Datalys Multi-Parameter Patient Monitor

K150691 · Lutech Industries, Inc. · MWI · May 15, 2015 · Cardiovascular

Device Facts

• Record ID: K150691
• Device Name: Datalys Multi-Parameter Patient Monitor
• Applicant: Lutech Industries, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: May 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

Datalys Multi-Parameter Patient Monitor 750, 760, 780 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be the user from the monitor. The monitor models monitor parameters such as ECG (3-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both. The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans. The monitor models are not designed for home use, and are restricted to be used on one patient at a time. The device has not been tested for and it is not intended for pediatric use.

Device Story

Multi-parameter patient monitor for professional clinical settings; inputs include ECG (3-lead), respiration, SpO2, NIBP, and temperature sensors. Device processes physiological signals to display real-time data and trigger alarms when operator-defined thresholds are exceeded or system faults occur. Operated by licensed healthcare practitioners; output used for patient status assessment and clinical decision-making. Not intended for pediatric patients, home use, or MRI/CT environments. Does not perform arrhythmia detection, ST-segment analysis, or apnea monitoring. Restricted to single-patient use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parameter monitor for ECG, RESP, SpO2, NIBP, and TEMP. Features operator-set alarm thresholds for physiological parameters and system faults. Designed for professional clinical use; not MRI/CT compatible. Software-based monitoring system.

Indications for Use

Indicated for adult patients in professional medical environments requiring monitoring of ECG (3-lead), respiration, SpO2, NIBP, and temperature. Not for pediatric use, home use, MRI/CT environments, or arrhythmia/ST-segment monitoring.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 15, 2015

Lutech Industries, Inc. % Jimmy Wu Associate Lee & Xiao 2600 Mission St., Suite 100 San Marino, California 91108

Re: K150691

Trade/Device Name: Datalys Multi-parameter Patient Monitor 750, 760, 780 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DPS, DOA, DXN, FLL Dated: March 11, 2015 Received: March 18, 2015

Dear Jimmy Wu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150691

Device Name

Datalys Multi-Parameter Patient Monitor 750, 760, 780

#### Indications for Use (Describe)

Datalys Multi-Parameter Patient Monitor 750, 760, 780 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be the user from the monitor.

The monitor models monitor parameters such as ECG (3-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.

The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.

The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

The device has not been tested for and it is not intended for pediatric use.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-family: Arial;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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