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The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided.

The provided document describes a 510(k) submission for the Concentric Balloon Guide Catheter, focusing on its substantial equivalence to a predicate device and a minor modification to its indications for use. As such, the document does NOT contain information about a study proving device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy, but rather verification testing for the physical device.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's the information that can be extracted or deduced from the document regarding the device's acceptance criteria and the verification testing performed:

1. Table of acceptance criteria and the reported device performance

• Hemolysis, Direct Contact Method: Successfully performed
• Hemolysis, Extract Method: Successfully performed
• Cytotoxicity - ISO MEM Elution: Successfully performed |
  | Balloon Fatigue | Meets predetermined specifications (remains applicable from predicate device) |
  | Inflation/Deflation Testing | Meets predetermined specifications (remains applicable from predicate device) |

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 sample sizes for these verification tests.
• The data provenance is not specified beyond being part of a 510(k) submission to the FDA (USA). The tests are verification tests for a physical device, not a study involving human data.

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. This is not a study involving diagnostic accuracy or human interpretation. The "ground truth" for the physical device tests would be established by engineering specifications and objective measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This concept is relevant for studies involving human interpretation and consensus establishment, not for objective physical device testing.

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. This is a 510(k) submission for a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation.

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

• No. This is not an AI/ML algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the physical tests, the "ground truth" is based on predetermined engineering specifications and objective measurements for mechanical and biological properties (e.g., tensile strength, leak rates, dimensional tolerances, biocompatibility standards).

8. The sample size for the training set

• Not applicable. This is not a machine learning model.

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

• Not applicable. This is not a machine learning model.

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The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for the Merci Retriever.

The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker on the distal end facilitates angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided. The Balloon Guide Catheter is identical to K010954 and K021899.

This document is a 510(k) premarket notification for a medical device called the "Concentric Balloon Guide Catheter." This type of submission is for demonstrating "substantial equivalence" to a predicate device, not for proving a device meets specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria and performance studies for this specific device is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance for the Concentric Balloon Guide Catheter. Instead, it relies on the principle of substantial equivalence to previously cleared devices (K010954 and K021899).

The "performance" described is that the device "is identical to K010954 and K021899 and there were no design changes." The submitter states, "The device design, materials used, function, physical properties and composition have not been changed."

Therefore, the "acceptance criteria" were essentially:

• Being identical in design, materials, function, physical properties, and composition to the predicate devices.
• Having the same Indications for Use as the predicate devices.

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

• Sample Size for Test Set: Not applicable for this 510(k) submission directly. This submission primarily relies on the identity to predicate devices.
• Data Provenance: The document states that Concentric Medical referenced "the bench testing, biocompatibility and sterility information in K010954 and K021899." It also referenced "the MERCI and Multi MERCI clinical trials in (K070521 and K082034)" to demonstrate safety and effectiveness.
  • K010954 and K021899 (Predicate Devices): The details of the original testing for these devices (sample size, provenance) are not provided here.
  • K070521 and K082034 (MERCI and Multi MERCI clinical trials): These are referenced for clinical trial data, implying the data would be prospective clinical data. However, the specific sample sizes for these trials as they relate to this specific 510(k) are not given. The trials are mentioned as supporting the safety and effectiveness in a broader sense, likely for the use case rather than the minute performance of this specific guide catheter in a dedicated study.

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

Not applicable. This 510(k) does not describe a new study with ground truth established by experts for this specific device. It relies on equivalence to predicate devices and previously reviewed clinical trial data.

4. Adjudication method

Not applicable. No new study with adjudication is described for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is typically for evaluating diagnostic imaging algorithms with human readers. This 510(k) is for a physical medical device (catheter) and does not describe such a study.

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

Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used

For the safety and effectiveness mentioned by referencing the MERCI and Multi MERCI clinical trials, the "ground truth" would likely be patient outcomes data (e.g., successful recanalization, functional independence, adverse event rates), established through clinical diagnoses, imaging, and follow-up in those trials. For the predicate device bench testing, the ground truth would be against engineering specifications for physical properties.

8. The sample size for the training set

Not applicable. This 510(k) is not for an AI/algorithm device that requires a training set.

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

Not applicable.

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The Concentric Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The Concentric Balloon Guide Catheter device, cleared under K010954, is a 9F coaxial lumen braided shaft, variable stiffness catheter with a radiopaque marker on the distal end. The balloon is flush mounted on the distal end of the catheter. The inner diameter of the balloon guide catheter is 0.085". The maximum inflation diameter is 10 mm, and the maximum inflation length is 10 mm.

The design of the modified Concentric Balloon Guide Catheter differs in dimension and includes a new material, Cristamid. All other characteristics remain the same as compared to the original device. The outer and inner diameters have been downsized to 7F and 0.059" respectively. Biocompatibility of Cristamid has been established and results provided in the Concentric HD Guide Catheter Premarket Notification (K003880).

The Concentric Balloon Guide Catheter (7F) is being submitted for a Special 510(k) Premarket Notification. The device is a modified version of the previously cleared Concentric Balloon Guide Catheter (9F, K010954). The primary modifications include a reduction in outer and inner diameters (7F and 0.059" respectively) and the introduction of a new material, Cristamid.

The submission focuses on establishing substantial equivalence to the predicate device (Concentric 9F Balloon Guide Catheter, K010954) rather than demonstrating performance against specific qualitative acceptance criteria. Therefore, the information provided does not contain a typical table of acceptance criteria and reported device performance in the manner usually associated with a new device's performance claims (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be interpreted as the requirement to demonstrate substantial equivalence through performance testing, and the "study" is this performance testing itself.

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

Since this is a Special 510(k) based on substantial equivalence to a predicate device, specific quantitative acceptance criteria for clinical performance (like sensitivity or specificity) are not provided in the document. The "acceptance criteria" here is that the modified device performs "as designed" and is "suitable for its intended use" when compared to the predicate through performance testing.

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 states "Performance testing has been conducted," but it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). This typically refers to bench testing rather than clinical data for this type of submission.

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 and not provided in the document. For a medical device like a catheter, "ground truth" as it relates to expert review of diagnostic output is not relevant. The "ground truth" for this device would be its mechanical and material properties meeting engineering specifications and its functional performance in a simulated environment replicating its intended use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or image review settings to establish a consensus ground truth, which is not relevant for the type of performance testing indicated for this device.

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

This information is not applicable and not provided. The device is a physical medical instrument (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant.

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

This information is not applicable and not provided. The device is a physical medical instrument and does not involve an algorithm operating in a standalone mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device modification would be based on:

• Engineering specifications and test standards: The device's physical dimensions, material properties (e.g., biocompatibility of Cristamid as established in K003880), mechanical strength, inflation characteristics, and guidability would be tested against established engineering parameters and predicate device performance.
• Functional performance: Testing would likely involve bench models simulating vascular systems to evaluate aspects like ease of guidance, occlusion capabilities, and catheter navigation.

The document states "Performance testing has been conducted and the results of the testing verified that the Concentric Balloon Guide Catheter performs as designed and is suitable for its intended use." This implies the ground truth was based on these types of objective engineering and functional evaluations.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical medical instrument, not a machine learning or AI model that requires a training set.

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

This information is not applicable and not provided. As the device is not an AI/ML model, there is no training set for which ground truth would be established.

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