(205 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on adding a module for new physiological measurements, not advanced data analysis.
No
Explanation: The device is described as a "Patient Monitoring System" intended for "monitoring, recording, and alarming of multiple physiological parameters." This indicates it is for diagnostic or monitoring purposes, not for treating a disease or condition.
No.
The device is described as a patient monitoring system, intended for monitoring, recording, and alarming of physiological parameters, rather than providing a diagnosis.
No
The device description explicitly states the modification involves the addition of a "firmware and software based change that involves the addition of the M3016A Module" to an existing patient monitor system. This indicates the inclusion of a hardware component (the M3016A Module) in addition to the software/firmware. Furthermore, the performance studies section mentions "hardware testing," confirming the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring, recording, and alarming of multiple physiological parameters" directly from the patient. This is in-vivo monitoring, not in-vitro testing of samples outside the body.
- Supported Measurements: The listed measurements (ECG, Respiration, Blood Pressure, SpO2, Temperature, CO2) are all physiological parameters measured directly from the patient. IVD devices typically measure analytes in biological samples like blood, urine, or tissue.
- Device Description: The description focuses on adding a module for CO-Pressure and Temperature measurements, which are also in-vivo parameters.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Hewlett-Packard Viridia M3/M4 Patient Monitoring System, Rel.B is a patient monitoring system, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hewlett-Packard Viridia M3/M4 Patient Monitoring System, Rel.B is intended for monitoring, recording, and alarming of multiple physiological parameters' of adults, pediatrics, and neonates in the hospital and medical transport environments.
- List of supported measurements
ECG (a) Respiration (b) Invasive blood pressure (c) Non-invasive blood pressue (d) SpO2 and Pleth (e) Temperature (f) CO2 (g)
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The modification is the addition of a firmware and software based change that involves the addition of the M3016A Module to the portable Viridia M3/M4 Patient Monitor System to allow CO-Pressure, and Temperature measurements with the unit.
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
adults, pediatrics, and neonates
Intended User / Care Setting
hospital and medical transport environments
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
Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems. Testing included system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test results showed substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
8.0 510 (k) Summary
JAN 2 8 2000
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
-
- The submitter of this premarket notification is: Egon Pfeil Regulatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 D-71034 Germany 011 49 (7031) 14-2243 Tel: Fax: 011 49 (7031) 14-4297 Email:egon pfeil@hp.com
This summary was prepared on June 10, 1999
- The submitter of this premarket notification is: Egon Pfeil Regulatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 D-71034 Germany 011 49 (7031) 14-2243 Tel: Fax: 011 49 (7031) 14-4297 Email:egon pfeil@hp.com
- The name of this device is the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3016A (Viridia M3/M4, Rel. B.). The common name is patient monitor. Classification names are as follows:
| Regulation
| Number | Classification Name |
|---|---|
| 870.2850 | Extravascular Blood Pressure Transducer |
| 870.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 870.1025 | Detector and Alarm, Arrythmia |
| 870.2900 | Cable, Transducer and Electrode, Patient (including |
| connector) | |
| 868.1499 | Carbon Dioxide Gas Analyzer |
| 880.2910 | Clinical Electronic Thermometer |
-
- The modification is the addition of a firmware and software based change that involves the addition of the M3016A Module to the portable Viridia M3/M4 Patient Monitor System to allow CO-Pressure, and Temperature measurements with the unit.
-
- The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment or mobile environment for patient transport monitoring, the device is intended for measuring and displaying, recording, and alarrie multiple physiological parameters and waves in adult, pediatmin, and neonatal patients.
-
- The new combination device has the same technological characteristics as the legally marketed predicate devices.
..
1
-
- Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using simulated systems. Testing included system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards, where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is facing left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2000
Mr. Egon Pfeil Hewlett-Packard GmbH Herrenberger Strasse 110-140 Boeblingen GERMANY 71034
Re: K992273 M3016A Measurement Server Extension Regulatory Class: III (three) Product Code: MHX Dated: October 27, 1999 Received: November 1, 1999
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 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). 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 IT (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 periedic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may rey busin 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.
3
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 at 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" (2) 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/dsma/dsmamain.html".
Sincerely yours,
Jeanne A. Wuterdauken fu,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ODE Indications Statement 3.1
Indications for Use Statement 510 (k) Number (if known) The Hewlett-Packard Company (HP) Viridia M3/M4 Device Name Patient Monitoring System, Rel.B, with M3016A Measurement Server Extension. The Hewlett-Packard Viridia M3/M4 Patient Indications for Monitoring System, Rel.B is intended for Use monitoring, recording, and alarming of multiple physiological parameters' of adults, pediatrics, and neonates in the hospital and medical transport environments. 1. List of supported measurements ECG (a) Respiration (b) Invasive blood pressure (c) Non-invasive blood pressue ( વ ) SpO2 and Pleth (e) Temperature ( ) ) CO2 ( વે ) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Christy foreman
| (Division Sign-Off) | |
|---|---|
| Cardiovascular, Respiratory, Devices | |
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |