Star 60 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3L / 5L), SpO2, Respiration, Temperature, NIBP, IBP, IBP and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, 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 and audible alarm signals. The monitor is not intended for home use.

Device Description

STAR 60 is a patient monitor with a wide range of communication options. Capacitive sensing buttons in keyboard is introduced. It fits in clearly to a new age of patient monitoring.

ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the main board and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the main board.
SpO2: This module is inbuilt inside the monitor on the main board. It is used to measure the partial pressure of oxygen in the human body.
. NIBP: This module is inbuilt inside the monitor on to the chassis. It is used to non-invasively measure the systolic, diastolic & mean blood pressure.
CO2: This module is inbuilt inside the monitor on to the chassis. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2).
. IBP: STAR 60 can support IBP modules. For ease of understands we shall name as IBP1 & IBP 2. IBP 1/2 module is inbuilt on the main board. It is used to invasively measure the systolic and diastolic blood pressure.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Skanray Technologies Private Limited Star 60 patient monitoring system, based only on the provided text.

It's important to note that this document is a 510(k) summary, not a full clinical study report. Therefore, detailed acceptance criteria for specific performance metrics (like accuracy ranges for ECG, SpO2, NIBP, etc.) and comprehensive study results are generally not found in this type of FDA document. Instead, it refers to compliance with recognized standards.

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for the Star 60 is implied by its adherence to various recognized medical device standards. The "reported device performance" is primarily the statement of substantial equivalence to predicate devices. This means the device is considered to perform "as well as or better than" the predicate devices and meets the safety and effectiveness requirements outlined in the standards.

Acceptance Criterion (Implied by Standard Compliance)	Reported Device Performance (Summary Statement)
Electrical Safety (IEC 60601-1)	Device passed Electrical and EMC Testing. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
EMC Compliance (IEC 60601-1-2)	Device passed Electrical and EMC Testing. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Usability (IEC 60601-1-6)	Device passed all non-clinical tests. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Alarm Systems (IEC 60601-1-8)	Device passed all non-clinical tests. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
ECG Monitoring Performance (IEC 60601-2-27, ANSI/AAMI EC 13)	Device passed all non-clinical tests specifically for ECG. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
NIBP Monitoring Performance (IEC 80601-2-30, ANSI/AAMI SP10)	Device passed all non-clinical tests specifically for NIBP. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
IBP Monitoring Performance (IEC 60601-2-34)	Device passed all non-clinical tests specifically for IBP. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Multifunction Patient Monitoring Performance (IEC 60601-2-49)	Device passed all non-clinical tests. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Respiratory Gas Monitoring Performance (CO2) (ISO 80601-2-55)	Device passed all non-clinical tests specifically for CO2. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Temperature Measurement Performance (ISO 80601-2-56)	Device passed all non-clinical tests specifically for Temperature. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Pulse Oximeter (SpO2) Performance (ISO 80601-2-61)	Device passed all non-clinical tests specifically for SpO2. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Software Life Cycle Processes (IEC 62304)	Device passed all non-clinical tests related to software. Deemed "as safe, as effective, and performs as well as or better than the predicate device."
Risk Management (ISO 14971)	Device passed all non-clinical tests related to risk management. Deemed "as safe, as effective, and performs as well as or better than the predicate device."

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- The document describes "Non Clinical Testing" which includes electrical and EMC tests and compliance with various IEC/ISO/ANSI/AAMI standards. These are typically laboratory-based tests of the device itself and its components, often using test equipment, simulators, and phantoms, rather than patient data.
- No sample size for a "test set" from patient data is mentioned for performance evaluation.
- Data provenance is not applicable in the context of these non-clinical, lab-based engineering and performance tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The testing described is non-clinical, focused on engineering and performance standards, not diagnostic or clinical interpretation needing expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to clinical studies where multiple human readers assess data, and a consensus method is used to establish ground truth or resolve discrepancies. The described tests are non-clinical hardware/software performance evaluations against known physical parameters or standard requirements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was reported. The Star 60 is a patient monitor, not an AI-assisted diagnostic tool that requires human interpretation in the same way. The document does not mention any AI components or human-in-the-loop performance studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, a "standalone" evaluation was done through the non-clinical testing. The device's direct performance (e.g., accuracy of ECG readings, NIBP measurements, SpO2 detection, etc.) was assessed against established standards purely based on its internal functioning, without human intervention for interpretation beyond operating the test equipment. However, this is not an "algorithm only" study in the sense of a standalone AI algorithm. It's a standalone device performance test.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be:
  - Reference standards/equipment: Calibrated test equipment (e.g., ECG simulators, NIBP simulators, SpO2 testers, temperature probes) providing known, accurate values.
  - Established engineering specifications: Performance limits defined by the relevant IEC/ISO/ANSI/AAMI standards.
The sample size for the training set:
- Not applicable / Not provided. The document does not describe a machine learning or AI algorithm that would require a "training set" for its development. The device is a traditional patient monitor.
How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set is mentioned, this information is not relevant to the described testing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 14, 2016

Skanray Technologies Private Limited % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K151512

Trade/Device Name: Star 60 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: January 7, 2016 Received: January 7, 2016

Dear Yolanda Smith:

