(281 days)
No
The summary describes a standard multi-parameter patient monitoring system with modular components for measuring vital signs. There is no mention of AI, ML, or any advanced data processing beyond basic display, recording, and networking of physiological data.
No
The device is described as a "patient bedside multiparameter monitoring unit" intended to "monitor a single patient's vital signs." It collects and displays clinical data such as heart rate, ECG waveforms, SpO2, and blood pressure. Monitoring vital signs is used for diagnostic purposes, not for treating a condition, disease, or injury.
No
Explanation: The device is described as a "patient bedside multiparameter monitoring unit" intended to "monitor a single patient's vital signs." While it displays clinical data, its primary function is monitoring, not diagnosing conditions.
No
The device description explicitly details hardware components including a mainframe, modules, and a monitor (display), which are essential for its function as a patient bedside multiparameter monitoring unit.
Based on the provided text, the DINAMAP Select MPS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "monitor a single patient's vital signs at the bedside." This involves directly measuring physiological parameters from the patient's body (ECG, blood pressure, oxygen saturation, etc.).
- Device Description: The description details how the device functions as a "patient bedside multiparameter monitoring unit" and measures "patient vital signs and patient airway gases."
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are specifically designed for this purpose.
The DINAMAP Select MPS is a patient monitoring device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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), entidal carbon dioxide (CO2), respiration rate and temperature.
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.
Product codes (comma separated list FDA assigned to the subject device)
870.2300, 870.2340, 870.2350, 868.1400, 868.2375, 870.1130, 870.1100, 870.2700, 870.2710, 880.2910, 870.2810
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), entidal 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).
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) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric and neonatal
Intended User / Care Setting
Health care professionals. Hospital and/or outpatient surgery center settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Several clinical studies were conducted which demonstrate safety and effectiveness of the MPS and modules/monitoring parameters: Noninvasive Blood Pressure in the adult, pedicatric and neonatal populations Pulse Oximetry
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K941811, K922058, K910490, K896030, K900598, K943709, K912188, K913695, K910019
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
K955/113
510(k) Summary
)
ﻤﺴﺘﻌﻤﺎ
AUG 1 5 1996
| Date | November 7, 1995 |
|---|---|
| Contact | Annette M. Hillring |
| Director, Regulatory Affairs | |
| Johnson & Johnson Medical, Inc. | |
| 4110 George Road | |
| Tampa, Florida 33634 | |
| Telephone: (813) 887-2256 | |
| Telefax: (813) 887-2263 | |
| 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 MonitorInvasive Blood Pressure & Heart Rate MonitorEndtidal Carbon Dioxide & Respiration Rate MonitorPulse Oximetry & Heart Rate MonitorElectrocardiograph (ECG), Respiration Rate, Heart Rate & Temperature MonitorRecorder | |
| 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 |
| Continued on next page |
1
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 |
| 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 |
Predicate Devices
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
ﻤﻤﻌﻠﻘﺔ
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 |
Continued on next page
2
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), entidal 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).
Continued on next page
43
3
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
ﭙ
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.
Continued on next page
4
)
ﺮ
| 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, pedicatric and neonatal populations Pulse Oximetry Continued on next page |
5
)
)
:
!
| 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 |