(197 days)
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The Arrow Peripherally Inserted Midline Catheter is made of polyurethane material that is similar to our existing PIC catheters. The midline catheter will be available in both single and double lumen configurations, several trimmable and non-trimmable lengths, and the option of inserting with or without a placement wire.
This 510(k) summary (K963257) for the Arrow Peripherally Inserted Midline Catheter describes a device substantially equivalent to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in a way that would require the detailed breakdown requested in the prompt (e.g., sample sizes for test sets, expert qualifications, MRMC studies, training sets, etc.). The provided text focuses on non-clinical performance testing for material properties and mechanical integrity, not clinical efficacy or diagnostic accuracy.
Therefore, most of the requested information is not applicable or cannot be extracted from this document.
Here's an attempt to answer the relevant sections based only on the provided text, while acknowledging its limitations:
Description of Acceptance Criteria and Device Performance Study
The Arrow Peripherally Inserted Midline Catheter (PIMC) is described as having comparable technological characteristics to several predicate devices. The submission focuses on demonstrating substantial equivalence through non-clinical test results comparing the Arrow Midline Catheter to the Menlo Care Landmark Catheter. The acceptance criteria are implicitly defined by "comparable technological characteristics" to the predicate, with the detailed numerical values for these comparisons not provided in the summary.
The "study" undertaken is a series of non-clinical bench tests comparing the new device to a predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Flow rate test | Comparable to (or within acceptable range of) Menlo Care Landmark Catheter. Specific numerical criteria not provided. | "Comparable… in terms of… Flow rate test." Specific numerical results not provided. |
| Priming volume test | Comparable to (or within acceptable range of) Menlo Care Landmark Catheter. Specific numerical criteria not provided. | "Comparable… in terms of… Priming volume test." Specific numerical results not provided. |
| Flex modulus test | Comparable to (or within acceptable range of) Menlo Care Landmark Catheter. Specific numerical criteria not provided. | "Comparable… in terms of… Flex modulus test." Specific numerical results not provided. |
| Burst pressure test | Comparable to (or within acceptable range of) Menlo Care Landmark Catheter. Specific numerical criteria not provided. | "Comparable… in terms of… Burst pressure test." Specific numerical results not provided. |
| Tensile strength test | Comparable to (or within acceptable range of) Menlo Care Landmark Catheter. Specific numerical criteria not provided. | "Comparable… in terms of… Tensile strength test." Specific numerical results not provided. |
| Biocompatibility requirements | Meets all biocompatibility requirements (e.g., ISO 10993 standards). Specific criteria not detailed in this summary. | "The device also meets all biocompatibility requirements." Specific results or reports not detailed in this summary. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the 510(k) summary. These would typically be small sample sizes for bench testing, sufficient to demonstrate equivalence for mechanical properties.
- Data Provenance: Not explicitly stated, but these are typically internal laboratory tests conducted by the manufacturer or a contract testing organization. Given the date (1997), it would entirely be retrospective for the submission, though the tests themselves would be specific to this device. Geographical origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical bench testing submission. No human "experts" in the sense of clinical reviewers (e.g., radiologists) are involved in establishing ground truth for mechanical or material properties. The "ground truth" is derived from standardized testing methods.
4. Adjudication method for the test set
Not applicable. There is no clinical imaging or diagnostic interpretation requiring adjudication. Results are numerical measurements.
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 catheter, not an AI-powered diagnostic tool. No MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-clinical device; there is no "algorithm" or standalone AI performance to assess.
7. The type of ground truth used
For mechanical and material tests (flow rate, priming volume, flex modulus, burst pressure, tensile strength): The "ground truth" is established by the specified test methodologies (e.g., ASTM, ISO standards, or internal validated protocols) and the measured performance of the predicate device.
For biocompatibility: The "ground truth" is established by conformance to recognized standards (e.g., ISO 10993 series for biological evaluation of medical devices).
8. The sample size for the training set
Not applicable. This document refers to non-clinical bench testing for a physical medical device. There is no training set in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device submission.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”