(16 days)
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, interhospital 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-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.
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.
This document describes a 510(k) submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a clinical study for a novel AI algorithm. Therefore, many of the requested points, particularly those related to detailed study design, ground truth establishment, expert review, sample sizes for training/test sets, and comparative effectiveness studies with AI, are not applicable or cannot be extracted from this type of regulatory submission.
The submission primarily states that the device is "as safe, as effective, and performs as well as the predicate devices" based on compliance with voluntary standards and internal quality assurance measures.
Here's an attempt to answer the questions based on the provided text, noting where information is not available:
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with voluntary standards (as detailed in Section 9) | The device complies with voluntary standards. |
| Safety (as compared to predicate devices) | The device is "as safe" as predicate devices. |
| Effectiveness (as compared to predicate devices) | The device is "as effective" as predicate devices. |
| Performance (as compared to predicate devices) | The device "performs as well as" predicate devices. |
| Physiological Parameter Monitoring | Capable of monitoring ECG, invasive BP, NIBP, SpO2, Temp, Respiration, End-tidal CO2, O2, N2O, anesthetic agents, arrhythmia, cardiac output, ST analysis, and interpretive 12 lead ECG analysis. |
| Functionality (e.g., display, trend, store, print data, network) | Intended to monitor, display, and print data; provide data over Unity network for clinical information systems and access hospital data at point of care. |
| Interface with third-party peripheral devices | Developed to interface with non-proprietary third-party peripheral devices that support serial data outputs. |
| Intended Use | Intended for adult, pediatric, and neonatal patients in various professional medical facilities and transport modes. |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The document states "The Dash 3000/4000 Patient Monitor complies with the voluntary standards as detailed in Section 9 of this submission" and lists quality assurance measures, which would typically involve testing, but no details on specific test sets or study types (e.g., patient data, simulated data) are provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a traditional medical device (patient monitor) regulatory submission based on substantial equivalence to predicate devices and compliance with performance standards, not a specific AI/machine learning algorithm requiring expert-established ground truth for a test set in the same manner.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the reasons stated above.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The device is a physiological patient monitor, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device; it's a patient monitor system. Its performance is inherent to the system's design and functionality in monitoring physiological parameters.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in terms of a "ground truth" as it would be for an AI diagnostic device. The "ground truth" for a patient monitor's accuracy would typically be established through validation against validated reference devices or established physiological measurement standards during product testing, as implied by "compliance with voluntary standards" and "safety testing."
-
The sample size for the training set
- Not applicable. This is not an AI/machine learning device that involves a "training set" in the conventional sense.
-
How the ground truth for the training set was established
- Not applicable for the reasons stated above.
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FEB 26 2003
510(k) Summary of Safety and Effectiveness
| Date: | February 7, 2003 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Karen M. LundeSr. Regulatory Affairs SpecialistGE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USAPhone: 414-362-3329Fax: 414-918-8114 |
| Device: | Trade Name: Dash 3000/4000 Patient Monitor |
| Common/Usual Name: | Physiological 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 |
| 21 CFR 870.1025 | Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) |
| 21 CFR 870.2770 | Plethysmograph, Impedance |
atient Monito 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).
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
Additionally, the network interface allows for the display and transfer of
GE Medical Systems Information Technologies Confidential
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K030431
page 2 of 2
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 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 technology as the 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 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 Patient Monitor is as safe, as effective, and performs as well as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Karen M. Lunde Sr. Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K030431
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: February 7. 2003 Received: February 10, 2003
Dear Ms. Lunde:
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. Iisting 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.
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Page 2 - Ms. Karen M. Lunde
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 (OS) 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,
N. O'Dell Miller, M.D.
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):
510(k) filed on February 7, 2003
Dash 3000/4000 Patient Monitor Device Name:
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, interhospital 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-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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K05043/
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__
(Optional Format 1-2-96)
§ 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.