(84 days)
The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:
- Can measure and display multiple physiological parameters and waves' a) of one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
-
- List of supported measurements
- ECG (a)
- Respiration (b)
The M1001B ECG and M1002B ECG/Respiration Modules are intended for monitoring, recording, and alarming of ECG and respiration for adult, pediatric, and neonatal patients. Existing hardware and software of the M1001B ECG and M1002B ECG/Respiration plug-in modules (which were originally cleared together with CMS under K882609) were modified. The CMS hardware and CMS software modules are unchanged. The modified M1001B ECG and M1002B ECG/Respiration plug-in modules were fully validated (including regression testing).
This document is a 510(k) summary for the M1001B ECG and M1002B ECG/Respiration Modules. It describes the intended use and states that the devices were fully validated, including regression testing, after modifications to their hardware and software. It also claims substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, specific device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications. The document focuses on regulatory approval and substantial equivalence rather than a detailed performance study.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The information you're asking for is not present in the provided text.
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P -- [510(k)] Summary of Safety and Effectiveness
DEC - 3 1997
The M1001B ECG and M1002B ECG/Respiration Modules are intended for monitoring, recording, and alarming of ECG and respiration for adult, pediatric, and neonatal patients. Existing hardware and software of the M1001B ECG and M1002B ECG/Respiration plug-in modules (which were originally cleared together with CMS under K882609) were modified. The CMS hardware and CMS software modules are unchanged. The modified M1001B ECG and M1002B ECG/Respiration plug-in modules were fully validated (including regression testing).
The comparison of intended use and technological characteristics of this device to other legally marketed devices taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness and intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 1997
Mr. Egon Pfeil Medical Products Group-Europe Hewlett-Packard GmbH Schickardstrasse 4 D-71034 Boeblingen Germany
Re: K973437 Models M1001B ECG and M1002B ECG/Respiration Plug-in Modules of Component Monitoring System (CMS) M1175A/76A Regulatory Class: II (two) Product Code: 74 DPS September 8, 1997 Dated: Received: September 10, 1997
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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 (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/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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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: M1001B ECG and M1002B ECG/Respiration Plug-in Modules
Indications For Use:
The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:
- Can measure and display multiple physiological parameters and waves' a) of one patient, and can generate alarms and printouts based on those measurements.
- Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
-
- List of supported measurements
- ECG (a)
- Respiration (b)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Woy Sezmdin M.D.
(Division Sign-Om)
Division of Cardiovascular, Respiratory,
and Neurological Devices K973437
510(k) Number.
Prescription Use: ves (Per 21 CFR 801.109) OR
Over-The-Counter Use: no
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(Optional Format 1-2-96)
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).