(27 days)
The Hewlett-Packard family of patient monitor products is intended for monitoring, recording, and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M1175A/76A/77A (Viridia CMS), the M1205A (Viridia 24/26), and the M3000A/M3046A (Viridia M3/4). The common name is patient monitor. The modification is a software based change that involves only the SpO2 algorithm of the measurement computer processing unit of each device.
The provided text describes a 510(k) submission for a software-based change to the SpO2 algorithm within the Hewlett-Packard family of Viridia Patient Monitors. Here's a breakdown of the acceptance criteria and study details based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specifications cleared for predicate devices (SpO2 algorithm performance) | All tested sensor-monitor combinations passed test criteria. Test results showed substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Neonatal patient data: Not explicitly stated, but clinical performance evaluations were conducted with "ICU neonates."
- Adult patient data: Not explicitly stated, but a "desaturation study" was conducted with "adults."
- Data Provenance: Not explicitly stated, but the studies were clinical performance evaluations. It's not specified whether the data was retrospective or prospective, or the country of origin, though the submitter is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. The text mentions "co-oximeters as a reference" for the adult desaturation study, implying a quantitative, objective ground truth rather than expert consensus for that specific measurement.
4. Adjudication Method for the Test Set
Not applicable/mentioned. The ground truth for the adult study was established using co-oximeters. The method for the neonatal data ground truth is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the updated SpO2 algorithm and its equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described appear to be standalone performance evaluations of the SpO2 algorithm. The text states: "Clinical performance evaluations using the new algorithm were conducted..." and describes validating the measurement of oxygen saturation.
7. The Type of Ground Truth Used
- Adult Study: Co-oximeters were used as a reference to validate the accuracy of the SpO2 measurement during a desaturation study. Co-oximetry is a gold standard for blood oxygen saturation measurement.
- Neonatal Study: The type of ground truth used to validate the measurement of oxygen saturation in ICU neonates is not explicitly stated.
8. The Sample Size for the Training Set
Not applicable/mentioned. The text describes verification, validation, and testing activities for a software change to an existing algorithm. There's no indication of a new algorithm being "trained" on a specific dataset in the context of this 510(k) summary. These are performance evaluations of an updated algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/mentioned, as a training set for a new algorithm is not described. The evaluation focused on the performance of a modified SpO2 algorithm against established predicate device specifications and clinical references.
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K 990972
4/19/99
10.0 510(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 Tel: 011 49 (7031) 14-2243 011 49 (7031) 14-4297 Fax: Email:egon pfeil@hp.com
This summary was prepared on March 11, 1999
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- The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M1175A/76A/77A (Viridia CMS), the M1205A (Viridia 24/26), and the M3000A/M3046A (Viridia The common name is patient monitor. Classification names are M3/4) . . as follows:
| RegulationNumber | Classification Name |
|---|---|
| 870.2700 | Oximeter |
| 870.2710 | Ear Oximeter |
| 870.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 870.1025 | Detector and Alarm, Arrythmia |
| 870.2900 | Cable, Transducer and Electrode, Patient (including connector) |
- The new combination device is substantially equivalent to previously 3. cleared HP devices marketed pursuant to K971910, K981576 and K990125, K903523, and K923343.
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- The modification is a software based change that involves only the SpO2 algorithm of the measurement computer processing unit of each device.
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- The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment or mobile environment for patient transport monitoring, the device is intended for measuring and displaying, recording and alarming multiple physiological parameters and waves in adult, pediatric, and neonatal patients.
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- The new combination device has the same technological characteristics as the legally marketed predicate devices.
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- Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new SpO2 algorithm using neonatal and adult patient data. 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 devices and test results showed substantial equivalence.
Clinical performance evaluations using the new algorithm were conducted with ICU neonates to validate the measurement of oxygen saturation, and with adults, for the purpose of validating accuracy by conducting a desaturation study with co-oximeters as a reference. All tested sensor-monitor combinations passed test criteria and test results showed substantial equivalence. No adverse events occurred during the studies.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 1999
Mr. Egon Pfeil Medical Products Group-Europe Hewlett-Packard GmbH Herrenberger Strasse 110-140 Boeblingen, Germany 71034
Re: K990972 Viridia Component Monitoring System M1175A/76A/77A and Viridia 24/26 M1205A Rev.K and The Viridia HP M3000A/M3056A, Rev.B Patient Monitors Requlatory Class: III (three) Product Code: 74 DSI Dated: March 20, 1999 Received: March 23, 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, 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 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 - Mr. Egon Pfeil
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. 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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3.1 ODE Indications Statement
Indications for Use Statement
510 (k) Number
(if known)
- The Hewlett-Packard Company (HP) family of Device Name Viridia patient monitors. These devices are individually known as the Viridia Component Monitoring System M1175A, M1176A, M1177A /Viridia 24/26 M1205A Rev.K, and the Viridia HP M3000A/M3046A Patient Monitor Rev.B.
- The Hewlett-Packard family of patient monitor Indications for products is intended for monitoring, recording, use and alarming of multiple physiological parameters. The devices are indicated for use in health care facilities by health care professionals whenever there is a need for monitoring the physiological parameters of adult, neonatal, and pediatric patients.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ath. A. Garlouski.
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number__
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.