(366 days)
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Not Found
No
The provided text describes a standard patient monitor and does not mention any AI or ML capabilities.
No
The device is a patient monitor, intended to monitor physiological parameters, not to treat a condition.
No
Explanation: The device is described as a "patient monitor" that measures and displays "basic physiological parameters." It is used for monitoring, not for diagnosing diseases or conditions.
No
The description explicitly states the device is a "patient monitor" intended to monitor "basic physiological parameters." It lists various physiological data points (ECG, blood pressure, pulse oximetry, etc.) which are typically acquired through hardware sensors connected to the patient. While it mentions providing data over a network, the core function of acquiring physiological data implies a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of this device clearly states its purpose is to monitor basic physiological parameters of the patient directly. These parameters (ECG, blood pressure, temperature, respiration, pulse oximetry, carbon dioxide) are measured in vivo (within the living body), not in vitro (in a test tube or lab setting).
The device is a patient monitor, which is a type of medical device used for real-time physiological monitoring of a patient.
N/A
Intended Use / Indications for Use
The patient monitor is intended to monitor the basic physiological parameters of the patient under the direct supervision of a licensed healthcare practitioner. It can be used for all patients from Adult to Neonatal. The monitor is designed as a bedside or portable monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities.
The UT 4000F is not intended for use as an apnea monitor. The UT 4000F is not intended for use during MRI or CT scans.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and carbon dioxide.
The UT 4000F Patient Monitor is also intended to provide physiological data over a network to clinical information systems and allow the user to access hospital data at the point of care.
Product codes
MWI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult to Neonatal
Intended User / Care Setting
licensed healthcare practitioner / emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2003
Goldway US. Inc. Intellectual Property Law Group LLP c/o Mr. Justin Chen 12 South First Street, Suite 1205 San Jose, CA 95113
Re: K021154
Trade Name: Goldway UT 4000F Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: March 26, 2003 Received: March 27, 2003
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
1
Page 2 - Mr. Justin Chen
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
K. Zartman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administration Center for Devices and Radiological Health (HFZ-401) Page 45 of 48
Exhibit J: Revised Indication For Use Statement
Statement of Indications for Use
| 510(k) Number (if known) | K0021154 |
|---|---|
| -------------------------- | ---------- |
Device Name: GOLDWAY UT 4000F PATIENT MONITOR
Indications for Use:
The patient monitor is intended to monitor the basic physiological parameters of the patient under the direct supervision of a licensed healthcare practitioner. It can be used for all patients from Adult to Neonatal. The monitor is designed as a bedside or portable monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post-anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities.
The UT 4000F is not intended for use as an apnea monitor. The UT 4000F is not intended for use during MRI or CT scans.
Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and carbon dioxide.
The UT 4000F Patient Monitor is also intended to provide physiological data over a network to clinical information systems and allow the user to access hospital data at the point of care.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
DeTilla
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K821154
Image /page/2/Picture/13 description: The image shows the words "Prescription Use" followed by a box with an X in it. The X indicates that the prescription use box has been selected. The text is in a simple, sans-serif font and is left-aligned. The image is a simple black and white graphic.
Or (per 21 CFR 801.109) Over-the Counter Use