Search Results
Found 2 results
510(k) Data Aggregation
(141 days)
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.
The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" quidewire 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.
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.
The provided text describes the 510(k) premarket notification for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria in a clinical setting. Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, ground truth methodology, expert qualifications, and MRMC studies) are not applicable or explicitly stated in this type of regulatory submission.
However, based on the provided text, I can infer and extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table with specific quantitative acceptance criteria or performance metrics directly from a clinical study for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). Instead, it states that the device underwent in vitro preclinical tests to verify safety and effectiveness and assure substantial equivalence to a predicate device.
The "acceptance criteria" for this device, as described, are passing various functional and safety tests, demonstrating biocompatibility, and achieving a certain sterility assurance level. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical and Mechanical Performance (In vitro) | Passed all functional destructive testing post validated EtO sterilization cycle exposure. |
| Packaging Integrity | Packaging can withstand the effects of transit and environmental conditions and remain intact and sterile. |
| Visual Inspection | Product not damaged through sterilization cycle and packing testing; handle markings legible. |
| Dimensional Accuracy | Product meets all dimensional performance attributes post validated EtO sterilization cycle exposure. |
| Simulated Use Performance | Performed and met functional attributes in an anatomically relevant model; no corrosion growth. |
| Flow Rate & Power Injection Capability | Tested and characterized (specific values not provided, but implies satisfactory performance). |
| Biocompatibility | Passed all biocompatibility testing per ISO 10993-1. |
| Sterility | Achieved a Sterility Assurance Level (SAL) of 1 x 10^-6 post EtO sterilization. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the in vitro preclinical tests. It mentions "devices" being tested, implying a quantity greater than one, but no specific number.
- Data Provenance: The data provenance is "in vitro preclinical tests" conducted by Hotspur Technologies, Inc., a subsidiary of Teleflex Medical, Inc. The location (country of origin) is not explicitly stated but is implied to be within the US, given the submission to the FDA. The tests are prospective in the sense that they were designed and executed to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not applicable. The "ground truth" for the in vitro tests would be the established engineering and biological standards (e.g., ISO 10993-1, FDA Guidance for PTCA Catheters) and the objective measurements demonstrating compliance. There were no human experts establishing a "ground truth" in the diagnostic sense for these device performance tests.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. As these were in vitro engineering and biological tests, the data would have been analyzed against pre-defined quantitative and qualitative specifications. There's no mention of an adjudication process by human reviewers for these types of tests.
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: No. This document is for a medical device (a catheter), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its design and manufacturing, tested through in vitro methods.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for these in vitro tests were established engineering specifications, regulatory standards (e.g., ISO 10993-1), and documented procedures based on FDA guidance for PTCA Catheters. For example, for biocompatibility, the ground truth is compliance with ISO 10993-1. For sterility, reaching an SAL of 1 x 10^-6.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device. There is no "training set" in this context. The device's design is based on engineering principles and knowledge, not data training.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned or relevant for this type of device submission.
Ask a specific question about this device
(121 days)
The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, 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.
The proposed Arrow GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The Arrow GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.
The provided text describes the Arrow GPSCath™ Balloon Dilatation Catheter and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of a diagnostic or AI-driven system.
The document is a traditional 510(k) notification for a physical medical device (a balloon catheter) and focuses on engineering and performance criteria for the device itself, rather than diagnostic accuracy or AI performance. The "performance data" section refers to bench testing, biocompatibility, and physical characteristics of the catheter.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria for an AI/diagnostic device, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The closest relevant section is:
I. Performance Data:
- Bench top tests: balloon compliance, catheter body burst strength, catheter torque strength, catheter balloon bond strength, catheter tip-pull strength, simulated use, balloon rated burst pressure, balloon fatigue, and balloon inflation/deflation time, contrast media flow rate, and catheter visual inspections.
- Other tests: biocompatibility (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, systemic toxicity, hemolysis, complement activation, thromboresistence, partial thromboplastin time, and MEM elution), package and simulated use test data.
J. Conclusions:
- "The Arrow GPSCath Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. All test results demonstrate that the Arrow GPSCath Balloon Dilatation Catheter met the established specifications necessary for consistent performance during its intended use."
This indicates that acceptance criteria were established and met for the physical device's engineering performance. However, these are not the type of acceptance criteria you would typically find for an AI diagnostic device.
Ask a specific question about this device
Page 1 of 1