(46 days)
No
The device description explicitly states that the software "does not operate on the information received except to format it for display" and "performs no calculations except for estimating HR." It also states it has "no detection capability." There is no mention of AI or ML in the document.
No.
The device is used for patient assessment by providing limited ECG and SpO2 information, not for treating any condition or disease.
Yes
This device provides limited ECG and SpO2 information for patient assessment, including uses such as determining tolerance to exercise, assessing patients awaiting monitoring equipment, and as input for physical assessments. It allows estimation of heart rate by measuring R-peaks, all of which are activities commonly associated with diagnostic or assessment tools in a clinical setting. While it explicitly states it does not enable detailed ECG diagnosis or act as a continuous monitor, the primary purpose of providing physiological information for clinical assessment aligns with the function of a diagnostic device, even if limited in scope.
Yes
The device is described as a "software application that executes on a palmtop computer" and its function is to display data received from a separate hardware transmitter. It does not include the hardware itself.
Based on the provided text, the Viridia Wave Viewer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Viridia Wave Viewer receives ECG and SpO2 information directly from a patient via a transmitter. It does not analyze biological samples like blood, urine, or tissue.
- The intended use focuses on patient assessment and displaying physiological signals. The description clearly states its purpose is to provide limited ECG and SpO2 information for clinical assessment, not to perform diagnostic tests on biological specimens.
- The device description details communication with a transmitter and displaying waveforms and numerics. This aligns with a patient monitoring or assessment tool, not an IVD device that would involve laboratory analysis.
Therefore, the Viridia Wave Viewer falls under the category of a patient monitoring or assessment device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use:
Viridia Wave Viewer may be used to provide limited ECG and SpO2 information to the clinician. Patient assessment includes uses similar to:
- Determination of a patient's tolerance to exercise during ambulation (e.g. while walking down a hallway).
- Patient assessment while waiting for monitoring equipment to arrive (e.g. a patient collapses in the hallway).
- Additional input to a routine physical assessment of a patient (e.g. for use on rounds).
Patient assessment does not include uses such as:
- Continuous monitoring of a patient (not intended for use as a bedside monitor).
- Determining detailed ECG diagnosis such as ST segment values, R-R variability or any other diagnostic ECG values.
The patient population is adult and pediatric patients.
There are no alarms. The device turns off after 10 minutes to prevent long term "monitoring" use. Viridia Wave Viewer is not intended to be a patient monitor.
In the USA, Federal law restricts Viridia Wave Viewer to sale by or on the order of a physician.
It is intended to be used in a professional health care facility. It is not intended for home use.
Indications for Use:
The device is intended to be used as an assessment tool that enables licensed clinicians in a clinical environment to determine the quality of ECG and SpO2 signals at the location of telemetry monitored patients. In addition, limited assessment of patients ECG and SpO2 vital signs can be determined. Viridia Wave Viewer is not intended for monitoring and has no alarm functions. The device is not intended for home use and is not suitable for patient monitoring.
Product codes
74DXJ, 74MSX
Device Description
Viridia Wave Viewer is a software application that executes on a palmtop computer. Viridia Wave Viewer software enables the palmtop computer to communicate with the M2601A transmitter using an infrared link for the purpose of displaying ECG waveform, or an SpO2 pleth waveform, and numerics for SpO2 and Pulse. Viridia Wave Viewer also allows the user to estimate the heart rate, HR, by using electronic calipers to measure the distance between two R-peaks. Viridia Wave Viewer does not operate on the information received except to format it for display on the palmtop screen. It performs no calculations except for estimating HR. It has no detection capability. It can not, therefore, annunciate any alarms.
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 and pediatric patients.
Intended User / Care Setting
Licensed clinicians in a professional health care facility.
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)
Documented test results obtained from extensive testing coupled with detailed user documentation of Viridia Wave Viewer and the computing platform produces a very high confidence level that the device is safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K961165, K922974, K945134, K923343
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Chapter 24: Summary of Safety and Effectiveness
1.0 Manufacturer/Submitter
1.1 Name and Address
Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099
Establishment Registration Number 1.2 1218950
Hewlett-Packard Manufacturing Site 1.3 Address
Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099
Manufacturing Site Establishment Registration 1.3.1 Number 9680888
- 1.4 Sterilization Site Does not apply.
1.5 Contact Persons
You may contact Ray Stelting at (978) 659-3445 or Mike Hudon at (978) 659-3173, or Chas Burr at (978) 659-2529
- 1.6 Date
12/4/97
2.0 Regulatory Information
2.1 References
-
· K945277, Hewlett-Packard Model M1490A Wireless Patient Data Communicator "PalmVue" System.
-
· K961165. Hewlett-Packard Model M2600A OmniCare Telemetry Monitoring System.
