DINAMAP SELECT MULTI-PARAMETER SYSTEM

K955113 · Johnson & Johnson Medical, Inc. · DPS · Aug 15, 1996 · Cardiovascular

Device Facts

• Record ID: K955113
• Device Name: DINAMAP SELECT MULTI-PARAMETER SYSTEM
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DINAMAP Select Multi Parameter System (MPS) is a prescription device intended for use only by health care professionals. It can be used in hospital and/or outpatient surgery center settings and functions as a patient bedside multiparameter monitoring unit. It is designed for monitoring adult, pediatric and neonatal patients in acute care settings such as critical care, emergency room, radiology, labor and delivery, and operating room. Using this monitoring system, the clinician can view, record and recall clinical data derived from the user-selectable modules/monitoring parameters. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), entidad carbon dioxide (CO2), respiration rate and temperature.

Device Story

Modular bedside patient monitor; mainframe accepts various parameter modules. Inputs: ECG leads, blood pressure cuffs (oscillometric), invasive pressure transducers, pulse oximetry sensors (red/IR), CO2 sensors (infrared), temperature probes. Processing: modules convert transducer signals to waveforms and numeric data; system displays, records, and stores 24 hours of data. Used in hospitals/outpatient surgery centers by clinicians. Networked capability allows remote viewing of vital signs. Output: real-time waveforms, numeric vital signs, paper strip records. Clinical decision-making: provides continuous monitoring to assist clinicians in patient assessment and intervention. Benefits: enables simultaneous multi-parameter monitoring, data recall, and centralized observation.

Clinical Evidence

Clinical studies conducted for noninvasive blood pressure (NIBP) and pulse oximetry across adult, pediatric, and neonatal populations. Bench testing performed for ECG, heart rate, respiration (impedance), continuous temperature, invasive pressure, CO2, environmental safety, and electromagnetic compatibility.

Technological Characteristics

Modular mainframe with 9 slots. Technologies: ECG (electrocardiography), Respiration (thoracic impedance/spectroscopy), NIBP (oscillometry), Invasive Pressure (strain-gauge transducer), Pulse Oximetry (red/IR spectroscopy), CO2 (infrared spectroscopy), Recorder (thermal). Connectivity: Ethernet network, remote view, central station interface. Software-driven electronic device.

Indications for Use

Indicated for monitoring vital signs in adult, pediatric, and neonatal patients in acute care settings including critical care, ER, radiology, labor and delivery, and operating rooms.

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

• Hewlett Packard Component Monitoring System (CMS) HP M1175A & M1176A (K941811, K922058, K910490, K896030)
• Hewlett Packard Omnicare™ Monitor (Unknown)
• Marquette Medical Tramscope™ System (K900598)
• JJMI DINAMAP PLUS Monitor Models 8710/9710 & 8720/9720 (K943709, K912188)
• Hewlett Packard HP M1002A ECG/Respiration Module (K941811)
• JJMI DINAMAP PLUS Monitor Models 8700/9700, 8710/9710 & 8720/9720 (K943709, K912188)
• JJMI DINAMAP PLUS Monitor Model 8720/9720 (K943709, K912188)
• Nellcor® Model N-180 Pulse Oximeter (K913695)
• Novametrix Model 1265 Endtidal CO2 Monitor (K910019)
• JJMI DINAMAP PLUS Monitor Recorder Model 8726 (K943709, K912188)

Reference Devices

• Johnson & Johnson Medical, Inc. OBSERVER* Central Station (K933404)

Submission Summary (Full Text)

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K955/13

# 510(k) Summary

AUG 15 1996

## Date

November 7, 1995

## Contact

Annette M. Hillring
Director, Regulatory Affairs
Johnson & Johnson Medical, Inc.
4110 George Road
Tampa, Florida 33634
Telephone: [phone]
Telefax: [phone]

## Device Name

DINAMAP* Select Multi-Parameter System (MPS)

