NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER

K963400 · Nellcor Puritan Bennett, Inc. · DPS · Nov 26, 1996 · Cardiovascular

Device Facts

• Record ID: K963400
• Device Name: NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The purpose and function of the N-3000 Patient Monitor is to: - noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory SpO2 sensor); - noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads). - noninvasively and continuously measure Respiration Rate. When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to: - display and print out associated ECG and Plethysmographic waveforms, SpO2, pulse rate, heart rate and respiration rate. When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000/N-3100/N-3200 is also to: - noninvasively and automatically measure systolic, diastolic and mean arterial blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 display/printer). The N-3000 Patient Monitor is intended for use in hospital and hospital-type environments as a "standalone" product and when connected to the N-3200 display/printer and/or the N-3100 blood pressure monitor. It is also intended for use during hospital transport when connected to and operating off of the N-3000 and/or N-3200 internal battery, to monitor neonatal, pediatric, or adult patients. The N-3000, N-3200 and N-3100 are for prescription use only.

Device Story

N-3000 Patient Monitor performs continuous noninvasive monitoring of SpO2, ECG, heart rate, and respiration rate. Device inputs include ECG lead signals and SpO2 sensor data. Respiration rate is derived via transthoracic impedance (TTI) using ECG electrodes. System can connect to N-3100 Blood Pressure Monitor for NIBP measurements and N-3200 Display/Printer for waveform/trend visualization. Used in hospital, hospital-type, and transport settings by clinicians. Output displayed numerically on N-3000 or graphically/printed on N-3200. Alarms provided for high/low respiration, SpO2, pulse, and heart rate. Data informs clinical assessment of patient respiratory and cardiovascular status.

Clinical Evidence

Bench testing only. Testing confirmed that the addition of the respiration rate function and data communication capabilities did not affect the safety or effectiveness of the existing SpO2 and ECG functions.

Technological Characteristics

Respiration rate measured via transthoracic impedance (TTI) using high-frequency current applied through standard ECG leads. System includes N-3000 monitor, N-3100 NIBP monitor, and N-3200 display/printer (EL or LCD display, thermal printer). Connectivity via stacked instrument configuration. Powered by internal battery for transport. SpO2 and ECG modalities identical to predicate N-3000E.

Indications for Use

Indicated for neonatal, pediatric, and adult patients in hospital, hospital-type, and transport environments for continuous noninvasive monitoring of functional arterial oxygen saturation, pulse rate, ECG, heart rate, respiration rate, and (when connected to N-3100) noninvasive blood pressure.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• PASSPORT Monitor (K911598)
• PROPAQ 104 Ultra-Portable Patient Monitor with SpO2 (K902730)
• ASSURANCE 2000 Monitor (K905575)
• NELLCOR SYMPHONY™ N-3000E Patient Monitor (K955642)
• NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor (K955642, K945947)

Submission Summary (Full Text)

{0}

K 963400

NOV 26 1996

# 16. 510(k) SUMMARY

(a) Date Summary Prepared:

26 August 1996

(b) Company Information:

Establishment:

Nellcor Puritan Bennett Inc.
4280 Hacienda Drive
Pleasanton, CA 94588

Official Correspondent:

David A. C. Green
Manager, Regulatory Affairs
Nellcor Puritan Bennett Inc.
11150 Thompson Avenue
Lenexa, KS 66219

[phone] (direct telephone)
[phone] (fax)

(c) Name of Device:

Proprietary:

NELLCOR SYMPHONY™ N-3000 Patient Monitor

Common/Usual:

Respiration Rate Monitor combined with ECG and Pulse Oximeter

Classification:

Breathing (Ventilatory) Frequency Monitor (§868.2375/73BZQ), combined with Electrocardiograph (§ 70.2340/79FYW) and with Oximeter (§ 870.2700 / 74DQA)

Proprietary:

NELLCOR SYMPHONY™ N-3200 Display/Printer

Common/Usual:

Display and printer accessory

Classification:

