(106 days)
For use as a wrap for pedicled arterial conduits.
The device identifies and protects pedicled arterial conduits during reoperative cardiac surgery.
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve configuration. The sleeve configuration allows a surgeon to use the device as is without the need to form and shape the device during surgical procedures. The sleeve has a nominal 17-24 mm internal diameter and a length of 10-20 cm.
This document describes a 510(k) premarket notification for a medical device called the "GORE PRECLUDE® IMA Sleeve". The device is an expanded polytetrafluoroethylene (ePTFE) sleeve intended for use as a wrap for pedicled arterial conduits during reoperative cardiac surgery. The basis for substantial equivalence is comparison to a predicate device, the PRECLUDE™ Pericardial Membrane.
Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense as might be seen for a diagnostic AI device (e.g., minimum sensitivity, specificity). Instead, the acceptance of the device is based on demonstrating substantial equivalence to a legally marketed predicate device. This equivalence is shown through shared material, manufacturing process, intended use, indications, and comparable performance in specific tests.
| Acceptance Criterion (Established by Predicate Equivalence) | Reported Device Performance (Applicant Device) |
|---|---|
| Material Composition | Biocompatible ePTFE (same as predicate) |
| Manufacturing Process | Same as predicate |
| Intended Use | Same as predicate: surgical membrane for covering and physical barrier of pedicled arterial conduits; identifies and protects during reoperative cardiac surgery. |
| Indications for Use | Same as predicate: wrap for pedicled arterial conduits. |
| Biocompatibility | No histopathological complications in animal studies (consistent with predicate). |
| Tissue Attachment Characteristics | In animal studies, consistent with predicate. |
| Mechanical Strength - Mean Suture Pull-Out Force | 0.67 kg (compared to predicate's 0.93 kg). Considered "substantially equivalent." |
| Mechanical Strength - Mean Peak Load | 9.56 kg (compared to predicate's 4.49 kg). Considered "substantially equivalent." |
| Quality Tests & Criteria | Subjected to essentially the same as predicate. |
| Packaging Processes & Materials | Will not differ from predicate. |
| Sterilization Methods | Same as predicate. |
| Post-Sterilization Release Criteria | Same as predicate. |
| Sterility Assurance Level (SAL) | ≤ 10^-6 (same as predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for mechanical tests. For animal studies, the number of animals used is not specified.
- Data Provenance: The studies are described as "animal studies." The country of origin is not specified, but the applicant (W.L. Gore & Associates, Inc.) is based in Flagstaff, AZ, USA. The studies are prospective in the sense that they were conducted for this submission, although the raw data might have been collected over a period.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. For animal studies, veterinary pathologists would typically establish ground truth regarding histopathological findings and tissue reactions.
4. Adjudication Method for the Test Set
- This information is not provided.
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 is not applicable to the device described. The PRECLUDE™ IMA Sleeve is a physical medical device (implant), not an AI/software device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable to the device described as it is not an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility and tissue attachment, the ground truth was based on histopathological findings from animal studies (pathology).
- For mechanical strength, the ground truth was the measured values from laboratory testing.
- For manufacturing and sterilization, the ground truth relates to adherence to established quality system processes and predetermined criteria.
8. The Sample Size for the Training Set
- This concept is not directly applicable. This is a physical medical device, not a machine learning model requiring a "training set." The development and refinement of the ePTFE material and sleeve configuration would have been informed by prior research and manufacturing experience with similar materials and devices (like the predicate), which could be considered analogous to a "training" process in a very broad sense, but not in the context of an AI training set.
9. How the Ground Truth for the Training Set was Established
- As above, the concept of a training set ground truth, as used in AI/ML, does not apply here. The material characteristics and performance expectations of ePTFE were established through scientific research, material engineering principles, and experience with similar devices over time.
§ 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).