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510(k) Data Aggregation
(239 days)
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)
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.
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.
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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