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The 0.018" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Description

The .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is an 0.018" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows iniection of fluids through the inflation lumen without removal of the quidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers identify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a quidewire female luer lock hub in the proximal end of the handle.

Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.

AI/ML Overview

This document is a 510(k) summary for the Hotspur Technologies, Inc. 0.018" Arrow GPSCath™ Balloon Dilatation Catheter (150 cm). It describes the device, its intended use, and substantial equivalence to a predicate device based on performance data.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria in a table format. Instead, it describes categories of in vitro preclinical tests performed and states that the product passed these tests. The reported device performance is qualitative, indicating compliance with established procedures and attributes.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Visual Testing	Product not damaged post-sterilization and packing; handle markings legible.	Performed to ensure product hasn't been damaged and handle markings are legible, and passed.
Dimensional Testing	Product meets all dimensional performance attributes post-validated EtO sterilization cycle.	Performed to ensure product meets all dimensional performance attributes post-validated EtO sterilization cycle exposure, and passed.
Performance Testing	Product passes all functional destructive testing post-validated EtO sterilization cycle.	Performed to ensure product passes all functional destructive testing post-validated EtO sterilization cycle exposure, and passed.
Simulated Use Testing	Product performs and meets functional attributes in an anatomically relevant model.	Performed in an anatomically relevant model to ensure product performs and meets functional attributes, and passed.
Biocompatibility	Meets requirements of ISO 10993-1.	Testing completed per requirements of ISO 10993-1.
Sterilization	Achieves a sterility assurance level (SAL) of 1 x 10^-6^ for EtO sterilization. (Validation performed on predicate is applicable).	Sterilization validation performed on the predicate device is applicable due to similarity; demonstrated SAL of 1 x 10^-6^.

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

The document does not specify the exact sample sizes (number of units tested) for each type of in vitro preclinical test. It generally states that "tests were performed" or "testing was conducted" without providing quantitative details on the number of samples.

The data provenance is in vitro preclinical tests. There is no mention of human subject data, animal studies, or specific geographic origin of the testing. The tests are described as being "in accordance with the FDA's Guidance for PTCA Catheters."

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

This information is not applicable as the studies described are in vitro preclinical tests and do not involve human diagnostic or clinical evaluation where expert interpretation of ground truth would be required. The "ground truth" for these tests would be the established engineering specifications, material properties, and functional performance requirements of the device.

4. Adjudication Method for the Test Set

This information is not applicable for the in vitro preclinical tests described. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving expert disagreement on a diagnosis or outcome.

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

There is no MRMC comparative effectiveness study mentioned. The device is a physical medical device (balloon dilatation catheter), not an AI/software-as-a-medical-device (SaMD) that assists human readers.

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

This information is not applicable as the device is a physical medical device, not an algorithm or AI.

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

For the in vitro preclinical tests, the "ground truth" implicitly used would be:

Engineering specifications and design requirements: For dimensional testing, visual inspection, and functional performance.
Established standards: Such as ISO 10993-1 for biocompatibility and validation protocols for sterilization (ensuring SAL).
Functional performance criteria: For simulated use testing, ensuring the device operates as intended in a model.

There is no mention of expert consensus, pathology, or outcomes data as type of ground truth for these specific tests.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical medical device submission based on in vitro testing and substantial equivalence to a predicate, not an AI or machine learning model.

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

This information is not applicable as there is no training set for this device submission.

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K Number

K142300

Device Name

Arrow GPSCath Balloon Dialation Catheter (150 cm)

Manufacturer

HOTSPUR TECHNOLOGIES, INC.,

Date Cleared

2014-09-17

(30 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K140351

Predicate For

K143093

Intended Use

The Arrow GPSCath Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Description

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.

AI/ML Overview

This document is a 510(k) summary for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). It is a "Special 510(k)", which means it refers to a previously cleared predicate device (K140351 from Hotspur Technologies). The submission focuses on minor changes and an update to performance data rather than a complete re-evaluation of the device's safety and effectiveness from scratch.

Therefore, the study details you are asking for, particularly related to clinical performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance, are not directly applicable or available within this specific 510(k) submission because it relies heavily on the predicate device's existing clearance.

However, I can extract the information that is present concerning the changes and the performance data provided for those changes.

Here's a breakdown based on the provided text, heavily emphasizing that clinical effectiveness studies for a new device are not detailed here because this is a Special 510(k) relying on a predicate:

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

The document mentions "additional testing of key performance data" for an update. It doesn't present a formal table of acceptance criteria and performance results in this summary. Instead, it states that the testing "result[ed] in an update to the Arrow GPSCath Balloon Dilatation Catheter (150cm) Compliance Chart and introducer sheath compatibility."

The "key performance data" tested includes:

Balloon compliance: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).
Balloon rated burst pressure: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).
Crossing profile: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).

Note: For a Class II peripheral transluminal angioplasty catheter, the FDA typically references a set of recognized standards and guidance documents (e.g., ISO, ASTM, FDA guidance for PTA balloon catheters) that would define acceptance criteria for these physical/mechanical properties. This summary implies these tests were done to those standards, but the specific details are not published here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified in this summary. The testing was for "key performance data, including balloon compliance, balloon rated burst pressure, and crossing profile." These are bench/mechanical tests, not clinical studies with human subjects.
Data Provenance: The testing was conducted by Hotspur Technologies, Inc. (a subsidiary of Teleflex Medical, Inc.) in the USA. These are laboratory/engineering tests not related to patient data.
Retrospective or Prospective: These are laboratory tests, not clinical studies.

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)

Number of Experts: Not applicable. The "ground truth" for mechanical properties like compliance, burst pressure, and crossing profile is established through validated test methods and engineering calculations, not through expert consensus in the medical sense.
Qualifications of Experts: Not applicable for this type of testing.

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

Adjudication Method: Not applicable. This is not a clinical study involving human assessment or interpretation for which adjudication would be required.

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

MRMC Study: Not applicable. This device is a balloon dilatation catheter, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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

Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm.

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

Type of Ground Truth: For the mechanical tests (balloon compliance, burst pressure, crossing profile), the "ground truth" would be the scientifically measured and validated physical properties of the device, determined by standardized engineering testing methods and equipment. This is not medical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

Training Set Ground Truth Establishment: Not applicable.

Summary Explanation:

This 510(k) submission (K142300) is a "Special 510(k)" for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). These submissions are used when a modification to an already cleared device does not raise new questions of safety and effectiveness and the modified device remains substantially equivalent to the predicate.

The "study" cited here refers to additional engineering and bench testing conducted to update the device's "Compliance Chart and introducer sheath compatibility" due to a change in the product (presumably a minor manufacturing update or material change that impacted these specific physical properties).

The document explicitly states: "All other performance data applicable to the subject device is the same as for the predicate device (K140351) since there has been no change to the device design, materials, manufacturing processes, or sterilization cycle." This means the original predicate device (K140351) would have had the comprehensive performance data and potentially other studies (e.g., biocompatibility, sterilization validation, aging) to demonstrate its safety and effectiveness. This current submission only addresses the specific changes mentioned.

Therefore, questions related to clinical trials, expert adjudication, AI performance, or large clinical data sets are outside the scope of this specific Special 510(k) summary.

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