Condition: Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients.

Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices.

Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician.

Physiological Purpose: Viridia 24 CT is indicated when the purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia 24 CT is well suited for patient monitoring.

Patient Population: Adult, pediatric, and neonatal non-ambulatory patients.

Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device.

Device Description

Viridia 24 CT is a patient monitor. This submission notifies the FDA that the power source was modified. No other significant changes were made to the device.

AI/ML Overview

The provided text describes a 510(k) submission for the Hewlett-Packard M1205A Viridia 24 CT, a patient monitor. This document focuses on the regulatory approval process for a medical device and its intended use, rather than a study evaluating its performance against specific acceptance criteria in the way an AI algorithm or a diagnostic tool would be evaluated.

Therefore, many of the requested elements for an acceptance criteria study, such as sample size, data provenance, ground truth establishment, expert qualifications, and comparative effectiveness studies, are not present in this type of regulatory submission. The document states that the device has undergone "Verification and Validation" and "extensive testing" to show "substantial equivalence" to legally marketed predicate devices, but it does not detail the specific performance metrics or the studies conducted to meet them.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific range of measurement error) or reported device performance for these criteria. Instead, the "acceptance criteria" are broad statements related to safety, effectiveness, and substantial equivalence to predicate devices.

Acceptance Criteria (Inferred from Document)	Reported Device Performance (Inferred from Document)
Safe and Effective when used as labeled	"Documented test results obtained from extensive testing coupled with detailed user documentation... produces a very high confidence level that the device is safe and effective when used as intended."
Substantial Equivalence to predicate devices	"Viridia 24 CT has been verified and validated to provide the test results needed to show substantial equivalence to legally marketed devices."
Measures and displays multiple physiological parameters and waves	Intended purpose of the device.
Generates alarms and recordings	Intended purpose of the device.
Exchanges information with compatible devices	Intended purpose of the device.
Suitable for intra-facility transport	Stated intended use.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/diagnostic algorithm evaluation. It mentions "extensive testing" but provides no details on sample sizes, data provenance (country of origin, retrospective/prospective nature), or patient characteristics for these tests. The focus is on the device's functional integrity and its ability to perform its stated purpose, not on its diagnostic accuracy or predictive power.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physiological monitor, not a diagnostic tool that relies on expert interpretation for "ground truth" establishment in the way an AI algorithm would.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set with human assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone patient monitor, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This device is not an algorithm, but a hardware patient monitor. Its performance is inherent in its measurement capabilities. The document states it is "not a therapeutic device" and "not intended for home use," aligning with a "standalone" monitoring function used by clinicians. The device's "performance" would be related to the accuracy and reliability of its physiological parameter measurements, which are not detailed here.

7. The type of ground truth used

For a physiological monitor, the "ground truth" would implicitly be the actual physiological parameters being measured by the device (e.g., heart rate, blood pressure, etc.), typically established through direct physical measurement or comparison with established gold-standard instruments. The document does not specify how this "ground truth" was established for verification/validation.

8. The sample size for the training set

Not applicable. This is a hardware patient monitor, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this device does not utilize a training set in the AI sense.

Summary

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DEC 9 1998

K981/376

CHAPTER 23: 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

1.2 Establishment Registration Number 1218950

1.3 Hewlett-Packard Manufacturing Site Address

Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099

1.3.1 Manufacturing Site Establishment Registration Number 9680888

1.4 Sterilization Site

Does not apply.

1.5 Contact Persons

You may contact David Osborn at (978) 659-3178 or Elisabeth George at (978) 659-4663 for additional information. Or, a fax may be sent to (978) 685-5624. Alternate contact: Chas Burr at (978) 659-2529.

