The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult or Pediatric patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values 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 the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature 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 module and trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.

AI/ML Overview

The provided document is a 510(k) summary for the Stellar 300 Patient Monitoring System. It describes the device, its intended use, and its technological characteristics compared to a predicate device. However, it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria. A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results or acceptance criteria and their fulfillment.

Therefore, I cannot provide the requested information from the given text as it is not present. Based on the document, the device received 510(k) clearance (K093017) based on its substantial equivalence to the Stellar 404T Patient Monitoring System (K060058), meaning it was deemed as safe and effective as the predicate device.

To answer your request, here's what the document does state, and what it does not state:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the document.
Reported Device Performance: The document only states that "The range and accuracy of the parameters & method of sensing are similar to the predicate devices." No specific performance metrics (e.g., accuracy, precision) for NIBP, SpO2, or Temperature are provided for the Stellar 300 or its predicate.

2. Sample size used for the test set and the data provenance

Sample Size: Not mentioned.
Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This document describes a patient monitoring system, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

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

This document describes a hardware patient monitor. Performance data from standalone algorithm testing, if any, is not included.

7. The type of ground truth used

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of Device and Regulatory Submission (from the document):

Device: STELLAR 300 Patient Monitoring System
Manufacturer: Larsen & Toubro Limited
Type: 3-parameter patient monitor (NIBP, Pulse oximetry, Temperature)
Intended Use: Monitoring a single Adult or Pediatric patient's vital signs at the bedside or during intra-hospital transport. Not for home use. Professional healthcare providers are responsible for interpreting data.
Predicate Device: STELLAR 404T Patient Monitoring System (K060058)
Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "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."
Compliance: Refers to IEC 60601-1 and IEC 60601-1-2 for safety and EMC requirements.

Summary

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093017

Larsen & Toubro Limited

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -

Mysore Canipus, KIADB Industrial Area, Hebbal - Hootegalli, Mysole - 570 018 - Tel.

E · Mail :

ત્ત્વના :

APR 2 9 2010

21" Aug 2009 Page: 01 of 04

510(K) SUMMARY

(Per section 84) 1.491 € j

CONTACT DATA
Submitter's Name		Larsen & Toubro Limited
Address		KIADB Industrial Area, Hebbal Hootagalli.Mysore - 570018, Karnataka, INDIA
Telephone	91-821-2402561	Fax	91-821-2402468
Contact Person	A.B.Deshpande	Title	Head - Quality Assurance &Management Representative
E-Mail address		DeshpandeAB@myw.ltindia.com
Date the summary was prepared		12th Aug 2009

Regd, Off : L & T House, Ballard Estate, P O. Box 278, Mumbai 400 001 · Phone : +91(22)67525658 · Fax : +91(22)67525858 Website : www.LNTEBG.com

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Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a circle with two mirrored symbols inside. The symbols are stylized letters, possibly "L" and "T", connected in the middle. The letters are slightly distorted, and the overall image has a grainy texture.

larsen & Toubro Limited

Mysore Campus, KIADB Industral Area, Hebbal - Hootegali, Mysore - 570 018 - Tel - 91 (821) 2402561 - Fax ' +91 (821) 2402458

E · Mail ·

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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)	MWI
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device /K#	STELLAR 404T Patient MonitoringSystem (L&T Medical Equipments &systems) / K060058

Regd. Off:L. & T House. Ballard Estate, P.O.Bex 278, Mumbai 400 001 ● Phone: +9 (122)67525658 ● Fax: +9 (22)67525358 Wabsite . www LNTEBG.com

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Image /page/2/Picture/0 description: The image shows a logo consisting of two stylized letters, likely 'L' and 'T', mirrored and placed side-by-side within a circle. The letters are designed with sharp, angular lines, giving them a modern and geometric appearance. The logo is rendered in black against a white background, creating a high-contrast image. The overall design is simple yet distinctive, suggesting a corporate or brand identity.

ARSEN & Toubro Limited

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campus, KIADƏ Indusmal Area, Hebbai - Hoolagalli, Mysore - 570 018 + Tol - +91 (821) 2402661 · Fax : +91 (821) 2402468

E - Mail :

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215 Aug 2009 Page: 03 of 04

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 arrav recorder for printing of Tabular trends & wavelorms.

STELLAR 300 have waveform display capability for Piethysmograph. It also displays the digital values of PR, SpO2_Non-Invasive Blood Pressure (Systolic. Displays Mean) and Temperature 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 adouls and rend for NIEP to store the last 100 readings. Allarm recall feature offers last 16 lam conditions.

INTENDED USE OF THE DEVICE

The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult or Pediatric patient's vital signs at the bedside or during intractor an transport along with the appropriate accessories mentioned / supplied with the with Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SpO3, 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 porable device, permits patient monitoring with adjustable alarm limits as well as vi piraond audifile alam signals. The monitor is not intended for houne use.

Regd. Off : L & T House Bailard Estate, P.O.Eox 278, Mumbai 400 001 · Phone · +91(22)67525658 Website : www.LNTEBG.com

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Image /page/3/Picture/0 description: The image shows a logo consisting of the letters 'LT' inside of a circle. The letters are stylized and appear to be connected. The logo is black and white and has a slightly distressed or vintage look. The image quality is somewhat low, with visible pixelation and artifacts.

larsen & Toubro Limited

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysora Campus, KIADB Industrial Araa. Hebbal · Hootagali, Mysore · 570 018 · Tel ·

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TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

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

STELLAR 4047 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 oximery 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 alaring are STCLAR 40 15 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 STELLAR 404T has Adult & Neonate modes of operation whereas STELLAR 300 has only Adult mode of operation.

STELEAR 300 has got TFT color display like STELLAR 404T. STELLAR 300 hass got thermal array recerder similar to that available in STELLAR 4047. Battery provided in STELLAR 300 is Lithium for, where as it is Lead acid battery in case of predicate device STELLAR 404T.

Companison 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 EC 60601-1-2 Medical Electrical Equipment-EMC requirements & sale

Conclusion:

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

(1) Ravindral Head - Design & Development

Regd. Off : L & 1 House. Bailaid Estate, P O. Ecx 276, Mumbai 400 001 · Prose · +9 (122)67525658 · Fax · +91(22)67525658 Website : www. UNTEBG.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure on the right side. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 2 9 2010

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

K093017 Re:

Trade/Device Name: Stellar 300 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (Two) Product Code: MWI Dated: April 20, 2010 Received: April 21, 2010

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 (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/ReportalProblem/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,
W.Wod.

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

K093017

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 Eyaluation (ODE)

W. Wess

Page 1 of 1

510(k) Number K085301

Division of Cardiovascular Device

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).