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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The Bantam (280mm balloon lengths) catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon expands to a known diameter at specific pressure.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bantam OTW PTA Catheter:

Executive Summary:

The Bantam OTW PTA Catheter (280mm balloon lengths) was cleared through a Special 510(k) pathway, demonstrating substantial equivalence to a predicate device (Bantam K093139). The clearance relies entirely on in vitro testing to show that its technological characteristics and performance criteria are comparable to the predicate. No clinical studies, human-in-the-loop performance, or AI-assisted studies were conducted or required for this type of device clearance.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as pass/fail thresholds with specific numerical values for each test. Instead, it describes "performance criteria" that were evaluated through in vitro testing to demonstrate comparability to the predicate device. The reported device performance is implicitly understood to have met these criteria because the device was granted substantial equivalence.

Note: The document states that the results "demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device." This implies that the Bantam (280mm) performed within acceptable ranges relative to the Bantam K093139 for all tested parameters. Specific numerical values for the predicate or the new device are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for each in vitro test. It generally states that "in vitro tests were performed."
• Data Provenance: The data is from in vitro testing conducted by Clearstream Technologies Ltd. The country of origin for the data is implicitly Ireland, where Clearstream Technologies Ltd. is located. This is a prospective study in the sense that the testing was performed specifically to support this 510(k) submission, but it is not a clinical (human) prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert ground truth or assessment of cases. The "ground truth" for these tests would be the established engineering standards and methodologies (e.g., ISO 10555-1) and the performance of the predicate device under these same tests.

4. Adjudication Method for the Test Set

Not applicable. As this was an in vitro engineering performance study, there was no human reader or panel involved in adjudicating the "correctness" of the findings in the way one would for a clinical study with subjective interpretations. The tests yield objective measurements against predefined standards or comparisons.

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

Not applicable.

• This submission is for a medical device (PTA catheter), not an AI algorithm.
• No MRMC or human-in-the-loop studies were conducted or required.
• The concept of human readers improving with AI assistance is not relevant to this device.

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

Not applicable. This is a physical medical device. There is no algorithm component to evaluate in a standalone manner.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

• Engineering standards: Compliance with ISO 10555-1.
• Predicate device performance: The performance of the legally marketed Bantam (K093139) under the same in vitro tests, as the new device is compared to it for "substantial equivalence."
• FDA guidance: Adherence to FDA guidance on non-clinical testing of medical devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The Sleek OTW PTA Catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document describes a medical device, the Sleek OTW PTA Catheter, and its equivalence to a predicate device, the Bantam α PTA Catheter. The "study" here refers to non-clinical bench testing to demonstrate this equivalence and the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters tested for in both the predicate device (Bantam α) and the Sleek OTW, as well as the additional tests performed for the Sleek OTW. The acceptance criteria for the Sleek OTW are broadly that it "PASSES" these tests.

Note on "PASS with deviation" for Leak and Rated Burst Pressure: The document states "Conclusion: All products had acceptable balloon fatigue performance, noted deviation accepted." This implies that while there might have been a minor deviation from the initial target, it was deemed acceptable for the intended use and did not compromise safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

The sample sizes for the test sets (grouped by specific catheter dimensions and lengths) are indicated in brackets within the "Results Sleek OTW" column of the tables. Examples include:

• Inflation/Deflation Time: 29 samples of 5x120mmx150cm catheters.
• Introducer Sheath Withdrawal: 29 samples of 5x120mmx150cm catheters.
• Leak and Rated Burst Pressure: 29 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
• Profile Measurements of Distal Tip: 29 samples each of 1.25x15x150 and 5.0x120x150 catheters.
• Tensile Test of the Distal Tip: 29 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
• Measurement of Working Surface, OD, TL of Balloon: 13 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
• Balloon Compliance: 13 samples of 1.25x15mmx150cm and 16 samples of 5x120mmx150cm catheters.
• Average Burst Pressure Testing: 13 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.

Data Provenance: The data is from non-clinical design verification and design validation bench tests conducted by ClearStream Technologies Ltd. The country of origin of the data is not explicitly stated but is implicitly the location of the manufacturing and testing, which is likely Ireland, where ClearStream Technologies Ltd is based. The data is prospective in the sense that these tests were performed specifically for this submission to validate the Sleek OTW PTA Catheter.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document describes a submission for a medical device (catheter), not an AI/software device. Therefore, the concept of "ground truth established by experts" in the context of medical imaging or diagnostic algorithms is not applicable here. The ground truth for device performance is established by engineering specifications and scientific measurement protocols (e.g., ISO 10555-1 and ISO 10555-4).

