(346 days)
The PERCEPTOR® Compensator MORSE® Manifold, like its predicates, the MORSE® DT Manifold and the Stand Alone Transducer, is a physiological blood pressure transducer. Both devices are intended for invasive pressure monitoring, catheterization procedures, fluid delivery and/or blood access maintenance.
A device which integrates a physiological pressure transducer directly into the side port lumen of a manifold. A catheter provides a fluid column which communicates pressure in the heart from the tip of the catheter to the transducer. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The signal is communicated to the monitor via the cable.
The provided text is a 510(K) summary for a medical device called the PERCEPTOR® Compensator MORSE® Manifold, which is a physiological blood pressure transducer. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. It does not contain information about a study involving acceptance criteria, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any form of AI/algorithm performance.
The document addresses compliance with engineering standards rather than clinical performance metrics in the way you've outlined for AI or diagnostic devices.
Therefore, I cannot populate the requested table or answer the subsequent questions based on the input provided. The summary is about a physical device's design, materials, and compliance with general transducer standards, not about a study assessing its diagnostic or interpretive accuracy.
Here's a breakdown of what can be inferred from the text, and why the other information is missing:
What's available in the text:
- The device is a physiological blood pressure transducer.
- It's intended for invasive pressure monitoring, catheterization procedures, fluid delivery, and/or blood access maintenance.
- It's expected to conform to specifications in ANSI/AAMI BP22-1994 "Blood Pressure Transducers."
- Biocompatibility testing was performed on predicate devices (implying the new device, using identical materials, doesn't need new biocompatibility testing).
- The fundamental design principles are outlined (integrates transducer into manifold, catheter communicates pressure, gel acts as vibratory membrane).
- Differences from predicates are described: redirected lumen for accurate zero balancing and pressure monitoring at any height, and discontinuation of an Over Pressure Protection Band.
Why the requested information is absent:
The 510(k) summary is for a physical medical device (a blood pressure transducer) that measures a physiological parameter. The "performance" in this context refers to its ability to accurately measure blood pressure according to established engineering standards (like ANSI/AAMI BP22-1994), not its ability to interpret images, diagnose conditions, or provide AI-assisted insights.
Therefore, there are no:
- "Acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic task. The acceptance criteria would be conformance to the ANSI/AAMI standard.
- "Reported device performance" in terms of diagnostic metrics. Performance is implied by adherence to the ANSI/AAMI standard.
- "Sample sizes for test set" related to diagnostic accuracy.
- "Experts" establishing ground truth for a diagnostic task.
- "Adjudication method."
- "MRMC comparative effectiveness study" involving human readers and AI.
- "Standalone algorithm performance."
- "Type of ground truth" (pathology, expert consensus, etc.).
- "Training set" or "how ground truth was established for training" because this isn't an AI/algorithm-driven device.
{0}------------------------------------------------
X: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
March 31, 1995 Date Prepared:
NAMIC U.S.A. Corporation Manufacturer: Glens Falls, New York 12801
Mary Meagher Rubin Contact Person: Telephone Number (518) 798-0067
The PERCEPTOR® Compensator MORSE® Manifold, like its predicates, the MORSE® DT Manifold and the Stand Alone Transducer, is a physiological blood pressure transducer. Both devices are intended for invasive pressure monitoring, catheterization procedures, fluid delivery and/or blood access maintenance.
Both devices are expected to conform to Specifications outlined in ANSI/AAMI BP22-1994 "Blood Pressure Transducers" which is a Revision/combination of ANSI/AAMI BP22-1986 and ANSI/AAMI BP23-1986.
Biocompatibility testing has been performed on the predicate devices, there are no changes in device material.
These devices are manufactured from identical materials and function based under the same design principles which are: 1) A device which integrates a physiological pressure transducer directly into the side port lumen of a manifold. 2) A catheter provides a fluid column which communicates pressure in the heart from the tip of the catheter to the transducer. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The signal is communicated to the monitor via the cable.
The difference between the Compensator MORSE® Manifold and its predicates is that the lumen of the Compensator has been redirected so that it is present above and below the sensor. This allows for the following: 1) Accurate zero balancing and 2) pressure monitoring at any transducer height. Secondly, the use of an Over Pressure Protection Band has been discontinued.
Compensator
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).