(21 days)
The device is intended to provide ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in a professional healthcare facility. It is intended to be used by trained health care personnel. It is not intended for home 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 vs. Over-the-Counter: The HP 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 a licensed physician.
- Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
- Patient Population: Adult and pediatric patients.
The HP M2600A Viridia Telemetry System is a radio frequency physiological signal transmitter and receiver. The modification in this submission is the addition of a battery extender to enable the operation of the transmitter from an external power source.
This 510(k) summary describes a modification to an existing medical device, the HP M2600A Viridia Telemetry System. The modification is the addition of a battery extender. The provided text does not contain specific acceptance criteria or a detailed study proving the modified device meets such criteria in terms of performance metrics. Instead, it emphasizes that the modified device has the "same fundamental technology" and "same intended use" as the legally marketed predicate devices, and that verification and validation activities were successfully conducted.
However, based on the information provided, we can infer the approach to demonstrating equivalence and safety, and address the specific points where information is available.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it states that "Pass/fail criteria were based on the specifications cleared for the predicate device and test results demonstrated substantial equivalence." This implies that the acceptance criteria for the modified device (with the battery extender) were alignment with the previously cleared specifications of the predicate device for parameters like ECG and SpO2 monitoring, and overall system functionality and safety.
Given the nature of the modification (a battery extender), the performance criteria would likely focus on:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device continues to perform ECG and SpO2 monitoring as specified by the predicate (HP M2600A Viridia Telemetry System, K980429). | "Testing involved system level tests, integration 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 demonstrated substantial equivalence." This statement implies that the device, with the battery extender, functioned equivalently to the predicate in terms of its core physiological monitoring capabilities. Specific performance metrics (e.g., accuracy of ECG or SpO2) are not provided in this summary. |
| Safety: Introduction of the battery extender does not introduce new safety hazards (e.g., electrical safety, electromagnetic compatibility, thermal). | "safety testing from hazard analysis" and "interference testing" were successfully conducted. This indicates that potential safety risks associated with the battery extender were assessed and met acceptable safety standards (implied to be those of the predicate and relevant medical device safety standards). |
| Reliability: The device, with the battery extender, maintains its reliability characteristics. | "Verification, validation, and testing activities were successfully conducted to establish the safety, performance, and reliability characteristics of the battery extender." This suggests that reliability was assessed and met prior standards, though specific metrics are absent. |
| No change in Intended Use: The device retains its original intended use. | "The modified device... has the same intended use as the legally marketed predicate devices." This is explicitly stated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for the test set. It mentions "system level tests, integration tests, safety testing... interference testing, and hardware testing." These are typically laboratory or bench tests, not clinical studies involving patient data to assess performance metrics like sensitivity or specificity.
Given that this is a modification adding a battery extender, the focus of the testing would be on the electrical, mechanical, and functional integrity of the device and its safety with the new component, rather than performance on patient data datasets. Therefore, there is no mention of country of origin or retrospective/prospective data as these are not relevant to the type of testing described for this modification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This type of device modification (battery extender for a telemetry system) typically involves engineering and safety testing, not clinical performance evaluation against expert-established ground truth. Ground truth as typically defined in diagnostic AI/ML studies is not relevant here.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for comparing the diagnostic performance of human readers with and without AI assistance, which is not applicable to a modification involving a battery extender for a telemetry monitoring system.
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 hardware system for physiological monitoring, not an AI/ML algorithm.
7. The Type of Ground Truth Used
Not applicable in the conventional sense of ground truth for diagnostic devices. The "ground truth" for the testing performed would be engineering specifications, performance standards, and safety regulations for telemetry systems.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training set" for the development of any device would implicitly be the engineering design and development process that leads to the device specifications and prototypes.
9. How the Ground Truth for the Training Set Was Established
Not applicable for an AI/ML training set. For the development of the device itself (including the battery extender), the "ground truth" or foundational knowledge would be established through established engineering principles, industry standards (e.g., for electrical safety, EMI/EMC), and medical device regulations. Initial specifications would have been derived from the intended use and performance requirements of the predicate device.
