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K Number
K951722
Device Name
PERCEPTOR COMPENSATOR MORSE MANIFOLD
Manufacturer
NAMIC
Date Cleared
1996-03-25

(346 days)

Product Code
DRS
Regulation Number
870.2850
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
K100319
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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.

§ 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).