K Number
K960356
Device Name
POSTERIOR ANNULOPLASTY BAND (MODEL 607)
Date Cleared
1996-08-27

(215 days)

Product Code
Regulation Number
870.3800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is indicated for the reconstruction and/or remodeling of the pathological mitral valve. Combined mitral valve stenosis and insufficiency may be corrected by appropriate commissurotomy and valvular remodeling. The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is contraindicated for use under the following conditions: the presence of heavy valvular calcification, valvular retraction with severely reduced mobility and the presence of active bacterial endocarditis.
Device Description
The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is constructed of a polyester fabric enclosing an open strip of pliable radiopaque sillicone elastomer impregnated with barium sulfate which enables radiographic visualization. The band is uniformly 3 mm in diameter and is provided in a single length of 63 mm. Colored suture markers, which facilitate implantation, are circumferentially located at the center of the band and at each end. The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be offered in one length, 63 mm and will not be mounted onto a holder. No sizers will be offered with the posterior band configuration as only one length is available. The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be supplied in a sterile double aseptic transfer pouch. The annuloplasty band will remain sterile if the pouch is undamaged and unopened. The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND uses the same materials and is processed, packaged and sterilized similarly to the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.
More Information

There are no predicate devices with K/DEN numbers mentioned in the text.

Not Found

No
The device description and performance studies focus on the physical construction, materials, and clinical history of a passive implantable device (annuloplasty band). There is no mention of software, algorithms, data processing, or any characteristics indicative of AI/ML technology.

Yes
The device is indicated for "reconstruction and/or remodeling of the pathological mitral valve" and can "correct" combined mitral valve stenosis and insufficiency, directly implying a therapeutic function.

No
The device is described as an annuloplasty band used for the reconstruction and/or remodeling of the mitral valve, indicating a therapeutic rather than diagnostic function.

No

The device description clearly indicates it is a physical implant constructed of polyester fabric and silicone elastomer, designed for surgical implantation. It is not software.

Based on the provided text, the MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for the "reconstruction and/or remodeling of the pathological mitral valve." This is a surgical procedure performed in vivo (within the living body) to repair a heart valve.
  • Device Description: The device is a physical implant designed to be surgically placed within the body.
  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device does not perform such testing.

The device is a surgical implant used for structural repair, not for diagnostic testing of biological samples.

N/A

Intended Use / Indications for Use

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is indicated for the reconstruction and/or remodeling of the pathological mitral valve. Combined mitral valve stenosis and insufficiency may be corrected by appropriate commissurotomy and valvular remodeling.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is contraindicated for use under the following conditions: the presence of heavy valvular calcification, valvular retraction with severely reduced mobility and the presence of active bacterial endocarditis.

Product codes

Not Found

Device Description

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is constructed of a polyester fabric enclosing an open strip of pliable radiopaque sillicone elastomer impregnated with barium sulfate which enables radiographic visualization. The band is uniformly 3 mm in diameter and is provided in a single length of 63 mm. Colored suture markers, which facilitate implantation, are circumferentially located at the center of the band and at each end.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be offered in one length, 63 mm and will not be mounted onto a holder. No sizers will be offered with the posterior band configuration as only one length is available.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be supplied in a sterile double aseptic transfer pouch. The annuloplasty band will remain sterile if the pouch is undamaged and unopened.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND uses the same materials and is processed, packaged and sterilized similarly to the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

radiographic visualization

Anatomical Site

mitral valve

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Clinical Experience:
Appendix 3 contains a copy of a published report comparing the clinical experience of posterior annuloplasty (This report details clinical experience utilizing 2/3's of a MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.) with that of commissural annuloplasty and full ring annuloplasty.

In addition, the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING has an established clinical record of documented performance for over 15 years. The MEDTRONIC® Posterior Annuloplasty Ring is composed of identical materials and is manufactured utilizing the same assembly, packaging and sterilization operations as the Duran Ring. Thus, the established clinical history of the Duran Flexible ring is germane to the MEDTRONIC® POSTERIOR ANNULOPLASTY BAND. Copies of publications documenting this performance can be found in Appendix 3.

Biocompatibility of Materials/Finished Device:
Cytotoxicity and Hemolysis testing was performed. This testing was performed in accordance with USP requirements.

Qualification:
The integrity of the Posterior Annuloplasty Band is considered to be the strength of the band, as measured by the "Wire Pull Out Test". "Wire Pull Out Test" Data for the Duran Flexible Annuloplasty Ring which had been subjected to a 100% Sterilization process (Appendix 9) while presented in an FDA notification provided in October, 1995. The data available for the Duran Flexible Annuloplasty Ring is considered to be germane for the Posterior Annuloplasty Band as the materials and manufacturing processes (inclusive of packaging and sterilization) are similar. The open configuration of the Posterior Annuloplasty Band has no bearing on the results of the "wire pull out test". For your convenience, a summary of this test data can be located in Appendix 5.

A process qualification was performed in order to determine if the band could be manufactured to specifications. The process qualification demonstrated that a pliable band could be produced in accordance with the established product specifications. The process qualification report can be found in Appendix 5.

