(96 days)
The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the hurnan body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact
The Mikro-Cath is a disposable/single use, sterile cardiovascular pressure catheter transducer for monitoring and measuring pressure anywhere in the cardiovascular system with an appropriately sized guide catheter.
Here's an analysis of the provided text regarding the Mikro-Cath device, outlining acceptance criteria and studies:
I. Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. It does not explicitly state numerical acceptance criteria for a single performance metric with a corresponding reported device performance value in a table format. Instead, it indicates that the device's performance "maintain[s] the same levels of safety and effectiveness as the predicate devices currently in commercial distribution" by complying with applicable standards.
Therefore, the table below reflects this approach:
| Acceptance Criterion (Standard) | Reported Device Performance (Compliance Claim) |
|---|---|
| Performance Testing (AAMI ANSI BP22:1994 (R) 2006) | "The performance [tooling] and therefore maintain the same levels of safety and effectiveness as the predicate devices currently in commercial distribution." (Implicitly, the device meets the performance requirements of this standard.) |
| Biocompatibility (ISO 10993-1:2003) | "Biocompatibility testing in accordance with ISO 10993-1:2003" (Implies compliance with the standard.) |
| Sterility Validation (ISO 11135-1:2007) | "Sterility validation testing in accordance with ISO 11135-1:2007" (Implies compliance with the standard.) |
| Electromagnetic Compatibility (EN 60601-1-2:2007) | "EMC testing in accordance with EN 60601-1-2:2007" (Implies compliance with the standard.) |
| Packaging Accelerating/Aging (ASTM F 1980 & ISO 11607) | "Packaging Accelerating/Aging testing in accordance with ASTM F 1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) and ISO 11607 (Packaging for Terminally Sterilized Medical Devices)." (Implies compliance with the standards.) |
II. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests (e.g., biocompatibility, sterility, EMC, packaging, performance testing to AAMI ANSI BP22). It does not mention specific clinical trials or a test set of patient data in the context of device performance to measure hemodynamic cardiac pressures. The performance testing refers to compliance with safety and effectiveness standards, likely through bench testing, rather than a clinical dataset.
Therefore, this information is not available in the provided text.
III. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical test set of patient data is described, there is no mention of experts establishing ground truth for such a set. The expertise involved would be in conducting and interpreting the non-clinical tests according to the cited standards.
Therefore, this information is not available in the provided text.
IV. Adjudication Method for the Test Set
As no clinical test set requiring adjudication is described, this information is not applicable and not available in the provided text.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not mentioned in the provided document. The device in question is a physical catheter transducer, not an AI or imaging diagnostic tool.
Therefore, this information is not applicable and not available in the provided text.
VI. Standalone (Algorithm Only) Performance Study
The Mikro-Cath is a physical medical device, specifically a catheter tip pressure transducer. It is not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not applicable to this device.
Therefore, this information is not applicable and not available in the provided text.
VII. Type of Ground Truth Used
For the non-clinical performance testing (e.g., to AAMI ANSI BP22), the ground truth would be the physical measurements and specifications defined by the standard itself, obtained through laboratory or bench testing. For biocompatibility, it would be the results of in vitro and in vivo biological tests as defined by ISO 10993. For sterility, it would be the microbiological test results demonstrating a sterility assurance level as defined by ISO 11135.
There is no mention of ground truth based on expert consensus, pathology, or outcomes data in the context of clinical performance, as no clinical study is described.
VIII. Sample Size for the Training Set
The device is a physical catheter, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The manufacturing and design process would follow established engineering principles and quality systems rather than data-driven training.
Therefore, this information is not applicable and not available in the provided text.
IX. How the Ground Truth for the Training Set Was Established
As the device is not an AI/ML model, the concept of establishing ground truth for a training set is not applicable.
Therefore, this information is not applicable and not available in the provided text.
§ 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).