The Star 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unpin Vital signs parameters include ECG (3 lead / 5 lead), SpO2, Respiration, Temperature, external optional 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, EyCO2, and FiCO2.

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Description

STAR 50N is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, SpO2 and external CO2 (optional).

STAR 50N is a 6-channel monitor with 10.4" TFT display capable of displaying ECG, Respiration, Spo2, CO2, digital values of HR/PR, SpO2, RR, Non-Invasive Blood pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has 168 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It has got optional communication features - USB, Wi/Fi (optional) and Ethernet. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display

AI/ML Overview

This document is a 510(k) summary for the STAR 50N Patient Monitoring System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

Therefore, many of the requested fields cannot be filled directly from the provided text, as the document describes a regulatory submission based on comparison to existing devices, not a de novo study proving new acceptance criteria.

Here's an analysis based on the provided text, highlighting what information can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria and reported device performance for the STAR 50N in the traditional sense of a clinical or technical validation study with specific metrics (e.g., accuracy, sensitivity, specificity). Instead, it states that the device is substantially equivalent to predicate devices.

The acceptance criteria are implicitly met by demonstrating that the STAR 50N shares the "same" technological characteristics and principles of operation, and performs "as well as" or "no worse than" the predicate devices. The document explicitly states:

Parameter	Star 50N	Star 55^(Predicate)^
Alarms	Same	Same
ECG	Same	Same
Respiration	Same	Same
Temperature	Same	Same
Pulse Oximetry	Same	Same
IBP (Invasive Blood Pressure)	Same	Same
Capnography	Same	Same

Parameter	Star 50N	Stellar 300^(Predicate)^
NIBP	Same	Same

Reported Device Performance: The only "performance" reported is that the characteristics are "Same" as the predicate devices. No specific numerical performance metrics are provided for the STAR 50N itself from a new study within this summary.

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 does not describe a new clinical test set or data collection for the STAR 50N. The basis for comparison is the performance of the predicate devices.

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. No ground truth establishment for a new test set is described.

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

Not applicable. No new test set or adjudication process is 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. This device is a patient monitoring system, not an AI-assisted diagnostic tool for human readers.

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

This is an integrated patient monitoring system. Its primary "performance" is the accurate capture and display of physiological parameters, which is implicitly standalone in its function once calibrated. However, the exact type of "standalone" study (e.g., specific accuracy tests against reference standards) is not detailed in this summary; instead, compliance with standards (IEC 60601-1, IEC 60601-1-2) which would involve such testing, is mentioned.

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

Not explicitly stated for the STAR 50N in a new study. For the predicate devices' prior approvals, the ground truth for vital sign measurements (ECG, SpO2, NIBP, etc.) would typically be reference standards (e.g., skilled manual blood pressure readings, reference ECG machines, oximeter simulators) according to recognized medical device standards.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI models with a "training set."

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

Not applicable. No training set is described.

Summary of what the document does provide regarding acceptance criteria and study:

The document serves as a 510(k) summary, which is a submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices. The "study" in this context is primarily a comparison of technological characteristics and intended use between the new device (STAR 50N) and already approved predicate devices (STAR 55 and Stellar 300).

Implicit Acceptance Criteria: The primary acceptance criterion for a 510(k) is that the new device is substantially equivalent to a predicate device in terms of:

Intended Use: The STAR 50N shares the same intended use (monitoring vital signs for adult, pediatric, and neonatal patients at the bedside or during intra-hospital transport) as its predicates.
Technological Characteristics: The document asserts that the parameters (ECG, Respiration, Temperature, SpO2, IBP, Capnography, NIBP) are "Same" as those of the predicate devices. This implies that the underlying technology for measuring these parameters is similar enough not to raise new questions of safety or effectiveness.
Safety and Effectiveness: L&T believes the device "doesn't pose any additional risk on safety & effectiveness" when compared to the predicates, supported by compliance with international standards IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).

"Study" Proving Acceptance: The "study" that proves these criteria are met is the comparison document (mentioned as "Substantial Equivalence Equipment comparison" document, though not fully provided) that systematically details the technological characteristics of the STAR 50N against those of the predicate devices (STAR 55 and Stellar 300). The conclusion is that because the device is "substantially equivalent," it meets the regulatory requirements for market clearance without requiring a new, comprehensive clinical trial for performance metrics beyond what the predicate devices already established.

