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.

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) ●

AI/ML Overview

Here's an analysis of the provided text regarding the DINAMAP Select Multi-Parameter System (MPS) and its acceptance criteria and supporting studies:

Important Note: The provided text is a 510(k) summary from 1995. Medical device regulatory practices and the level of detail required in summaries have evolved significantly since then. This summary provides high-level information but lacks the granular detail often found in more recent submissions concerning acceptance criteria and study methodologies.

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., accuracy percentages, precision ranges) for the DINAMAP Select MPS or its individual modules. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if the new device performs similarly or meets the standards of the predicate, it is acceptable.

However, the summary indicates that "Several bench studies were conducted which demonstrate safety and effectiveness" and "Several clinical studies were conducted which demonstrate safety and effectiveness." These studies implicitly aimed to show the device's performance met an unstated standard, likely mirroring the performance of the predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Parameter/Module	Inferred Acceptance Criterion (Based on Substantial Equivalence to Predicate Devices)	Reported Device Performance (Summary indicates "safety and effectiveness" demonstrated through studies)
ECG & Heart Rate	Performance similar to predicate ECG monitors (K943709, K912188)	Demonstrated safety and effectiveness via bench studies.
Respiration (Impedance)	Performance similar to predicate respiration monitors (K941811)	Demonstrated safety and effectiveness via bench studies.
Continuous Temperature	Performance similar to predicate temperature monitors (K943709, K912188)	Demonstrated safety and effectiveness via bench studies.
Invasive Pressure	Performance similar to predicate invasive pressure monitors (K943709, K912188)	Demonstrated safety and effectiveness via bench studies.
CO2 & Respiration (Endtidal CO2)	Performance similar to predicate CO2 monitors (K910019)	Demonstrated safety and effectiveness via bench and clinical studies.
Pulse Oximetry	Performance similar to predicate pulse oximeters (K913695)	Demonstrated safety and effectiveness via bench and clinical studies.
Noninvasive Blood Pressure (Adult, Pediatric, Neonatal)	Performance similar to predicate NIBP monitors (K943709, K912188)	Demonstrated safety and effectiveness via clinical studies in adult, pediatric, and neonatal populations.
Environmental	Compliance with relevant environmental standards.	Demonstrated safety and effectiveness via bench studies.
Electromagnetic Compatibility	Compliance with relevant EMC standards.	Demonstrated safety and effectiveness via bench studies.

Detailed Study Information:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The summary does not specify the sample sizes for any of the clinical studies. It only states "Several clinical studies were conducted which demonstrate safety and effectiveness," specifically mentioning "Noninvasive Blood Pressure in the adult, pedicatric and neonatal populations" and "Pulse Oximetry."
- Data Provenance: The summary does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission in the US, it's highly probable the studies were conducted in the US. Clinical studies mentioned would typically be prospective to evaluate a new device, but this is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The summary provides no information on the number or qualifications of experts used to establish ground truth for any clinical studies mentioned. For vital signs monitors, ground truth is typically established by well-established reference methods and trained clinical staff, rather than a panel of "experts" in the sense of image interpretation.
Adjudication method for the test set:
- The summary provides no information on any adjudication method. This type of detail is more common in studies involving subjective assessments (e.g., image interpretation) than in objective physiological measurements where ground truth is typically measured directly.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human "readers" (e.g., radiologists interpreting images). Therefore, this question is not applicable to the DINAMAP Select MPS. The concept of "AI assistance" or "human reader improvement" does not apply to this type of medical device as described in the 1995 submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is also not directly applicable in the modern sense of "standalone AI performance." The DINAMAP Select MPS itself is a "standalone" device in the sense that its algorithms process physiological signals and display results without requiring continuous real-time human interpretation of raw data for every output. Its performance, as demonstrated in the bench and clinical studies, is the "algorithm-only" performance as it provides direct numerical and waveform output. The human "in-the-loop" is the healthcare professional using the data for patient care.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Noninvasive Blood Pressure and Pulse Oximetry, ground truth would typically be established using simultaneous measurements from a recognized gold standard invasive method (e.g., arterial line for NIBP in some studies, or co-oximetry for SpO2) or highly accurate non-invasive reference devices, under controlled clinical conditions.
- For other parameters like ECG, Respiration, Temperature, CO2, and Invasive Pressure, the ground truth would similarly involve validated reference equipment and methodologies known for their accuracy in measuring those specific physiological parameters (e.g., precision thermometers, capnographs, direct-reading transducers). The summary does not specify the exact methods.
The sample size for the training set:
- The summary does not mention a training set. This is consistent with the era and the nature of the device. While the device contains algorithms, it's unlikely they used "training sets" in the modern machine learning sense. More likely, algorithms were developed and calibrated by engineering teams using physiologically relevant data from various sources (simulators, animal models, limited human data) which are not detailed in a 510(k) summary.
How the ground truth for the training set was established:
- As no "training set" in the modern sense is mentioned, there is no information on how its ground truth would have been established. Any "ground truth" used for internal algorithm development would have been established through a combination of engineering principles, established physiological models, and data from laboratory or early clinical testing, likely against established reference methods.

