(113 days)
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on its distal tip. A hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port used to inflate the balloon. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon for all sizes. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.
The provided text, K072947 Premarket Notification - ClearStream Technologies PTA Catheters, describes the 510(k) submission for the Savvy Long and Sleek Peripheral Transluminal Angioplasty (PTA) Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of device performance metrics like sensitivity, specificity, etc.
It operates under the assumption that if the new device is substantially equivalent in intended use, design characteristics, and general physical characteristics, and satisfies recognized standards, then it can be marketed.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this 510(k) submission.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance Study (as per the provided document):
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that an AI/diagnostic device would have. Instead, the "acceptance criteria" for this device's premarket notification revolved around demonstrating substantial equivalence to a legally marketed predicate device and compliance with recognized standards.
The document states: "Performance testing and compliance with recognized standards have established substantial equivalence." This is the core "study" and "conclusion" for this type of device submission. The specific details of this performance testing are not provided in the 510(k) summary, but are typically included in the full submission to the FDA.
Table of Acceptance Criteria and Reported Device Performance:
Given the nature of this 510(k) for a medical catheter (Class II medical device), the acceptance criteria are not in terms of diagnostic performance metrics like those for an AI system. Instead, they relate to functional performance and safety to ensure substantial equivalence. The document does not provide a table with quantitative performance data. The "reported device performance" is summarized as having "established substantial equivalence" through performance testing and compliance with recognized standards.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Balloon dilatation of specific arteries. | Matches predicate: "This device is equivalent to the predicate device in intended use." |
| Design Characteristics: Semi-compliant coaxial design, balloon, hub/"Y" connector, platinum iridium bands. | Matches predicate: "This device is equivalent to the predicate device in... design characteristics." |
| General Physical Characteristics: Various sizes. | Matches predicate: "This device is equivalent to the predicate device in... general physical characteristics." |
| Biocompatibility: Safe for contact with human tissue. | Not explicitly detailed in the summary, but implied by "compliance with recognized standards." |
| Sterility: Must be sterile for use. | Not explicitly detailed in the summary, but implied by "compliance with recognized standards." |
| Functional Performance (e.g., burst pressure, fatigue, trackability, pushability): | "Performance testing... have established substantial equivalence." (Specific values not provided in summary) |
| Compliance with Recognized Standards: (e.g., ISO, ASTM standards for catheters). | "Compliance with recognized standards have established substantial equivalence." (Specific standards not listed in summary) |
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided: This 510(k) summary does not describe a clinical study or a test set in the context of diagnostic accuracy for a software algorithm. The "performance testing" referenced would typically involve bench testing and potentially some in-vivo animal testing to confirm functional performance and safety, not a human clinical test set for diagnostic accuracy with provenance details.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable: There is no mention of experts establishing a "ground truth" for a test set, as this is not a diagnostic device relying on expert interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: No test set or adjudication process is described in the context of diagnostic accuracy.
4. 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:
- No: This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is a physical medical device, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable: For a physical device like a catheter, "ground truth" would relate to its physical properties meeting specifications (e.g., balloon burst pressure, catheter dimensions) and its safety and efficacy in an in-vivo model (animal or human), which is assessed through a different set of methods than diagnostic ground truth. The document speaks of "performance testing."
7. The sample size for the training set:
- Not Applicable: This is a physical device, not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established:
- Not Applicable: No training set or associated ground truth establishment for a training set is relevant or mentioned.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a PTA catheter to a predicate device through performance testing and compliance with recognized standards. It does not contain the detailed information regarding acceptance criteria or studies that would be present for an AI/diagnostic device, due to the fundamental difference in device type and regulatory pathway expectations.
§ 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).