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510(k) Data Aggregation
(38 days)
ReVive PV (Peripheral Vasculature) Thrombectomy Device
The ReVive™ PV Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels,
- · The non-surgical removal of thrombi from synthetic grafts,
- · Temporary use in peripheral vessel/graft occlusion,
- Use with aspiration and with the injection or infusion of contrast media and other . fluids
The ReVive" PV (Peripheral Vasculature) Thrombectomy Device is a sterile, disposable, thrombectomy device that is intended to restore blood flow via non-surgical removal of emboli and thrombi from peripheral blood vessels, non-surgical removal of thrombi from synthetic grafts and also for temporary use in peripheral vessel/graft occlusion. The ReVive " PV Thrombectomy Device is radiopaque so that fluoroscopy can be used to guide insertion and verify position as necessary.
The ReVive™ PV Thrombectomy Device consists of a self-expanding Nitinol basket attached to a core pusher wire. Platinum markers at the proximal and distal ends of the basket facilitate visualization under fluoroscopy. A flexible radiopaque tip is attached to the distal aspect of the basket.
The ReVive™ PV Thrombectomy Device is provided as a sterile device and is intended for single patient use only. It is not intended to be resterilized and/or reused. No accessories are provided with the ReVive™ PV Thrombectomy Device. The system is used in conjunction with the appropriately sized microcatheter, as indicated in the proposed Instructions for Use.
The provided document is a 510(k) summary for the ReVive™ PV Thrombectomy Device. It primarily focuses on demonstrating substantial equivalence to a predicate device (F.A.S.T. System SED) rather than providing detailed acceptance criteria and a study proving performance against those criteria.
The document explicitly states: "No new technological characteristics are being introduced with the proposed ReVive™ PV Thrombectomy Device and the design, materials, mechanism of action, performance specifications, and clinical utility of the device are the same as the predicate device (K092623). Codman performed non-clinical testing necessary to demonstrate substantial equivalence to the predicate device. Bench testing was conducted using the same test methods as the predicate device. Resulting data demonstrated that the ReVive™ PV Thrombectomy Device performed according to the established performance characteristics of the predicate device."
And, importantly: "No clinical studies were required as appropriate verification and validation of device modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing."
Therefore, the study supporting this submission is a non-clinical bench testing study designed to demonstrate that the ReVive™ PV Thrombectomy Device performs equivalently to its predicate device across various physical and functional characteristics, and that changes (sterilization method, shelf life, labeling, packaging) do not negatively impact safety or effectiveness.
Here’s a breakdown based on the information provided, keeping in mind that the specific acceptance criteria values are not detailed, but inferred to be "met" based on equivalence to the predicate device's established performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Radial Force | Performance equivalent to predicate device (F.A.S.T. System SED) | All acceptance criteria were met, demonstrating equivalence to predicate's established performance. |
| Tip Deflection Force | Performance equivalent to predicate device | All acceptance criteria were met. |
| Rapid Flow Restoration | Performance equivalent to predicate device | All acceptance criteria were met. |
| Corrosion | No unacceptable corrosion; equivalent to predicate device | All acceptance criteria were met. |
| Tensile Testing | Strength equivalent to predicate device | All acceptance criteria were met. |
| Track Test | Tracking performance equivalent to predicate device | All acceptance criteria were met. |
| Cyclic Fatigue | Durability equivalent to predicate device | All acceptance criteria were met. |
| Deploy and Recapture | Ability to deploy and recapture reliably, equivalent to predicate device | All acceptance criteria were met. |
| Torsion | Torsional stability/resistance equivalent to predicate device | All acceptance criteria were met. |
| Force for Recapture | Force required for recapture within acceptable limits, equivalent to predicate device | All acceptance criteria were met. |
| Biocompatibility | Meets ISO 10993-1:2009 standards for Cytotoxicity, Sensitization, Pyrogenicity, Irritation, Acute Systemic Toxicity, Hemocompatibility (hemolysis, thrombogenicity, complement activation, PTT) | All acceptance criteria were met (demonstrated compliance with ISO 10993-1:2009). |
| Sterilization | Validation according to ISO 11137:2006 (e.g., bioburden, verification/confirmatory dose, B/F, LAL) | All acceptance criteria were met (demonstrated compliance with ISO 11137:2006 for eBeam irradiation). |
| Packaging | Validation according to ISO 11607-1:2006 and ISO 11607-2:2006 (e.g., integrity, dye leak, seal strength) | All acceptance criteria were met (demonstrated compliance with ISO 11607 standards). |
| Shelf Life | 3 years (increased from 1 year for predicate) | Achieved the 3-year shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical bench test. It generally states that "verification and validation testing was identified as appropriate to support device modifications."
Data Provenance: The data is from non-clinical bench testing conducted by Codman & Shurtleff, Inc. The country of origin for the data is not explicitly stated but would likely be the location of the manufacturing and R&D facilities (e.g., USA, as the company contact is in Massachusetts). The tests are prospective in the sense that they were designed and executed to validate the modified device and demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by engineering specifications, material standards (e.g., Nitinol properties), and international standards (ISO). There are no human experts "establishing ground truth" in the way a clinical study uses expert consensus readings. The "experts" would be the engineers and quality control personnel performing and evaluating the bench tests against established physical and performance metrics.
4. Adjudication Method for the Test Set
Not applicable. Bench testing results are typically objective measurements against predefined specifications or comparative measurements against a predicate device. There is no ambiguous "case" requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A MRMC comparative effectiveness study is a type of clinical study, commonly used for diagnostic imaging devices, comparing diagnostic performance among multiple readers and cases. This submission explicitly states "No clinical studies were required."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ReVive™ PV Thrombectomy Device is a physical medical device (catheter with a basket) for mechanical thrombectomy, not an algorithm or AI. Its performance is inherent in its physical characteristics and how it interacts with the vascular system and thrombus, not in any computational standalone analysis.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Engineering Specifications: Designed tolerances, material properties, and functional parameters of the device.
- International Standards: Adherence to ISO standards like ISO 10993-1 (biocompatibility), ISO 11137 (sterilization), and ISO 11607 (packaging).
- Predicate Device Performance: The established, cleared performance characteristics and functionality of the F.A.S.T. System SED serve as the benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model or algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a physical device, this question is not relevant.
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