(87 days)
Not Found
No
The document describes a standard patient monitoring system with features like arrhythmia detection and ECG analysis, but there is no mention of AI or ML in the intended use, device description, or performance studies. The "interpretive 12 lead ECG analysis (12SL)" is a common feature in patient monitors and does not inherently imply the use of AI/ML.
No
The device is a monitoring system that measures and displays physiologic parameters, but it does not treat or alleviate a medical condition.
No
Explanation: The document explicitly states the system "is intended to monitor physiologic parameter data" and "monitor, display, and print a patient's basic physiological parameters." While devices that monitor can sometimes be used to inform a diagnosis, the primary stated purpose here is monitoring, not diagnosing. A diagnostic device would explicitly state its purpose as aiding in the diagnosis of a disease or condition.
No
The device description explicitly states it is a "Patient Monitor" and describes hardware components like display and printing capabilities, as well as mentions "Software and hardware testing". This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, the Dash 3000 Patient Monitoring System is not an IVD (In Vitro Diagnostic) device.
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.
- Dash 3000 Function: The Dash 3000 monitors physiologic parameters directly from the patient's body (ECG, blood pressure, temperature, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states monitoring physiologic parameter data on adult, pediatric and neonatal patients.
- Device Description: The description reinforces that it monitors, displays, and prints a patient's basic physiological parameters.
Therefore, the Dash 3000 is a patient monitoring system that measures physiological signals directly from the patient, not an in vitro diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL).
The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.
This information can be displayed, trended, stored, and printed.
Product codes
MHK
Device Description
The Dash 3000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, noninvasive blood pressure, oxygen saturation, temperature, impedance respiration, and end-tidal carbon dioxide. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.
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 neonatal patients.
Intended User / Care Setting
under the direct supervision of a licensed healthcare practitioner.
The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.
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
The Dash 3000 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Dash 3000:
- . Requirements specification review
- . Code inspections
- Software and hardware testing ●
- . Safety testing
- . Environmental testing
- Final validation .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 2 6 1999
510(k) Summary of Safety and Effectiveness
Date:
Submitter:
August 24, 1999
GE Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223 USA
Contact Person:
David Wahlig Sr. Regulatory Affairs Specialist GE Marquette Medical Systems Phone: (414) 362-2090 Fax: (414) 355-3790
Device: Trade Name:
Dash 3000 patient Monitor Common/Usual Name:
Patient monitor
Classification Names:
21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
21 CFR 868.2375 Breathing Frequency Monitor
21 CFR 870.1025 Detector and Alarm, Arrhythmia
21 CFR 870.1100 Monitor, Blood Pressure, Indwelling
21 CFR 870.1130 Noninvasive Blood Pressure Measurement System
21 CFR 870.1100 Blood Pressure Alarm
21 CFR 870.1425 Programmable Diagnostic Computer
21 CFR 870.2340 Electrocardiograph
21 CFR 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter)
21 CFR 880.2910 Monitor, Temperature (with probe)
21 CFR 870.2300 Monitor, Cardiac (Incl. Cardiotachometer & rate alarm)
21 CFR 870.2700 Oximeter, Pulse
Predicate Devices:
K964750 Eagle 4000 Patient Monitor
K921669 Marquette SL Series Transport Remote Acquisition Module
Device Description:
The Dash 3000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, noninvasive blood pressure, oxygen saturation, temperature, impedance respiration, and end-tidal carbon dioxide. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data. Intended Use:
The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional
1
medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual.
The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.
This information can be displayed, trended, stored, and printed.
Technology:
The Dash 3000 employs the same functional technology as the predicate devices.
Test Summary:
The Dash 3000 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Dash 3000:
- . Requirements specification review
- . Code inspections
- Software and hardware testing ●
- . Safety testing
- . Environmental testing
- Final validation .
Conclusion:
The results of these measurements demonstrated that the Dash 3000 is as safe, as effective, and performs as well as the predicate devices.
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 stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1999
Mr. David Wahliq Corporate Regulatory Affairs GE Marquette Medical Systems 8200 W. Tower Ave. Milwaukee, WI 53223
K992929 Re: Dash 3000 Patient Monitor Regulatory Class: III (three) Product Code: MHK August 24, 1999 Dated: Received: August 31, 1999
Dear Mr. Wahlig:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2 - Mr. David Wahlig
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its t.oll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
A.H. Cordons L.
J. Celia M. Witten, Ph.D., M.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Unknown: 510(k) filed on August 24, 1999
Device Name: Dash 3000 Patient Monitor
Indications For Use:
The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL).
The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.
This information can be displayed, trended, stored, and printed.
(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)
A.H.A. Lackland.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_K992929