(43 days)
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.
The device is a non-absorbable monofilament ePTFE suture using 4 Chord-X ePTFE sutures in a looped configuration provided in the following sizes and meeting the USP standards: 2-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. Also, 3-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. All configurations are supplied with two (2) 0.118 X 0.276 X 0.059 inches (3 X 7 X 1.5 mm) pledgets. All suture strands used in the construction of the prosthesis are 32 inches in length. The loops are made simply as a convenience for the surgeon who currently must tie these at the operating table as described in the medical literature (Gillinov AM, Banbury MK. Pre-Measured Artificial Chordae for Mitral Valve Repair. Ann Thorae Surg 2007;84:2127-2129.) It eliminates a step in the operation. They are provided as sterile, single use products and contain no dyes or additives.
The provided text is a 510(k) summary for the "Chord-X Pre-Measured Loops for Mitral Chordal Replacement" device. It is a submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device. This document focuses on the technical characteristics, biocompatibility, and sterilization of the device, rather than clinical study results establishing performance against acceptance criteria in the way an AI/ML device would be evaluated for clinical performance.
Therefore, many of the requested points regarding acceptance criteria and clinical performance studies for an AI/ML device (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical outcomes) are not applicable or available in this type of regulatory document.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and functionality.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document focuses on demonstrating substantial equivalence to existing predicate devices (Chord-X ePTFE Suture and Covidien Tetraflouroethylene (TFE) Polymer Pledget) based on material, intended use, and various physical and biological tests. There isn't a direct "acceptance criteria" table with performance metrics in the way one would define for an AI/ML diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated by meeting USP standards, passing biological tests, and exhibiting comparable physical properties to the predicate devices.
| Characteristic / Test | Acceptance Criteria / Standard | Reported Device Performance (Chord-X Loops) |
|---|---|---|
| Material(s) | ePTFE monofilament | ePTFE monofilament (Same as predicate Chord-X ePTFE Suture, different from Covidien Pledget which is PTFE felt but implied to be equivalent in function) |
| Intended Use | Chordal repair | Chordal repair (Same as predicate Chord-X ePTFE Suture, Covidien Pledget is for Cardiovascular suture buttress but deemed equivalent) |
| Meets USP | Yes | Yes |
| Configuration | USP 2-0 and 3-0 with pledgets | USP 2-0 and 3-0 with pledgets |
| Needle Choices | 3/8 and ½ circular taper point | 3/8 and ½ circular taper point |
| Knot Pull Tensile Strength (2-0) | Comparable to predicate (4.85 lbf for Chord-X ePTFE Suture) | 4.85 lbf |
| Stiffness | Comparable to predicate (62779 kgf for Chord-X ePTFE Suture) | 62779 kgf |
| % Elongation | Comparable to predicate (2.23% for Chord-X ePTFE Suture) | 2.23% |
| Usage | Single use | Single use |
| Sterilization | Validated to ISO 11135-1 | Meets requirements of standard |
| Shelf Life | Robust packaging, maintains integrity for 3 years (accelerated aging) | Confirmed for at least 3-years |
| Biological Endpoint: Cytotoxicity | Non-Cytotoxic | Grade 0, Non-Cytotoxic |
| Biological Endpoint: Sensitization | Non-Sensitizer | Non-Sensitizer |
| Biological Endpoint: Intracutaneous Irritation | Nonirritant | Nonirritant |
| Biological Endpoint: Acute Systemic Toxicity | No signs of acute, systemic toxicity | No signs of acute, systemic toxicity |
| Biological Endpoint: Material Mediated Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Biological Endpoint: Hemocompatibility | Nonhemolytic & Not an activator (for Complement) | Nonhemolytic (ASTM Hemolysis - Direct Contact & Extraction), Not an activator (C3a & SC5b-9 Complement Activation) |
| Physicochemical: Residue Mass (PW extraction) | Low residue (e.g., |
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).