STELLAR 300 by LARSEN & TOUBRO LIMITED

The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the benside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also disolay the digital wallus of PR, SpO2, Non-Invasive Blood Pressure (Systolic Diastolic and Mean) and Temperature readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable 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

This STELLAR 300 unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.

STELLAR 300 have waveform display capability for Plethysmograph. It also displays Meen of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Displays Mean) and Temperatire readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.

AI/ML Overview

This document is a 510(k) summary for the STELLAR 300 Patient Monitoring System, seeking clearance for a neonate mode addition. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new AI/software-as-a-medical-device.

Based on the provided text, the following information can be extracted, with significant limitations for aspects related to "acceptance criteria" and "study" in the context of detailed performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for vital sign monitoring. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, STELLAR 404T. The "reported device performance" is essentially that its parameters are "similar" to the predicate.

Parameter Monitored	Acceptance Criteria (Implied)	Reported Device Performance (STELLAR 300)
NIBP	Range and accuracy similar to STELLAR 404T	Parameters are similar to predicate device
Pulse Oximetry	Range and accuracy similar to STELLAR 404T	Parameters are similar to predicate device
Temperature	Range and accuracy similar to STELLAR 404T	Parameters are similar to predicate device
Audible & Visual Alarms	Similar functionality to STELLAR 404T	Provided similar to predicate device
Display	TFT color display like STELLAR 404T	Has TFT color display
Recorder	Thermal array recorder similar to STELLAR 404T	Has thermal array recorder
Battery	Lithium ion battery similar to STELLAR 404T	Lithium ion battery
Neonate Mode	Functionality and safety for neonates (imparted by similarity to existing modes and predicate)	Added to an already FDA-approved device (K093017) for adult & pediatric modes

The statement on page 3, "The range and accuracy of the parameters & method of sensing are similar to the predicate devices," is the closest the document comes to defining performance. A detailed comparison would likely be contained in the "Substantial Equivalence Equipment comparison" document, which is referenced but not provided here.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set or any performance studies with human subjects for the NIBP, Pulse Oximetry, or Temperature parameters, nor does it describe data provenance (e.g., country of origin, retrospective/prospective). The claim of similarity to the predicate likely relies on engineering testing and comparison of technical specifications, rather than a clinical performance study with a distinct test set.

For the addition of the "Neonate mode," the document states, "STELLAR 300 device with Adult & Pediatric mode is already FDA approved -K093017. In this submission, Neonate mode is added to STELLAR 300." This suggests that the extension to neonates might be justified based on established technology and potentially bench testing or comparisons to standards without a new clinical study in neonates described in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. As there's no mention of a clinical performance study with a test set requiring ground truth established by experts, this detail is absent.

4. Adjudication Method

This information is not provided in the document. There is no mention of a study involving expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved. The STELLAR 300 is a patient vital signs monitor. Therefore, an MRMC comparative effectiveness study was not done as it is not applicable for this type of device. The concept of "human readers improve with AI vs without AI assistance" does not apply to a vital signs monitor.

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

The STELLAR 300 is a hardware device that measures vital signs. Its core function is to produce quantitative measurements (NIBP, SpO2, Temperature). Its performance is inherently standalone in the sense that the device measures and displays these parameters directly. It's not an AI algorithm that provides an輔助 diagnosis needing "human-in-the-loop" interaction in the described context. Therefore, the device operates in a standalone capacity by providing raw vital sign data.

7. The Type of Ground Truth Used

Given the nature of a patient monitor, the ground truth for vital sign parameters would typically be established using reference standard measurement devices (e.g., a calibrated sphygmomanometer for NIBP, a co-oximeter for SpO2, a calibrated thermometer for temperature). The document does not explicitly state the type of ground truth used, but it implies that performance is evaluated against established standards or a predicate device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is because the STELLAR 300 is a traditional medical device (patient monitor) and not an AI/Machine Learning device that undergoes a "training" phase in the computational sense. Its design and validation rely on engineering principles, compliance with standards (IEC 60601-1, IEC 60601-1-2), and comparison to a predicate device.

9. How the Ground Truth for the Training Set was Established

As there is no training set in the AI/ML sense, this question is not applicable to the STELLAR 300 device as described in this 510(k) summary.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes the "study" (or rather, the justification for substantial equivalence) as a comparison to a legally marketed predicate device, STELLAR 404T (K060058). The core argument is based on the technological characteristics of the STELLAR 300 being "similar" to the predicate device regarding primary parameters (NIBP, Pulse Oximetry, Temperature), their range, accuracy, and method of sensing. Other features like display, recorder, alarm functionality, and battery type are also cited as similar. The addition of the neonate mode to the STELLAR 300 is an extension to an already FDA-approved device for adult and pediatric use (K093017).

