(17 days)
MEMO 3D ReChord device is intended for correction of mitral insufficiencies or steno-insufficiences.
The use of the MEMO 3D ReChord device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the implant of the annuloplasty ring on its own. For type II insufficiencies, characterised by valve prolapse sustained by elongation/ breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterised by partially immobilised leaflets due to the fusion/hypertrophy of the chordae tendineae, the device implantation must be accompanied by corrective valvuloplasty.
Like its predicate device (the MEMO 3D Semirigid Annuloplasty Ring, K071327), the MEMO 3D ReChord Semirigid Annuloplasty Ring is supplied as a sterile, non-pyrogenic ring pre-mounted on a disposable holder.
Both the predicate and subject device are manufactured by embedding a superelastic metallic alloy inner core with medical grade silicone.
The resulting silicone sheath around the inner core is then encased within a tubular knitted fabric coated with a thin layer of turbostratic carbon (Carbofilm™). The fabric is then sewn along its length with a Carbofilm™ coated polyester thread.
The MEMO 3D ReChord features a fully removable system (the ReChord System) in the posterior curve of the annuloplasty ring, composed by a series of loops made by a single piece of yellow surgical thread retained in place by a single piece of blue surgical thread.
The ReChord System is designed to provide a temporary reference element to facilitate the sizing of the artificial chord length at the annular plane level when performing the replacement of mitral chordae tendineae in concomitance with the implant of the annuloplasty ring.
Both ReChord System threads end with a knot protruding from the ring surface, which is pulled at the end of the implant procedure to remove the threads from the ring. The annuloplasty ring is attached to a disposable holder (i.e., the two-piece holder) composed of a polysulfone disk and a polyetherimide template.
The disk attaches to a handle accessory and allows device handling, whilst the template keeps the device sufficiently stiff during suturing.
The MEMO 3D ReChord Semirigid Annuloplasty Ring is available in sizes 24 mm through 38 mm, in 2 mm increments. The number of the ReChord System thread loops varies based on the size of the annuloplasty ring: six (6) loops for ring sizes 24-30, eight (8) loops for ring sizes 32-38.
A complete set of accessories instrumentation is available separately to properly size the annulus and implant the annuloplasty ring.
This document is a 510(k) Summary for the MEMO 3D ReChord Semirigid Annuloplasty Ring. It does not describe a study to prove acceptance criteria for a new device's performance but rather demonstrates substantial equivalence to a predicate device. Therefore, many of the requested categories related to clinical performance data, expert review, training sets, and sample sizes for a new device's performance metrics are not applicable to this submission.
However, I can extract the information provided regarding the non-clinical performance data used to support substantial equivalence.
Here's a breakdown based on your request, highlighting what is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria (e.g., specific quantitative thresholds for performance) for the MEMO 3D ReChord device itself, nor does it list specific reported numerical performance results against such criteria. Instead, it states that non-clinical testing was conducted based on risk analysis and lists the types of tests performed. The basis for acceptance is demonstrating that these tests support substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for any of the non-clinical tests.
- Data provenance: Not explicitly stated, but the submission is from Sorin Group Italia S.r.l. in Italy, suggesting the tests might have been conducted there or by affiliated entities. The study is non-clinical (bench testing, biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a non-clinical evaluation of a physical medical device, not an AI/diagnostic device requiring expert consensus for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This pertains to expert review of diagnostic findings, which is not relevant for this device submission.
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
Not applicable. This is a physical annuloplasty ring, not an AI-assisted diagnostic or decision support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by validated test methodologies and engineering specifications for aspects like:
- Physical integrity (tensile strength, rigidity)
- Biocompatibility
- Sterility
- Functionality (e.g., ReChord System thread removal)
These are assessed against established standards and internal specifications, not expert consensus or pathology in a biological sense.
8. The sample size for the training set
Not applicable. This product does not involve machine learning algorithms with training sets.
9. How the ground truth for the training set was established
Not applicable. This product does not involve machine learning algorithms with training sets.
Summary of Reported Non-Clinical Performance Data & Study:
The primary study type mentioned is non-clinical verification and validation testing.
Description of Non-Clinical Testing Performed for MEMO 3D ReChord:
- Tests conducted specifically for MEMO 3D ReChord:
- Extraction tests for the ReChord System threads and disposable holder.
- Biocompatibility testing for the ReChord System thread and disposable holder components.
- Simulated distribution testing (likely testing packaging integrity under shipping conditions).
- Simulated use testing (wet lab on isolated porcine hearts) – this tested the functionality of the ReChord System in a simulated surgical environment.
- Tests not repeated for MEMO 3D ReChord (as the implantable part is identical to the predicate):
- Ultimate tensile strength
- Suture pull-out
- Rigidity determination
- Computational stress analysis
- Fatigue and durability testing
- Corrosion resistance
- Biocompatibility on the implanted materials
- Shelf life testing
Acceptance Criteria for Non-Clinical Testing:
The document states: "Sorin Group Italia S.r.l. has conducted verification and validation testing of the MEMO 3D ReChord based on the risk analysis for the device." This implies that the acceptance criteria for these non-clinical tests were derived from the device's risk analysis and were deemed sufficient to demonstrate the safety and effectiveness of the new features and components, and to uphold the substantial equivalence claim. Specific numerical acceptance values are not provided in this summary.
Conclusion:
The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (MEMO 3D Semirigid Annuloplasty Ring, K071327) by showing that the changes (introduction of the ReChord System and new holder) do not alter the fundamental safety, effectiveness, or indications for use of the implantable ring. Therefore, the "study" is a series of non-clinical bench tests and biocompatibility assessments targeting the new components, rather than a clinical trial with performance metrics typically found for new diagnostic or therapeutic devices. No clinical testing was conducted.
§ 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.”