(61 days)
K031376 DINAMAP PRO 1000 V3 MONITOR
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard vital sign monitoring and alarm detection, without mentioning any advanced analytical or learning capabilities.
No
The device is a patient monitor, explicitly designed to monitor and display vital signs and clinical data, not to provide therapy.
No
The device monitors vital signs and displays data, but it does not diagnose a condition. Its purpose is to provide continuous measurement and display of physiological parameters for clinical assessment.
No
The device description explicitly states it is a "self-contained" "multi-parameter monitor" with a "carrying handle" and various mounting options, indicating it is a physical hardware device. It also mentions being powered by batteries or AC and having the capability to interface with other devices, further confirming its hardware nature.
Based on the provided text, the Dash 2500 Patient Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring adult, pediatric, and neonate patient vital signs." This involves measuring physiological parameters directly from the patient (e.g., blood pressure, heart rate, temperature, SpO2).
- Device Description: The description reinforces that it's a "multi-parameter monitor designed for monitoring adult, pediatric, and neonate patient vital signs."
- Lack of IVD Characteristics: 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 Dash 2500 does not perform any such analysis of bodily specimens.
The Dash 2500 is a patient monitoring device, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.
The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
Product codes
MHX
Device Description
The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-parameter monitor designed for monitoring adult, pediatric, and neonate patient vital signs.
The Dash 2500 Patient Monitor is self-contained and can be powered by batteries or AC. The Monitor has a carrying handle and can be operated on a shelf or table. It can also be mounted in a variety of ways (e.g., wall, pole, bed rail, or head/foot board) using a mounting plate located on the bottom of the Monitor. The Monitor can be used as a stand-alone monitor with the capability to interface to a central station, a server or any other device capable of receiving data using the host communications protocol.
The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
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 neonate
Intended User / Care Setting
licensed healthcare practitioner. hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.
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)
Test Summary: The Dash 2500 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:
- 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 2500 is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031376 DINAMAP PRO 1000 V3 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
Section 5: 510(k) Summary or 510(k) Statement
| | MAR 24 2008
510(k) Summary of Safety and Effectiveness |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 21, 2008 |
| Submitter: | GE Medical Systems Information Technologies
8200 West Tower Avenue
Milwaukee, Wisconsin 53223 |
| Contact Person: | Sharon Untz
Quality and Regulatory Affairs Manager
GE Medical Systems Information Technologies
Telephone: 414-362-2436
Fax: 414-362-2585
E-mail: Sharon.Untz@med.ge.com |
| Device: | |
| Trade Name: | Dash 2500 Patient Monitor |
| Common/Usual Name: | Physiological Patient Monitor (Multi-parameter Module) |
| Classification Names: | 21 CFR 870.1025 Physiologic Patient Monitor (with arrhythmia
detection or alarms) |
| Predicate Device: | K031376 DINAMAP PRO 1000 V3 MONITOR |
| Device Description: | The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-
parameter monitor designed for monitoring adult, pediatric, and neonate
patient vital signs.
The Dash 2500 Patient Monitor is self-contained and can be powered
by batteries or AC. The Monitor has a carrying handle and can be
operated on a shelf or table. It can also be mounted in a variety of ways
(e.g., wall, pole, bed rail, or head/foot board) using a mounting plate
located on the bottom of the Monitor. The Monitor can be used as a
stand-alone monitor with the capability to interface to a central station,
a server or any other device capable of receiving data using the host
communications protocol. |
| Intended Use: | The Dash 2500 Patient Monitor is intended for use under the direct
supervision of a licensed healthcare practitioner. The intended use of
this device is a portable (intra-hospital) multiparameter unit designed
for monitoring adult, pediatric, and neonate patient vital signs in a
hospital subacute care environments, such as same-day surgery,
emergency rooms, recovery/PACU, progressive care, interventional
radiology, special care units, and GI/endoscopy.
The Dash 2500 Patient Monitor monitors and displays oscillometric
non-invasive blood pressure (systolic, diastolic and mean arterial
pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation
(SpO2) by non-invasive pulse oximetry, and temperature with an
reusable electronic thermometer (predictive mode for oral and rectal
temperature measurement, monitor mode for axillary temperature
measurement). |
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(08057
The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
Technology: The Dash 2500 employs the same functional technology as the predicate devices.
Test Summary: The Dash 2500 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:
- � 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 2500 is as safe, as effective, and performs as well as the predicate device.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems Information Technologies c/o Ms. Sharon Untz Quality Assurance and Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, WI 53223
MAR 2 4 2008
Re: K080157
Dash 2500 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: January 21, 2008 Received: January 23, 2008
Dear Ms. Untz:
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 I ou mayy ators 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 - Ms. Sharon Untz
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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
1080157
Section 4: Indications for Use Statement
Indications for Use
510(k) Number (if known): Device Name: Dash 2500 Patient Monitor
Indications for Use:
The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.
The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.
The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Div | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number: | K080057 |
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