The document states, "Comparison of all the parameters of STELLAR 300 to that of the predicate devices is given in the 'Substantial Equivalence Equipment comparison' document." This implies that a detailed technical comparison, likely including bench testing against specifications or established standards, was performed to support the claim of similarity in range and accuracy.

Compliance with international standards (IEC 60601-1 for safety and IEC 60601-1-2 for EMC) further supports the device's acceptable performance and safety. The conclusion is that the device "doesn't pose any additional risk on safety & effectiveness of the device" compared to the predicate.

Summary

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K103763

MAR 1 1 2011

08th Sep 2010 Page: 01 of 04

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	8th Sep 2010

L&T Medical Equipment & Systems, Larsen & Toubro Limited Mysore Campus, Gate No. 5, Plot No. 358-360, KIADB Industrial Area, Hebbal, Mysore - 570 018. INDIA Tel : +91 821 2407000 Fax : + 91 821 2407001. ClC Toll free: 1800-200-5858, 1800-233-5858 www.LNTMEDICAL.com

Registered Office: L&T House, N. M. Marg Ballard Estate Mumbai 400 001, India | C

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8th Sep 2010 Page: 02 of 04

DEVICE
Trade name	STELLAR 300
Common name	Patient Monitoring System
Classification name	Vital Signs Monitor

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	870.2300	Product code (optional)
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device / K#	STELLAR 404T Patient Monitoring System (L&T Medical Equipments & systems) / K060058
		MWI

・・.

Registered Office: L&T House, N. M. Marg Ballard Estate Ballard Estate
Mumbai 400 001, India QD

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80 Sep 2010 Page: 03 of 04

DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE

The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Piethysmograph. It can also display the digital walues of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings.

Registered Office: L&T House, N. M. Marq Ballard Estate Mumbai 400 001, India رو

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8th Sep 2010 Page: 04 Of 04

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device: Larsen & Toubro limited make STELLAR 300 Patient Monitoring System. Predicate device:

STELLAR 404T Patient Monitoring System (Make: L&T Medical Equipments & systems) / K060058

The parameters available with the Larsen & Toubro Limited make STELLAR 300 Patient monitoring system (NIBP, Pulse oximetry and Temperature) are also available with the predicate device. The range and accuracy of the parameters & method of sensing are similar to the predicate devices. In STELLAR 300 monitor audible & visual alams are provided similar to that in the Predicate device.

STELLAR 300 has got TFT color display like STELLAR 404T. STELLAR 300 has got thermal array recorder similar to that available in STELLAR 404T. Battery provided in STELLAR 300 is Lithium ion, which is same as that of predicate device STELLAR 404T.

STELLAR 300 device with Adult & Pediatric mode is already FDA approved -K093017. In this submission, Neonate mode is added to STELLAR 300.

Comparison of all the parameters of STELLAR 300 to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document.

Compliance to standards:

The following international standards are referred.

IEC 60601-1 Medical Electrical Equipment-General requirement for safety IEC 60601-1-2 Medical Electrical Equipment-EMC requirements & tests

Conclusion:

Based on the Technological characteristics of STELLAR 300 and its comparison with that of predicate device STELLAR 404T, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitor and doesn't pose any additional risk on safety & effectiveness of the device.

(N Ravindran) Head - Design & Development

L&T Medical Equipment & Systems, Larsen & Toubro Limited Mysore Campus, Gate No. 5, Plot No. 358-360, KIADB Industrial Area, Hebbal, Mysore - 570 018. INDIA Tel : +91 821 2407000 Fax : + 91 821 2407001. CIC Toll free: 1800-200-5858, 1800-233-5558 www.LNTMEDICAL.com

Registered Office: L&T House, N. M. M. Marq Ballard Estate Mumbai 400 001, India 22

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

Larsen & Toubro Limited c/o Mr. E.J. Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114

MAR 1 1 201

Re: K103763

Trade/Device Name: Stellar 300 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: 74 MWI Dated: March 2, 2011 Received: March 4, 2011

Dear Mr. 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.

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.

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

umer R. Vahmer

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):

Device name: STELLAR 300

Indication for use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma t2. volumer

. ·

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K103763

Page 1 of 1

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).