4. Adjudication Method for the Test Set

As this is a physical medical device and the tests are objective engineering measurements, an "adjudication method" in the sense of expert consensus for medical diagnoses is not applicable. The test results are quantitative and pass/fail criteria are based on predefined specifications.

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 comparative effectiveness study was not done. This submission is for a physical medical device (catheter), not an AI/software product. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device (catheter), not an AI/software product.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this physical medical device is based on engineering specifications, established industry standards (ISO 10555-1 and ISO 10555-4 requirements), and objective measurements derived from bench testing. It's essentially a set of predefined performance targets that the device must meet to be considered safe and effective.

8. The Sample Size for the Training Set

There is no training set in the context of this traditional medical device submission. The device is not learning or being trained from data. The tests performed are for validation of the final product.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this traditional medical device, this question is not applicable.

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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The LitePAC PTA Catheter is a standard rapid exchange PTA catheter. The proximal end provides a mono luer hub connector which allows the attachment of an inflation device used to inflate and deflate the balloon through the outer lumen. The rapid exchange port is positioned at the transition area between the stiffer hypotube and the more flexible distal portion and facilitates single operator use for insertion into a 0.014" guidewire.

This response is based on the provided text, which details a 510(k) submission for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than clinical studies with human subjects or AI algorithms. Therefore, many of the requested categories related to clinical study design (sample size for test/training sets, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable to this document.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria Met:

The study that proves the device meets the acceptance criteria is a non-clinical design verification and design validation testing and analysis. This involved a series of in vitro tests performed in accordance with FDA guidance documents on non-clinical testing of medical devices, as well as ISO 10555-1 and ISO 10555-4 standards.

The conclusion drawn from this testing is that "the technological characteristics and performance criteria of the LitePAC PTA catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use." This demonstrates substantial equivalence, which is the primary criterion for 510(k) clearance.

Detailed Information as Requested (where applicable):

Since this is a 510(k) submission for a physical medical device (catheter) and not an AI/software device, many of the requested items related to study design for AI are not applicable.

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

• Sample Size for Test Set: The document does not specify the exact number of units or samples tested for each in vitro test. It refers to "in vitro testing" without providing specific sample numbers.
• Data Provenance: The testing was conducted by ClearStream Technologies Ltd. The data is retrospective in the sense that it's generated for submission after device design, but it's not retrospective clinical data. It is laboratory-generated test data. The country of origin for the testing itself is not explicitly stated, but the applicant's address is Moyne Upper, Enniscorthy, Co.Wexford, Ireland.

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

• This is not applicable as the "ground truth" for a physical device's performance in in vitro testing is determined by engineering specifications, validated test methods, and measurement accuracy, not by expert human interpretation in the way it would be for medical image analysis or similar AI applications.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing ground truth from subjective data. In vitro physical testing relies on objective measurements and established pass/fail criteria.

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:

• Not applicable. This device is a physical medical instrument, not an AI software intended to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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:

• The "ground truth" in this context is defined by engineering specifications, industry standards (ISO 10555-1 and ISO 10555-4), and FDA guidance documents for non-clinical testing of medical devices. The device's performance is measured against these established criteria.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a physical device's non-clinical safety and performance testing. Training sets are relevant for machine learning algorithms.

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

• Not applicable. As there is no training set, there is no ground truth to be established for it.

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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The Bantam and Bantam & PTA Catheters are standard over-the-wire PTA catheters. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018" and 0.014"). The balloon expands to a known diameter at specific pressure.

The provided document is a 510(k) summary for a medical device (PTA Catheters) and does not describe acceptance criteria, a study proving device meeting acceptance criteria, or any of the specific details requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Instead, it focuses on:

• Applicant Information: ClearStream Technologies Ltd, contact details.
• Device Information: Trade name (Bantam and Bantam α PTA Catheter), common name, classification, product code.
• Predicate Device: Savvy Long PTA Catheter (K072947).
• Device Description: Standard over-the-wire PTA catheters with a balloon for inflation and a lumen for guidewire insertion.
• Intended Use: Balloon dilatation of femoral, popliteal, and infra-popliteal arteries (excluding coronary arteries).
• Comparison to Predicate Device: Stated as "substantially equivalent."
• Test Data: Mentions safety and effectiveness demonstrated through "non-clinical design verification and design validation tests and analyses," but provides no details on these tests, their results, or acceptance criteria.
• FDA Correspondence: Official letter from FDA granting marketing clearance based on substantial equivalence to the predicate device.
• Indications for Use Form: Reiterates the intended use.

Therefore, I cannot provide the requested information based on the input document. The document primarily serves as a regulatory submission and clearance notice, not a detailed scientific study report.

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