HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A by HEWLETT-PACKARD CO.

The HP M2331A CareVue 9000 is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.

Device Description

The Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System. The modification is primarily a software based change that expands access to more information data bases. Also, improvements were made to upgrade the hardware and operating system environments.

AI/ML Overview

The provided text is a 510(k) summary for the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System, seeking clearance from the FDA in 1999. This document is focused on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the manner one might expect for a new diagnostic or AI-powered medical device today.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, expert involvement, and ground truth establishment is not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pass/Fail criteria based on specifications cleared for predicate devices.	"Testing involved system level tests, integration tests, and safety testing from risk analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." The document implies that all tests met these internal "pass/fail" or "specifications."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The summary refers to "system level tests, integration tests, and safety testing from risk analysis," which typically involve internal testing and possibly simulated data rather than patient data from a specific country or collected retrospectively/prospectively.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Given the nature of a Clinical Information Management System (CIMS), "experts" might have been clinicians or IT professionals evaluating system functionality and data integrity rather than medical diagnosticians establishing ground truth for disease detection, which is not the primary function of this device.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The CareVue 9000 is a Clinical Information Management System for data collection, storage, and management, not a diagnostic interpretation tool in itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not explicitly stated or in the context of an "algorithm only" performance as understood in AI/ML devices today. The device is a system with software, and its "performance" would be evaluated in terms of its functionality (e.g., data accuracy, accessibility, computational correctness for drug dosages), not standalone diagnostic accuracy.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated as "ground truth" in the modern sense (e.g., pathology, clinical outcomes). For a CIMS, the "ground truth" for its performance would likely relate to:
- Data Integrity: Whether data is accurately collected, stored, and retrieved.
- Functional Correctness: Whether computations (e.g., drug dosages) are performed correctly.
- System Reliability: Whether the system operates as intended without errors or crashes.
- This would be verified against system specifications and known correct computations/data.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. The CareVue 9000 is a rule-based or procedural software system, not an AI/machine learning device that requires a "training set" in the modern sense. Its development would involve software engineering and testing against requirements, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Establishment of Ground Truth for Training Set: Not applicable/not specified, as there is no "training set" in the context of this device.

Summary of Device and Study Context for K992636:

The K992636 submission for the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System is a premarket notification for a software-based change that expanded access to more information databases and upgraded hardware/operating systems. Its primary function is for data collection, storage, management of patient records, and computation of drug dosages.

The review process for this type of device in 1999 primarily relied on demonstrating substantial equivalence to existing predicate devices. This means the key argument was that the new device had the same intended use, technological characteristics, and performed safely and effectively as its predecessors. The "study" mentioned is general "Verification, validation, and testing activities" that included system-level tests, integration tests, and safety testing aligned with risk analysis. The acceptance criteria were based on the specifications of the predicate devices. This is a very different submission and review context compared to what would be required for a novel AI-powered diagnostic device today, which would necessitate rigorous clinical studies with detailed methodologies for ground truth, expert adjudication, and statistical performance metrics.

Summary

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K992636

AUG 3| 1999

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: Mike Hudon, Regulatory Engineer

Hewlett-Packard Company Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1085

978 659 3173 Tel: 978 685 5624 Fax: Email:mike hudon@hp.com

This summary was prepared on August 03, 1999

1. The name of this device is the Hewlett-Packard M2331A CareVue 9000 Clinical Information Management System. Classification names are as follows:

Regulation No.	Classification Name
870.2450	Medical cathode-ray tube display
None	Computers and software, medical

1. The new device is substantially equivalent to previously cleared HP devices marketed pursuant to K922210, K922058, K990125, K984194, and K822695.
1. The modification is primarily a software based change that expands access to more information data bases. Also, improvements were made to upgrade the hardware and operating system environments.
1. The new device has the same intended use as the legally marketed predicate devices. When used in the hospital environment for patient records management, the device is intended for collecting, storing, and managing patient records, and for computation of drug dosages.
1. The new device has the same technological characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities were conducted to establish the performance and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, and safety testing from risk analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three wavy lines that resemble a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 1999

Mr. Mike Hudon Regulatory Engineer Hewlett-Packard Company Medical Products Group 3000 Minuteman Road Andover, MA 01810

к992636 Re : HP Carevue 9000 Regulatory Class: II (Two) Product Code: DXJ August 6, 1999 Dated: Received: August 26, 1999

Dear Mr. Hudon:

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. Mike Hudon

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" (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. Callehan

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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K992636 510(k) Number (if known): __

Device Name:

'ﺩﺳ

Hewlett Packard Clinical Information System, CareVue 9000, Model M2331A

Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Valla Teli

diovascular. Respiratory.

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).