(121 days)
Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.
The device is a non-absorbable monofilament ePTFE suture provided in the following configurations and meeting the USP standards:
USP 2-0 with 3/8 circle needle (Model - CX2038A)
USP 2-0 with ½ circle needle (Model CX2012A)
USP 3-0 with 3/8 circle needle (Model - CX3038A)
USP 3-0 with ½ circle needle (Model CX3012A)
It is provided as a sterile, single use product and contains no dyes or additives.
The Chord-X ePTFE Suture is a non-absorbable monofilament expanded polytetrafluoroethylene (ePTFE) suture intended for the repair or replacement of chordae tendineae. The device's performance was evaluated through various biological, physicochemical, and sterilization tests to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Chord-X ePTFE Suture) |
|---|---|---|
| General | ||
| Material(s) | ePTFE monofilament | ePTFE monofilament |
| Intended Use | Chordal repair / Cardiovascular soft tissue | Chordal repair |
| Meets USP | Yes (for Osteogenics Cytoplast Suture) | Yes |
| Configuration | USP 2-0 and 3-0 equivalents (CV-4, CV-5) or USP 4-0 | USP 2-0 and 3-0 |
| Needle Choices | 3/8 and ½ circular taper point (Gore-Tex) / ½ circular taper point (Osteogenics) | 3/8 and ½ circular taper point |
| Packaging | Double peel-pouch type | Double peel-pouch type |
| Usage | Single use | Single use |
| Sterilized | EtO | EtO |
| Shelf Life | 3-year (Gore-Tex) / Unknown (Osteogenics) | 3-year (Validated via accelerated aging per ISO 11607-1) |
| Physical Properties (2-0 Suture) | ||
| Knot Pull Tensile Strength (2-0) | 3.99 lbf (Gore-Tex) | 4.85 lbf |
| Stiffness | 35814 kgf (Gore-Tex) | 62779 kgf |
| % Elongation | 3.30% (Gore-Tex) | 2.23% |
| Biological Safety (ISO 10993) | Expected to be biocompatible | |
| Cytotoxicity | Non-cytotoxic | Grade 0, Non-Cytotoxic |
| Sensitization | Non-sensitizer | Non-Sensitizer |
| Intracutaneous Irritation | Non-irritant | Nonirritant |
| Acute Systemic Toxicity | No signs of acute, systemic toxicity | No signs of acute, systemic toxicity |
| Material Mediated Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Hemocompatibility (Hemolysis) | Nonhemolytic | Nonhemolytic (Direct Contact), Nonhemolytic (Extraction) |
| Hemocompatibility (Complement) | Not an activator | C3a Complement Activation: Not an activator, SC5b-9 Complement Activation: Not an activator |
| Physicochemical | No significant extractable residues | |
| Extraction Residue Mass (PW) | Minimal | 0.2 mg (0.002 mg/cm length) |
| Extraction Residue Mass (Ethanol) | Minimal | 0.4 mg (0.004 mg/cm length) |
| Extraction Residue Mass (Hexane) | Minimal | 0.5 mg (0.006 mg/cm length) |
| IR Scans of Residues | No major bands detected | No major bands detected |
2. Sample Size and Data Provenance
The document does not specify details about "test sets" in the context of clinical studies with patients. The performance data presented are from in vitro laboratory tests. Therefore, information about sample size for a "test set" in the common sense of clinical data, as well as data provenance (country of origin, retrospective/prospective), is not applicable here. The biological endpoints were evaluated on product samples.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The data presented are from laboratory test results (physical properties, biological safety, physicochemical analysis) rather than clinical evaluations requiring expert interpretation for ground truth establishment.
4. Adjudication Method
This information is not applicable for laboratory test results.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done for this device. The nature of the device (a surgical suture) and the presented data (laboratory tests) do not align with studies typically requiring MRMC analysis.
6. Standalone Performance (Algorithm Only) Study
This information is not applicable. The device is a physical medical product (suture), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the performance data presented is derived from objective laboratory measurements and established test methodologies (e.g., USP standards for sutures, ISO 10993 standards for biocompatibility) that yield quantifiable and reproducible results. For example:
- Physical properties: Measured values (lbf, kgf, %) directly from mechanical testing.
- Biocompatibility: Categorical results (e.g., "Non-Cytotoxic," "Non-Sensitizer") based on established criteria within the ISO 10993 series.
- Physicochemical: Measured residue masses and infrared spectral analysis.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
§ 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).