(260 days)
The Cronus HP - High Pressure Peripheral Balloon Catheted for Percutaneous Transluminal Angioplasty in the following vessel areas:
- Femoral arteries
- Popliteal arteries
- Iliac arteries
- Renal arteries
- For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
These catheters are not intended for use in coronary arteries or the neurovasculature.
The Cronus HP - High Pressure Peripheral Balloon Catheter is intended for PTA (Percutaneous Transluminal Angioplasty) procedures. It is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi- compliant inflatable balloon and a flush cut tip. The catheter manifold includes two lumens. A y-connector adaptation is located at the proximal part of the catheter and provides access to the two different lumens. The lumen marked "GW" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon segment expands to a known diameter at a specific inflation pressure.
The provided text describes a 510(k) premarket notification for a medical device, the Cronus HP - High Pressure Peripheral Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing full clinical trials to prove efficacy and safety.
Therefore, the document does not contain the kind of information typically found in a study designed to prove a device meets acceptance criteria, especially for a new, innovative device that would require such studies. Specifically:
- No acceptance criteria table and reported performance: The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device; or a clinical outcome measure for a therapeutic device) with corresponding acceptance thresholds. Instead, it relies on demonstrating that the device meets various non-clinical engineering and biocompatibility tests and is similar in function to predicate devices.
- No test set sample size or data provenance: There is no "test set" in the sense of a clinical dataset used for performance evaluation that would require information on sample size, country of origin, or whether it was retrospective/prospective. The non-clinical tests are bench tests or lab-based biocompatibility, not studies on patient data.
- No experts used for ground truth: Since there's no clinical test set requiring ground truth, there are no experts involved in establishing it.
- No adjudication method: Not applicable as there's no clinical test set.
- No multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is typically done for diagnostic imaging devices to assess human reader performance with and without AI assistance. This document describes a balloon catheter, not an imaging device.
- No standalone (algorithm-only) performance: This is a physical medical device, not an algorithm.
- No type of ground truth used: Not applicable as there's no clinical test set.
- No training set sample size: This is not an AI/ML device that requires a training set.
- No ground truth for the training set: Not applicable.
What the document does describe are:
- Non-clinical (bench) tests: A comprehensive list of physical, mechanical, and biological tests (biocompatibility, packaging, guidewire compatibility, dimensional verification, trackability, pushability, balloon inflation/deflation, burst pressure, radiopacity, etc.). The conclusion states these tests were "conducted and passed," demonstrating the device performs equivalently to predicate devices in these aspects.
- Comparison to predicate devices: The "Comparison of technological characteristics" table (Table 4) outlines similarities in physical characteristics, operational mode, basic scientific technology, and intended use between the Cronus HP and its predicate devices (Covidien Evercross and Bard Conquest).
- Conclusion of Substantial Equivalence: The ultimate "acceptance criteria" for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The document explicitly states: "The results of the performance testing and the comparison of technological characteristics with the predicate devices demonstrate that the Cronus HP- High Pressure Peripheral Balloon Catheter has an equivalent performance compared to the predicate devices and it is substantially equivalent for its intended use."
- No clinical tests: The document explicitly states: "This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission." This reinforces that the "proof" is through non-clinical testing and comparison to predicates, not through clinical trials.
In summary, the provided text is an FDA 510(k) clearance letter and summary for a physical medical device. It proves the device meets regulatory acceptance criteria for substantial equivalence through a series of non-clinical (bench) tests and a direct comparison of technological characteristics to existing, legally marketed predicate devices, rather than through a clinical study with a test set, ground truth, and human expert evaluation as might be seen for a novel diagnostic or AI-powered 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).