(304 days)
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No
The provided text describes a standard patient monitor and does not mention any AI or ML capabilities.
No
This device is a patient monitor, which measures and displays physiological parameters; it does not provide therapy.
No
This device is a patient monitor that measures and displays physiological parameters. While it provides data that can be used for diagnosis, its primary stated function is monitoring, not making a diagnosis itself.
No
The device description explicitly states "Compact Portable Patient Monitor," which is a hardware device designed to measure and display physiological parameters. The listed measurements (ECG, Respiration, Blood Pressure, SpO2, Temperature) are all collected via physical sensors connected to the patient, which are components of a hardware monitor.
Based on the provided information, the HP M3000A/M3046A Compact Portable Patient Monitor is not an IVD (In Vitro Diagnostic) 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 HP M3000A/M3046A focuses on measuring physiological parameters directly from the patient's body (ECG, respiration, blood pressure, SpO2, temperature). These are in-vivo measurements, not in-vitro (outside the body) measurements of specimens.
The device is a patient monitor used for real-time physiological monitoring of a patient.
N/A
Intended Use / Indications for Use
The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:
- Can measure and display multiple physiological parameters and waves' of a) one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in the b) Technical Data Sheets. The non-intrasive pressure can be used for adult and pediatric patients.
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- List of supported measurements
- ECG (a)
- Respiration (b)
- Invasive blood pressure (c)
- Non-invasive blood pressure (d)
- SpO2 and Pleth (e)
- Temperature (f)
-
Product codes
74 DSI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult, pediatric, and neonatal patients. The non-intrasive pressure can be used for adult and pediatric patients.
Intended User / Care Setting
Health care professionals in health care facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Mr. Egon Pfeil Hewlett-Packard GmbH Schickardstrasse 4 D-71034 Boeblingen Germany
Re: K971910 Hewlett-Packard Models M3000A Multi-Measurement Server and M3046A Compact Portable Patient Monitor Requlatory Class: III (three) Product Code: 74 DSI December 5, 1997 Dated: Received: December 12, 1997
Dear Mr. Pfeil:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, labelinq, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. Egon Pfeil
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K971910
Device Name: M3000A/M3046A Compact Portable Patient Monitor
Indications For Use:
The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:
- Can measure and display multiple physiological parameters and waves' of a) one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in the b) Technical Data Sheets. The non-intrasive pressure can be used for adult and pediatric patients.
-
- List of supported measurements
- ECG (a)
- Respiration (b)
- Invasive blood pressure (c)
- Non-invasive blood pressure (d)
- SpO2 and Pleth (e)
- Temperature (f)
-
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: yes (Per 21 CFR 801,109)
OR
Over-The-Counter Use: no
3
(Optional Format 1-2-96)
. Praz
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _