The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire 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 (3 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 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 and audible alarm signals. The monitor is not intended for home use.

Device Description

The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.

Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include:

. ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.
SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
. IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
. AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.

AI/ML Overview

This document is an FDA 510(k) summary for the Skanray Technologies Pvt Ltd. "Star 90" patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics for an AI/algorithm-driven device.

Based on the provided text, the device is a cardiac monitor, and the studies mentioned are non-clinical (electrical and EMC testing, and performance testing against recognized standards). There is no information provided about AI or algorithms, human reader studies, or detailed performance metrics against specific acceptance criteria for a new AI function.

Therefore, many of the requested items cannot be extracted from this document.

For the information that can be extracted, here's a summary:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table for acceptance criteria specific to the device's performance (e.g., accuracy, sensitivity, specificity for an AI-driven function). Instead, it lists the standards against which the device was tested for electrical safety, EMC, and basic performance of its various modules. The "reported device performance" is summarized by the statement: "Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The document describes non-clinical engineering and performance testing against standards, not clinical testing with a specific test set of patient data to evaluate an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no mention of human experts establishing ground truth for a test set in the context of an algorithm's performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there is no human-in-the-loop performance test described.

5. 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

Not applicable. There is no mention of an MRMC study or AI assistance. The device is a patient monitoring system, not an AI-driven interpretive device in the context of this 510(k).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The document does not describe an algorithm's standalone performance study. The device is a hardware patient monitor.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For the non-clinical tests mentioned, ground truth would be defined by the technical specifications and measurement precision requirements of the standards themselves (e.g., a known, precisely generated ECG signal, or a calibrated NIBP cuff pressure).

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This document does not describe the development or training of an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized profiles facing right, representing the department's focus on people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

June 17, 2015

Skanray Technologies Pvt Ltd. c/o Ms. Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton. Marvland 21114

Re: K150512

Trade/Device Name: Star 90 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: May 12, 2015 Received: May 14, 2015

Dear Ms. 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

forBram 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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below.

Device Name STAR90

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)

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EWAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions. search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwoork 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."

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K150512 Page 1 of 4

510(k) Summary

(As Per 21 CFR 807.92)

SPONSOR
Company Name:	Skanray Technologies PVt LtdHealthcare Division
Company Address:	Skanray Technologies PVT Ltd. No. 15-17,Hebbal Industrial Area, Mysore, KA 570016India
Telephone:	91-821-2407200
Fax:	92-821-2407001
Contact Person:	Hema Singh
Summary Prepared	September 5, 2014
Trade Name:	Star 90
Common/Usual Name:	Patient Monitoring System
Classification Name:	Physiological Patient Monitor (without arrhythmiadetection or alarms)
Product Code:	MWI
Device Class:	Class II
Regulation Number:	21 CFR 870.2300
Predicate Device
Company	Product	510(k) #
Larsen & Toubro Ltd	Star 55	K08073
Philips medizin Systeme Boeblingen	Philips Intellivue patient Monitor	K093268

Device Description

The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons.

. ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card.

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SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body.
NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure.
CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available
. IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure
. AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.

Indications for Use

The STAR 90 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 (3 lead / 12 lead), Spo2, Respiration, Temperature and Capnography (CO2), IBP. It can also display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean). Temperature, IBP, EtCO2 and FiCO2 readings.

Summary of Technological Characteristics

Star 90 is designed and developed with reference to our previous 510K cleared product Star55 with same product code as Star90 – MWI. These 2 products are same in terms of:

ECG,
Respiration, ●
Temperature, ●
IBP,
NIBP,

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SpO2 and ●
CO2
Display type ●
Alarm systems
Thermal recorder / printer ●
Equipment classification, applicable standards

Star90 is compared with MP70 for advanced features that are included in the Star 90 and include:

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

Differences between Star 90 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 90 included the following

IEC 60601-1-2	EMC Test Report
IEC 60601-1	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance
IEC 60601-1-6	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability
IEC 60601-1-8	Medical electrical equipment -- Part 1-8: Generalrequirements for basic safety and essential performance --Collateral standard: General requirements, tests andguidance for alarm systems in medical electricalequipment and medical electrical systems
IEC 60601-2-27	Medical electrical equipment - Part 2-27: Particularrequirements for the basic safety and essentialperformance of electrocardiographic monitoringequipment
IEC 80601-2-30	Medical electrical equipment -- Part 2-30: Particularrequirements for the basic safety and essentialperformance of automatic cycling non-invasive bloodpressure monitoring equipment.

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IEC 60601-2-34 Medical electrical equipment -- Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment.
IEC 60601-2-49 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-55 Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Medical electrical equipment -- Part 2-56: Particular ISO 80601-2-56 requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Medical electrical equipment -- Part 2-61: Particular ISO 80601-2-61 requirements for basic safety and essential performance of pulse Oximeter equipment

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 90 is substantially equivalent to the predicate device in Indications for Use, Materials and Design. Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices.

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).