The STELLAR 404T - three 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 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 404T 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 404T has 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 tabular 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 404T Patient Monitoring System. It does not contain information about specific acceptance criteria or an explicit study proving the device meets said criteria in the format typically used for AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and validation data.

However, I can extract information related to the device's characteristics and the comparison study used for substantial equivalence.

Here's an analysis of the provided text in relation to your request:

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

The document does not specify quantitative acceptance criteria or a performance report with numerical results like sensitivity, specificity, or F1-score. Instead, it states that the "range and accuracy of the parameters & method of sensing are similar to the predicate devices."

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

The document does not describe a "test set" in the context of an AI/ML device evaluation. The assessment is based on comparing the technological characteristics of the STELLAR 404T with its predicate devices. There's no mention of sample sizes or data provenance.

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)

This information is not applicable as the document does not describe an evaluation where experts established ground truth for a test set. The comparison is based on the device's design and specifications against existing, legally marketed devices.

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

Not applicable. No test set or expert 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 is a traditional medical device submission, not an AI/ML device, and therefore, no MRMC study or human reader improvement analysis is mentioned.

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

Not applicable. This is a patient monitoring system, not an algorithm. Its performance is inherent in its measurement capabilities, which are asserted to be similar to predicate devices.

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

Not applicable. The ground for "substantial equivalence" is based on comparing the device's design, intended use, and technological characteristics to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires training data.

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

Not applicable for the same reason as above.

Summary of available information from the document that loosely relates to your request:

Device Name: STELLAR 404T Patient Monitoring System
Predicate Devices:
- PLANET patient Monitoring System (K032871)
- STELLAR 404 Patient Monitoring System (K042560)
Comparison Focus: "The range and accuracy of the parameters & method of sensing are similar to the predicate devices."
Parameters Monitored: NIBP (Non-Invasive Blood Pressure), Pulse oximetry (SpO2, PR), and Temperature. Also displays Plethysmograph.
Key Design Similarities to Predicate:
- Available parameters (NIBP, Pulse oximetry, Temperature)
- Range and accuracy of parameters
- Method of sensing
- Audible & visual alarms
- TFT color display (like PLANET)
- Thermal array recorder (similar to PLANET)
Key Design Difference from Predicate:
- Battery type: Lithium-ion in STELLAR 404T vs. Lead-acid in PLANET. The submission states this difference does not pose additional risk.
Compliance to Standards: IEC 60601-1, IEC 60601-1-2.

Conclusion stated by the submitter: Based on the technological characteristics and comparison to the predicate device, Larsen & Toubro Limited believes their device is substantially equivalent and "doesn't pose any additional risk on safety & effectiveness of the device."

This 510(k) summary provides a comparison for regulatory purposes to demonstrate substantial equivalence, not a detailed performance study with explicit acceptance criteria and corresponding results as one would typically find for an AI/ML device.

Summary

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JAN 20 2006

K060058
P1/4

Image /page/0/Picture/2 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circular emblem with the letters "L" and "T" intertwined inside the circle. Below the emblem, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagali, Mysore - 570 018 • Tel : +91(821) 2402468

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2154 May, 2005 Page : 01 of 04

510(K) SUMMARY

(Per section 807.92 ©)

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	21st May,2005

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Image /page/1/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" inside of a circle. Below the logo, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters. The logo and text are all in black.

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402661 • Fax : +91(821) 2402468

E - Mail :

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2154 May, 2005 Page : 02 of 04

DEVICE
Trade name	STELLAR 404T
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#	PLANET patient Monitoring System (L&T Medical Equipments & systems) / K032871 STELLAR 404 Patient Monitoring System (L&T Medical Equipments & systems) / K042560

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Image /page/2/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circular emblem with the letters "L" and "T" intertwined inside the circle. Below the emblem, the words "LARSEN & TOUBRO LIMITED" are written in bold, uppercase letters.

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402468

E - Mail

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2151 May, 2005 Page : 03 of 04

DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE

The STELLAR 404T 3 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 parameter includes Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings.

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Image /page/3/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" symbol enclosed in a circle above the company name. The text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.

ELECTRICAL & ELECTRONICS DIVISION - FI ECTRONIC PRODUCTS

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 • Tel : +91(821) 2402661 • Fax : +91(821) 2402468

E - Mail :

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21 56 May, 2005 Page : 04 Of 04

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device : Larsen & Toubro limited make STELLAR 404T Patient Monitoring System. Predicate device:

PLANET patient Monitoring System (Make: L&T Medical Equipments & . systems) / K032871
STELLAR 404 Patient Monitoring System (Make: L&T Medical Equipments & . systems) / K042560

The parameters available with the Larsen & Toubro Limited make STELLAR 404T 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 404T monitor audible & visual alarms are provided similar to that in the Predicate device.

STELLAR 404T has got TFT color display like PLANET. STELLAR 404T has got thermal array recorder similar to that available in PLANET. Battery provided in STELLAR 404T is Lithium ion, where as it is Lead acid battery in case of predicate device PLANET.

Comparison of all the parameters of STELLAR 404T 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 404T and its comparison with that of predicate device PLANET, 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

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Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with three intertwined strands, representing health, services, and human well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2006

Larsen & Toubro Ltd. c/o Mr. Neil E. Devine Jr. Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719

Re: K060058

Trade Name: Stellar 404T Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: January 6, 2006 Received: January 9, 2006

Dear Mr. Devine:

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. Iisling 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 such 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. Neil E. Devine, Jr.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfimmerman 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

Korovice 510(k) Number (if known)

Device name: STELLAR 404T

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 RPAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Kimmuna

on Sign-Off) Division of Cardlove : 10(g) Number

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).