The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use. The intended use is unaffected by the modification.

The indications for use of the Viridia Telemetry System are:

Condition: The licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.
Prescription versus over-the-counter: Viridia Telemetry System is a prescription device.
Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO2 signal is obtained from an accessory sensor in contact with the patient's skin.
Frequency of use: As prescribed by licensed clinician.
Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
Patient population: Adult and pediatric patients.

Device Description

The Hewlett-Packard HP M2600A Viridia Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized that a and receiver, accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device. The modification allows the user to utilize an EtO Sterilization process for the purpose of cross-infection prevention and changes the labeling to reflect a change in battery life specification and in the device name.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, recognizing that this is a 510(k) summary for a product modification, not a comprehensive clinical study report:

Analysis of the Provided Document:

The provided document is a 510(k) summary for a modification to the HP M2600A Viridia Telemetry System. The primary modification being described is the enablement of EtO sterilization for the device, and a change in battery life specification and device name. This is a pre-market submission to demonstrate substantial equivalence to a legally marketed predicate device, not a comprehensive clinical study proving new clinical efficacy or performance against defined acceptance criteria in the typical sense of a novel device.

Therefore, the "acceptance criteria" and "study" described herein are primarily focused on demonstrating that the modification does not adversely affect the safety and effectiveness of the device, particularly concerning the new sterilization process, and that the device remains equivalent to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Safety Post-Sterilization	The device's safety (including electrical safety, biocompatibility of materials, etc.) must not be degraded by EtO sterilization.	"Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process...and is that safety was not degraded. The test results support that purpose." The 510(k) clearance further confirms FDA's agreement that the modified device is "safe and effective when used as intended and indicated."
Performance Post-Sterilization	The device must continue to perform to its specifications (e.g., ECG and SpO2 monitoring accuracy) after EtO sterilization.	"Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process." "The device was thoroughly tested to verify that performance claims in the labeling are met."
Functionality (General)	The device functions as intended for ECG and SpO2 monitoring.	Implied to be maintained as the modification only concerns sterilization and labeling, not the core monitoring function. The statement "The device was thoroughly tested to verify that performance claims in the labeling are met" applies here.
Substantial Equivalence (Overall - Key Criterion)	The modified device must be substantially equivalent to the predicate device in terms of safety, effectiveness, and intended use.	"The comparison shows the device to be substantially equivalent in safety, effectiveness, and intended use to a legally marketed device." "Based on comparison to the predicated device and on the test results, the Viridia Telemetry System is substantially equivalent to the HP M 1403A." FDA concluded the device is "substantially equivalent."

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

Sample Size for Test Set: The document does not specify a numerical sample size for devices tested. It mentions "The device was thoroughly tested to verify that performance claims in the labeling are met." and "Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process."
Data Provenance: The data is generated from prospective testing conducted by the manufacturer (Hewlett-Packard) and "A qualified independent laboratory" specifically for this 510(k) submission to demonstrate the impact of the modification. There's no indication of country of origin for the data other than the manufacturer being in Andover, MA, USA. It's a technical validation, not clinical data from patients.

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

This type of information is not applicable to this 510(k) submission. The "ground truth" for this modification is the device's original specifications and safety profiles. The testing is to verify that the modification (EtO sterilization) does not alter these. This is a technical performance verification, not a diagnostic or AI-based assessment requiring expert consensus on a clinical condition.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense. The "adjudication" is implied to be the validation process itself, where test results are compared against predefined performance specifications and safety standards for the device. An independent laboratory was involved in performing tests related to EtO sterilization. The ultimate 'adjudication' is the FDA's review and determination of substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a modification (sterilization process, battery life, name change) of an existing medical device, not a new diagnostic algorithm or an AI-assisted system that would involve human readers.

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

No, a standalone algorithm performance study was not done. This device is a physiological monitoring system (telemetry for ECG and SpO2), not an AI algorithm. Its performance is intrinsic to its hardware and software for signal acquisition and display, which was already established with previous 510(k) clearances. The current submission focuses on the impact of a new sterilization process.

7. The Type of Ground Truth Used

The "ground truth" for this submission refers to the established performance specifications and safety requirements of the HP M2600A Viridia Telemetry System prior to the modification, and by extension, the characteristics of its predicate device (HP M1403A). The testing aimed to confirm that the modified device still met these existing benchmarks.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm that requires a training set.

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

Not applicable. As there is no AI algorithm or training set, this question is irrelevant to the provided document.

