(27 days)
The REVIVE™ Intermediate Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
The REVIVE™ Intermediate Catheter is a variable stiffness, single lumen catheter designed to aid the physician in access to vasculature and in the delivery and retrieval of devices. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires. The Revive IC may also be delivered through the lumen of a larger bore guiding catheter. The catheter has an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories.
This document is a 510(k) summary for the REVIVE™ Intermediate Catheter, submitted to the FDA. It establishes substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and reported performance for a new device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a new, novel device's performance study is not available here.
However, based on the provided text, I can infer the acceptance criteria were that the device performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness, as demonstrated by preclinical testing. The study that "proves" this is the series of preclinical tests conducted by Codman & Shurtleff, Inc.
Here's a breakdown of the requested information, addressing what is present and what is absent in the provided 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of specific numerical acceptance criteria and corresponding numerical reported device performance for each test. Instead, it states that "The REVIVE IC met all the biocompatibility requirements..." and "Results of verification and validation conducted on the REVIVE IC demonstrate that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new issues of safety and effectiveness."
Inferred "Acceptance Criteria" (Implicit from the text):
- Device performs as designed.
- Device is suitable for its intended use.
- Device is substantially equivalent to predicate devices (ENVOY Guiding Catheter, Courier Microcatheter).
- Device does not raise any new issues of safety and effectiveness.
- Device meets all biocompatibility requirements as specified by ISO 10993 Part I and G95-1.
- Device successfully passes all listed physical and mechanical tests.
Reported Device Performance (Implicit from the text):
- "...demonstrate that it performs as designed..."
- "...is suitable for its intended use..."
- "...is substantially equivalent to the predicate device..."
- "...does not raise any new issues of safety and effectiveness."
- "The REVIVE IC met all the biocompatibility requirements..."
- (Implied: The REVIVE IC successfully passed all the conducted tests detailed in the "Testing Summary".)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the preclinical tests.
The data provenance is from Codman & Shurtleff, Inc., which is based in Raynham, MA. The study appears to be prospective in nature, as it involves testing a newly developed device against pre-established criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. This 510(k) relies on preclinical engineering and biological testing, not on human expert interpretation of data to establish a "ground truth" for a test set in the way a diagnostic AI device might. The "ground truth" for these tests would be established by validated test methods and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving multiple human readers to resolve discrepancies in diagnoses or assessments. This document describes preclinical engineering and biological tests, where such adjudication is not typically relevant.
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
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This is a 510(k) for an intermediate catheter, which is a physical medical device, not a diagnostic AI device. The submission focuses on physical and biological performance for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the preclinical tests, the "ground truth" is established by adherence to validated test methods and industry standards. For example:
- Biocompatibility: ISO 10993 Part I and General Program Memorandum # G95-1 (reference standards).
- Physical/Mechanical Tests: The specific methods for "Shaft Kink Resistance," "Flow Rate Test," etc., would serve as the "ground truth" or reference for evaluating performance, though the specific standards or internal protocols are not detailed.
8. The sample size for the training set
This information is not applicable/not provided. This is a physical medical device, and the concept of a "training set" is not relevant in the context of its preclinical testing for 510(k) clearance based on substantial equivalence to predicate devices.
9. How the ground truth for the training set was established
This information is not applicable/not provided, as there is no "training set" in the context of this device's regulatory submission.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).