(59 days)
The Nipro Bio-Flex Catheter is intended to be inserted into a patient's vascular system for short-term use to sample blood or administer fluids intravenously.
The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are similar to those already marketed by Nipro Medical Corporation under K960051. Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles ¾ to 1¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
The provided text is a 510(k) premarket notification for a medical device (Nipro Bio-Flex Catheter) and includes an FDA letter confirming substantial equivalence. This type of regulatory document typically focuses on comparing a new device to a legally marketed predicate device rather than presenting detailed acceptance criteria and studies in the same way one would for a novel AI/software product.
However, based on the information provided, I can deduce how the device aims to meet "acceptance criteria" through the lens of a 510(k) submission, which is primarily demonstrating substantial equivalence.
Here's the breakdown, addressing the points you requested where applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, metrics-based format like sensitivity/specificity for a diagnostic AI. Instead, the core acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This is primarily achieved by showing that the new device has:
- Same intended use as the predicate.
- Same technological characteristics as the predicate, or if there are differences, these differences do not raise new questions of safety and efficacy.
- Performance data to support substantial equivalence if technological characteristics are different.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Intended Use | "The Nipro Bio-Flex Catheter is intended to be inserted into a patient's vascular system for short-term use to sample blood or administer fluids intravenously." (Matches predicate's use for short-term vascular insertion for sampling blood, monitoring blood pressure, or administering fluids intravenously). |
| Technological Characteristics | "The Nipro subject and predicate devices are very similar except for one material change discussed within this application." |
| Performance to Support Equivalence | "Performance tests demonstrated that the devices are substantially equivalent." (No specific metrics or raw data provided in this summary, but the FDA's clearance confirms they were considered sufficient.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not report specific sample sizes or data provenance for any "test set" as would be done for a clinical trial or AI validation study. The performance tests mentioned are likely bench tests (e.g., material compatibility, flow rates, tensile strength) to confirm the new material change doesn't negatively impact performance. These are not typically human-subject clinical trials with "test sets" in the AI sense.
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 to this type of device and submission. "Ground truth" established by experts is characteristic of diagnostic or image analysis AI, which is not the nature of an intravascular catheter. The "ground truth" for catheter performance relies on established engineering standards and physiological principles, and comparison to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used for resolving disagreements among multiple experts when establishing ground truth, typically in image interpretation or diagnostic studies.
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
An MRMC study is not applicable to this device. MRMC studies are used for evaluating diagnostic performance of systems that involve human interpretation (e.g., radiologists reading images with and without AI assistance). This is a physical medical device (catheter).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable as this is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is established by:
- Engineering specifications and standards: The catheter's dimensions, material properties, and functional performance (e.g., flow rate, tensile strength) would be measured against pre-defined engineering standards.
- Comparison to the predicate device: The new device's performance characteristics would be directly compared to those of the Nipro Safelet Cath (K960051) to ensure they are equivalent within acceptable tolerances.
- Safety and Efficacy history of the predicate: The predicate device itself has an established history of safe and effective use, which the new device leverages by demonstrating equivalence.
8. The sample size for the training set
This information is not applicable to this type of device. There is no "training set" in the context of an AI algorithm learning from data.
9. How the ground truth for the training set was established
This information is not applicable to this type of device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).