## Common Names

Physiological or Vital Signs Monitor, Patient Monitor
Includes the following monitoring modules:
- Noninvasive Blood Pressure & Heart Rate Monitor
- Invasive Blood Pressure & Heart Rate Monitor
- Endtidal Carbon Dioxide & Respiration Rate Monitor
- Pulse Oximetry & Heart Rate Monitor
- Electrocardiograph (ECG), Respiration Rate, Heart Rate & Temperature Monitor
- Recorder

## Classification

The classification names, 21 Code of Federal Regulations (CFR) Part and Paragraph numbers, and classification of the DINAMAP Select MPS and its modules follow. The tier categorization based on the list (January 27, 1994) distributed by the Office of Device Evaluation is also included.

| Classification Name | 21 CFR § & Class | Tier |
| --- | --- | --- |
| Monitor, Cardiac (including cardiotachometer & rate alarm) | 870.2300 II | 2 |
| Electrocardiograph | 870.2340 II | 2 |
| Adapter, Lead Switching, Electrocardiograph | 870.2350 II | 1 |

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## Classification (continued)

| Classification Name | 21 CFR § & Class | Tier |
| --- | --- | --- |
| Analyzer, Gas, CO2, Gaseous Phase | 868.1400 II | 2 |
| Monitor, Breathing Frequency | 868.2375 II | 2 |
| System, Measurement, Blood Pressure, Noninvasive | 870.1130 II | 2 |
| Computer, Blood Pressure | 870.1110 II | 2 |
| Alarm, Blood Pressure | 870.1100 II | 2 |
| Oximeter | 870.2700 II | 2 |
| Oximeter, Ear | 870.2710 II | 2 |
| Thermometer, Clinical Electronic | 880.2910 II | 2 |
| Recorder, Paper Chart | 870.2810 II | 1 |
| Display, Cathode-Ray Tube, Medical | 870.2450 II | 1 |

## Predicate Devices

The following table summarizes the predicate devices for the MPS and its monitoring parameters/modules and 510(k) numbers:

| Select MPS | Predicate Device & Model | 510(k) Number(s) |
| --- | --- | --- |
| System | Hewlett Packard Component Monitoring System (CMS) HP M1175A & M1176A | K941811
K922058
K910490
K896030 |
| System | Hewlett Packard Omnicare™ Monitor | Unknown |
| System | Marquette Medical Tramscope™ System | K900598 |
| ECG | JJMI DINAMAP PLUS Monitor Models 8710/9710 & 8720/9720 | K943709
K912188 |
| Respiration | Hewlett Packard HP M1002A ECG/Respiration Module for the Hewlett Packard CMS | K941811 |
| Temperature | JJMI DINAMAP PLUS Monitor Models 8700/9700, 8710/9710 & 8720/9720 | K943709
K912188 |
| NIBP | JJMI DINAMAP PLUS Monitor Models 8700/9700, 8710/9710 & 8720/9720 | K943709
K912188 |
| IP | JJMI DINAMAP PLUS Monitor Model 8720/9720 | K943709
K912188 |

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510(k) Summary, Continued

## Predicate Devices (continued)

| Select MPS | Predicate Device & Model | 510(k) Number(s) |
| --- | --- | --- |
| Oximetry | Nellcor® Model N-180 Pulse Oximeter | K913695 |
| CO2 | Novametrix Model 1265 Endtidal CO2 Monitor | K910019 |
| Recorder | JJMI DINAMAP PLUS Monitor Recorder Model 8726 | K943709
K912188 |

## Device Description

The DINAMAP Select Multi Parameter System (MPS) is a prescription device intended for use only by health care professionals. It can be used in hospital and/or outpatient surgery center settings and functions as a patient bedside multiparameter monitoring unit. It is designed for monitoring adult, pediatric and neonatal patients in acute care settings such as critical care, emergency room, radiology, labor and delivery, and operating room. Using this monitoring system, the clinician can view, record and recall clinical data derived from the user-selectable modules/monitoring parameters. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), entidad carbon dioxide (CO2), respiration rate and temperature.

