(96 days)
The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.
The LimFlow ARC is a single-use device designed to facilitate placement and positioning of quide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.
The provided text is a 510(k) summary for the LimFlow ARC device. It details a comparison to a predicate device and lists performance data presented to the FDA. However, it does not explicitly state acceptance criteria or provide a study with detailed performance results against those criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (OUTBACK® Elite Re-Entry Catheter, K150836) rather than independently proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in the provided text.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document states that "performance data were provided to establish that the LimFlow ARC does not raise new questions of safety or effectiveness compared to the predicated OUTBACK Elite." It lists types of tests (Biocompatibility, Dimensional and Functional, Packaging, Sterilization) but does not give specific acceptance criteria for these tests nor the quantitative performance results of the LimFlow ARC against such criteria. For example, it doesn't say "Tensile Strength acceptance criterion: > X N; LimFlow ARC result: Y N."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "Biocompatibility testing was performed on finished and sterilized LimFlow ARC" and "Device Dimensional and Functional Testing" but does not specify the sample sizes used for these tests. Data provenance (country, retrospective/prospective) is also not mentioned.
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)
- Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation or performance, such as diagnostic accuracy studies. The tests described (biocompatibility, mechanical properties) are engineering and biological tests that do not involve expert interpretation or ground truth establishment in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. As with point 3, adjudication methods are typically for studies involving human interpretation of data, which is not the nature of the tests described.
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. An MRMC study was not done. The device (LimFlow ARC) is a mechanical percutaneous catheter aimed at facilitating guidewire placement, not an AI-powered diagnostic tool. Therefore, human readers or AI assistance in interpretation are not relevant to its stated function or the tests conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data provided relate to the physical and biological characteristics of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in the context of ground truth validation. For the engineering tests, the "ground truth" would be established mechanical and material science principles, and for biocompatibility, it would be established biological safety standards (e.g., ISO 10993).
8. The sample size for the training set
- Not applicable/Not provided. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8)
Summary of available information related to performance:
The provided document describes the types of tests conducted to demonstrate substantial equivalence, but not detailed acceptance criteria or quantitative performance results for the LimFlow ARC.
Performance Data Categories:
- Biocompatibility Testing (in compliance with 21 CFR Part 58 (GLP) and ISO 10993-1):
- Cytotoxicity
- Hemolysis
- Complement Activation
- Intracutaneous Irritation
- Maximum Sensitization
- Acute Systemic Toxicity
- Pyrogenicity
- Partial Thromboplastin Time
- Thrombogenicity
- Device Dimensional and Functional Testing:
- Dimensional Verification
- Device Joint Tensile Strength
- Catheter Torqueability
- Device Joint Torque to Failure
- Flex / Kink Testing
- Simulated Use
- Packaging and Sterilization Testing:
- Packaging Validation
- Sterilization Validation
The conclusion states that these tests "confirm the LimFlow ARC raises no new questions of safety and effectiveness and meets the requirements that are considered essential for its intended use and that the LimFlow ARC is substantially equivalent to the predicate device, OUTBACK Elite." This indicates that the device met the implicit acceptance criteria for substantial equivalence based on these tests.
§ 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).