Summary

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21st January 2011 Page: 01 of 04

MAR 1 5 2011

K103686 7/5

510(K) SUMMARY

(Per section 807.92 ©)

CONTACT DATA
Submitter's Name	Larsen & Toubro Limited
Address	L&T Medical Equipment & Systems,Mysore Campus, Gate No.5, Plot No. 358-360,KIADB Industrial Area, Hebbal,Mysore – 570018, Karnataka, INDIA
Telephone	91-821-2407200
Fax	91-821-2407001
Contact Person	A.B.Deshpande
Title	Head – QA & Regulatory Affairs
E-Mail address	DeshpandeAB@myw.ltindia.com
Date the summary was prepared	21 st January 2011

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21st January 2011 Page: 02 of 04

K103686 ネス/5

DEVICE
Trade name	STAR 50N
Common name	Patient Monitoring System
Classification name	Vital Signs Monitor

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	870.2300	Product code (optional)	MWI
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device / K#	• STAR 55 Patient Monitoring System(L&T Medical Equipments &systems) / K080173• Stellar 300 Patient MonitoringSystem (L&T Medical Equipments &systems) / K093017

215t January 2011

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and the comments of the country

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Page: 03 of 04

03/5

DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE

The STAR 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and 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 (3 lead /5 lead), SpO2, Respiration, Temperature, external optional Capnography (CO2). It can also display the digital values of HR/PR, SpO₂, RR, Non-Invasive Blood Pressure (Systolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, and FiCO2. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

21st January 2011 Page: 04 Of 04

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TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Predicate Devices:

		Company Name Name Name Trade Name - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Larsen & Toubro LTD	Star 55	K080173
Larsen & Toubro LTD	Stellar 300	K09301-

Predicate device:

Star 55 is a Multi parameter patient monitor used as a predicate device for all the parameters of Star 50N Multi parameter patient monitor, except for NIBP parameter.

Stellar 300 is a three parameter (NIBP, SpO2 & single channel Temperature) patient monitor used as a predicate device for 'NIBP parameter' of Star 50N Multi parameter patient monitor.

Comparison of all the parameters of STAR 50N to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document.

Parameter	Star 50N	Star 55
510(k) Number		K080173
Alarms	Same	Same
ECG	Same	Same
Respiration	Same	Same
Temperature	Same	Same
Pulse Oximetry	Same	Same
IBP (Invasive Blood Pressure)	Same	Same
Capnography	Same	Same

Summary of Critical Parameters

Parameter	Star 50N	Stellar 300
510(k) Number		K093017
NIBP	Same	Same

Compliance to standards:

The following international standards are referred. IEC 60601-1 Medical Electrical safety IEC 60601-1-2 EMC compliance

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Conclusion:

Based on the Technological characteristics of STAR 50N and its comparison with that of predicate devices Star 55 and Stellar 300, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitors and doesn't pose any additional risk on safety & effectiveness of the device.

(N Ravindran) Head – Design & Development

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services. The symbol consists of three curved lines that converge at the bottom.

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

Larsen & Turbo Limited c/o Mr. E. J. Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

MAR 1 5 2011

K103686 Re:

Trade/Device Name: Star 50N Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: February 25, 2011 Received: February 28, 2011

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your 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 for use stated in the endrooms) to trggers and ment date of the Medical Device Amendments, or to commerce pror to May 20, 2011 11:12 in accordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). and Cosmotion For (11et) that be novice, subject to the general controls provisions of the Act. The r ou may, merelore, manner of the Act include requirements for annual registration, listing of general controlly provisions of nactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your derree is elassified (200 a00 - )
it may be subject to additional controls. Existing major regulations affecting your device can be It inay be subject to additional controllars, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. E. J. Smith

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

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 Form

Indications for Use

510(k) Number (if known): K103686

Device Name: Star 50N

Indications for Use:

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence/of CDRH, Office of Device Evaluation (ODE)

fer B Zuckerman Page1of1
(Division Sign-Off)
3/15/2011
Division of Cardiovascular Devices
510(k) Number K103686

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).