(192 days)
The EnGuard™ Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery.
The Replication Medical Vessel Guard is indicated as a cover for vessels following anterior vertebral surgery. The Vessel Guard is available in several sizes and is manufactured from biocompatible materials.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
Overview:
This 510(k) submission for the Replication Medical Vessel Guard is primarily based on substantial equivalence to legally marketed predicate devices, rather than a novel clinical effectiveness study with specific performance metrics. Therefore, explicit "acceptance criteria" in the sense of predefined numerical thresholds for a new study's performance are not presented. Instead, the substantial equivalence argument itself serves as the "proof" that the device meets the necessary safety and effectiveness standards, as demonstrated by the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission (substantial equivalence), the "acceptance criteria" are predominantly related to demonstrating similar technological characteristics, biocompatibility, and mechanical integrity to the predicate devices. Explicit numerical performance metrics for a novel clinical study are not specified.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use Equivalence | "indicated as a cover for vessels following anterior vertebral surgery" - matches predicate's indication. |
| Similar Technological Characteristics | "similar to legally marketed devices... in that they share similar indications for use and incorporate similar technological characteristics." |
| Biocompatibility | "Biocompatibility testing was conducted and the testing indicated that the material is suitable for long term implantation." |
| Mechanical Integrity (Suture Pullout) | "Suture pullout testing was also performed and the testing confirmed that the Vessel Guard is equivalent to predicate devices." |
| Safety and Effectiveness | "The safety and effectiveness of Vessel Guard is based upon the determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a new clinical test set. The submission relies on preclinical testing (biocompatibility, suture pullout) and the established safety and effectiveness of predicate devices. There is no mention of a human test set in this summary for the purpose of demonstrating device performance against specific clinical efficacy criteria.
- Data Provenance: The preclinical data (biocompatibility, suture pullout) would have been generated internally by Replication Medical, Inc. The basis for substantial equivalence is "legally marketed predicate devices" which would be subject to FDA regulations in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This submission does not describe a clinical study where human experts would establish a "ground truth" for a test set. The "ground truth" for the device's acceptable performance is established through equivalence to the predicate devices and standard preclinical testing.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set described that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of an MRMC study or any clinical comparative effectiveness study in this 510(k) summary. This type of study is more common for diagnostic imaging devices or devices where human interpretation plays a key role in effectiveness.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No. This device is a physical implant (vessel cover), not an algorithm or software. Therefore, an "algorithm only" or "standalone" performance study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (W.L. Gore & Associates, Inc.'s PRECLUDE Vessel Guard and PRECLUDE IMA Sleeve).
- Biocompatibility Standards: Adherence to established standards for biocompatibility testing for long-term implants.
- Mechanical Performance Standards: Equivalence to predicate devices in mechanical tests like suture pullout, implying an acceptable level of mechanical integrity.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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).