(26 days)
Not Found
No
The document describes a standard patient monitor with various physiological parameter measurements and analysis features (like arrhythmia, ST analysis, 12-lead ECG analysis), but there is no mention of AI or ML in the device description, intended use, or performance studies. The analysis features mentioned are typical of traditional signal processing and algorithmic approaches, not necessarily AI/ML.
No.
The device is a patient monitor, which is used to monitor, display, and print a patient's basic physiological parameters. It is intended for monitoring and diagnostic purposes, not for providing therapy.
No
This device is a patient monitor, which is used to display, trend, and store physiological data. While monitoring can inform diagnosis, the document states its intended use is to "monitor physiologic parameter data" and does not describe it as making a diagnosis or providing diagnostic conclusions.
No
The device description explicitly states it is a "Patient Monitor" and describes hardware components and functionalities like displaying and printing data, interfacing with peripheral devices, and monitoring various physiological parameters which require hardware sensors and processing units.
Based on the provided information, the DASH 3000/4000/5000 Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring physiologic parameter data on patients. This involves measuring vital signs and other bodily functions directly from the patient.
- Device Description: The description details the monitoring of parameters like ECG, blood pressure, oxygen saturation, temperature, etc., which are all measured in vivo (within the living body).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the DASH 3000/4000/5000 Patient Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The DASH 3000/4000/5000 Patient Monitor 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 3000/4000/5000 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.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.
The DASH 3000/4000/5000 Patient Monitor 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.
The DASH 3000/4000/5000 Patient Monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
Product codes (comma separated list FDA assigned to the subject device)
CCK, FLS, DSI, CAA, BXD, DSJ, DQK, FYW, KFN, BWX, DRT, DQA, MHX, DSB
Device Description
The DASH 3000/4000/5000 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, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. 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
licensed healthcare practitioner; 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 nospitals, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The DASH 3000/4000/5000 Patient Monitor 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 system: Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation. The results of these measurements demonstrated that the DASH 3000/4000/5000 Patient Monitor is as safe, as effective, and performs as well as the predicate devices.
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.
K033304, K012891, K983684, K040183
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
JUN 2 0 2005
pg'12
11051367
510(k) Summary of Safety and Effectiveness
Date: | May 23, 2005 |
---|---|
Submitter: | GE Medical Systems Information Technologies |
8200 West Tower Avenue | |
Milwaukee, WI 53223 USA | |
Contact Person: | Tyler Sedone |
Senior Regulatory Affairs Specialist | |
GE Medical Systems Information Technologies | |
Phone: 813-887-2133 | |
Fax: 813-887-2545 | |
Device: Trade Name: | DASH 3000/4000/5000 Patient Monitor |
Common/Usual Name: | Physiological Patient Monitor |
Classification Names: | |
21 CFR 868.1400 | Analyzer, Gas, Carbon Dioxide, Gaseous-Phase CCK |
21 CFR 868.2375 | Breathing Frequency Monitor FLS |
21 CFR 870.1025 | Detector and Alarm, Arrhythmia DSI |
21 CFR 870.1100 | Monitor, Blood Pressure, Indwelling CAA |
21 CFR 870.1130 | Noninvasive Blood Pressure Measurement System BXD |
21 CFR 870.1100 | Blood Pressure Alarm DSJ |
21 CFR 870.1425 | Programmable Diagnostic Computer DQK |
21 CFR 870.2340 | Electrocardiograph FYW |
21 CFR 870.1435 | Monitor, Cardiac Output, Thermal (Balloon Type Catheter) KFN |
21 CFR 880.2910 | Monitor, Temperature (with probe) BWX |
21 CFR 870.2300 | Monitor, Cardiac (Incl. Cardiotachometer & rate alarm) DRT |
21 CFR 870.2700 | Oximeter, Pulse DQA |
21 CFR 870.1025 | Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) MHX |
21 CFR 870.2770 | Plethysmograph, Impedance DSB |
Predicate Device: K033304 DASH 3000/4000 Patient Monitor
K012891 Neilcor Puritan Bennett N-595 Pulse Oximeter
K983684 Datex Ohmeda SpO2
K040183 Aspect Medical
The DASH 3000/4000/5000 Patient Monitor is a device that is designed Device Description: to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. 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 3000/4000/5000 Patient Monitor 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 3000/4000/5000 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,
GE Medical Systems Information Technologies Confidential
1
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 nospitals, 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, blood pressure, noninvasive blood pressure, pulse, invasive temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.
The DASH 3000/4000/5000 Patient Monitor 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.
The DASH 3000/4000/5000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.
Technology:
The DASH 3000/4000/5000 Patient Monitor employs the same functional technology as the predicate devices.
Test Summary: The DASH 3000/4000/5000 Patient Monitor 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 system:
- ◆ 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 3000/4000/5000 Patient Monitor is as safe, as effective, and performs as well as the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
JUN 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Mr. Tyler Sedone Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K051367
Trade Name: DASH 3000/4000/5000 Patient Monitor Physiological Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-Segment Measurement and Alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: May 23, 2005 Received: May 25, 2005
Dear Mr. Sedone:
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.
3
Page 2 - Mr. Tyler Sedone
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), please contact the Office of Compliance at (240) 276-0295. 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/industry/support/index.html.
Sincerely yours,
Blymmumar, for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 11 Indications For Use
Page 1 of 1
510(k) Number (if known): KOS 1367
DASH 3000/4000/5000 Patient Monitor Device Name:
Indications For Use:
The DASH 3000/4000/5000 Patient Monitor 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 3000/4000/5000 is designed as a bedside, portable, and transport moniter 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, intrahospital 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, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.
The DASH 3000/4000/5000 Patient Monitor 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.
The DASH 3000/4000/5000 Patient Monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Copyrightence of CDRH, Office of Device Evaluation (ODE) College of CDRH, Office of Device Evaluation (ODE) | of the country of the country of the country of the county of the county of the county of the county of the county of the county of the county of the county of the county of | Not another in province of contra consistent from the many of the many | |
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IDAsion Sign-Off Division of Cardlovascular Devices 510fk) Number
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