(30 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and illo femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided text describes a Special 510(k) Premarket Notification for the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. This document is a regulatory submission to the FDA, not a study report demonstrating the device's performance against specific acceptance criteria in a clinical or analytical setting.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The document focuses on demonstrating substantial equivalence to predicate devices through in-vitro testing and manufacturing controls, rather than a standalone clinical study with detailed performance outcomes.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in a table format with specific quantitative acceptance criteria or reported numerical performance data. The document states that the device was "subjected to the following tests to assure reliable design and performance under the specified testing parameters," but it does not list the specific acceptance thresholds for these tests or the exact results obtained.
| Acceptance Criterion (Not explicitly stated) | Reported Device Performance (Summary statement only) |
|---|---|
| (e.g., Tensile Strength > X N) | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." |
| (e.g., Inflation/Deflation Time Z atm) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions various "tests" (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile) but does not provide any details about the number of devices or samples tested for each.
- Data Provenance: The tests are described as being conducted "to assure reliable design and performance." This implies in-vitro (laboratory) testing performed by the manufacturer, Cook Incorporated, likely in the USA, as Cook Incorporated is an American company. The data is retrospective in the sense that these tests were performed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This type of information is relevant for studies involving human interpretation (e.g., imaging studies where experts establish a diagnostic ground truth). The tests described are benchtop/in-vitro performance tests, not clinical studies requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. See point 3. Benchtop tests typically have objective, measurable outcomes, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any clinical study, let alone an MRMC comparative effectiveness study. The submission focuses on substantial equivalence based on materials, intended use, and in-vitro performance testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a physical medical device (a balloon catheter), not a software algorithm or AI component.
7. Type of Ground Truth Used
For the in-vitro tests mentioned (Tensile, Balloon deflation, Balloon burst, etc.), the "ground truth" would be established by objective engineering specifications and measurements. For example, a burst test's ground truth is the pressure at which the balloon ruptures, measured by calibrated equipment, and then compared against a pre-defined performance specification. It's not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a physical device, not an AI/ML model being developed. The document refers to manufacturing processes and quality assurance, which fall under good manufacturing practices rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).