K Number
K020022
Device Name
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
Date Cleared
2002-02-01

(29 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities.

No.
The device is intended to monitor vital signs, which is a diagnostic or monitoring function, not a therapeutic one. It does not deliver any treatment or therapy.

No

The device monitors vital signs (blood pressure, pulse rate, temperature, oxygen saturation) and is explicitly described as a "Monitor." It does not mention diagnosing conditions or processing images to aid in diagnosis.

No

The device description explicitly states it is a "portable device" that includes an "integrated printer" and operates from an "external AC mains power source or an internal lead-acid rechargeable battery," indicating it is a hardware device with integrated software.

Based on the provided text, the DINAMAP® Pro Series 110-410 Monitor is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
  • Device Function: The DINAMAP Pro Series 110-410 Monitor measures vital signs directly from the patient (non-invasive blood pressure, pulse rate, temperature, and oxygen saturation). It does not analyze samples taken from the body.
  • Intended Use: The intended use describes monitoring a patient's vital signs at the bedside or during transport. This is a direct physiological measurement, not an in vitro analysis.

Therefore, the device falls under the category of a patient monitoring device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes

DXN, DSK, DSJ, DQA, DPZ, FLL, DSF, MWI

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.

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 or neonatal

Intended User / Care Setting

prescription device intended for use only by health care professionals. 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.

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

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

Key Metrics

Not Found

Predicate Device(s)

K992638

Reference Device(s)

K992238, K955846, K002248

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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 NameProduct Code21 CFR
System, Measurement, Blood Pressure, NoninvasiveDXN870.1130
Computer, Blood PressureDSK870.1110
Alarm, Blood PressureDSJ870.1100
OximeterDQA870.2700
Oximeter, EarDPZ870.2710
Thermometer, Clinical ElectronicFLL880.2910
Recorder, Paper ChartDSF870.2810

D. Predicate/Legally Marketed Devices

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

E. 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.

1

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 110-410Predicate Device & Model510(k) Numbers
MonitorDINAMAP Pro Series 100-400K992638
Pulse OximetryMasimoK992238
TemperatureAlaris Medical SystemK955846
NIBPDINAMAP Pro 1000K002248

Page 2 of 2

2

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.

3

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,

y

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

Enclosure

4

INDICATIONS FOR USE

510(k) Number (if known): K020022

Device Name: DINAMAP® Pro Series 110-410 Monitor

Indications for 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 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.

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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)

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