Key Metrics

Not Found

Predicate Device(s)

Not Found

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.”

0

K960356
5/27/96

Summary of Safety and Effectiveness

MEDTRONIC® POSTERIOR ANNULOPLASTY BAND

  • l. General Information
    Device Generic Name:

Device Trade Name:

MEDTRONIC® POSTERIOR

MEDTRONIC® Heart Valves, Inc.

ANNULOPLASTY BAND

Annuloplasty Band

Applicant's Name:

Applicant's Address:

18011 South Mitchell Irvine, CA 92714

ll. Description of the Diseases and Conditions for Which the Device is Intended

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is indicated for the reconstruction and/or remodeling of the pathological mitral valve. Combined mitral valve stenosis and insufficiency may be corrected by appropriate commissurotomy and valvular remodeling.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is contraindicated for use under the following conditions: the presence of heavy valvular calcification, valvular retraction with severely reduced mobility and the presence of active bacterial endocarditis.

  • lll. Device Description
    The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is constructed of a polyester fabric enclosing an open strip of pliable radiopaque sillicone elastomer impregnated with barium sulfate which enables radiographic visualization. The band is uniformly 3 mm in diameter and is provided in a single length of 63 mm. Colored suture markers, which facilitate implantation, are circumferentially located at the center of the band and at each end.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be offered in one length, 63 mm and will not be mounted onto a holder. No sizers will be offered with the posterior band configuration as only one length is available.

A2-1
Gb00018

1

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will be supplied in a sterile double aseptic transfer pouch. The annuloplasty band will remain sterile if the pouch is undamaged and unopened.

The MEDTRONIC® POSTERIOR ANNULOPLASTY BAND uses the same materials and is processed, packaged and sterilized similarly to the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.

IV. Alternatives

Alternatives for patients requiring mitral valve annuloplasty is valve replacement surgery. Alternatives to use of the MEDTRONIC® POSTERIOR ANNULOPLASTY BAND is commissural annuloplasty and other commercially available annuloplasty bands or rings.

V. Potential Adverse Effects

Potential adverse effects of annuloplasty includes thromboembolic events, ring dehiscence, hemolysis, stenosis, uncorrected or residual incompetence, heart block, and endocarditis.

Summary of Studies VI.

Clinical Experience:

Appendix 3 contains a copy of a published report comparing the clinical experience of posterior annuloplasty (This report details clinical experience utilizing 2/3's of a MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING.) with that of commissural annuloplasty and full ring annuloplasty.

In addition, the MEDTRONIC® DURAN FLEXIBLE ANNULOPLASTY RING has an established clinical record of documented performance for over 15 years. The MEDTRONIC® Posterior Annuloplasty Ring is composed of identical materials and is manufactured utilizing the same assembly, packaging and sterilization operations as the Duran Ring. Thus, the established clinical history of the Duran Flexible ring is germane to the MEDTRONIC® POSTERIOR ANNULOPLASTY BAND. Copies of publications documenting this performance can be found in Appendix 3.

Biocompatibility of Materials/Finished Device:

Cytotoxicity and Hemolysis testing was performed. This testing was performed in accordance with USP requirements.

MEDTRONIC POSTERIOR ANNULOPLASTY BAND

A2 - II
00019

2

Qualification:

The integrity of the Posterior Annuloplasty Band is considered to be the strength of the band, as measured by the "Wire Pull Out Test". "Wire Pull Out Test" Data for the Duran Flexible Annuloplasty Ring which had been subjected to a 100% Sterilization process (Appendix 9) while presented in an FDA notification provided in October, 1995. The data available for the Duran Flexible Annuloplasty Ring is considered to be germane for the Posterior Annuloplasty Band as the materials and manufacturing processes (inclusive of packaging and sterilization) are similar. The open configuration of the Posterior Annuloplasty Band has no bearing on the results of the "wire pull out test". For your convenience, a summary of this test data can be located in Appendix 5.

A process qualification was performed in order to determine if the band could be manufactured to specifications. The process qualification demonstrated that a pliable band could be produced in accordance with the established product specifications. The process qualification report can be found in Appendix 5.

  • V. Conclusions
    The testing performed for the MEDTRONIC® POSTERIOR ANNULOPLASTY BAND and examination of the clinical experience of the POSTEDIOD ANNU: ORLASTIC CREASOnable assurance that the MEDTRONIC® POSTERIOR ANNULOPLASTY BAND will perform in a safe and effective manner when used as indicated.

l believe, to the best of my knowledge, that all data and information submitted in this 510(k) are truthful and accurate, and that no material fact has been omitted in

Kathleen T. Bahr

athleen T. Boehm Product Regulation Manager MEDTRONIC® Heart Valves, Inc.

1-24-96
Date

Image /page/2/Picture/9 description: The image shows a combination of handwritten text and numbers. The text "A2 - III" is written in the upper right corner of the image. Below the text, the number "00020" is written. To the left of the number, there is a handwritten symbol that looks like a number 8.

MEDTRONIC POSTERIOR ANNUL OPLASTY RAND