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Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system

The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.

The medical device in question is the Millar Instruments Cardia-Cath, a Pressure-Volume (PV) Catheter Transducer. The provided text outlines the acceptance criteria and corresponding study results for this device, primarily focusing on verification testing, biocompatibility, sterility, and accelerated aging, demonstrating its substantial equivalence to a legally marketed predicate device (Millar model SPC-550).

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Compliance with BP-22 standard requirements.
• Temperature Error Band at Zero Pressure: ≤ 3.24 mmHg (for predicate device).
• Sensitivity Error Band: ≤ 3.16% (for predicate device). | - All tested catheters met the testing requirements and complied with BP-22 standard requirements.
• Deviation 1: Temperature Error Band at Zero Pressure relaxed to 3.5 mmHg.
• Deviation 2: Sensitivity Error Band relaxed to 3.5%.
• The modified device IFU includes the new (relaxed) values to ensure end-users obtain the same level of data accuracy. |
  | Transportation Testing | - Compliance with ASTM D4169-08 standards for fully packaged finished product.
• Samples must pass all tests including bubble leak and packaging integrity.
• No impact on device functionality (safety and effectiveness) after transportation testing. | - Samples passed all tests including bubble leak test and packaging integrity, as per DDL report No: 1009057 Rev. A.
• Functionality testing (Millar reference VRP-2010-0423-01 VAL-180) confirmed no impact on device functionality, safety, and effectiveness. |
  | Biocompatibility (ISO 10993-1) | - Requirements for External communicating device, circulating blood, contact duration A-Limited (

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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:

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.

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The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor. It is intended for use in monitoring diagnostic pressures, such as noninvasive or invasive blood pressures, intracranial pressures, gastrointestinal pressures, esophageal pressures, urinary tract pressures, intrauterine pressures, intraocular pressures and other physiological pressures with similar ranges. It is intended for use in critical care areas in a hospital and in diagnostic centers in hospitals or medical clinics. It is intended for use by trained clinicians or research personnel

The PCU-2000 Pressure Control Unit is a two-channel electrically isolated amplifier that is intended for use with Millar Mikro-Tip Pressure Catheters that have the standard medical sensitivity of 5 microvolts per mmHg of applied pressure and per volt of bridge excitation. The PCU-2000 provides an electrical interface between a physiological pressure transducer and a data acquisition module or medical monitor.

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Pressure Control Unit PCU-2000" and an "Indications for Use Statement" attachment.

This document describes a medical device (transducer signal amplifier and conditioner) and its intended use, rather than an AI/algorithm-driven device that would undergo significant performance evaluation with acceptance criteria, ground truth, and studies like MRMC or standalone performance.

Therefore, the requested information about acceptance criteria and studies (including sample sizes, ground truth establishment, expert involvement, adjudication methods, and AI-specific studies) cannot be extracted from this document because:

• The device is a hardware component: The PCU-2000 is described as a "two-channel electrically isolated amplifier" intended to provide an "electrical interface" between a pressure transducer and a data acquisition module or medical monitor. It conditions analog signals, not processes complex image or sensor data with AI.
• The 510(k) clearance process for this type of device focuses on substantial equivalence: The letter confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This typically involves demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This is different from the extensive performance validation required for AI/ML devices.
• No mention of AI, algorithms, or complex data analysis: The entire document refers to basic signal amplification and conditioning for physiological pressure measurements. There is no indication of any AI component, predictive modeling, or diagnostic algorithms that would necessitate the type of detailed performance studies you're asking about.

In summary, the provided text does not contain the information requested because the device described is not an AI/algorithm-driven device that would typically undergo such studies and evaluations.

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The Millar Angiographic catheter is designed to provide high fidelity pressure readings and deliver radiopaque contrast medium to selected sites in the vascular system.

Not Found

This document is a 510(k) clearance letter for the Mikro-Tip Angiographic Catheter and does not contain the detailed study information requested. The letter states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the information requested in the prompt based on the provided document. The document only confirms the FDA clearance for the device and its intended use, but it does not include details on acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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