The Duran Flexible Annuloplasty Ring is indicated for the reconstruction and/or remodeling of the pathologic mitral and tricuspid valves. Combined atrioventricular valve insufficiency and stenosis may be corrected by appropriate commissurotomy and valvular remodeling.

Device Description

The delivery system for the Duran Flexible Annuloplasty Ring consists of the ring holder, template and handle. The annuloplasty ring is mounted onto a rigid, colored plastic holder via sutures. The ring holder is connected to a rigid clear plastic template. The Duran Annuloplasty Ring and Delivery system is available in 25, 27, 29, 31, 33, and 35 mm sizes. A plastic colored handle is provided as part of the delivery system. The handle contains a wire portion for flexibility during use. The handle is provided to assist in the implantation of the assembly to the surgical site.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical Performance (after routine sterilization, resterilization, accelerated aging cycles)	Delivery components perform as intended.
Packaging Integrity	Packaging configuration provides a double aseptic sterile system with no detrimental effects from routine shipping and handling.
Shelf Life	Qualified expiration dates of 3 and 5 years.
Sterilization Efficacy	Complete sterilization validations using a 100% Ethylene Oxide sterilization cycle were acceptable.
Biocompatibility	Biocompatibility testing of materials, in accordance with ANSI/AAMI 10993-1, was acceptable.

Study Details

This submission is a 510(k) premarket notification for the Duran Flexible Annuloplasty Ring and Delivery System. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, the Medtronic Duran Flexible Annuloplasty Ring and Obturator (K893678). This is not a study designed to prove clinical efficacy through new clinical trials as would be common for novel, high-risk devices. Instead, it relies on demonstrating that the new device shares fundamental technical characteristics with, and performs at least as safely and effectively as, the predicate.

Here's a breakdown of the information requested, based on the provided text:

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in terms of a specific numerical test set. The performance data section refers to "performance bench testing," "packaging testing," "shelf life studies," and "sterilization validations" and "biocompatibility testing." These are typically conducted on a representative sample of devices and materials, but the exact sample sizes are not provided within this summary.
- Data provenance: The testing would have been conducted by Medtronic Heart Valves, Inc. (the device manufacturer), in accordance with applicable industry and clinical standards. The text does not specify the country of origin of the data beyond the manufacturer's location in Irvine, CA, USA. The studies are prospective in the sense that they are designed and conducted specifically to support this regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is not applicable to this submission. The device is a physical annuloplasty ring and delivery system. Its performance criteria are largely objective engineering and material science metrics (e.g., structural integrity, sterility, biocompatibility) rather than subjective clinical assessments requiring expert interpretation of diagnostic images or patient outcomes. Ground truth for these types of tests is established by laboratory measurements against predefined specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. As noted above, the performance tests described are objective and do not involve human interpretation or adjudication in the way a clinical diagnostic study would. Results are based on meeting predetermined engineering and biological specifications.
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 is not an AI-enabled diagnostic device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance tests described (physical performance, packaging, shelf life, sterilization, biocompatibility) is based on objective measurements against established industry and clinical standards and specifications. For example:
  - Physical performance: Engineering specifications for strength, durability, and functionality.
  - Packaging: Sterile barrier integrity standards.
  - Shelf life: Stability data over time according to defined degradation limits.
  - Sterilization: Sterility assurance level (SAL) targets.
  - Biocompatibility: ISO 10993 series standards for material safety.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI-driven device that requires a "training set." The device is a physical medical implant and delivery system.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K980534

APR 3 0 1998

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SECTION 18: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 18.1

a. Company Name:	Medtronic Heart Valves, Inc.
b. Company Address:	18011 South MitchellIrvine, CA. 92714
c. Company Phone:Company Facsimile:	(714) 474-3943(714) 474-3953
d. Contact Person:	Jean ChampionManager, Regulatory Affairs
e. Date Summary Prepared:	February 5, 1998

DEVICE IDENTIFICATION 18.2.

a. Trade/Proprietary Name:	Duran Flexible Annuloplasty Ring andDelivery System
b. Classification Name:	Annuloplasty Ring21 CFR 870.3800

IDENTIFICATION OF PREDICATE DEVICE 18.3

Company	Device	510(k)-No.	Date Cleared
Medtronic, Inc.	Duran Flexible AnnuloplastyRing and Obturator	K893678	11/27/89

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DEVICE DESCRIPTION 18.4

SUBSTANTIAL EQUIVALENCE 18.5

The Duran Flexible Annuloplasty Ring and Delivery System is substantially equivalent to the current Duran Flexible Annuloplasty Ring and Obturators in commercial distribution by Medtronic, Inc.

The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission. The annuloplasty ring has not changed from the predicate device, and is identical. The intended use of the ring holder and handle has not changed from the predicate device. Similar materials are used in the Duran Flexible Annuloplasty Ring and Delivery System as in the predicate device.

18.6 INTENDED USE

The Duran Flexible Annuloplasty Ring is indicated for the reconstruction and/or remodeling of the pathologic mitral and tricuspid valves.

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TECHNOLOGICAL CHARACTERISTICS 18.7

A comparison of the technological characteristics of the Duran Flexible Annuloplasty Ring and Delivery System with the predicate device is provided within this submission. Both the Duran Flexible Annuloplasty Ring and Delivery System and the predicate device are composed of an annuloplasty ring, ring holder, template and obturators. A handle can be used with both systems to assist in delivery of the ring to the surgical site. The materials used in the devices are similar and the sizes of the annuloplasty rings have not changed.

PERFORMANCE DATA 18.8

The Duran Flexible Annuloplasty Ring Delivery System is subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies are conducted to verify that the delivery components perform as intended after routine sterilization, resterilization and accelerated aging cycles. Packaging testing was completed to verify that the packaging configuration was able to provide a double aseptic sterile system and no detrimental effects occurred during routine shipping and handling of the product. Shelf life studies are used to qualify expiration dates of 3 and 5 years.

Complete sterilization validations of the product using a 100% Ethylene Oxide sterilization cycle were found to be acceptable.

Biocompatibility testing of materials in accordance with the "Biological Evaluation of Medical Devices - Part I: Guidance on Selection of Tests," ANSI/AAMI 10993-1, were conducted and found to be acceptable.

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18.9 510(K) CHECKLIST

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This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR 30 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jean Champion Senior Regulatory Affairs Manager Medtronic Cardiac Surgery Medtronic Heart Valves, Inc. 18011 South Mitchell Irvine, CA 92714

K980534 Re: Medtronic Duran Flexible Annuloplasty Ring Model #H680H Regulatory Class: III (Three) Product Code: KRH Dated: February 10, 1998 February 11, 1998 Received:

Dear Ms. Champion:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Jean Champion

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number:	To Be Assigned By FDA
Device Name:	Duran Flexible Annuloplasty Ring Delivery System
Indications For Use:	The Duran Flexible Annuloplasty Ring is indicated for thereconstruction and/or remodeling of the pathologic mitral andtricuspid valves. Combined atrioventricular valve insufficiencyand stenosis may be corrected by appropriate commissurotomyand valvular remodeling.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beice R. Camperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.”