The DINAMAP Select MPS functions as a single-patient monitor or as part of an Ethernet network. Patient data may be viewed in graphical or text form and is stored for twenty-four hours. If the MPS is networked, the user may observe vital signs data from other devices by using the Remote View feature. The MPS is modular and monitors multiple parameters simultaneously. When necessary, the user can temporarily suspend all activity of the monitor while in Standby mode. The MPS consists of the mainframe, modules and monitor (display).

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## Device Description, continued

The mainframe provides a single rack with nine slots for modules. All patient connectors are on the front of the mainframe. All network and device connectors are on the back. The indicators, on the right side of the mainframe, informs the user when the battery is being charged and when the MPS is operating on AC or battery power. The mainframe provides connection for the currently marketed Johnson & Johnson Medical, Inc. (JJMI, formerly Critikon, Inc.) OBSERVER* Central Station (K933404), other monitoring devices, such as the currently marketed Johnson & Johnson Medical, Inc., DINAMAP PLUS Monitors (K943709 & K912188), a remote monitor, a full-page printer, data collection system, remote alarm and/or host information system.

Modules measure patient vital signs and patient airway gases, and provide thermal paper strip records. The MPS accepts two types of modules: parameter modules and recorder modules. Parameter modules process data from transducers to generate waveforms and numeric data on the display screen. The waveforms and parameter measurements on the screen vary according to the modules inserted into the mainframe. The user can continue to monitor a patient with any of the remaining modules while inserting or removing other modules.

Currently, the Select MPS will offer the following modules:

- ECG (3 lead)/Respiration/Heart Rate/Continuous Temperature
- ECG (6 lead)/Respiration/Heart Rate/Continuous Temperature
- Noninvasive Blood Pressure (single wide)/Heart Rate
- Noninvasive Blood Pressure (double wide)/Heart Rate
- Invasive Pressure/Heart Rate
- Pulse Oximetry (Oxygen Saturation)/Heart Rate
- Endtidal Carbon Dioxide/Respiration
- Recorder (double wide)

## Indications

The DINAMAP Select MPS is intended to monitor a single patient’s vital signs at the bedside. The patient populations include adult, pediatric and neonatal. Remote monitoring is available if a network of monitors exists.

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## Technological Characteristics

The DINAMAP Select MPS and its monitoring modules/parameters have the same technological characteristics as the predicate devices. There are no new technological characteristics. The MPS and the predicate devices are all software-driven electronic devices. The MPS monitoring parameters and predicate devices monitoring parameters utilize the following technologies:

- ECG & Heart Rate: Electrocardiography
- Respiration: Thoracic impedance (ECG) and spectroscopy (endtidal CO2)
- Noninvasive Blood Pressure & Heart Rate: Oscillometry
- Invasive Pressure & Heart Rate: Direct measurement with strain-gauge pressure transducer
- Pulse Oximetry & Heart Rate: Nellcor®, Inc., red & infrared spectroscopy
- Endtidal CO2: Novametrix Medical Systems, Inc., infrared spectroscopy
- Recorder: Thermal

## Nonclinical Tests

Several bench studies were conducted which demonstrate safety and effectiveness of the MPS and modules/monitoring parameters:

- ECG & Heart Rate
- Respiration (Impedance)
- Continuous Temperature
- Invasive Pressure
- CO2 & Respiration
- Pulse Oximetry
- Environmental
- Electromagnetic Compatibility

## Clinical Tests

Several clinical studies were conducted which demonstrate safety and effectiveness of the MPS and modules/monitoring parameters:

- Noninvasive Blood Pressure in the adult, pediatric and neonatal populations
- Pulse Oximetry

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# 510(k) Summary, Continued

## Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, Johnson & Johnson Medical concludes that the new device, the DINAMAP Select Multi-Parameter System and modules, is safe, effective and substantially equivalent to the predicate devices as described herein.

## Other Information

Johnson & Johnson Medical will update and include in this summary any other information deemed reasonably necessary by the FDA