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Mitchell Stein

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) K151512

Device Name

STAR 60

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary (As Per 21 CFR 807.92)

SPONSOR
Company Name:	Skanray Technologies PVt LtdHealthcare Division
Company Address:	#360, KIADB Industrial Area,Hebbal, Mysore – 570018, Karnataka, India.
Telephone:	91-821-2407202
Fax:	92-821-2407001
Contact Person:	J. Mahadevan
Summary Prepared	May 19, 2015
Trade Name:	Star 60
Common/Usual Name:	Patient Monitoring System
Classification Name:	Physiological Patient Monitor (without arrhythmia detection oralarms)
510(k) Number	K151512
Product Code:	MWI
Device Class:	Class II
Regulation Number:	21 CFR 870.2300
Predicate Device

Company	Product	510(k) #
Welch Allyn	Spot Vital Signs LXi	K101680
Philips Medical Systems	SureSigns VS4	K120132
Suntech Medicals	Cycle BP Monitor & Pulse
	Oximeter, Model 1060	K060820
L&T Medical & Systems	Stellar 300	K103763

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Device Description

STAR 60 is a patient monitor with a wide range of communication options. Capacitive sensing buttons in keyboard is introduced. It fits in clearly to a new age of patient monitoring.

ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the main board and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the main board.
SpO2: This module is inbuilt inside the monitor on the main board. It is used to measure the partial pressure of oxygen in the human body.
. NIBP: This module is inbuilt inside the monitor on to the chassis. It is used to non-invasively measure the systolic, diastolic & mean blood pressure.
CO2: This module is inbuilt inside the monitor on to the chassis. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2).
. IBP: STAR 60 can support IBP modules. For ease of understands we shall name as IBP1 & IBP 2. IBP 1/2 module is inbuilt on the main board. It is used to invasively measure the systolic and diastolic blood pressure.

Indications for Use

Vital signs parameters include ECG (3L/5L), SpO2, Respiration, Temperature, NIBP, IBP and Capnography (CO2). It can also display the numerical values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, FiCO2 readings.

Summary of Technological Characteristics

Star 60 is designed and developed with reference to our previous 510K cleared product Star55 with same product code as Star60 - MWI.

These 2 products are same in terms of:

ECG,
· Respiration,
· Temperature,
IBP,
· NIBP,
SpO2 and
CO2
Display type
Alarm systems
Thermal recorder / printer
Equipment classification, applicable standards

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Star60 is compared with MP70 for advanced features that are included in the Star 60 and include:

Communication with external equipment including analog and system outputs
Display size and resolution.

Differences between Star 60 and Star 55

The differences between the two devices includes advanced features that include:

Number of waveform traces displayed
Waveform display options / selections

The inclusion of the advanced features have been validated and verified to ensure that the new features do not impact performance and the safety and efficacy of the device.

Non Clinical Testing

Electrical and EMC Testing for the Star 60 included the following

IEC 60601-1-2	EMC Test Report
IEC 60601-1	Medical electrical equipment - Part 1: General requirements for basic safety andessential performance
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirements for basic safetyand essential performance -Collateral standard: Usability
IEC 60601-1-8	Medical electrical equipment -- Part 1-8: General requirements for basic safetyand essential performance --Collateral standard: General requirements, tests andguidance for alarm systems in medical electrical equipment and medical electricalsystems
IEC 60601-2-27	Medical electrical equipment - Part 2-27: Particular requirements for the basicsafety and essential performance of electrocardiographic monitoring equipment
IEC 80601-2-30	Medical electrical equipment -- Part 2-30: Particular requirements for the basicsafety and essential performance of automatic cycling non-invasive bloodpressure monitoring equipment.
IEC 60601-2-34	Medical electrical equipment -- Part 2-34: Particular requirements for the basicsafety and essential performance of invasive blood pressure monitoringequipment.
IEC 60601-2-49	Medical electrical equipment - Part 2-49: Particular requirements for the basicsafety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-55	Medical electrical equipment -- Part 2-55: Particular requirements for the basicsafety and essential performance of respiratory gas monitors
ISO 80601-2-56	Medical electrical equipment -- Part 2-56: Particular requirements for basicsafety and essential performance of clinical thermometers for body temperaturemeasurement
ISO 80601-2-61	Medical electrical equipment -- Part 2-61: Particular requirements for basicsafety and essential performance of pulse Oximeter equipment

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Additional Performance Testing:

ANSI/AAMI EC 13	Cardiac Monitors, Heart rate Meter and Alarms
ANSI/SSMI SP10	Manual, Electronic or Automated Sphygmomanometers
IEC 62304	Medical device software – software life cycle processes (Software/Informatics)
ISO 14971	Application of risk management to medical devices

Substantial Equivalence

The Star 60 is substantially equivalent to the predicate device in Indications for Use, Materials and Design. The conclusions drawn from the non-clinical tests demonstrate that the Star 60 is as safe, as effective, and performs as well as or better than the predicate device.

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Indications for Use

510(k) Number (if known) K151512

Device Name

STAR 60

Indications for Use (Describe)

Star 60 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 along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3L / 5L), SpO2, Respiration, Temperature, NIBP, IBP and Capnography (CO2). 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), Temperature, EtCO2, FiCO2 readings.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 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).