Electrocardiograph (visual display feature) (§870.2340 / 74FYW) and Paper Chart Recorder (§ 870.2810 / 74DSF)

1102

{1}

CONFIDENTIAL

One or both devices may also be connected to:

Proprietary: NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor

Common/Usual: Noninvasive Blood Pressure Monitor

Classification: Noninvasive Blood Pressure Measurement System (§870.1130 / 74DXN)

## (d) Equivalent Devices:

Substantial equivalence to the following legally marketed pedicate devices with the same or similar indications for use has been demonstrated by comparison of product features, as described in the labeling and promotional literature for the predicate devices, as well as testing to accepted industry standards.

(1) PASSPORT Monitor, Datascope Corp., K911598.

(2) PROPAQ 104 Ultra-Portable Patient Monitor with SpO2, Protocol Systems Inc., K902730.

(3) ASSURANCE 2000 Monitor, EdenTec Corp., K905575

(4) NELLCOR SYMPHONY™ N-3000E Patient Monitor and N-3200 Display/Printer, Nellcor Puritan Bennett Incorporated, K955642.

(5) NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor, standalone and in combination with the NELLCOR SYMPHONY™ N-3000 Patient Monitor, Nellcor Puritan Bennett, Incorporated, K955642 and K945947.

## (e) Device Description:

The device which is the subject of this submission comprises a patient monitor, namely, a Respiration Rate Monitor combined with a Pulse Oximeter and ECG, model N-3000. The submitted device can also be connected to a noninvasive Blood Pressure Monitor, model N-3100 and to an accessory display/printer, model N-3200. Previous 510(k) submissions K945947 and K955642 cleared the N-3100 Blood Pressure Monitor and the related N-3000 Patient Monitor with ECG and SpO2 modalities and N-3200 display/printer for market release in 1995 and 1996, respectively.

1193

{2}

CONFIDENTIAL

The present submission covers software and hardware modifications to the predicate N-3000 patient monitor in order to incorporate a Respiration Rate measurement function and enable the display and printout of Respiration Rate information on the optional N-3200 Display/Printer. No hardware or software changes are required to the N-3100 blood pressure monitor or the N-3200 Display/Printer to accomplish the above.

This submission also covers software changes incorporated in the N-3000, N-3100 and N-3200 to enable data communication between these individual monitors and with the N-3200 display/printer when operating in the connected configuration.

The N-3000 can operate as a standalone monitor or it can be connected to (stacked with) other NELLCOR SYMPHONY instruments, such as the N-3100 Blood Pressure Monitor. The N-3200 Display/Printer accessory is functional only when connected to either the N-3000, N-3100 or both monitors stacked together.

The $\mathsf{SpO}_2$, ECG and noninvasive blood pressure functions and algorithms remain unchanged from those described in K955642 and K945947 respectively. The new Respiration Rate feature utilizes the ECG lead set and patient surface ECG electrodes, together with additional electronics processing on the ECG PC board located within the N-3000 housing. Respiration Rate in breaths/minute is displayed numerically on the N-3000 front panel display, when selected by the user. As a standalone device, the N-3000 incorporates alarms for high and low Respiration Rate, SpO2, pulse rate and heart rate.

The N-3200 Display/Printer accessory comprises an electroluminescent, EL or, alternatively, a liquid crystal, LCD graphic display, a User Interface (UIF) PCB, a display driver PCB and a sealed, lead-acid battery. The N-3200 also incorporates a thermal strip printer.

The N-3200 displays and prints Respiration Rate, $\mathsf{SpO}_2$, ECG or NIBP waveforms, graphical and trend data when connected to an N-3000 or to an N-3100 or to both monitors.

(f) Intended Use:

The purpose and function of the N-3000 Patient Monitor is to:

- noninvasively and continuously monitor functional arterial oxygen saturation and pulse rate (using an accessory $\mathsf{SpO}_2$ sensor);
- noninvasively and continuously monitor ECG and heart rate (using accessory ECG leads).
- noninvasively and continuously measure Respiration Rate.

