(74 days)
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Not Found
No
The document describes a standard patient monitor with physiological parameter measurement and alarming capabilities, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a patient monitor used for measuring and displaying physiological parameters and generating alarms, not for providing therapy.
No
The device description clearly states "The M3000A/M3046A Compact Portable Patient Monitor is intended for monitoring, and alarming". While it measures physiological parameters, its stated purpose is continuous monitoring and alarming rather than diagnosing a condition.
No
The device description explicitly states it is a "Compact Portable Patient Monitor" and measures multiple physiological parameters, which inherently requires hardware components (sensors, display, processing unit) to acquire and present the data. While it contains software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that the HP M3000A/M3046A Compact Portable Patient Monitor is used for monitoring and alarming of physiological parameters directly from the patient (ECG, respiration, blood pressure, SpO2, temperature). These are measurements taken in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient.
Therefore, the device's function aligns with patient monitoring, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The M3000A/M3046A Compact Portable Patient Monitor is intended for monitoring, and alarming of ECG, respiration, oxygen saturation, invasive and non-invasive pressure, and temperature.
This [510(k)] modification adds a new feature (patient population) to the M3000A/M3046A Compact Portable Patient Monitor: the capability of monitoring neonatal patients is added to the noninvasive blood pressure measurement.
Product codes
MHX
Device Description
The M3000A/M3046A Compact Portable Patient Monitor contains software.
Mentions image processing
Not Found
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
The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use on adult, pediatric, and neonatal patients as specified in the Technical Data Sheets.
Intended User / Care Setting
The HP M3000A/M3046A Compact Portable Patient Monitor is indicated for use in health care facilities by health care professionals.
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)
The HP M3000A/M3046A Compact Portable Patient Monitor was fully validated.
The comparison of intended use and technological characteristics of this device to other legally marketed devices taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness, and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The characters appear to be 'K981576'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly distorted.
Page 83
P -- [510(k)] Summary of Safety and Effectiveness
The M3000A/M3046A Compact Portable Patient Monitor is intended for monitoring, and alarming of ECG, respiration, oxygen saturation, invasive and non-invasive pressure, and temperature.
This [510(k)] modification adds a new feature (patient population) to the M3000A/M3046A Compact Portable Patient Monitor: the capability of monitoring neonatal patients is added to the noninvasive blood pressure measurement.
The M3000A/M3046A Compact Portable Patient Monitor contains software.
The HP M3000A/M3046A Compact Portable Patient Monitor was fully validated.
The comparison of intended use and technological characteristics of this device to other legally marketed devices taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness, and intended use.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Mr.. Egon Pfeil Requlatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Schickardstrasse 4 D-71034 Boeblingen Germany
K981576 Re: Hewlett-Packard Models M3000A/M3046A Patient Monitor Requlatory Class: III (three) Product Code: MHX Dated: April 30, 1998 Received: May 4, 1998
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, Drug, 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, labeling, 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 requlation (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 regulations.
2
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.qov/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
3
INDICATIONS FOR USE
510(k) Number (if known):
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 a) waves' of one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
-
- List of supported measurements
- (a) ECG
- (b) Respiration
- 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)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Device
Prescription Use: yes (Per 21 CFR 801.109) OR
Over-The-Counter Use: no
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number