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.

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.

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.

AI/ML Overview

This document, K974567, details a 510(k) submission for the Hewlett-Packard M2605A Viridia Wave Viewer. However, it does not contain specific acceptance criteria, performance metrics, or a detailed study description that would allow for a complete response to your request. The document acts as a summary for FDA clearance, not a full scientific study report.

The "Verification and Validation" section (6.0) states: "Viridia Wave Viewer has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices." This implies that testing was performed, but the details are not provided within this summary.

Therefore, I can only provide information based on what is available in the provided text. Many sections of your request cannot be answered due to the lack of detailed study information.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The document states that verification and validation were performed to show substantial equivalence, but it does not list specific numeric acceptance criteria (e.g., accuracy, precision) or the results of those tests.

2. Sample Size Used for the Test Set and Data Provenance

This information is not present in the provided document. The document refers to "extensive testing" but does not specify sample sizes or data origin (country, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not present in the provided document.

4. Adjudication Method for the Test Set

This information is not present in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device, Viridia Wave Viewer, is described as a software application for a palmtop computer that displays ECG and SpO2 waveforms and numerics. It specifically states: "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." This functionality suggests a display-only device with a simple HR estimation, not one that would typically be involved in a comparative effectiveness study of AI assistance for human readers in decision-making.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This document does not report a standalone performance study. While testing certainly occurred to ensure proper display and basic HR estimation, the nature of this device (a display and rudimentary HR estimation tool) means that "standalone performance" in the sense of a complex algorithm's diagnostic accuracy is not applicable or elaborated upon here. Its function is to present data from existing monitoring equipment.

7. Type of Ground Truth Used

This information is not explicitly stated in the provided document. Given the device's function to display ECG and SpO2 waveforms and numerics from existing monitoring equipment, the "ground truth" for its verification and validation would likely involve:

Comparison to the source monitoring equipment: Ensuring the displayed waveforms and numerics accurately reflect what the M2601A transmitter is sending.
Manual calculation verification: For the estimated heart rate, comparison to a manually calculated heart rate derived from the displayed ECG.

8. Sample Size for the Training Set

This information is not present in the provided document. As the device mainly displays information and performs a simple HR estimation, it is unlikely to have a "training set" in the sense of a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not present in the provided document. As mentioned above, a "training set" in the context of device learning is likely not applicable to this particular device's functionality.

Summary

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K974567

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

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:

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· 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.

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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.

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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

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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-

Regulation Number and Section

§ 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).