The DINAMAP® Pro Series 110-410 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

Device Description

The DINAMAP Pro Series 110-410 Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:

DINAMAP 110: Non-Invasive Blood Pressure and Pulse Rate
DINAMAP 210: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
DINAMAP 310M: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry
DINAMAP 410M: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry . and Temperature.
This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the DINAMAP® Pro Series 110-410 Monitor. This document is primarily focused on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a clinical study with acceptance criteria and device performance as typically expected for complex AI/ML devices.

However, based on the information provided, here's what can be extracted and what is NOT available:

1. A table of acceptance criteria and the reported device performance

The document mentions several "bench studies" for safety and effectiveness, but it doesn't provide specific acceptance criteria values or the quantitative results of these tests for the DINAMAP Pro Series 110-410 Monitor itself. Instead, it relies on the substantial equivalence to predicate devices and the transfer of existing, proven technologies.

Parameter	Acceptance Criteria	Reported Device Performance
Non-Invasive Blood Pressure (NIBP)	Not explicitly stated for this device.	NIBP ASAP algorithm wholly implemented from the DINAMAP Pro 1000 Monitor. (Implies performance is consistent with K002248 predicate).
Temperature	Not explicitly stated for this device.	Wholly implemented Alaris IVAC Turbo thermometry technology. (Implies performance is consistent with K955846 predicate).
Pulse Oximetry (SpO2)	Not explicitly stated for this device.	Wholly implemented Masimo SpO2 SET technology. (Implies performance is consistent with K992238 predicate).
Mechanical and Environmental	Not explicitly stated (standard compliance).	Bench studies conducted.
Electromagnetic Compatibility	Not explicitly stated (standard compliance).	Bench studies conducted.
Electrical Safety	Not explicitly stated (standard compliance).	Bench studies conducted.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document primarily refers to "bench studies" and "wholly implemented" technologies from predicate devices. There is no mention of a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no description of a clinical study involving experts establishing ground truth. The device is a physiological monitor, where the "ground truth" for its measurements (e.g., blood pressure, temperature, SpO2) would typically be established through comparison with a reference standard (e.g., invasive blood pressure, rectal thermometer, co-oximetry), not via expert consensus on an image or diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. There is no description of a test set requiring adjudication.

5. 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

This is not applicable to this device. The DINAMAP® Pro Series 110-410 Monitor is a vital signs monitor, not a diagnostic imaging device that involves human readers or AI assistance in interpretation. The "AI" mentioned in the input query is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a standalone vital signs monitor. Its "performance" is its ability to accurately measure physiological parameters. The document states that the NIBP ASAP algorithm, Alaris IVAC Turbo thermometry, and Masimo SpO2 SET technologies were "wholly implemented" from predicate devices. This implies that the algorithms, as part of the integrated system, operate without human-in-the-loop performance for the measurement itself, though healthcare professionals interpret and act on the displayed values. However, no specific standalone performance study results for these specific integrated components of the 110-410 monitor are provided beyond the statement of implementation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the underlying technologies (NIBP, temperature, SpO2), the ground truth would typically be established by a universally accepted reference standard for each parameter (e.g., arterial catheter for NIBP, highly accurate thermometer for temperature, co-oximeter for SpO2). However, this document does not describe how the ground truth was established for the development or validation of the implemented technologies for the 110-410 monitor, as it relies on the predicate devices' prior approvals.

8. The sample size for the training set

This information is not provided. The document makes no mention of a training set as it describes the integration of existing, proven technologies rather than the development of entirely new algorithms for this specific device.

9. How the ground truth for the training set was established

This information is not provided, as there is no mention of a training set.

In summary, the provided document is a regulatory submission for a vital signs monitor based on substantial equivalence. It describes the integration of existing, proven technologies but does not detail the specific performance studies, acceptance criteria, or ground truth establishment processes for these technologies as applied to the new device, instead leveraging the prior approvals of the predicate devices.

Summary

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KO20022

FEB 01 2002

SUMMARY OF SAFETY AND EFFECTIVENESS Dec 31 ,2001

DINAMAP® Pro Series 110-410 Monitor

A. Submitter

GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614

B. Company Contact

Thomas J English Director, Regulatory Affairs Phone: 813-887-2107 Fax: 813-887-2413

C. Common Name

Physiological or Vital Signs Monitor, Patient Monitor

Classification Name	Product Code	21 CFR
System, Measurement, Blood Pressure, Noninvasive	DXN	870.1130
Computer, Blood Pressure	DSK	870.1110
Alarm, Blood Pressure	DSJ	870.1100
Oximeter	DQA	870.2700
Oximeter, Ear	DPZ	870.2710
Thermometer, Clinical Electronic	FLL	880.2910
Recorder, Paper Chart	DSF	870.2810

D. Predicate/Legally Marketed Devices

DINAMAP® Pro Series Monitor 100-400-K992638 Critikon Company, LLC

E. Device Description

DINAMAP 110: Non-Invasive Blood Pressure and Pulse Rate
DINAMAP 210: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
DINAMAP 310M: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry
DINAMAP 410M: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry . and Temperature.

This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

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K020022
P.2/2

F. Intended Use

The DINAMAP® Pro Series 110-410 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

G. Technological Characteristics

The DINAMAP® Pro Series 110-410 Monitor has the same technological characteristics as the predicate device, the DINAMAP® Pro Series 100-400 Monitor. There are no new technologies used on the DINAMAP® Pro Series 110-410 Monitor.

H. Parameter Technology

The DINAMAP® Pro Series 110-410 Monitor has the following parameter technologies:

•NIBP ASAP algorithm wholly implemented from the DINAMAP Pro 1000 Monitor

· Wholly implemented Alaris IVAC Turbo thermometry technology
· Wholly implemented Masimo SpO2 SET technology

I. Testing

Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® Pro Series 110-410 Monitor:

· Mechanical and Environmental
· Electromagnetic Compatibility
· Electrical Safety

K. Substantial Equivalence

Pro Series 110-410	Predicate Device & Model	510(k) Numbers
Monitor	DINAMAP Pro Series 100-400	K992638
Pulse Oximetry	Masimo	K992238
Temperature	Alaris Medical System	K955846
NIBP	DINAMAP Pro 1000	K002248

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Thomas English Director, Regulatory Affairs GE Medical Systems Information Technologies 4502 Woodland Corporate Blvd. Tampa, FL 33614

Re: K020022

Trade Name: DINAMAP® Pro Series 110-410 Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: December 31, 2001 Received: January 3, 2002

Dear Mr. English:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section - Forty promation is substantially equivalent (for the indications felerenced above and nave determined the asketed predicate devices marketed in interstate for use stated in the encrosule, to regally manative personal perice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recarsined in accerdance what a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require approvial of the general controls provisions of the Act. The You may, therefore, market me devreet, belyer to the or general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (see above) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Entisang may - " " " " oc found in the Oous overning your device in the Federal Register.

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Page 2 - Mr. Thomas English

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K020022

Device Name: DINAMAP® Pro Series 110-410 Monitor

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The Counter Use Prescription Use (per 21 CFR 801.109 (Optional Format 1-2-96)

00009

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).