(87 days)
The Duran Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves.
Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.
The Duran product family (including the Duran products listed in Section II -DEVICE IDENTIFICATION), consist of permanent, implantable, flexible annuloplasty rings or bands made of polyester fabric with a 3-mm cross-section. A silicone marker, impregnated with barium sulfate enables radiographic visualization. The individual ring and band sizes range from 23mm to 35mm, in two-millimeter increments.
The Duran products are used with associated accessories that include a holder, handle and sizers. The ring or band is provided on a holder to facilitate implantation of the device. The sizers are used to assess appropriate ring or band size and the handle interfaces with the holder to allow for proper positioning of the ring or band.
This K032810 summary describes the Medtronic Heart Valves' Duran Product Family, which includes various annuloplasty rings and bands. The submission indicates that these devices are substantially equivalent to a previously cleared device, the Duran Ring (Model H608H - K980534), and references earlier cleared devices as well.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative "acceptance criteria" in the typical sense of a pre-defined threshold that the device must meet (e.g., accuracy > 90%). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance data" provided relates to material properties and sterilization efficacy, showing that the new devices perform equivalently or meet established safety standards.
| Acceptance Criteria (Implied from Substantial Equivalence and Safety Standards) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Materials used are safe for implantation. | Materials are identical to those in the predicate (Duran Ring H608H) and have been used since 1978 with no biocompatibility issues. Accessories use commonly accepted biocompatible materials. |
| Mechanical Strength (Suture Pull-out): Fabric can withstand suture forces. | Suture pull-out testing on polyester fabric showed an average force of 26.90 lbs for looping through the fabric and 2.61 lbs for an individual fiber. (No changes to fabric, so test was not repeated for new devices). |
| Sterilization Efficacy: Device is sterile. | Requalified 100% ethylene oxide sterilization cycle provides a Sterility Assurance Level (SAL) of 10^-6. Sterilant residual levels meet ISO 10993-7 (1995). Annual re-verification of sterilization qualification. |
| Biological Safety (Endotoxins, Microbial Contamination): Device is free from harmful biological contaminants. | Biological testing (bioburden and pyrogen) and manufacturing process controls are established based on processes for the predicate device. |
| Shelf-life / Stability: Device remains safe and effective over its shelf-life. | Constructed from materials already qualified through Medtronic product shelf-life validation testing. Packaging is identical to previously cleared packaging, thus no additional shelf-life testing required. |
| Indications for Use: New devices perform for the same indications as the predicate. | The devices have the same indications for use: reconstruction and/or remodeling of pathological mitral and tricuspid valves. (With a specific note for the Chordal Guide feature). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not describe a traditional "test set" or a study involving a specific number of implanted devices or clinical cases for the purpose of evaluating device performance in humans. The testing described focuses on laboratory-based material properties and sterilization.
- Data Provenance: Not applicable in the context of a clinical test set. The data originates from Medtronic's internal testing and historical usage of similar materials/devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission is for a medical device (annuloplasty rings/bands) and relies on material and manufacturing equivalency to a predicate device, rather than a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as #3.
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:
This information is not applicable as the device is an implantable medical device (annuloplasty ring/band), not an AI-powered diagnostic or interpretation tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth or basis for acceptance in this submission relies on:
- Historical Performance: Long-term safe and effective use of the same materials and manufacturing processes in previously cleared predicate devices (since 1978).
- Industry Standards: Compliance with recognized international standards for sterilization (ISO 10993-7).
- Laboratory Testing: Mechanical and biological performance verified through internal Medtronic testing (e.g., suture pull-out force).
- Substantial Equivalence: Direct comparison to a legally marketed predicate device (Duran Ring Model H608H) to demonstrate similar fundamental technology, materials, and intended use.
8. The sample size for the training set:
This information is not applicable as the device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML model that requires a training set.
§ 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.”