(13 days)
Not Found
No
The summary describes a software modification to an existing patient monitor focusing on arrhythmia and ST measurement algorithms. There is no mention of AI, ML, or related concepts, nor is there any description of training or test sets typically associated with AI/ML development.
No
The device is described as a patient monitor intended for monitoring, recording, and alarming of physiological parameters, which is a diagnostic/monitoring function, not a therapeutic one. It does not actively treat or alleviate a disease or condition.
Yes
The device is intended for "monitoring, recording, and alarming of multiple physiological parameters," which is a diagnostic function to assess a patient's health status. The description also mentions "arrhythmia and ST measurement algorithm," indicating its use in diagnosing cardiac conditions.
No
The device description explicitly states it is a modification to existing hardware (Hewlett-Packard family of Viridia Patient Monitors) 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 for "monitoring, recording, and alarming of multiple physiological parameters." This describes a device that monitors the patient directly, not a device that analyzes samples taken from the patient.
- Device Description: The description focuses on a "patient monitor" and modifications to its "arrhythmia and ST measurement algorithm." This further reinforces that it's a device used for direct patient monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to monitor physiological signals from the patient's body.
N/A
Intended Use / Indications for Use
The new device has the same intended use as the leqally 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DSI
Device Description
The modified device is substantially equivalent to previously cleared HP devices that contain the same STAR software and that are marketed pursuant to K964122, K971910, and K981576. The modification consists of the addition of software that involves only the arrhythmia and ST measurement alqorithm of the measurement computer processing unit of each device. The new combination device has the same technological characteristics as the legally marketed predicate devices.
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
adult, pediatric, and neonatal patients.
Intended User / Care Setting
hospital environment or mobile environment for patient transport monitoring, in health care facilities by health care professionals
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)
Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the STAR algorithm using bench studies. Testing involved system level tests, inteqration tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on the specifications cleared for the predicate device and 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
JUN 7 1999
10.0 510(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.
l. 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 Tel: 011 49 (7031) 14-2243 011 49 (7031) 14-4297 Fax: Email:egon pfeil@hp.com
This summary was prepared on April 27, 1999
-
- The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M3000A/M3046A (Viridia The common name is patient monitor. Classification names are M3/4) . . as follows:
| Regulation
| Number | Classification Name |
|---|---|
| 870.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 870.1025 | Detector and Alarm, Arrhythmia |
| 870.2900 | Cable, Transducer and Electrode, Patient (including |
| connector) |
-
- The modification consists of the addition of software that involves only the arrhythmia and ST measurement alqorithm of the measurement computer processing unit of each device.
-
- The new device has the same intended use as the leqally 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.
1
-
- Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the STAR algorithm using bench studies. Testing involved system level tests, inteqration tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 1999
Mr. Egon Pfeil Hewlett-Packard GmbH Medical Products Group - Europe Herrenberger Strasse 110-140 D-71034 Boeblingen GERMANY
Re: K991773 Viridia HP M3000A/M3046A (M3/M4), Rel.B Portable Patient Monitor Requlatory Class: III (three) Product Code: 74 DSI Dated: May 10, 1999 Received: May 25, 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 reqistration, 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Collehan
Thomas J. Caflahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical 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 Device Name M3000A/M3046A Patient Monitor Rev.B with ST/AR Software. Viridia HP M3000A/M3046A Patient Monitor Rel.B
- Indications for The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, Use and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ath. A. Ciachochi.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use