaluated by an outside expert (King, et. al: Evaluating the Dialine Vascular Prosthesis knitted from an alternative source of polyester yarns Journal of Biomedical Materials Research, Vol 29, 595-610 (1995)).
Key Results: Dialine polyester fabric was essentially equivalent to Dupont based (Dacron®) polyester fabrics in terms of physical and tissue response characteristics.
- Long term animal testing
Purpose: To evaluate the performance of the prosthesis in-vivo for up to two years.
Study Type: Animal study.
Key Results: Animals monitored for stenosis, regurgitation, or other complications. Post-explant, rings subjected to macroscopic, microscopic, and histological examinations for structural failure and healing characteristics. All results considered excellent.
Conclusion: Animal testing demonstrated that the performance of the Seguin Annuloplasty Ring is similar to the Physio™ annuloplasty ring.
Key Metrics
Not Found
Predicate Device(s)
Carpentier-Edwards Physio™ annuloplasty ring
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '961246'. The characters are written in a bold, sans-serif style, and they appear to be slightly uneven, suggesting they were written by hand.
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
1
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
3
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
4
00000
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.