GOLDWAY PATIENT MONITOR, MODEL # UT4000F

K021154 · Goldway Us, Inc. · MWI · Apr 11, 2003 · Cardiovascular

Device Facts

• Record ID: K021154
• Device Name: GOLDWAY PATIENT MONITOR, MODEL # UT4000F
• Applicant: Goldway Us, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Apr 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Goldway UT 4000F is a bedside/portable patient monitor for professional medical facilities. Inputs include ECG, invasive/non-invasive blood pressure, pulse, temperature, respiration, pulse oximetry, and CO2. Device processes physiological signals to display real-time data and provides network connectivity to clinical information systems. Operated by clinicians to monitor patient status at point of care. Output allows healthcare providers to assess patient vitals, supporting clinical decision-making. Benefits include continuous patient surveillance across various hospital departments.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Bedside/portable patient monitor. Measures ECG, IBP, NIBP, pulse, temperature, respiration, SpO2, and CO2. Features network connectivity for data transmission to clinical information systems. Class II device (21 CFR 870.2300).

Indications for Use

Indicated for monitoring basic physiological parameters in patients ranging from neonates to adults. Used under direct supervision of licensed healthcare practitioners in professional medical facilities (hospitals, clinics, surgical centers). Contraindicated for use as an apnea monitor and during MRI or CT scans.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone]. 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 [phone] or [phone] 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

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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