(26 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 ilio 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 submission K023504 describes a Special 510(k) Premarket Notification for a PTA Balloon Catheter, the ATB™ All-Terrain Balloon™ PTA Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing rather than clinical study.
Here's an analysis based on the provided text, addressing the requested information:
1. A table of acceptance criteria and the reported device performance
The submission lists the tests performed but does not explicitly state the acceptance criteria for each test or the detailed numerical results (performance data) in the provided text. It generally states that "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."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document (e.g., "Balloon burst pressure shall be X psi ± Y%"). | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not specify the sample sizes used for each of the listed tests (Tensile, Balloon deflation, Balloon burst, Balloon compliance, Balloon fatigue, Balloon profile).
The data provenance is not explicitly stated, but it would be from internal laboratory testing conducted by Cook Incorporated, likely in the USA where the company is based. This is prospective testing, as it's performed specifically to demonstrate device performance prior to marketing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device submission. The "ground truth" for evaluating a PTA balloon catheter's physical performance is established through established engineering and materials science testing standards, not by expert medical consensus. The tests are objective measurements of the device's physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human interpretation of data is involved and discrepancies need to be resolved. This submission details engineering and performance testing.
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 medical instrument (PTA balloon catheter), not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing mentioned, the "ground truth" is defined by established engineering specifications and physical measurement standards. For example, balloon burst pressure would be compared against a pre-defined minimum pressure specification derived from clinical needs and recognized standards for such devices.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).