1.6 Date

4/14/98

2.0 Regulatory Information

2.1 References

· K950821 and K960934, Hewlett-Packard M1205A Viridia 24 (formally OmniCare 24)
· K922974 and K945134, Hewlett-Packard Model M1275A Component Transport System.
· K961247, Datex AS/3 Compact Monitor

Device Name. Trade Name 2.2

Proprietary: Hewlett-Packard M1205A Viridia 24 CT

Trade: Viridia 24 CT

Products (Components) Included As Part Of 2.3 This Device:

Accessories or additional components are included as part of the Hewlett-Packard M1205A Viridia 24 CT as indicated in the technical data sheet.

2.4 Device Classification

We believe the proper classification for the device is 870.1025, Monitor, Physiological, Patient.

2.5 Performance Standard:

None established under section 514.

3.0 Description

Viridia 24 CT is a patient monitor. This submission notifies the FDA that the power source was modified. No other significant changes were made to the device.

4.0 Intended use

4.1 Purpose

"Viridia 24 CT measures and displays multiple physiological parameters and waves, and generates alarms, and recordings. It exchanges information with compatible devices. Viridia 24 CT is not a therapeutic device." on page 3-1.

4.2 Patient Population

"Viridia 24 CT is intended to be used on adult, pediatric, and neonatal patients." on page 3-1.

4.3 Environment

"Viridia 24 CT is intended to be used in a clinical environment by licensed clinicians. It is not intended for home use." on page 3-1.

"It communicates with devices such as a central station through network interface ports and a serial I/O port. It is suitable for intra facility transport." on page 3-1.

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"Viridia 24 CT is a prescription device and will carry the following label, 'United States Federal law restricts this device to sale by or on the order of a physician.'" on page 3-1.

"Viridia 24 CT is not a therapeutic device." on page 3-1.

5.0 Indications for Use

5.1 510(k) Number

The 510(k) number has not been assigned.

5.2 Device Name

The device name is Hewlett-Packard M1205A Viridia 24 CT.

5.3 Indications for Use Statement

The paragraphs below are the elements of the indications for use statement for Viridia 24 CT.

Condition 5.3.1

"Condition: Viridia 24 CT is generally indicated when the clinician decides there is a need to measure and display multiple physiological parameters and waves, to generate alarms and recordings of adult, pediatric, or neonatal patients." on page 4-1.

5.3.2 Part of Body or Type of Tissue with Which the Device Interacts

"Part of Body or Type of Tissue with Which the Device Interacts: Viridia 24 CT does not contact the body or tissue of the patient. Signals are obtained from accessory electrode, transducer, and sensor devices." on page 4-1. Viridia 24 CT does not contact the body or tissue of the patient.

Frequency of Use 5.3.3

"Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician." on page 4-1.

Physiological Purpose 5.3.4

"Physiological Purpose: Viridia 24 CT is indicated when the purpose is to gain information for treatment, to assess adequacy of treatment, or to rule out causes of symptoms. Viridia 24 CT is well suited for patient monitoring." on page 4-1.

5.3.5 Patient Population

"Patient Population: Adult, pediatric, and neonatal non-ambulatory patients." on page 4-1.

5.3.6 Prescription Versus Over-the-Counter

"Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device." on page 4-1.

6.0 Verification and Validation

Viridia 24 CT 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 24 CT and host devices 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, with three profiles facing to the right, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 4 1999

Mr. David Osborn Medical Products Group Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810

K981376 Re: Hewlett-Packard M1205A Viridia 24CT Regulatory Class: III (three) Product Code: 74 DSI Dated: September 11, 1998 Received: September 14, 1998

Dear Mr. Osborn:

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 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 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. David Osborn

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. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Chapter 4:

< 981376 510(k) Number (if known)

Device Name: Hewlett-Packard M1205A Viridia 24 CT

Indications for Use Statement:

Frequency of Use: Viridia 24 CT is indicated for use when prescribed by a clinician.

Patient Population: Adult, pediatric, and neonatal non-ambulatory patients.

Prescription Versus Over-the-Counter: Viridia 24 CT is a prescription device.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use
✓

(Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Hewlett-Packard Company

Regulation Number and Section

§ 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.