The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HRPR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA 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

GALAXY 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead). Respiration, NIBP. TBP. Temperature. SpO2. CO2 & Gas monitoring.

GALAXY 55 is a 8-channel monitor with 15"/17"/19" external monitor 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, Diastolie and Mean), Temperature, EiCO2. FiCO2. NoO. On, EiAA and FiAA readings. It has selective 24148172 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. It has got optional communication features -USB. RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

AI/ML Overview

The provided 510(k) summary for the Larsen & Toubro Limited GALAXY 55 Patient Monitoring system primarily focuses on its substantial equivalence to a predicate device (STAR 55 Patient Monitoring System). Therefore, the study described is a comparison study against a predicate device, rather than a standalone performance study with specific acceptance criteria for diagnostic metrics.

Based on the provided documents, I can extract information related to the comparison with the predicate device and the general intended use. However, explicit acceptance criteria with specific performance metrics and a detailed study report proving these criteria are met are not present in this type of 510(k) summary. This document typically asserts substantial equivalence based on technological characteristics and compliance with standards, without presenting detailed clinical performance data in the same way a clinical trial report would.

Here's a breakdown of what can be inferred and what is not available:

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

This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to the predicate device based on technological characteristics and compliance with standards, rather than defining specific performance acceptance criteria for diagnostic metrics (e.g., sensitivity, specificity, accuracy) and then reporting the device's performance against them.

The "Conclusion" states:
"Based on the Technological characteristics of GALAXY 55 and its comparison with that of predicate devices Star 55, 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."

This implies that the "acceptance criteria" were met by demonstrating similar technological characteristics and compliance with general medical device standards to the legally marketed predicate device.

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

This information is not provided. The document does not describe a test set or a clinical study with patient data. The comparison is based on the device's technological characteristics.

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/provided. No expert review or ground truth establishment for a test set is mentioned, as no clinical study on patient data is described.

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

This information is not applicable/provided. No adjudication method for a test set is mentioned.

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

This information is not applicable/provided. This device is a patient monitoring system, not an AI-assisted diagnostic tool, and the document does not describe an MRMC study.

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

This information is not applicable/provided. As above, this is a patient monitoring system, and its performance is evaluated in comparison to a predicate device's technological characteristics, not through a standalone algorithm performance study.

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

This information is not applicable/provided. No ground truth for specific diagnostic outcomes is discussed. The "ground truth" for the substantial equivalence claim is the functional and safety profile of the predicate device, against which the new device's technological characteristics and standards compliance are compared.

8. The sample size for the training set

This information is not applicable/provided. The document does not describe an AI/algorithm that would require a training set.

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

This information is not applicable/provided. The document does not describe an AI/algorithm or a training set.

Summary of the Study described in the 510(k) Summary:

The study described is a comparison of technological characteristics of the GALAXY 55 Patient Monitoring System to a legally marketed predicate device, the STAR 55 Patient Monitoring System (K080173), also manufactured by L&T Medical Equipments & Systems.

Objective: To establish substantial equivalence to the predicate device.
Methodology: A detailed comparison of all parameters available in the GALAXY 55 system with those of the STAR 55 system, presented in a "Predicate device comparison table" (which is referenced but not included in these provided pages). The document also states compliance with international standards IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).
"Acceptance Criteria" implicitly met: The new device must possess similar technological characteristics and performance specifications to the predicate device to be considered substantially equivalent. It must also comply with relevant safety and EMC standards. The document asserts that based on this comparison, the GALAXY 55 "doesn't pose any additional risk on safety & effectiveness of the device" compared to the predicate.
Study Type: A comparative analysis of device specifications and documented compliance to recognized standards, rather than a clinical performance study.
Data Provenance: Not human or patient data, but rather device specifications and engineering data.

Therefore, while the document confirms the device's regulatory pathway and the basis for its market clearance, it does not provide the detailed performance metrics and study design typically associated with demonstrating performance against specific, quantitative acceptance criteria for diagnostic accuracy.

Summary

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SEP 2 6 2008

LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 = Tel : (91) - 821 - 2402561 ● Fax : (91) - 821 - 2402468

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Hei :

Date: 20.02.2008 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	91-821-2405439	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	20th Feb, 2008

Regd. Off : L & T House, Ballard Estate, P. O. Box 276, Mumbai 400 001 • Phone : 261 8181 / 82 • 262 0223 Website : www.intelug.com

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K082685
p2/4

ﺇﻟﻰ ﺍﻟﺘﻲ ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1991 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP + ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 ▲ Tel : (91) - 821 - 2402561 ● Fax : (91) - 821 - 2402468

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મેદા :

Date: 20.02.2008 Page: 02 of 04

DEVICE
Trade name	GALAXY 55
Common name	Patient Monitoring System
Classification name	Vital Signs Monitor

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	Product code (optional)	MWI
870.2300
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device / K#	STAR 55 Patient Monitoring System (L&T Medical Equipments & systems) / K 080173

Regd. Off : L & T House, Ballard Estate, P. O. Box 278, Mumbai 400 001 ● Phone : 261 6181 / 82 ● Fax : 91 - 22 - 262 0223
Website : 20 - 201 - 1 - 2 - Website : www.intebg.

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ELECTRONICS DIVISION - ELECTRONIC PRODUC Mysore Campus, KIADB Industrial Area, Hebbal · Hootagalli, Mysore · 570 018 · Tel: +91 (821) 2402468

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Date: 20.02.2008 Page: 03 of 04

વિદ્યા :

DEVICE DESCRIPTION

GALAXY 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead). Respiration, NIBP. TBP. Temperature. SpO2. CO2 & Gas monitoring.

INTENDED USE OF THE DEVICE

The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2. Respiration, Temperature, Capnography (CO2) & optional Gas module unit. 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, EICO2, FiCO2, NoO. O2, EtAA and FiAA readings,

Regd. Off:L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 ● Phone:+91(22)6762668 ● Fax: 191(22)67625858 Website : www.LNTEBG.com

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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 symbol above the company name. The symbol is a circle with the letters 'L' and 'T' intertwined inside. The company name is written in bold, uppercase letters.

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal - Hoolagali, Mysore - 570 018 ● Tel : (91) - 821 - 24022661 ● Fax : (91) - 821 - 2402468

E - Mail :

ମ୍ପରା :

Date: 20.02.2008 Page: 04 Of 04

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device: Larsen & Toubro limited make GALAXY 55 Patient Monitoring System. Predicate device:

STAR 55 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K 080173
The parameters available with the Larsen & Toubro Limited make GALAXY 55 Patient monitoring system are available with the predicate devices - Larsen & Toubro Limited make STAR 55 patient monitoring system

Comparison of all the parameters of GALAXY 55 to that of the predicate devices is given in the "Predicate device comparison table" document.

Compliance to standards:

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

Conclusion:

Based on the Technological characteristics of GALAXY 55 and its comparison with that of predicate devices Star 55, 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

Regd. Off : L & T House, Ballard Estate, P. O. Box 276, Mumbai 400 001 ● Phone : 261 8181 / 82 • Fax : 91 - 22 - 262 0223 Website : www.intebg.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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2008

Larsen & Toubro Limited c/o Underwriters Laboratories, Inc. (Third Party Review) Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, IL 60062

Rc: K082685

Trade/Device Name: Galaxy 55 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: Scptember 2, 2008 Received: September 15, 2008

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, 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 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. 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

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Page 2 - Mr. Ned Devine

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dura R. Holmes

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: Galaxy 55

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)

Duna R. Jenkins

(Division Sign-Off) Division of Cardiovascular Devices

K082685 510(k) 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).