1104

{3}

CONFIDENTIAL

When connected to the N-3200 Display/Printer, the purpose and function of the combined device is expanded to:

- display and print out associated ECG and Plethysmographic waveforms, SpO2, pulse rate, heart rate and respiration rate.

When further connected to the N-3100 Blood Pressure Monitor, the intended use of the interconnected N-3000/N-3100/N-3200 is also to:

- noninvasively and automatically measure systolic, diastolic and mean arterial blood pressure and to derive pulse rate from these measurements (using accessory blood pressure cuffs); and display and print out systolic, diastolic and mean arterial blood pressure (on the N-3200 display/printer).

The N-3000 Patient Monitor is intended for use in hospital and hospital-type environments as a "standalone" product and when connected to the N-3200 display/printer and/or the N-3100 blood pressure monitor. It is also intended for use during hospital transport when connected to and operating off of the N-3000 and/or N-3200 internal battery, to monitor neonatal, pediatric, or adult patients. The N-3000, N-3200 and N-3100 are for prescription use only.

The N-3000, the N-3000 connected to the N-3200, the N-3000 connected to the N-3100 and the N-3000 connected to both the N-3200 and N-3100 have the following similar intended uses to the predicate devices, in terms of function/purpose, environment of use and patient population:

Datascope PASSPORT - respiration rate, pulse oximetry, ECG, NIBP, display/printing functions; hospital and hospital-type environments; adult/pediatric/neonatal patients.

Protocol Systems PROPAQ 104 - respiration rate, pulse oximetry, ECG, NIBP, display/printing functions; hospital, hospital-type, transport/mobile environments; adult/pediatric patients.

EdenTec ASSURANCE 2000 - respiration rate, ECG, heart rate functions, hospital environment, adult/pediatric/neonatal patients.

NELLCOR SYMPHONY™ N-3000E Patient Monitor - pulse oximetry, ECG functions; hospital, hospital-type environments; adult/pediatric/ neonate patients.

NELLCOR SYMPHONY™ N-3100 Blood Pressure Monitor, standalone and in combination with the NELLCOR SYMPHONY™ N-3000 Pulse Oximeter; pulse oximetry, NIBP functions; hospital, hospital-type and transport/mobile environments; adult/pediatric/neonate patients.

1105

{4}

CONFIDENTIAL

The N-3000, differs from the PASSPORT and PROPAQ 104 in having fewer measurement/monitoring parameters available, but more than the ASSURANCE. It also differs from the PROPAQ in that it includes neonates in the intended patient population. Considering Environment of Use, the PASSPORT and PROPAQ include mobile use.

The N-3000 has the same patient population as the predicate N-3000E patient monitor and predicate N-3100 blood pressure monitor, including adult, pediatric and neonate patients. It differs only in that it features Respiration Rate as an additional measurement parameter

(g) Technological Characteristics

A respiratory-related signal is generated by a low-level, high frequency current, applied to the patient via conventional ECG leads to measure the patient's trans thoracic impedance, TTI. Variations in the collected TTI signal are analyzed to determine Respiration Rate.

The technological characteristics of the pulse oximetry and ECG modalities of the N-3000 Patient Monitor are identical to those in the predicate N-3000E Patient Monitor. The same algorithms are used in both products. Testing has been conducted to confirm that modification of the N-3000E Patient Monitor to add a respiration rate function and access to the N-3200 display/printer has not affected the safety or effectiveness of the oximetry or ECG functions of the N-3000.

Safety and effectiveness of the N-3000, alone and in combination with the N-3200 display/printer and/or the N-3100 blood pressure monitor, have been confirmed by complying with the requirements of the Reviewer Guidance for Premarket Notification Submissions, November 1993, through design, testing and labeling.

1196

{5}

CONFIDENTIAL

# CERTIFICATION STATEMENT

In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:

Nellcor Puritan Bennett Inc. believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.

David A. C. Green

Manager, Regulatory Affairs
for Nellcor Puritan Bennett Inc.

26 August 1996

1197