PERCEPTOR COMPENSATOR MORSE MANIFOLD

K951722 · Namic · DRS · Mar 25, 1996 · Cardiovascular

Device Facts

• Record ID: K951722
• Device Name: PERCEPTOR COMPENSATOR MORSE MANIFOLD
• Applicant: Namic
• Product Code: DRS · Cardiovascular
• Decision Date: Mar 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

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 Story

Physiological blood pressure transducer integrated into manifold side port lumen; catheter fluid column transmits heart pressure to transducer; gel membrane passes signal to sensor; signal transmitted via cable to monitor. Used in clinical settings for invasive monitoring/catheterization. Compensator design redirects lumen above/below sensor to enable accurate zero balancing and height-independent monitoring. Discontinued over-pressure protection band. Output used by clinicians for real-time hemodynamic monitoring.

Clinical Evidence

Bench testing only; biocompatibility testing performed on predicate devices; no changes in device materials.

Technological Characteristics

Physiological pressure transducer; integrated into manifold side port; gel membrane sensor; ANSI/AAMI BP22-1994 compliant; materials identical to predicate devices.

Indications for Use

Indicated for patients requiring invasive blood pressure monitoring, catheterization, fluid delivery, or blood access maintenance.

Regulatory Classification

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.

Predicate Devices

• MORSE® DT Manifold
• Stand Alone Transducer

Submission Summary (Full Text)

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PREMARKET NOTIFICATION K951722

# X: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date Prepared: March 31, 1995

Manufacturer: NAMIC U.S.A. Corporation
Glens Falls, New York 12801

Contact Person: Mary Meagher Rubin
Telephone Number [phone]

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 NAMIC® USA CORPORATION Page 48 176