-
· K922974 and K945134, Hewlett-Packard Model M1275A Component Transport System.
-
JAN 20 1998
24-1 -
· K923343 HP M1020A SpO2 Parameter Plug-in Module.
2.2 Device Name, Trade Name
Proprietary: Hewlett-Packard M2605A Viridia Wave Viewer
Trade: Viridia Wave Viewer
Products (Components) Included As Part Of 2.3 This Device:
No accessories or additional components are included as part of the Hewlett-Packard M2605A Viridia Wave Viewer.
2.4 Device Classification
We believe the proper classification for the computing platform is 870.2450, Class 2, Tier 2, Procode 74DXJ even though the display technology is liquid crystal. We find no classification for the Viridia Wave Viewer software.
2.5 Performance Standard:
None established under Section 514.
3.0 Description
Viridia Wave Viewer is a software application that executes on a palmtop computer. Viridia Wave Viewer software enables the palmtop computer to communicate with the M2601A transmitter using an infrared link for the purpose of displaying ECG waveform, or an SpO2 pleth waveform, and numerics for SpO2 and Pulse. Viridia Wave Viewer also allows the user to estimate the heart rate, HR, by using electronic calipers to measure the distance between two R-peaks. Viridia Wave Viewer does not operate on the information received except to format it for display on the palmtop screen. It performs no calculations except for estimating HR. It has no detection capability. It can not, therefore, annunciate any alarms.
4.0 Intended use
Viridia Wave Viewer may be used to provide limited ECG and SpO2 information to the clinician. Patient assessment includes uses similar to:
1
- · Determination of a patient's tolerance to exercise during ambulation (e.g. while walking down a hallway).
- · Patient assessment while waiting for monitoring equipment to arrive (e.g. a patient collapses in the hallway).
- · Additional input to a routine physical assessment of a patient (e.g. for use on rounds).
Patient assessment does not include uses such as:
- · Continuous monitoring of a patient (not intended for use as a bedside monitor).
- · Determining detailed ECG diagnosis such as ST segment values, R-R variability or any other diagnostic ECG values.
The patient population is adult and pediatric patients.
There are no alarms. The device turns off after 10 minutes to prevent long term "monitoring" use. Viridia Wave Viewer is not intended to be a patient monitor.
In the USA, Federal law restricts Viridia Wave Viewer to sale by or on the order of a physician.
It is intended to be used in a professional health care facility. It is not intended for home use.
5.0 Indications for Use
5.1 Condition
Viridia Wave Viewer is generally indicated when the clinician decides to assess the ECG or SpO2 vital signs of adult and pediatric patients while at the patient location and does not need a diagnostic quality display.
5.2 Part of Body or Type of Tissue with Which the Device Interacts
Viridia Wave Viewer does not contact the body or tissue of the patient.
5.3 Frequency of Use
Viridia Wave Viewer is indicated for use when prescribed by a clinician.
5.4 Physiological Purpose
Viridia Wave Viewer is indicated when the physiological purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia Wave Viewer is not suitable for patient monitoring.
5.5 Patient Population
Adult, and pediatric ambulatory and non-ambulatory patients.
Prescription Versus Over-the-Counter 5.6
Viridia Wave Viewer is a prescription device.
6.0 Verification and Validation
Viridia Wave Viewer has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices.
7.0 Safe and Effective When Used as Labeled
Documented test results obtained from extensive testing coupled with detailed user documentation of Viridia Wave Viewer and the computing platform produces a very high confidence level that the device is safe and effective when used as intended.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
JAN 2 0 1998
Mr. Ray Stelting Regulatory Engineer Medical Products Group Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810
Re: K974567 Trade Name: Viridia Wave Viewer Regulatory Class: III Product Code: 74 MSX Dated: December 4, 1997 December 5, 1997 -------------------------------------------------------------------------------------------------------------------------------------------------------------Received:
Dear Mr. Stelting:
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 A substantially equivalent determination assumes compliance ------to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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. Ray Stelting
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Calla Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 1 of of 1 1
510(k) Number (if known): K974567
Device Name: Hewlett-Packard M2605A Viridia Wave Viewer
Indications For Use: The device is intended to be used as an assessment tool that enables licensed clinicians in a clinical environment to determine the quality of ECG and SpO2 signals at the location of telemetry monitored patients. In addition, limited assessment of patients ECG and SpO2 vital signs can be determined. Viridia Wave Viewer is not intended for monitoring and has no alarm functions. The device is not intended for home use and is not suitable for patient monitoring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qceyt Miller
(Division Sign-Off)
Division of Cardiovascular, Respiratory, ------------------------------------------------------------------------------------------------------------------------------------and Neurological Devices 510(k) Number _ _ ____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
Prescription Use X (Per 21 CFR 801.109) OR
Optional Format 1-2-