(16 days)
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No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities.
No
The device is described as a monitor intended to measure vital signs, which makes it a diagnostic device, not a therapeutic one. It does not provide any treatment or therapy.
Yes
Explanation: The device monitors vital signs parameters (non-invasive blood pressure, pulse rate, temperature, oxygen saturation) to assess a patient's physiological state, which is a diagnostic function.
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 information, the DINAMAP® Pro Series 110N-410N Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The DINAMAP monitor directly measures vital signs on the patient (non-invasive blood pressure, pulse rate, temperature, oxygen saturation). It does not analyze samples taken from the body.
- The intended use and device description clearly state that it monitors vital signs of a patient at the bedside or during transport. This is a direct physiological measurement, not an in vitro analysis.
Therefore, the DINAMAP Pro Series 110N-410N Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
DXN, DSK, DSJ, DQA, DPZ, FLL, DSF, MWI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult, pediatric or neonatal
Intended User / Care Setting
health care professionals. 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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 DINAMAP® Pro Series 110N-410N Monitor:
· Electromagnetic Compatibility
· Electrical Safety
· Mechanical and Environmental
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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
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.
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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:
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.
(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
OR
Over-The Counter Use (Optional Format 1-2-96)