(346 days)
There is no K/DEN number present in this text.
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No
The document describes a purely mechanical and electronic device for pressure monitoring, with no mention of AI or ML terms, data sets, or performance metrics typically associated with such technologies.
No
The device is described as a physiological blood pressure transducer intended for monitoring, not for treating a disease or condition.
Type: No
Explanation: While the device is used for "invasive pressure monitoring," it functions as a transducer to measure physiological blood pressure, not to diagnose a condition. It provides data for monitoring but does not interpret that data for diagnostic purposes.
No
The device description clearly outlines physical components like a transducer, manifold, catheter, gel, and cable, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "invasive pressure monitoring, catheterization procedures, fluid delivery and/or blood access maintenance." This involves monitoring physiological parameters within the body, not analyzing samples outside the body.
- Device Description: The description details how the device measures pressure in the heart via a catheter and transducer. This is a direct physiological measurement, not an analysis of a biological sample.
- Lack of IVD Characteristics: The description does not mention analyzing blood, urine, tissue, or any other biological sample in vitro (outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to measure a physiological parameter directly within the body.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
The PERCEPTOR® Compensator MORSE® Manifold and its predicates 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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