(90 days)
No
The summary describes a standard EEG monitoring system and its validation through traditional performance and clinical studies, with no mention of AI or ML algorithms for signal processing or interpretation.
No
The device measures and displays electroencephalograms, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for "measurement and display of the electroencephalogram," which is a diagnostic procedure used to assess brain activity for the diagnosis and monitoring of neurological conditions.
No
The device description explicitly states the addition of a hardware component, the M1027A EEG Measurement Module, and the performance studies include hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure and display the electroencephalogram (EEG) of patients. This involves monitoring electrical activity within the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device measures electroencephalographic signals, which are electrical signals from the brain. This is an in vivo measurement (within a living organism), not an in vitro measurement (in glass or outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures typically associated with IVD devices.
Therefore, the Hewlett-Packard Viridia CMS Patient Monitoring System with the M1027A EEG Measurement Module is a patient monitoring device that performs in vivo measurements, not an IVD.
N/A
Intended Use / Indications for Use
The Hewlett-Packard Viridia CMS Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, MHX
Device Description
The modification is the addition of new applications software and firmware that involves the addition of the M1027A EEG Module to the HP M1175A/76A/77A Component Monitoring System to allow the measurement of electroencephalographic signals.
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
Operating Room and intermediate/critical care 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using 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. Clinical performance evaluations were conducted with the EEG module to validate two channel functionality under conditions existing in the indicated hospital environments. More than 90% of the users found the applicability, usability, and efficiency of EEG M1027A module monitoring acceptable or better. Apart from one instance of minor skin irritation, no adverse events were reported during the studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
More than 90% of the users found the applicability, usability, and efficiency of EEG M1027A module monitoring acceptable or better.
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.
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
510(k) Summary 9.0
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 Requlatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 D-71034 Germany Tel: 011 49 (7031) 14-2243 011 49 (7031) 14-4297 Fax: Email:egon pfeil@hp.com
This summary was prepared on July 28, 1999
- The name of this device is the Hewlett-Packard Viridia M1175A/76A/77A Component Monitoring System with M1027A EEG module. The common name is patient monitor. Classification name is as follows:
| Regulation
| Number | Classification Name |
|---|---|
| 882.1400 | Electroencephalograph |
-
- The modification is the addition of new applications software and firmware that involves the addition of the M1027A EEG Module to the HP M1175A/76A/77A Component Monitoring System to allow the measurement of electroencephalographic signals.
-
- The new device has the same intended use as the legally marketed predicate devices. When connected by appropriate electrodes, and used in the operating room and intermediate/critical care environments, the device is intended for measuring EEG signals in adult, pediatric, and neonatal patients.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- Validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards,
1
where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence.
Clinical performance evaluations were conducted with the EEG module to validate two channel functionality under conditions existing in the indicated hospital environments. More than 90% of the users found the applicability, usability, and efficiency of EEG M1027A module monitoring acceptable or better. Apart from one instance of minor skin irritation, no adverse events were reported during the studies.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and features an abstract image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Egon Pfeil Regulatory Affairs Hewlett-Packard GmbH Medical Products Group - Europe Herrenberger Strasse 110-140 D-71034 Boeblingen Germany
8 1999 NOV
Re: K992674
Trade Name: Hewlett-Packard Viridia Component Monitoring System Regulatory Class: III Product Code: GWQ, MHX Dated: August 5, 1999 Received: August 10, 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 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 requirement, as set forth in the Quality System Regulation (OS) 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.
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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) 594-4595. 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,
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative 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 CMS Device Name Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module.
- The Hewlett-Packard Viridia CMS Patient Indications for Monitoring System, Rel.K, with M1027A EEG Use Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K992674
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
er Use