(203 days)
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No
The document describes standard vital sign monitoring and arrhythmia detection using a validated algorithm, with no mention of AI or ML technologies.
No
The device is a monitor that measures, displays, records, and recalls vital signs data; it does not provide any therapeutic intervention.
Yes
The device is intended to monitor various physiological parameters and includes an additional feature for the detection of three lethal arrhythmias, which implies the identification of specific medical conditions based on the collected data. This function goes beyond mere measurement and involves the analysis of data to identify a specific medical state.
No
The device description explicitly states it is a "Monitor" and describes hardware components like internal batteries and networking capabilities (VHF, 900 MHz, hardwire communication), indicating it is a physical device with integrated software, not software-only.
Based on the provided text, the DINAMAP® Pro 1000 V2 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 treatment.
- The DINAMAP® Pro 1000 V2 Monitor directly monitors physiological parameters of a living patient (blood pressure, heart rate, respiration, ECG, SpO2, temperature). It does not analyze samples taken from the patient.
The description clearly indicates it's a patient monitoring device used in a clinical setting to gather real-time vital signs from the patient's body.
N/A
Intended Use / Indications for Use
The DINAMAP® Pro 1000 V2 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO22) by non-invasive nears pulse rate, respirative temperature with an electronic thermometer in the pulse onlinery, and pronate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular thece tethal arrifyininde "tay store, "onitor 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, DQA, DPZ, FLL, DRT, DPS, DRW, DSI, BZQ, DSF, MHX
Device Description
The DNAMAP® Pro 1000 V2 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 V2 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.
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 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
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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)
A software validation was performed to demonstrate the implementation of the arrhythmia detection feature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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1/2
MAR 2 1 2002
General Electric Company 4502 Woodland Corporate Blvd., Tampa, FL 33614 813 887-2000
SUMMARY OF SAFETY AND EFFECTIVENESS
DINAMAP® Pro 1000 V2 Monitor
August 28, 2001
A. Submitter
GE Medical Systems Information Technologies. 4502 Woodland Corporate Boulevard Tampa, FL 33614
B. Company Contact
Thomas J English, Director, Regulatory and Quality Affairs Phone: 813-887-2107 Fax: 813-887-2413
C. Device Name
| Trade Name: | Pro 1000 V2 Monitor |
|---|---|
| Common Name: | Physiological Monitor, Patient Monitor |
| Classification/Device Product Code: |
System, Measurement, Blood Pressure, Noninvasive-870.1130-DXN Computer, Blood Pressure-870.1110-DSK Alarm, Blood Pressure-870.1100-DSJ Oximeter-870.2700-DQA Oximeter, Ear-870.2710-DPZ Thermometer, Clinical Electronic-880.2910-FLL Monitor, Cardiac (including cardiotachometer & rate alarm)-870.2300-DRT Electrocardiograph-870.2340-DPS Adapter, Lead Switching, Electrocardiograph-870.2350-DRW Arrhythmia Detection and Alarm-870.1025-DSI Monitor, Breathing Frequency-868.2375-BZQ
Recorder, Paper Chart-870.2810-DSF
D. Predicate/Legally Marketed Devices
DINAMAP® Pro 1000 Monitor, K002248 Critikon Company LLC
1
E. Device Description
The DNAMAP® Pro 1000 V2 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 V2 Monitor may be operated from internal batteries making the device portable and suitable for intra-hospital transport.
F. Intended Use
The DINAMAP® Pro 1000 V2 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 V2 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 V2 Monitor has the same technological characteristics as the predicate device, the DINAMAP® Pro 1000 Monitor. There are no new technological characteristics. The Pro 1000 Monitor and the Pro 1000 V2 Monitor are both software-driven electronic devices that include the same monitoring parameters.
H. Testing
The Pro 1000 V2 Monitor complies with the same regulatory standards as the Pro 1000 predicate device. A software validation was performed to demonstrate the implementation of the arrhythmia detection feature.
I. Conclusion
The DINAMAP® Pro 1000 V2 Monitor is substantially equivalent to the currently marketed DINAMAP® Pro 1000 Monitor, K002248 cleared on 9/21/00 and the EkPro ECG algorithm in the DASH 3000/4000 Patient Monitor, K001359 cleared on 7/18/00.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized image of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2002
Mr. Thomas J. English Director, Regulatory and Quality Affairs GE Medical Systems Information Technologies 4502 Woodland Corporate Blvd. Tampa, FL 33614
Re: K012915
Trade Name: DINAMAP® Pro 1000 V2 Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: December 18, 2001 Received: December 21, 2001
Dear Mr. English:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor to May 28, 1976, the enactment date of the Medical Device Amendments, or to Commerce prior to Milly 20, 1976, are excordance with the provisions of the Federal Food, Drug, de rices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, mains of the Act include requirements for annual registration, listing of general controll profiterials of ractice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to been awares 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 - Mr. Thomas J. 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,
K Denlon Telleh
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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Page 1 of 1.
August 24, 2001
510(K) Number (if known): K012915
Device Name: DINAMAP® Pro 1000 V2 Monitor
Indications for Use:
The DINAMAP® Pro 1000 V2 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO22) by non-invasive nears pulse rate, respirative temperature with an electronic thermometer in the pulse onlinery, and pronate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular thece tethal arrifyininde "tay store, "onitor 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 : $\checkmark$
or
Over-The Counter Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K082915
(Optional Format 1-2-96)