STAR 65

K172147 · Skanray Technologies Pvt, Ltd. · MWI · May 25, 2018 · Cardiovascular

Device Facts

• Record ID: K172147
• Device Name: STAR 65
• Applicant: Skanray Technologies Pvt, Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: May 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians. In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).

Device Story

Star 65 is a multi-parameter modular patient monitoring system for bedside or intra-hospital transport use. It accepts inputs via sensors for ECG (3/5 lead), SpO2, respiration, temperature, IBP, NIBP, CO2, CO, and anesthesia gases. The device processes these signals to display real-time numeric values and waveforms on a 12.1-inch touchscreen. It features adjustable alarm limits with visual (color-coded) and audible signals, 240-hour trend storage, and a drug calculator. Operated by trained clinicians, the output allows for continuous patient assessment and clinical decision-making regarding vital sign stability. It supports connectivity via Ethernet, Wi-Fi, and USB for central nursing station integration and data management. The device benefits patients by providing continuous physiological monitoring and timely alerts for abnormal conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), alarm systems (IEC 60601-1-8), and parameter-specific performance standards (ECG, NIBP, IBP, CO2, temperature, pulse oximetry).

Technological Characteristics

Modular patient monitor with 12.1" TFT LCD touchscreen. Parameters: ECG, SpO2 (Nellcor), NIBP (Suntech), IBP, CO (thermodilution), CO2 (Medtronic Microstream), and AGM (Artema). Connectivity: Ethernet, Wi-Fi, USB, HDMI. Power: 100-240V AC or internal 14.8V 4.0Ah Li-ion battery. Software: Major level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971.

Indications for Use

Indicated for monitoring vital signs of single adult, pediatric, or neonatal patients at bedside or during intra-hospital transport. Parameters include ECG, SpO2, Respiration, Temperature, IBP, NIBP, CO2, CO, and anesthesia gases. Arrhythmia/ST detection indicated for adult/pediatric patients only (not available in USA). Not for home use; for use by trained clinicians only.

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.

Predicate Devices

• Star 90 (K150512)
• MP50 (K161531)
• Star 55 (K080173)

Submission Summary (Full Text)

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May 25, 2018

Skanray Technologies Pvt Ltd % Parul Chansoria Regulatory Consultant Elexes 6494 Tralee Village Dr. Dublin, California 94568

Re: K172147 Trade/Device Name: Star 65 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm). Regulatory Class: Class II Product Code: MWI, DRT, DSJ, DXN, DXG, DSF, DRS, CCK, FLL, NHO, CBO, DQA, NHP, CCL, MNR, CBS, NHQ, CBR, KRB Dated: April 23, 2018 Received: April 27, 2018

Dear Parul Chansoria:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K172147

Device Name Star 65

#### Indications for Use (Describe)

Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.

In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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#### SECTION 5. 510 (K) SUMMARY (AS PER 21 CFR 807.92)

## I. SUBMITTER

Skanray Technologies Pvt Ltd, Healthcare division, #360, KIADB Industrial Area, Hebbal, Mysore - 570018, Karnataka, India.

Contact Person: Parul Chansoria, Regulatory Consultant, Elexes Telephone: [phone] E-mail: [e-mail]

Summary Prepared: May 23, 2018

FDA Establishment Number: 3002513440

## II. DEVICE

Common/Usual Name: Patient Monitoring System Trade Name: Star 65 Regulation Description: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Classification Panel: Cardiovascular Primary Product Code: MWI Regulation Number: 870.2300

| Product Code | Regulation Number | Regulation Description |
|--------------|-------------------|----------------------------------------------------------------|
| DXN | 870.1130 | Noninvasive blood pressure measurement system |
| KRB | 870.1915 | Thermodilution probe |
| DRT | 870.2300 | Cardiac monitor (including cardiotachometer and rate<br>alarm) |
| DQA | 870.2700 | Oximeter |
| DSJ | 870.1100 | Blood Pressure Alarm |
| DXG | 870.1435 | Single-function, preprogrammed diagnostic computer |
| DSF | 870.2810 | Paper chart recorder |
| DRS | 870.2850 | Extravascular blood pressure transducer |
| CCK | 868.1400 | Carbon dioxide gas analyzer |
| CBQ | 868.1500 | Enflurane gas analyser |
| NHO | 868.1500 | Enflurane gas analyser |
| NHP | 868.1500 | Enflurane gas analyser |
| NHQ | 868.1500 | Enflurane gas analyser |
| CBS | 868.1620 | Halothane gas analyser |
| CBR | 868.1700 | Nitrous oxide gas analyser |
| CCL | 868.1720 | Oxygen gas analyser |

