MX960 REUSABLE PRESSURE TRANSDUCER

K961404 · Medex, Inc. · DRS · Jun 27, 1996 · Cardiovascular

Device Facts

• Record ID: K961404
• Device Name: MX960 REUSABLE PRESSURE TRANSDUCER
• Applicant: Medex, Inc.
• Product Code: DRS · Cardiovascular
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

Intended Use

The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.

Device Story

The MX960 is a reusable pressure transducer designed for hemodynamic monitoring. It functions as a non-fluid pathway device; a pressure waveform is conveyed through a disposable dome coupled to the transducer. The device utilizes a piezoresistive Wheatstone bridge circuit to convert mechanical pressure waveforms into electrical signals. These signals are transmitted to external monitoring equipment for display. The device is intended for clinical use by healthcare professionals. It benefits patients by enabling continuous, accurate invasive blood pressure monitoring. The design ensures fluid contact is limited to the disposable dome, protecting the reusable transducer component.

Clinical Evidence

Bench testing only. The device was tested against ANSI/AAMI BP22-1994 standards for blood pressure transducers. Parameters evaluated include sensitivity, unbalance, zero drift, impedance, accuracy, temperature coefficients, operating pressure, overpressure, symmetry, defibrillator withstand, leakage current, light sensitivity, mechanical shock, and phase shift. Results confirm the device meets or exceeds all AAMI specifications.

Technological Characteristics

Reusable pressure transducer; piezoresistive Wheatstone bridge network; polycarbonate construction. Materials tested per ANSI/AAMI/ISO 10993 and Tripartite Biocompatibility Guidance. Operating pressure range 30 to 300 mmHg; overpressure range -400 to 4000 mmHg. Connectivity via electrical signal output to external monitoring equipment. No software or firmware components.

Indications for Use

Indicated for use in hemodynamic pressure monitoring for patients requiring invasive blood pressure measurement.

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

• Medex, Inc.’s MX860 NOVATRANS II® reusable pressure transducer (K951129)

Submission Summary (Full Text)

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JUN 27 1996
K961404
medexinc
510(k) Summary

This summary regarding 510(k) safety and effectiveness and being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

## § 807.92 (a)(1) Submitter’s (and Contact) Names, Address, Telephone No., Summary Date

- John Toomey
Senior Project Engineer
Medex, Inc.
6250 Shier-Rings Road
Dublin, Ohio 43017
[phone]

- 04.09.96

## § 807.92 (a)(2) Device Name (Including Trade Name), Common Name, Classification Name

- MX960
- Reusable Pressure Transducer
- Transducer, Blood Pressure, Extravascular (CV, 74 DRS)

## § 807.92 (a)(3) Legally Marketed Predicate Device to Which Equivalence is Claimed

- Medex, Inc.’s MX860 NOVATRANS II® reusable pressure transducer (K951129).

## § 807.92 (a)(4) Description of the Premarket Notification Device

- The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system.

- The materials which comprise the MX960 have been aggressively tested per the ANSI/AAMI/ISO 10993 “Biological Evaluation of Medical Devices” and the “Tripartite Biocompatibility Guidance for Medical Devices”. All materials have successfully met these standards.

## § 807.92 (a)(5) Intended Use

- The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.

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6250 Shier-Rings Road Dublin, Ohio 43017-1295 [phone] fax [phone]

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medexinc

# § 807.92 (a)(6) Technical Characteristics Summary

| Procedure | Predicate MX860 | MX960 | AAMI SPECIFICATION |
| --- | --- | --- | --- |
| Intended Use | The MX860 reusable pressure transducer’s intended use is to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment. | 0 ± 50 | 0 ± 75 |
| Pressure Set or Component | Piezoresistive Wheatstone bridge network | ≤ 2 in 4 hrs after 5 min | Disclosure |
| Cylinder Flow Rate | Yes | 630 Nominal | 0 ± 75 |
| Performance Specification | Meets or exceeds ANSI/AAMI BP22-1994 | 300 ± 10% | Disclosure |
| Procedure Physical | Polycarbonate | 100 ± 3 | Not Specified |
| Effective Bandwidth | 0.657" | 100 ± 3 | < ±1 % or < ±3% |

# § 807.92 (b)(1), (b)(3) Performance Testing Assessment

- The MX960 was aggressively tested against the American National Standard for Blood Pressure Transducers, ANSI/AAMI BP22-1994. In all cases, the MX960 meets or exceeds AAMI specifications. The following table list the AAMI requirements, and the respective performance of the MX860 and the MX960.

| PARAMETER | PREDICATE MX860 | MX960 | AAMI SPECIFICATION |
| --- | --- | --- | --- |
| Sensitivity - μV/V/mmHg | 5.0 Nominal | 5.0 Nominal | Disclosure |
| Unbalance - mmHg | 0 ± 50 | 0 ± 50 | 0 ± 75 |
| Zero Drift - mmHg | ≤ 2 in 4 hrs after 5 min | ≤ 2 in 4 hrs after 5 min | Disclosure |
| Input Impedance - OHMS | 630 Nominal | 630 Nominal | < 3000 |
| Output Impedance - OHMS | 300 ± 10% | 300 ± 10% | > 200 |
| Calibration Requirement - mmHg | 100 ± 3 | 100 ± 3 | Not Specified |
| Accuracy - mmHg | meets or exceeds AAMI | meets or exceeds AAMI | < ±1 % or < ±3% |
| Compensated Temperature Range - °C | 10 to 45 | 15 to 40 | 15 to 40 |
| Storage Temperature Range - °C | 25 to 70 | -25 to 70 | -25 to 70 |
| Temperature Coefficient of Sensitivity - %/C° | 0 ± 0.1 | 0 ± 0.1 | Disclosure |
| Temperature Coefficient of Offset - mmHg/C° | 0 ± 0.3 | 0 ± 0.3 | Disclosure |
| Operating Pressure - mmHg | 30 to 300 | 30 to 300 | -30 to 300 |
| Overpressure - mmHg | -700 to 4000 | -400 to 4000 | -400 to 4000 |
| Volumetric Displacement - μL/100mmHg | Not Specified | Not Specified | Not Specified |
| Symmetry - | 1 ± 5% | 1 ± 5% | 1 ± 5% |
| Defibrillator Withstand - per AAMI | 5 in 5 min at 360J | 5 in 5 min at 360J | 5 in 5 min at 360J |
| Leakage Current of 115 VAC at 60 Hz - μA | < 3 | < 5 | <10 |
| Light Sensitivity - per AAMI | < 1mmHg shift | < 1mmHg shift | Disclosure |
| Mechanical Shock Withstand - per AAMI | 3 falls from 1m | 3 falls from 1m | Disclosure |
| Phase Shift - per AAMI | < 5° | < 5° | < 5° |

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