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510(k) Data Aggregation
(43 days)
PAW
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., |
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(121 days)
PAW
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.
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