FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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.”