(25 days)
Not Found
No
The summary describes a clinical information system focused on data management and dosage computation, with no mention of AI or ML technologies.
No.
The device is described as a clinical information system for data collection, storage, and management, and for generating patient records and computing drug dosages. It does not directly provide therapy or treatment.
No
The device is described as a "clinical information system intended for use in data collection, storage, and management." Its functions, such as patient record generation and drug dosage computation, do not involve directly diagnosing medical conditions, but rather managing data related to patient care.
No
The device description explicitly states that improvements were made to upgrade the hardware and operating system environments, indicating it is not solely software.
Based on the provided information, the HP M2331A CareVue 9000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "clinical information system intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems." It focuses on managing patient data and computing drug dosages. This is not the typical function of an IVD, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that it's a "Clinical Information Management System" with software and hardware upgrades. There is no mention of analyzing biological samples.
- Lack of IVD-specific information: The document does not mention analyzing biological specimens, diagnostic testing, or providing diagnostic information based on laboratory results.
Therefore, the HP M2331A CareVue 9000 falls under the category of a clinical information system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment, health care providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K922210, K922058, K990125, K984194, K822695
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
-
- 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 |
-
- 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.
-
- 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.
-
- The new device has the same technological characteristics as the legally marketed predicate devices.
-
- 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.
1
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.
2
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
3
Page
K992636 510(k) Number (if known): __
Device Name:
'ﺩﺳ
Hewlett Packard Clinical Information System, CareVue 9000, Model M2331A
Indications for Use:
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.
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
|---|
| -------------------------------------------------------------------------- |
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use |
|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use |
|---|
| (Optional Format 1-2-96) |
Valla Teli
diovascular. Respiratory.