(99 days)
The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. The catheter is used as a minimally invasive device under short term limited body contact (
The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. A pressure sensor is mounted at the distal tip of the catheter. The proximal end terminates in a connector. The sensor produces an electrical output signal which varies in direct proportion to the magnitude of sense pressure or sound.
The provided text is a 510(k) summary for the Millar Mikro-Cath Pressure Catheter, Model 825-0101. This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study.
Therefore, the document does not contain the information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert adjudication.
Specifically, the document states:
- "No FDA performance standards have been established for the Mikro-Cath Pressure Catheter."
- "No additional testing was provided in this submission in order to demonstrate substantial equivalence."
- "Millar believes that the Mikro-Cath Pressure Catheter is substantially equivalent to the predicate devices based on the information summarized here: The subject device has identical design and dimensions, and uses similar or identical materials as the device cleared in K093111. The patient contacting materials, mechanical characteristics, and electrical characteristics of the subject device have not changed from the predicate device cleared in K093111."
This means the submission relies on the proven safety and performance of the predicate device (K093111) and asserts that the new device is essentially the same in design, materials, and characteristics, and therefore does not require new testing to establish its safety and effectiveness.
To directly answer your questions based solely on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The submission doesn't report performance against specific acceptance criteria.
- Sample sized used for the test set and the data provenance: Not applicable. No new test set data was provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set data or ground truth establishment was conducted for this submission.
- Adjudication method for the test set: Not applicable. No new test set data was provided.
- 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 pressure catheter, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pressure catheter.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No new ground truth for performance evaluation was established for this submission.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device that measures pressure, not a clinical study report for an AI or diagnostic imaging device. Therefore, it does not contain the information requested regarding acceptance criteria and performance data from a study.
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).