(76 days)
Not Found
No
The document describes a vital signs monitor with standard physiological parameter measurements and arrhythmia detection, but there is no mention of AI or ML in the intended use, device description, or any other section. The performance studies listed are standard bench tests for medical devices.
No.
The device is used to monitor vital signs and detect arrhythmias, not to treat any conditions.
No
The device is intended to monitor physiological parameters and detect certain arrhythmias, but it does not provide a diagnosis. It collects data that a clinician can use for assessment.
No
The device description explicitly states it is a "Monitor" and describes hardware components like internal batteries, networking capabilities (VHF, 900 MHz, hardwire), and portability for intra-hospital transport, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, the DINAMAP® Pro 1000 V3 Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the living body.
- DINAMAP Pro 1000 V3 Function: The description clearly states that the DINAMAP Pro 1000 V3 Monitor is intended to monitor vital signs directly from the patient. It uses non-invasive methods like oscillometric blood pressure, pulse oximetry, ECG, and temperature measurement. These are all measurements taken on or from the living patient, not on samples taken from the patient.
The device is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2) by non-invasive pulse oximetry, and predictive temperature with an electronic thermometer in the adult, pediatric and neonate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib). The Pro 1000 V3 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DSK, DSJ, CAA, DQA, DPZ, FLL, DRT, DPS, DRW, DSI, BZQ, DSF, MHX
Device Description
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric, and neonatal. The device's networking capabilities include connection to a central station via VHF, 900 MHz or hardwire communication; host communications for use with other devices. In addition, the DINAMAP Pro 1000 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.
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, and neonate populations.
Intended User / Care Setting
hospital, outpatient surgery and healthcare practitioner facilities.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® PRO 1000 V3 Monitor:
- · Electromagnetic Compatibility
- · Electrical Safety
- · Mechanical and Environmental
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
JUL 16 2003
K031376
p. 112
SUMMARY OF SAFETY AND EFFECTIVENESS
April 29, 2003
DINAMAP® PRO 1000 V3 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. Device Name
Trade Name: PRO 1000 V3 Monitor Common Name: Physiological Monitor, Patient Monitor
Classification/Device Product Code:
| 21 CFR 870.1130 | System, Measurement, Blood Pressure, Noninvasive | DXN |
|---|---|---|
| 21 CFR 870.1110 | Computer, Blood Pressure | DSK |
| 21 CFR 870.1100 | Alarm, Blood Pressure | DSJ |
| 21 CFR 870.1100 | Monitor, Blood Pressure, Indwelling | CAA |
| 21 CFR 870.2700 | Oximeter | DQA |
| 21 CFR 870.2710 | Oximeter, Ear | DPZ |
| 21 CFR 880.2910 | Thermometer, Clinical Electronic | FLL |
| 21 CFR 870.2300 | Monitor, Cardiac (including cardiotachometer & rate alarm) | DRT |
| 21 CFR 870.2340 | Electrocardiograph | DPS |
| 21 CFR 870.2350 | Adapter, Lead Switching, Electrocardiograph | DRW |
| 21 CFR 870.1025 | Arrhythmia Detection and Alarm | DSI |
| 21 CFR 868.2375 | Monitor, Breathing Frequency | BZQ |
| 21 CFR 870.1025 | Recorder, Paper Chart | DSF |
D. Predicate/Legally Marketed Devices
DINAMAP® PRO 1000 V2 - K012915 GE Medical Systems Information Technologies
E. Device Description
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric, and neonatal. The device's networking capabilities include connection to a central station via VHF, 900 MHz or hardwire communication; host communications for use with other devices. In addition, the DINAMAP Pro 1000 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.
1
F. Intended Use
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2) by non-invasive pulse oximetry, and predictive temperature with an electronic thermometer in the adult, pediatric and neonate populations. The Pro 1000 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
G. Technological Characteristics
The DINAMAP® PRO 1000 V3 Monitor has the same technological characteristics as the predicate device, the DINAMAP® PRO 1000 V2 Monitor. There are no new technologies used on the DINAMAP® PRO 1000 V3 Monitor.
H. Testing
Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® PRO 1000 V3 Monitor:
- · Electromagnetic Compatibility
- · Electrical Safety
- · Mechanical and Environmental
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or eagle with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 2003
GE Medical Systems Information Technologies c/o Ms. Melissa Robinson Regulatory Affairs Specialist 4502 Woodland Corporate Boulevard Tampa, FL 33614
Re: K031376
Trade Name: PRO 1000 V3 Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: June 12, 2003 Received: June 17, 2003
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.
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
3
Page 2 – Ms. Melissa Robinson
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: DINAMAP® PRO 1000 V3 Monitor
Indications for Use:
The DINAMAP® Pro 1000 V3 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO2) by non-invasive pulse oximetry, and predictive temperature with an electronic thermometer in the adult, pediatric and neonate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib). The Pro 1000 V3 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Cardiovascular Devices
Division of Cardiovascular Devices
510(k) Number K03376