#### Secondary Product Codes:

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| MNR | 868.2375 | Breathing frequency monitor |
|-----|----------|---------------------------------|
| FLL | 880.2910 | Clinical electronic thermometer |

## III. PREDICATE DEVICE

The Patient Monitoring System (Model: Star 65) is substantially equivalent to the following cleared device:

| Company | Predicate<br>Priority | Product | 510(k)<br>Number | Product<br>Code | Regulation<br>Number | Regulation<br>Description |
|----------------------------------------------|-----------------------|---------|------------------|-----------------|----------------------|-------------------------------------------------------------------------------------------|
| Skanray<br>Technologies Pvt.<br>Ltd. | Primary | Star 90 | K150512 | MWI | 21 CFR<br>870.2300 | Cardiac Monitor<br>(including<br>Cardiotachometer<br>and Rate Alarm) |
| Philips<br>MedizinSysteme<br>Boeblingen GmbH | Secondary | MP50 | K161531 | MHX | 21 CFR<br>870.1025 | Arrhythmia<br>Detector and<br>Alarm (Including<br>ST-Segment<br>Measurement<br>and Alarm) |
| L&T Medical &<br>Systems | Tertiary | Star 55 | K080173 | MWI | 21 CFR<br>870.2300 | Cardiac Monitor<br>(including<br>Cardiotachometer<br>and Rate Alarm) |

## IV. DEVICE DESCRIPTION

Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2.

Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings.

Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details.

Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour.

Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.

#### V. INDICATIONS FOR USE

Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic and Mean), Non-invasive Blood

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#### K172147

Pressure (Systolic, Diastolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.

In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients (ST and Arrhythmia detection functionality is not available for U.S.A).

## VI. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The monitoring of vital sign physiological parameters is the technological principle for both the subject and predicate devices. It is based on the use of modules and accessories that are either connected internally or externally to the monitors in order to monitor the specific physiological parameter.

