(90 days)
The Hewlett-Packard Viridia CMS Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.
The modification is the addition of new applications software and firmware that involves the addition of the M1027A EEG Module to the HP M1175A/76A/77A Component Monitoring System to allow the measurement of electroencephalographic signals.
The provided text describes a 510(k) summary for the Hewlett-Packard Viridia M1175A/76A/77A Component Monitoring System with M1027A EEG module. However, it does not contain detailed acceptance criteria or a study design structured in the way requested by the prompt for a device performance evaluation. The document primarily focuses on the device's substantial equivalence to predicate devices and describes general validation and testing activities.
Here's an attempt to extract and infer information based on the provided text, highlighting the missing details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System level tests pass | Test results showed substantial equivalence. |
| Integration tests pass | Test results showed substantial equivalence. |
| Environmental tests pass | Test results showed substantial equivalence. |
| Safety testing from hazard analysis passes | Test results showed substantial equivalence. |
| Interference testing passes | Test results showed substantial equivalence. |
| Hardware testing passes | Test results showed substantial equivalence. |
| Standards compliance | Pass/Fail criteria based on standards, where applicable. |
| Specifications cleared for predicate devices met | Pass/Fail criteria based on specifications cleared for predicate devices. |
| Acceptable applicability, usability, and efficiency during clinical performance evaluation | More than 90% of users found applicability, usability, and efficiency acceptable or better. |
| No adverse events (beyond minor skin irritation) | Only one instance of minor skin irritation reported. |
Missing Information: Specific quantitative thresholds for hardware, software, and clinical performance are not detailed. For example, what constitutes "acceptable" usability or specific signal-to-noise ratios for EEG acquisition are not provided.
2. Sample size used for the test set and the data provenance
The text mentions "Clinical performance evaluations were conducted with the EEG module to validate two channel functionality under conditions existing in the indicated hospital environments."
- Sample Size: Not specified. It only refers to "users."
- Data Provenance: The studies were conducted "under conditions existing in the indicated hospital environments" for the specified patient populations (adult, pediatric, and neonatal). No country of origin is explicitly mentioned, but the submitter is from Germany and the notification is to the US FDA. It's implied to be prospective clinical observations, but not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The clinical evaluation focused on "applicability, usability, and efficiency" as perceived by "users," not on diagnostic accuracy requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the study did not focus on diagnostic accuracy 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
- No MRMC study was done. This device is a measurement module for EEG signals, not an AI-assisted diagnostic tool for human readers. The clinical evaluation focused on system usability and functionality.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the device's core functionality (measuring EEG signals) was evaluated as a standalone component within the larger monitoring system during "system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing." These tests would assess the algorithm's performance in signal acquisition and processing. However, a separate "algorithm only" performance study in the context of diagnostic accuracy (e.g., classifying EEG patterns) is not described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical performance evaluation mentioned, the "ground truth" was user perception of "applicability, usability, and efficiency," rather than a clinical ground truth for diagnostic accuracy (like expert consensus on EEG abnormalities or pathology). For the technical tests, the "ground truth" would be established by engineering specifications, relevant standards, and the performance of predicate devices.
8. The sample size for the training set
This information is not provided. The document describes validation and testing activities, but not the development or training of any machine learning algorithms. The device's functionality seems to be based on established signal processing and measurement principles rather than a learning-based approach requiring a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a training set or machine learning components requiring a "ground truth" for training.
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510(k) Summary 9.0
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 Requlatory 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 July 28, 1999
- The name of this device is the Hewlett-Packard Viridia M1175A/76A/77A Component Monitoring System with M1027A EEG module. The common name is patient monitor. Classification name is as follows:
| RegulationNumber | Classification Name |
|---|---|
| 882.1400 | Electroencephalograph |
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- The modification is the addition of new applications software and firmware that involves the addition of the M1027A EEG Module to the HP M1175A/76A/77A Component Monitoring System to allow the measurement of electroencephalographic signals.
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- The new device has the same intended use as the legally marketed predicate devices. When connected by appropriate electrodes, and used in the operating room and intermediate/critical care environments, the device is intended for measuring EEG signals in adult, pediatric, and neonatal patients.
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- The new device has the same technological characteristics as the legally marketed predicate devices.
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- Validation, and testing activities were conducted to establish the performance and reliability characteristics of the new module using system level tests, integration tests, environmental tests, safety testing from hazard analysis, interference testing, and hardware testing. Pass/Fail criteria were based on standards,
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where applicable, and on the specifications cleared for the predicate devices. The test results showed substantial equivalence.
Clinical performance evaluations were conducted with the EEG module to validate two channel functionality under conditions existing in the indicated hospital environments. More than 90% of the users found the applicability, usability, and efficiency of EEG M1027A module monitoring acceptable or better. Apart from one instance of minor skin irritation, no adverse events were reported during the studies.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Egon Pfeil Regulatory Affairs Hewlett-Packard GmbH Medical Products Group - Europe Herrenberger Strasse 110-140 D-71034 Boeblingen Germany
8 1999 NOV
Re: K992674
Trade Name: Hewlett-Packard Viridia Component Monitoring System Regulatory Class: III Product Code: GWQ, MHX Dated: August 5, 1999 Received: August 10, 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 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 requirement, as set forth in the Quality System Regulation (OS) 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 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. 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) 594-4595. 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/dsmamain.html".
Sincerely yours,
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ODE Indications Statement 3.1
Indications for Use Statement
510 (k) Number (if known)
- The Hewlett-Packard Company (HP) Viridia CMS Device Name Patient Monitoring System, Rel.K, with M1027A EEG Measurement Module.
- The Hewlett-Packard Viridia CMS Patient Indications for Monitoring System, Rel.K, with M1027A EEG Use Measurement Module is intended for measurement and display of the electroencephalogram of adults, pediatrics, and neonates in the Operating Room and intermediate/critical care environments.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K992674
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
er 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.