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10.0 510(k) Summary of Safety and Effectiveness
This Special 510(k) submission notifies the FDA of our intention to modify the HP M2600A Viridia Telemetry System.
1.0 Manufacturer/Submitter
Denise Haley Quality and Regulatory Engineer
Hewlett Packard Company Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099
Telephone: 978-659-2701 978-Fax: e-mail: denise haley(@hp.com
2.0 Establishment Registration Number 1218950
3.0 Manufacturing Site Address
Hewlett Packard Company Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099
4.0 Sterilization Site
Does not apply.
5.0 Date
October 15, 1999
6.0 Device Name, Trade Name
Proprietary Name: HP M2600A Viridia Telemetry System (Formerly known as the HP M2600A OmniCare Telemetry System)
Common Name: HP Viridia Telemetry System
Classification Name: Radio frequency physiological signal transmitter and Receiver (per CFR 870.2910)
Hewlett Packard Company
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Component Classifications:
Device classification information is presented in the following table. This table also identifies the tier categorization based on the list distributed by the DDE on January 27, 1994:
| Classification | Procode | Description | Tier |
|---|---|---|---|
| 870.2910 II | DRG | Radio frequency physiological signal transmitter and receiver | 2 |
| 870.2700 II | DQA | Oximeter | 2 |
| 870.1025 III | DSI | Arrhythmia Detector with alarm | 2 |
Table 1: Panel 74, Cardiovascular
7.0 Substantial Equivalence
The modified device is substantially equivalent to the previously cleared HP M2600A Viridia Telemetry System, marketed pursuant to Premarket Notification K980429. Additional predicate devices are listed below:
| Manufacturer | Device | Model | 510(k) |
|---|---|---|---|
| Hewlett Packard | Telemetry Monitoring System | M1403A | K894277 |
| Hewlett Packard | Telemetry Monitoring System, Rev. 1.2 | M1403A | K911139 |
| Hewlett Packard | Telemetry Monitoring System, added Analog Output | M1403A | K913533 |
| Hewlett Packard | Telemetry Monitoring System, added ST monitoring | M1403A | K920429 |
| Hewlett Packard | M2600A Viridia Telemetry System | M2600A | K980429 |
| Hewlett Packard | M2605A Viridia Wave Viewer | M2605A | K974567 |
8.0 Modification Description
The modification in this submission is the addition of a battery extender to enable the operation of the transmitter from an external power source.
9.0 Intended Use
The modified device, HP M2600A Viridia Telemetry System, Release B, has the same intended use as the legally marketed predicate devices.
The intended use of the modified device has not changed from that of the predicate device:
The device is intended to provide ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in a professional healthcare facility. It is intended to be used by trained health care personnel. It is not intended for home use.
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Confidential
10.0 Fundamental Technology
The modified device subject to this submission has the same fundamental technology as the legally marketed predicate devices.
11.0 Design Controls
Verification, validation, and testing activities were successfully conducted to establish the safety, performance, and reliability characteristics of the battery extender. Testing involved system level tests, integration 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 demonstrated substantial equivalence.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov = 8 1999
Denise Haley Quality and Regulatory Engineer Hewlett Packard Company Medical Products Group 3000 Minuteman Road, MS 0491 Andover, MA 01810-1099
Re: K993516 HP M2600A Viridia Telemetry System Regulatory Class: III (three) Product Code: DSI Dated: October 15, 1999 Received: October 18, 1999
Dear Ms. Haley:
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 requlations 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 regulation may result in requlatory 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. Denise Haley
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 Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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,
Donk Telle
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Confidential
- 3.1 ODE Indications for Use Statement
Indications for Use Statement
510(k) Number: K993316
(if known)
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 vs. Over-the-Counter: The HP 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 a licensed physician. .
- Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a . licensed clinician.
- Patient Population: Adult and pediatric patients. .
PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Division Sign-Off) |
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K993516 |
|---|---|
| --------------- | --------- |
§ 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.