(198 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard physiological monitoring and calculations.
No
The device is described as a "Patient Monitor" intended to "monitor, display, and print a patient's basic physiological parameters," and does not indicate any therapeutic function.
No
The device is a patient monitor, which measures and displays physiological parameters. While this data can be used to inform diagnosis, the primary function described is monitoring, not diagnosing medical conditions or diseases.
No
The device description explicitly states it is a "Patient Monitor" and describes hardware components and functionalities like displaying, printing, and interfacing with peripheral devices, indicating it is a physical device with integrated software, not software only.
Based on the provided text, the Dash 3000/4000 Patient Monitor is not an In Vitro Diagnostic (IVD) 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 description of the Dash 3000/4000 focuses on monitoring physiological parameters directly from the patient (ECG, blood pressure, temperature, etc.).
- The intended use and device description clearly state that it monitors and displays real-time physiological data from the patient. There is no mention of analyzing samples or specimens.
Therefore, the Dash 3000/4000 Patient Monitor is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Dash 3000/4000 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 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 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-ofcare.
This information can be displayed, trended, stored, and printed.
The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.
Product codes
MHX
Device Description
The Dash 3000/4000 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 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 3000/4000 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 Dash 3000/4000 Patient Monitor:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental testing
The results of these measurements demonstrated that the Dash 3000/4000 Patient Monitor are as safe, as effective, and perform as well as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K001359 Dash 3000/4000 Patient Monitor
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
K 020290
F "/=-
AUG 1 4 2002
Section 2 Summary and Certification
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | January 23, 2002 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Karen Webb |
| Sr. Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 362-3329 | |
| Fax: (414) 918-8114 | |
| Device: Trade Name: | Dash 3000/4000 Patient Monitor |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Names: | 21 CFR 870.1025 Detector and Alarm, Arrhythmia |
| Predicate Devices: | K001359 Dash 3000/4000 Patient Monitor |
| Device Description: | The Dash 3000/4000 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. | |
| Intended Use: | The Dash 3000/4000 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 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 |
1
0700
operator's manual.
.
The Dash 3000/4000 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 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.
Technology:
The Dash 3000/4000 Patient Monitor employs the same functional scientific technology as its predicate devices.
Test Summary:
The Dash 3000/4000 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 Dash 3000/4000 Patient Monitor:
- Risk Analysis ●
- Requirements Reviews ●
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification)
- Final acceptance testing (Validation) .
- . Performance testing
- Safety testing .
- Environmental testing .
Conclusion:
The results of these measurements demonstrated that the Dash 3000/4000 Patient Monitor are as safe, as effective, and perform as well as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
GE Medical Systems Information Technologies c/o Ms. Karen M. Webb Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K020290
Trade Name: Dash 3000/4000 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: May 21, 2002 Received: May 23, 2002
Dear Ms. Webb:
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
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known):
510(k) Number (if known):
Device Name:
Dash 3000/4000 Patient Monitor
Indications for Use:
The Dash 3000/4000 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 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, surqical 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 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-ofcare.
This information can be displayed, trended, stored, and printed.
The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | ____ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off) for Ban Juhur 8/14/92
Division of Cardiovascular
and Respiratory Devices
| 510(k) Number. | K020290 |
|---|---|
| ---------------- | --------- |