Summary

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K955/113

510(k) Summary

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AUG 1 5 1996

Date	November 7, 1995
Contact	Annette M. HillringDirector, Regulatory AffairsJohnson & Johnson Medical, Inc.4110 George RoadTampa, Florida 33634Telephone: (813) 887-2256Telefax: (813) 887-2263
Device Name	DINAMAP* Select Multi-Parameter System (MPS)
CommonNames	Physiological or Vital Signs Monitor, Patient MonitorIncludes 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 andParagraph numbers, and classification of the DINAMAP Select MPS and itsmodules 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 (includingcardiotachometer & 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)

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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

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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 MonitoringSystem (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 Models8710/9710 & 8720/9720	K943709 K912188
Respiration	Hewlett Packard HP M1002A ECG/RespirationModule for the Hewlett Packard CMS	K941811
Temperature	JJMI DINAMAP PLUS Monitor Models8700/9700, 8710/9710 & 8720/9720	K943709 K912188
NIBP	JJMI DINAMAP PLUS Monitor Models8700/9700, 8710/9710 & 8720/9720	K943709 K912188
IP	JJMI DINAMAP PLUS Monitor Model8720/9720	K943709 K912188

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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 RecorderModel 8726	K943709 K912188

Device Description

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Device Description. continued

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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

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TechnologicalCharacteristics	The DINAMAP Select MPS and its monitoring modules/parameters have thesame technological characteristics as the predicate devices. There are no newtechnological characteristics. The MPS and the predicate devices are allsoftware-driven electronic devices. The MPS monitoring parameters andpredicate 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
NonclinicalTests	Several bench studies were conducted which demonstrate safety andeffectiveness 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 andeffectiveness of the MPS and modules/monitoring parameters:Noninvasive Blood Pressure in the adult, pedicatric and neonatal populations Pulse Oximetry Continued on next page

TechnologicalCharacteristics

The DINAMAP Select MPS and its monitoring modules/parameters have thesame technological characteristics as the predicate devices. There are no newtechnological characteristics. The MPS and the predicate devices are allsoftware-driven electronic devices. The MPS monitoring parameters andpredicate 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

NonclinicalTests

Several bench studies were conducted which demonstrate safety andeffectiveness 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 andeffectiveness of the MPS and modules/monitoring parameters:Noninvasive Blood Pressure in the adult, pedicatric and neonatal populations Pulse Oximetry Continued on next page

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Conclusions	In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFRPart 807, and based on the information provided in this premarketnotification, Johnson & Johnson Medical concludes that the new device, theDINAMAP Select Multi-Parameter System and modules, is safe, effectiveand substantially equivalent to the predicate devices as described herein.
OtherInformation	Johnson & Johnson Medical will update and include in this summary anyother information deemed reasonably necessary by the FDA

Regulation Number and Section

§ 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).