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The LimFlow ARC is intended to facilitate placement and positioning of guide wires 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 guide 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 FDA 510(k) clearance letter for the LimFlow ARC indicates that the device is substantially equivalent to a predicate device (LimFlow ARC, K221541) and that no new clinical data was required for this submission. The modifications made to the device are described as "incremental, non-significant modifications," and the clearance relies heavily on non-clinical performance testing and substantial equivalence to the previously cleared predicate.

Therefore, there is no information about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of new clinical performance for this specific 510(k) submission (K251376). The document explicitly states: "Animal testing was not required for the determination of substantial equivalence." This implies that human clinical studies, multi-reader multi-case studies, or standalone algorithm performance studies were also not required or conducted for this re-submission.

The "studies" that were performed were primarily non-clinical and pre-clinical tests to demonstrate that the modified device still performs as safely and effectively as the predicate device.

Given this, I cannot provide the detailed information requested in the prompt based on the provided text, as the type of studies and criteria outlined in your request (e.g., sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance) are typically associated with new and clinical performance evaluations of AI or diagnostic devices, which is not the case for this 510(k) clearance.

However, I can extract the acceptance criteria and "performance" in the context of the non-clinical testing conducted to demonstrate substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance for each test performed. Instead, it lists the types of non-clinical tests performed, implying that the device "met" the unstated acceptance criteria for each, thereby demonstrating substantial equivalence. The "performance" is implicitly stated as having satisfied the requirements for each test.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for any of the non-clinical tests. Standard sample sizes for device testing are typically based on statistical methods to ensure representativeness and confidence, but the exact numbers are not in this public document.
• Data Provenance: Not applicable in the context of clinical data for this submission. The "data" refers to the results of in-vitro and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this was not a clinical study requiring expert ground truth for patient data evaluation.

4. Adjudication method for the test set

• Not applicable.

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 MRMC comparative effectiveness study was not done. The device (LimFlow ARC) is a physical medical device (catheter) not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The LimFlow ARC is a physical catheter, not an algorithm.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" is defined by the specifications of the device and the standards against which it is tested (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging, internal engineering specifications for mechanical properties).

8. The sample size for the training set

• Not applicable. No training set was involved as this is a physical device, not a machine learning model.

9. How the ground truth for the training set was established

• Not applicable.

Summary based on provided text:

The LimFlow ARC K251376 clearance is based on demonstrating substantial equivalence to its predicate (K221541) through incremental, non-significant modifications and comprehensive non-clinical (bench) and pre-clinical (biocompatibility) testing. No new clinical or animal testing was required for this particular submission. The "acceptance criteria" and "performance" refer to the device successfully meeting various engineering specifications, biocompatibility standards, sterilization validation, and packaging integrity tests.

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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.

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