(26 days)
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.
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.
The provided text is a 510(k) summary for the GE Medical Systems Information Technologies DASH 3000/4000/5000 Patient Monitor. It focuses on demonstrating substantial equivalence to predicate devices and detailing the monitor's intended use and functionality.
However, the summary does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in detailed performance studies. It primarily states that the device "complies with the voluntary standards as detailed in Section 9 of this submission" (which is not provided in the extract) and that "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."
Therefore, I cannot populate the requested table and answer the study-specific questions based solely on the provided text. The submission itself likely contained the detailed test results and acceptance criteria, but they are not included in this summary.
Based on the provided text, here’s what can be inferred and what is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states "The DASH 3000/4000/5000 Patient Monitor complies with the voluntary standards as detailed in Section 9 of this submission." Section 9, which would contain the details of these standards, specific acceptance criteria, and specific performance results, is not included.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. The document mentions general "Software and hardware testing," "Safety testing," and "Environmental testing" but does not detail the methodology, sample sizes, or data provenance of these tests as they pertain to specific performance metrics.
3. 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):
This information is not provided. The device is a physiological patient monitor, and its performance would typically be evaluated against established physiological measurement standards, not by expert interpretation in the way an imaging device might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
5. 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:
This information is not provided. MRMC studies are typically for diagnostic imaging devices where human interpretation is a key component, and AI assistance can augment that. This device is a physiological monitor, not an AI-assisted diagnostic tool in the sense of image analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided explicitly, but as a physiological monitor, its primary function is standalone measurement and display of parameters. The tests mentioned (software, hardware, safety, environmental) suggest standalone performance was evaluated, but details are lacking.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated, but for physiological monitors, the ground truth would typically be established by comparison to highly accurate reference instruments or established clinical methodologies for each physiological parameter (e.g., a known pressure source for BP accuracy, a calibrated gas analyzer for CO2 measurement, ECG simulation for arrhythmia detection).
8. The sample size for the training set:
This information is not provided. The document describes the system development process ("Requirements specification review," "Code inspections," "Software and hardware testing," etc.) but doesn't mention a "training set" in the context of an AI/machine learning model. This indicates the device likely uses established algorithms and signal processing techniques rather than a machine learning approach that requires a separate training set for model development.
9. How the ground truth for the training set was established:
This information is not provided, as a "training set" in the context of machine learning is not mentioned or implied for this device's development as described.
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JUN 2 0 2005
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11051367
510(k) Summary of Safety and Effectiveness
| Date: | May 23, 2005 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Tyler SedoneSenior Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 813-887-2133Fax: 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
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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.
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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.
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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
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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 | |
|---|---|---|---|
IDAsion Sign-Off Division of Cardlovascular Devices 510fk) Number
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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.