The DINAMAP® Pro Series 110N-410N 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 110N-410N 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 110N: Non-Invasive Blood Pressure and Pulse Rate ●
DINAMAP 210N: Non-Invasive Blood Pressure and Pulse Rate, Temperature ●
DINAMAP 310N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry ●
DINAMAP 410N: 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 text describes a medical device, the DINAMAP® Pro Series 110N-410N Monitor, and its regulatory submission (510(k)). However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets said criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices in the US. While it mentions "Several bench studies were conducted which demonstrate safety and effectiveness," these are listed generally (Electromagnetic Compatibility, Electrical Safety, Mechanical and Environmental) and no performance metrics or acceptance criteria for these studies are provided.

Therefore, I cannot directly answer your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, ground truth establishment, or clinical study specifics like MRMC analysis or standalone performance.

Here's a breakdown of what cannot be extracted from the provided text based on your request:

Table of acceptance criteria and reported device performance: Not present. The document states the device has the "same technological characteristics" as the predicate but doesn't list specific performance thresholds or how the new device measured against them.
Sample size used for the test set and data provenance: Not present. The document only mentions "bench studies" without specifying test sets or data origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No information about ground truth establishment is included for the "bench studies."
Adjudication method for the test set: Not present.
Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned. The document describes a device for vital sign monitoring, not image analysis or diagnostic support where MRMC studies are typically conducted.
Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated. The device is a monitor, implying continuous measurement. Its performance isn't described in terms of an "algorithm only" without human interaction.
The type of ground truth used: Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

In summary, the provided document serves as a regulatory submission emphasizing technological equivalence. It does not contain the detailed study information regarding acceptance criteria and performance metrics that your request seeks. This type of information would typically be found in detailed engineering reports, clinical validation studies, or specific performance standards documents, which are not part of this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are decorative swirls or flourishes around the letters and the outer edge of the circle. The logo is black and white.

Image /page/0/Picture/2 description: The image shows the text "KC21435 page 1 of 2" written in black ink on a white background. The text appears to be handwritten. The phrase "page 1 of 2" indicates that this is the first page of a two-page document. The text "KC21435" could be a reference number or code.

GE Medical Systems Information Technologies

General Electric Company 4502 Woodland Corporate Blvd., Tampa, FL 33614 813 887-2000

SUMMARY OF SAFETY AND EFFECTIVENESS

May 3, 2002

DINAMAP® Pro Series 110N-410N Monitor

A. Submitter

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

B. Company Contact

Melissa Robinson Regulatory Affairs Specialist Phone: 813-887-2133 Fax: 813-887-2552

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 110-410-K020022 GE Medical Systems Information Technologies

E. Device Description

DINAMAP 110N: Non-Invasive Blood Pressure and Pulse Rate ●
DINAMAP 210N: Non-Invasive Blood Pressure and Pulse Rate, Temperature ●
DINAMAP 310N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry ●
DINAMAP 410N: 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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F. Intended Use

The DINAMAP® Pro Series 110N-410N 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, transport: "Than tiglis 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 110N-410N Monitor has the same technological characteristics as the predicate device, the DINAMAP® Pro Series 110-410 Monitor. There are no new technologies used on the DINAMAP® Pro Series 110N-410N Monitor.

H. Parameter Technology

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

·NIBP ASAP algorithm as implemented on the Pro Series 110-410

· Alaris IVAC Turbo thermometry technology as implemented on the Pro Series 110-410
· Wholly implemented Nellcor N-595 SpO2 technology

I. Testing

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

· Electromagnetic Compatibility
· Electrical Safety
· Mechanical and Environmental

K. Substantial Equivalence

Pro Series 110N-410N	Predicate Device & Model	510(k) Numbers
Monitor	DINAMAP Pro Series 110-410	K020022
Pulse Oximetry	Nellcor N-595 Pulse Oximeter	K012891
Temperature	Alaris Medical System	K955846
NIBP	DINAMAP Pro Series 110-410	K020022

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2002

Ms. Melissa Robinson Regulatory Affairs Specialist GE Medical Systems Information Technologies 4502 Woodland Corporate Blvd. Tampa, FL 33614

Re: K021435

Trade Name: DINAMAP® Pro Series 110N-410N Monitor Regulation Number: 21 CFR 870.2300 and 870.2700 Regulation Name: Cardiac Monitor and Oximeter Regulatory Class: Class II (two) Product Code: MWI and DQA Dated: May 2, 2002 Received: May 6, 2002

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Melissa Robinson

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,

Kenta Tuller

Donna-Bea Tillman, Ph.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 US

K021435 510(k) Number (if known):

Device Name: DINAMAP® Pro Series 110N-410N Monitor

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021435

Prescription Use (per 21 CFR 801.109

Over-The Counter Use (Optional Format 1-2-96)

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).