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| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Star 65 | Star 90 | MP50 | Star 55 | --- |
| Indication For Use | Star 65 multi-parameter Patient<br>Monitoring system is intended to<br>monitor a single Adult, Pediatric<br>or Neonatal patient's vital signs<br>at the bedside or during intra-<br>hospital transport with the<br>appropriate accessories<br>mentioned / supplied with the<br>unit. Vital signs parameters<br>include ECG (3 lead /5 lead),<br>SpO2, and Respiration,<br>Temperature, Invasive Blood<br>Pressure (Systolic, Diastolic and<br>Mean), Non-invasive Blood<br>Pressure (Systolic, Diastolic and<br>Mean), Capnography (CO2),<br>Cardiac Output (CO) & AGM<br>module. It can display the<br>numeric values of HR/PR, SpO2,<br>RR, Non-Invasive Blood Pressure<br>(Systolic, Diastolic and Mean),<br>Invasive Blood Pressure<br>(Systolic, Diastolic and Mean),<br>Temperature, CO, EtCO2 and<br>FiCO2, N2O, O2, EtAA and<br>FiAA readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device | Star 90 multi-parameter<br>Patient monitoring system<br>is intended to monitor a<br>single adult, pediatric or<br>neonatal patient's vital<br>signs at the bedside or<br>during intra- hospital<br>transport along with the<br>appropriate accessories<br>mentioned / supplied with<br>the unit. Vital signs<br>parameters include ECG<br>(3 lead / 5 lead / 12 lead).<br>Spo2, Respiration,<br>Temperature and<br>Capnography (CO2), IBP.<br>It can also display the<br>numeric values of HR/PR,<br>SpO2, RR, Non-Invasive<br>Blood Pressure (Systolic,<br>Diastolic, and Mean)<br>Temperature, IBP, EtCO2<br>and FiCO2 readings. The user responsible to interpret the monitored data made available will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible | The monitors are<br>indicated for use by<br>health care<br>professionals whenever<br>there is a need for<br>monitoring the<br>physiological<br>parameters of patients.<br>The monitors are<br>intended to be used for<br>monitoring and<br>recording of, and to<br>generate alarms for,<br>multiple physiological<br>parameters of adults,<br>pediatrics, and<br>neonates. The monitors<br>are intended for use by<br>trained healthcare<br>professionals in a<br>hospital environment. The MP50 monitors are additionally intended for use in<br>transport situations<br>within hospital environments. The monitors are only for use on one patient at a time. They are not | Star 55 multi-<br>parameter Patient<br>Monitoring system<br>is intended to<br>monitor a single<br>Adult, Pediatric or<br>Neonatal patient's<br>vital signs at the<br>bedside or during<br>intra-hospital<br>transport along with<br>the appropriate<br>accessories<br>mentioned /<br>supplied with the<br>unit. Vital signs<br>parameters include<br>ECG (3 lead /5 lead/<br>12 lead), SpO2,<br>Respiration,<br>Temperature,<br>Capnography (CO2), & optional Gas module unit. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean) | Same |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| | permits patient monitoring with<br>adjustable alarm limits as well as<br>visible and audible alarm signals.<br>The monitor is not intended for<br>home use. It shall be used only by<br>trained clinicians. | and audible alarm signals.<br>The monitor is not<br>intended for home use. | intended for home use.<br>Not therapeutic<br>devices. The monitors<br>are for prescription use<br>only. | (Systolic, Diastolic<br>and Mean),<br>Temperature,<br>EtCO2, FiCO2,<br>N2O, O2, EtAA and<br>FiAA readings.<br>The user,<br>responsible to<br>interpret the<br>monitored data<br>made available, will<br>be a professional<br>health care provider.<br>The device permits<br>patient monitoring<br>with adjustable<br>alarm limits as well<br>as visible and<br>audible alarm<br>signals. The monitor<br>is not intended for<br>home use. | |
| | In addition Star 65 got<br>Arrhythmia and ST detection<br>from 3L/5L ECG measurements.<br>The Arrhythmia and ST analysis<br>module is intended for use with<br>Adult & Pediatric patients and is<br>not intended for use with<br>Neonatal patients(ST and<br>Arrhythmia detection<br>functionality is not available for<br>U.S.A). | | | | |
| DISPLAY: | | | | | |
| Type | Colour TFT LCD display | Colour TFT LCD<br>display | Colour TFT LCD<br>display | --- | Same as Star 90 |
| Size | 12.1 inch | 15 inch | 12.1 inch | --- | Same as MP50 |
| Resolution | 1024 X 768 | 1024 X 768 | 800 X 600 | | Same as Star 90 |
| No. of traces | 8 traces | 10 traces | 6 traces | | Similar to Star 90 |
| Sweep (trace) speed | 12.5, 25, 50mm/Sec for ECG,<br>SpO2, IBP1, IBP2, IBP3 & IBP4.<br>6.25, 12.5, 25mm/Sec for<br>Respiration, AGM &<br>Microstream Capnography | 12.5, 25, 50mm/Sec for<br>ECG, SpO2 IBP1, IBP2,<br>IBP3 & IBP4.<br>6.25, 12.5, 25mm/Sec<br>for Respiration, AGM<br>& Microstream | --- | | Same as Star 90 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| | | Capnography | | | |
| Waveform<br>display options | a) Standard Formats: 3<br>b) User Formats: 4<br>c) Auto Format<br>d) Quick ECG format | e)Standard Formats: 3<br>f) User Formats: 4<br>g) Auto Format<br>h) Quick ECG format | --- | --- | Same as Star 90 |
| CONTROLS: | | | | | |
| | Front Panel:<br>1 switch for Unit ON / OFF.<br>1 switch for Alarm<br>Acknowledgment<br>1 switch for NIBP start/stop<br>1 switch for Freeze<br>1 switch for Home<br>1 switch for Recording<br>1 switch for Pump on<br>1 switch for to set Monitor<br>in stand-by Mode<br>1 switch for GOTO (Short cut<br>Key)<br>1 switch for Optical encoder<br>with switch.<br>1 switch for IBP zeroing | --- | --- | Front Panel:<br>1 switch for Unit<br>ON / OFF.<br>1 switch for<br>Alarm<br>Acknowledgment<br>1 switch for NIBP<br>start/stop<br>1 switch for Freeze<br>1 switch for Home<br>1 switch<br>for<br>Recording<br>1 switch<br>for Pump<br>on<br>1 switch for to<br>set Monitor in<br>stand-by<br>Mode<br>1 switch for<br>GOTO (Short<br>cut Key)<br>1 switch for<br>Optical encoder | Same as Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| ALARMS: | | | | with switch.<br>1 switch for IBP<br>zeroing…