(156 days)
The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI-ECG Option is indicated for:
- Assessment of symptoms that may be related to rhythm disturbances of the heart: patients with palpitations, the evaluation of arrhythmia's in adult and pediatric patients.
- Assessment of risk in patients with or without symptoms of arrhythmia.
- Assessment of efficacy of antiarrhythmic therapy.
- Assessment of pacemaker function.
- Assessment of symptomatic or asymptomatic patients to evaluate for ischemic heart disease.
- Assessment is indicated for single-hospital environment.
The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI electrode system. The EASI option is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.
This 510(k) summary (K990476) describes a software enhancement to the Hewlett-Packard Viridia Component Monitoring System (CMS) and Viridia 24/26 Rev. K, adding an EASI-ECG Option. This option allows the system to derive a 12-lead electrocardiogram from a 5-lead EASI electrode system. The submission focuses on substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria for the EASI-ECG option itself.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria for the EASI-ECG option's performance (e.g., accuracy of derived 12-lead ECG compared to standard 12-lead ECG) are mentioned. The submission focuses on equivalence to predicate devices for the overall system's function and intended use. Therefore, a table for this specific information cannot be generated from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission does not describe a clinical study of the EASI-ECG option proving its performance against specific acceptance criteria. The focus is on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no performance study is detailed.
4. Adjudication Method
Not applicable, as no performance study is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on the functionality of the EASI-ECG option and its equivalence to predicate devices.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study for the EASI-ECG algorithm is not described. The document discusses a "software enhancement enabling the CMS system to accommodate an electrode placement pattern," implying a feature integration rather than a standalone algorithm performance evaluation.
7. Type of Ground Truth Used
Not applicable, as no performance study is detailed with a defined ground truth.
8. Sample Size for the Training Set
Not applicable. The submission describes a software enhancement, not a machine learning algorithm requiring a training set in the typical sense.
9. How Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
Summary of Device Acceptance and Study Information (Based on Provided Text):
| Feature/Criterion | Description (Based on K990476) |
|---|---|
| Acceptance Criteria | Not explicitly stated for the EASI-ECG option's performance. The basis for clearance is Substantial Equivalence to legally marketed predicate devices (Totemite EASI Lead System Cable K872781B and Zymed T8010 Telemetry Central Station Monitor K951370). The device's "technological characteristics are essentially the same as those of the legally marketed predicate devices" in terms of measurement technology and ECG signal transmission. |
| Device Performance Reported | No specific performance metrics (e.g., accuracy, sensitivity, specificity for derived 12-lead ECG) are reported in the provided summary. The device "accommodate[s] an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI electrode system." |
| Sample Size (Test Set) | Not applicable. No performance study with a test set is detailed. The submission focused on demonstrating substantial equivalence. |
| Data Provenance (Test Set) | Not applicable. |
| Number & Qualifications of Experts (Ground Truth - Test Set) | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| Effect Size (MRMC) | Not applicable. |
| Standalone Performance Study | No. The submission describes a software enhancement integrated into an existing system, cleared based on substantial equivalence. |
| Type of Ground Truth Used | Not applicable, as no performance study is detailed with specific ground truth data for the EASI-ECG derived leads. The substantial equivalence argument relies on the predicate devices' established safety and effectiveness. |
| Sample Size (Training Set) | Not applicable. This summary describes a software enhancement, not an AI/ML algorithm requiring a training set. |
| Ground Truth Establishment (Training Set) | Not applicable. |
Conclusion from the Provided Text:
The K990476 submission for the Hewlett-Packard Viridia Component Monitoring System Rev.K with EASI-ECG Option does not present a performance study with explicit acceptance criteria, sample sizes, expert adjudication, or ground truth details for the EASI-ECG feature itself. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Totemite EASI Lead System Cable K872781B and Zymed T8010 Telemetry Central Station Monitor K951370) by asserting that the new device shares the same intended use and essentially similar technological characteristics (measurement technology and ECG signal transmission). The clearance is based on the premise that the EASI-ECG option is a software enhancement that allows an existing, cleared system to utilize a different electrode placement pattern to derive 12-lead ECG signals, implicitly assuming the derivation method's performance is acceptable within the context of the overall system's substantial equivalence to the predicate.
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7.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is: Egon Pfeil Regulatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 D-71034 Germany 011 49 (7031) 14-2243 Tel: Fax: 011 49 (7031) 14-4297 Email:egon pfeil@hp.com
This summary was prepared on February 3, 1999
-
- The name of this device is Hewlett-Packard Viridia Component Monitoring System, Rev.K, with EASI-ECG Option. The common name is HP Virdia CMS, Rev.K. Classification names are as follows:
| RegulationNumber | Classification Name |
|---|---|
| 870.2300 | Monitor, Cardiac (including Cardiotachometer & RateAlarm) |
| 870.2350 | Adapter, Lead Switching, Electrocardiograph |
| 870.1025 | Detector and Alarm, Arrythmia |
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- The new device with the EASI-ECG Option is substantially equivalent to the following predicate devices: the Totemite EASI Lead System Cable K872781B (12/29/87), and the Zymed T8010 Telemetry Central Station Monitor K951370 (10/6/95). The accessories and materials are optional and are the same accessories originally cleared for use with HP M1175A/76A CMS K882609 (1/19/89). The EASI-ECG will operate with the HP M1001A/B and M1002A/B ECG plug-in modules previously cleared under K973437 (12/3/97).
-
- The new device consists of a software enhancement enabling the CMS system to accommodate an electrode placement pattern allowing signals for deriving the 12-lead electrocardiogram from the 5-lead EASI electrode system. The EASI option is fully compatible with the existing HP ECG frontend modules M1001A/B or M1002A/B.
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-
- The CMS Rev.K with the EASI-ECG option has the same intended use as the legally marketed predicate devices. When used in the hospital environment, the HP EASI-ECG option is intended for use where 12-Lead ECG monitoring is indicated in adult patients.
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- The CMS Rev.K with the EASI-ECG option operates using a monitoring technology rather than a telemetry system as used in the predicates. The measurement technology and the transmission of ECG signals, however, are similar and therefore the technological characteristics are essentially the same as those of the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring three parallel lines that curve and resemble a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 1999
Mr. Egon Pfeil Regulatory Affairs Medical Products Group-Europe Hewlett-Packard GmbH Herrenbergerstresse 110-140 D-71034 Boeblingen Germany
Re: K990476 HP Viridia CMS and 24/26 Rev K with EASI-ECG Requlatory Class: III (three) Product Code: MHX Dated: May 21, 1999 Received: May 26, 1999
Dear Mr. Pfeil:
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, qood 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 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
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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.
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 diaqnostic 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, 2 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,
Thomas J. Callahan
Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known) | K990476 |
|---|---|
| Device Name | The Hewlett-Packard Viridia Component Monitoring System (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev. K with EASI-ECG Option |
| Indications for Use | The Hewlett-Packard Viridia Component Monitoring System, (M1175A/76A/77A), and Viridia 24/26 (M1205A) Rev.K with EASI-ECG Option is indicated for: Assessment of symptoms that may be related to rhythm disturbances of the heart: patients with palpitations, the evaluation of arrhythmia's in adult and pediatric patients.Assessment of risk in patients with or without symptoms of arrhythmia.Assessment of efficacy of antiarrhythmic therapy.Assessment of pacemaker function.Assessment of symptomatic or asymptomatic patients to evaluate for ischemic heart disease.Assessment is indicated for single-hospital environment. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation/(ODE) |
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| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K990476 |
| Prescription Use(Per 21 CFR 801.109) X | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ----------------------------- |
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§ 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.