(118 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on adding hardware and firmware for additional physiological measurements.
No
The device is described as a "Patient Monitoring System" intended for "monitoring, recording, and alarming of multiple physiological parameters." It does not mention any therapeutic function or intervention.
Yes
Explanation: The device is described as a "Patient Monitoring System" intended for "monitoring, recording, and alarming of multiple physiological parameters," which are functions of a diagnostic device. It specifically mentions measuring "sidestream CO2, and a second invasive blood pressure and temperature measurements."
No
The device description explicitly states the modification involves the addition of a "firmware and software based change" and the addition of the "M3015A Module" to the existing hardware. The performance studies also mention "hardware testing," indicating it is not solely software.
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 of adults, pediatrics, and neonates in the hospital and medical transport environments." This describes a device that monitors physiological signals directly from the patient, not a device that analyzes samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description focuses on adding modules for "sidestream CO2, and a second invasive blood pressure and temperature measurements." These are all measurements taken directly from or in close proximity to the patient, not from in vitro samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with in vitro diagnostics.
Therefore, the Hewlett-Packard Viridia M3/M4 Patient Monitoring System, Rel.B is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hewlett-Packard Viridia M3/M4 (M3000A/M3046A) 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.
Product codes
74 DSI
Device Description
The modification is the addition of a firmware and software based change that involves the addition of the M3015A Module to the portable Viridia M3/M4 Patient Monitor System to allow sidestream CO2, and a second invasive blood 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. The test results showed substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
8.0 510(k) Summary
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
- The submitter of this premarket notification is:
Tel: 011 49 (7031) 14-2243 Fax: 011 49 (7031) 14-4297
This summary was prepared on August 20, 1999.
-
- The name of this device is the Hewlett-Packard Viridia Patient Monitor M3000A/M3046A with M3015A (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 | |
| 870.1400 | Carbon Dioxide Gas Analyzer |
| 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 |
1
- 4 . The modification is the addition of a firmware and software based change that involves the addition of the M3015A Module to the portable Viridia M3/M4 Patient Monitor System to allow sidestream CO2, and a second invasive blood 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 alarming multiple physiological parameters and waves in adult, pediatric and neonatal patients.
-
- The new combination device has the same technological characteristics as the legally marketed predicate devices.
-
- 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.........
3 2000 FEB
Mr. Egon Pfeil Regulatory Affairs Medical Products Group - Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 Boeblingen, Germany 71034
Re: K993383 HP Viridia Model M3015A Measurement Server Module Regulatory Class: III (three) Product Code: 74 DSI Dated: January 10, 2000 Received: January 13, 2000
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 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 A substantially equivalent determination assumes compliance to 895. 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 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. 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/dsma/dsmamain.html".
Sincerely yours,
Quisite A. Goode for
Celia M. Witten, Ph.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3.1 ODE Indications Statement
Indications for Use Statement
510 (k) Number (if known)
Device Name The Hewlett-Packard Company (HP) Viridia M3/M4 (M3000A/M3046A) Patient Monitoring System, Rel.B, with M3015A & M3016A Measurement Server Extensions.
Indications for The Hewlett-Packard Viridia M3/M4 Use (M3000A/M3046A) 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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Stace N. Ricord, MD for Tillman
Division Sign-Off
Division of Cardiovascular, Fle
and Neurological Devices
510(k) Number K993383
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use