Summary

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CHAPTER 14: 1510(K)] Summar

This submission notifies the FDA of our SEP d 1998 intention to modify the HP M2600A Viridia Telemetry System.

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
1.4 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
February 2, 1998

2.0 Regulatory Information

2.1 References

510(k) Notifications:

후 DC # K961165 - HP M2600A OmniCare Telemetry System
l DC # K894277 - HP M1403A

2.2 Device Name, Trade Name

Proprietary: HP M2600A Viridia Telemetry System Common Name: HP Viridia Telemetry System.

Classification name: Radio frequency physiological signal transmitter and receiver (per CFR 870.2910)

2.3 Predicate Device(s) Predicate device information is tabulated below.

Table 3: Predicate Device Information

MFG	Device	Models	K#
Hewlett-Packard	Telemetry Monitoring System	M1403A System	K894277
Hewlett-Packard	Telemetry Monitoring System, Revision 1.2	M1403A System	K911139
Hewlett-Packard	Telemetry Monitoring System, added Analog Output	M1403A System	K913533
Hewlett-Packard	Telemetry Monitoring System, added ST monitoring	M1403A System	K920429

2.4 Products (Components) Included as Part of This Device:

No accessories or additional components are affected by this modification of the HP M2600A Viridia Telemetry System device.

2.5 Device Classification
74DRG

2.6 Performance Standard:

None established under section 514.

3.0 Description

The Hewlett-Packard HP M2600A Viridia Telemetry System consists of a pocket sized

{1}------------------------------------------------

digital synthesized transmitter, synthesized that a and receiver, accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device.

The modification allows the user to utilize an EtO Sterilization process for the purpose of cross-infection prevention and changes the labeling to reflect a change in battery life specification and in the device name.

4.0 Intended Use

device is intended to provide The ambulatory and nonambulatory monitoring of ECG and SpO, parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use. The intended use is unaffected by the modification.

5.0 Indications for Use

An indications for use statement is included in

this notification but was not part of the earlier notification, K961165.

The indications for use of the Viridia Telemetry System are:

Condition: The licensed clinician 비 Viridia Telemetry decides that the System should be used to monitor the patient.
Prescription versus over-the-counter: li System Viridia Telemetry is ਕ prescription device.
I Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO, signal is obtained from an accessory sensor in contact with the patient's skin.
트 Frequency of use: As prescribed by licensed clinician.
Physiological purpose: To monitor the ECG or SpO, of patients on the order of a licensed clinician.
D Patient population: Adult and pediatric patients.

Substantial Equivalence 6.0

Comparison of technological 6.1 characteristics

HP M2600A Viridia Telemetry System is now substantially equivalent to the M1403A regarding cross-infection prevention in that both transmitters now utilize similar EtO sterilization processes. The comparison shows the device to be substantially equivalent in safety, effectiveness, and intended use to a legally marketed device.

Verification and Validation 6.2

The device was thoroughly tested to verify that performance claims in the labeling are met. A qualified independent laboratory performed tests related to the EtO sterilization process. Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process. The purpose was to verify that the device continued to perform to its specification and is that safety was not degraded. The test results support that purpose.

6.3 SE Conclusion

Based on comparison to the predicated device and on the test results, the Viridia Telemetry System is substantially equivalent to the HP M 1403A.

7.0 Conclusion:

The logic of the SE Decision Tree leads to a determination of SE. We agree with that logic. The modified device is very similar to the predicate device. The modified device was thoroughly validated. We conclude, therefore, that it is safe and effective when used as intended and indicated.

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વે નિર્ઝિક

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elisabeth George Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810

K980429 Re: HP M2600A Viridia Telemetry System Mofication Regulatory Class: III (three) Product Code: 74 DSI Dated: May 28, 1998 Received: June 8, 1998

Dear Ms. George:

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 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 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.

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Page 2 - Ms. Elisabeth George

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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. allahan, 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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510(k) Number (if known):

K980429

Device Name: HP M2600A Viridia Telemetry System

Indications for Use:

The indications for use of the Viridia Telemetry System are:

· Condition: the licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.
· Prescription versus over-the-counter: Viridia Telemetry System is a prescription device.
Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in r art of bouy of type of tissue meeraces innal is obtained from an accessory sensor in contact with the patient's skin.
· Frequency of use: As prescribed by licensed clinician.
· Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
· Patient population: Adult and pediatric patients.

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asd

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kon
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number __
Prescription Use ✓ OR Over-The

Over-The-Counter Use

(Per 21 CFR 801.1109)

(Optional Format 1-2-96)

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.