(13 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 Hewlett-Packard family of Viridia Patient Monitors individually known as the M3000A/M3046A (Viridia M3/4). The common name is patient monitor. The modification consists of the addition of software that involves only the arrhythmia and ST measurement algorithm of the measurement computer processing unit of each device.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. It primarily describes a 510(k) submission for a patient monitor, focusing on its substantial equivalence to previously cleared devices.
Here's an attempt to extract and infer information based on the limited text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain performance and reliability characteristics of the STAR algorithm. | Substantial equivalence to predicate device specifications (implied). |
| Pass system-level tests. | Tests conducted and passed (implied). |
| Pass integration tests. | Tests conducted and passed (implied). |
| Pass safety testing from hazard analysis. | Tests conducted and passed (implied). |
| Pass interference testing. | Tests conducted and passed (implied). |
| Pass hardware testing. | Tests conducted and passed (implied). |
Note: The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This implies that the acceptance criteria for the new device were the same as those established for the predicate device, and the new device met them. However, the specific metrics or values for these criteria are not detailed.
2. Sample size used for the test set and the data provenance
The document mentions "bench studies" for verification, validation, and testing activities. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). There's no indication of patient data being used for these bench studies; rather, it suggests laboratory or simulated environments.
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 testing described focuses on the algorithm's performance against predicate device specifications, not on expert-adjudicated ground truth from patient data.
4. Adjudication method for the test set
This information is not provided in the document. Given the nature of "bench studies" and evaluation against predicate specifications, an adjudication method in the context of human expert review is unlikely to have been relevant.
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 mentioned or implied. The testing described is focused on the device's adherence to its own specifications and equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the testing described appears to be a standalone algorithm evaluation. The document states, "Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the STAR algorithm using bench studies." This implies evaluating the algorithm's performance independent of human interaction.
7. The type of ground truth used
The "ground truth" for the testing described seems to be the "specifications cleared for the predicate device." The device's performance was compared against these established specifications, and "test results showed substantial equivalence." There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission's testing.
8. The sample size for the training set
The document does not provide information regarding a training set or its sample size. The focus is on the performance and reliability characteristics of an existing algorithm (STAR software) that has been modified, not on the development or training of a new AI model with new data.
9. How the ground truth for the training set was established
Since no training set is mentioned or implied for the modifications described in this 510(k) summary, how its ground truth was established is not applicable or provided. The document is about a modification to an already existing and presumably validated algorithm (STAR software).
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JUN 7 1999
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.
l. 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 April 27, 1999
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- The name of this device is the Hewlett-Packard family of Viridia Patient Monitors individually known as the M3000A/M3046A (Viridia The common name is patient monitor. Classification names are M3/4) . . as follows:
| RegulationNumber | Classification Name |
|---|---|
| 870.1435 | Computer, Diagnostic, Pre-Programmed, Single-Function |
| 870.1025 | Detector and Alarm, Arrhythmia |
| 870.2900 | Cable, Transducer and Electrode, Patient (includingconnector) |
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- The modification consists of the addition of software that involves only the arrhythmia and ST measurement alqorithm of the measurement computer processing unit of each device.
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- The new device has the same intended use as the leqally 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 STAR algorithm using bench studies. Testing involved system level tests, inteqration 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 showed substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 1999
Mr. Egon Pfeil Hewlett-Packard GmbH Medical Products Group - Europe Herrenberger Strasse 110-140 D-71034 Boeblingen GERMANY
Re: K991773 Viridia HP M3000A/M3046A (M3/M4), Rel.B Portable Patient Monitor Requlatory Class: III (three) Product Code: 74 DSI Dated: May 10, 1999 Received: May 25, 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 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 requlation (21 CFR Part 820) and that, through periodic OS 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 - 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 requlation (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. Collehan
Thomas J. Caflahan, 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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ODE Indications Statement 3.1
Indications for Use Statement
510(k) Number
(if known)
The Hewlett-Packard Company (HP) Viridia Device Name M3000A/M3046A Patient Monitor Rev.B with ST/AR Software. Viridia HP M3000A/M3046A Patient Monitor Rel.B
- Indications for The Hewlett-Packard family of patient monitor 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. Ciachochi.
Prescription Use
(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.