(213 days)
The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.
The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, which are used to determine the exact catheter trim length. The PICC catheter is offered with or without plastic clamps on the proximal extension tubes.
The provided text is a 510(k) summary for a medical device called a Peripherally Inserted Central Catheter (PICC). It specifically states that the device is being submitted as substantially equivalent to existing legally marketed devices.
Therefore, the document does not describe an acceptance criteria or a study that proves the device meets those criteria in the way one might expect for a novel AI/software device. Instead, the focus is on demonstrating equivalence to predicate devices.
Let's break down why and then address the specific points you requested based on the information provided:
Key Takeaway: This is a substantial equivalence submission, not a performance study for a novel algorithm.
Here's how to address your request based on the provided text, highlighting what's not applicable (N/A) due to the nature of a 510(k) substantial equivalence submission for a physical medical device:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Not specified, as this is a substantial equivalence submission for a physical medical device. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device, rather than meeting specific performance metrics against a defined standard or clinical trial endpoint. The device is substantially equivalent to the PICC catheters offered by Cook Inc. and Luther Medical. Indicated for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. Distal catheter tip must provide maximum dilution for therapy and assurance of continued, uncompromised vascular access. The PICC catheter system is designed for these indications, and the manufacturer believes it meets the minimum requirements for its intended use. Made from polyurethane material with 5 cm incremental markings. Offered with or without plastic clamps. The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, and is offered with or without plastic clamps on the proximal extension tubes. Packaged in a heat-sealed Tyvek/mylar pouch. Sterilized using ethylene oxide gas. Bacterial endotoxin levels monitored. The PICC catheter is packaged as described, sterilized using ethylene oxide gas, and bacterial endotoxin levels are monitored for sterility release purposes. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a physical medical device and relies on demonstrating substantial equivalence to existing predicate devices, not on a clinical performance study with a test set of data in the context of AI/software. There is no mention of a test set, data provenance, or study design for performance.
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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. As there is no "test set" or performance data analysis in the AI/software context, there is no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set is described, so no adjudication method is mentioned.
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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 is a physical medical device, not an AI/software device. No MRMC study or AI assistance is involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As there is no clinical performance study involving AI/software analysis of data, the concept of "ground truth" as typically applied in AI studies is not relevant here. The "truth" in this context is that the device design, materials, manufacturing processes, and intended use are similar enough to predicate devices to ensure safety and effectiveness.
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The sample size for the training set
- Not Applicable. This is a physical medical device. There is no training set for an algorithm.
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How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, the method for establishing its ground truth is irrelevant.
In summary: The provided document is a 510(k) premarket notification for a physical medical device (a catheter). The core of a 510(k) submission for such a device is to demonstrate substantial equivalence to devices already legally on the market. It does not involve performance studies, test sets, training sets, ground truth establishment, or AI/software specific criteria that you've listed.
§ 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).