The STAR 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead/ 12 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, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings.

In addition, Star 55 Model 100 has got Arrhythmia and ST detection from 3L/5L/12L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients

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

STAR 55 Model 100 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5/12 lead), Arrhythmia & ST analysis, Respiration, NIBP, IBP, Temperature, SpO2, CO2 & Gas monitoring,

STAR 55 Model 100 is a 8-channel monitor with 12.1" 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 Blond Pressure (Systolic. Diastolic and Mean), Temperature, EtCO2, FiCO2, NoO. O2, EtAA and FiAA readings. It has selective 2448172 Hours tabular and graphical trends. It han special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facilius 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 fratures . USB, RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable aların limits as well as visible and audible alarm signals.

AI/ML Overview

The provided document K090172 is a 510(k) summary for the STAR 55 Model 100 patient monitoring system. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria with reported performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device's technical characteristics and intended use, and listing compliance with general safety and EMC standards.

Based on the provided text, I can only provide the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding reported device performance for specific physiological parameters. It states that the device is intended for "continuous monitoring of the physiological parameters ECG (3/5/12 lead), Arrhythmia & ST analysis, Respiration, NIBP, IBP, Temperature, SpO2, CO2 & Gas monitoring." It also mentions "Arrhythmia and ST detection," implying these are functions of the device.

The only specific performance mention is:

"The data acquired by 12L ECG Module is interpreted utilizing Mortara Instruments algorithm (cleared by FDA under notification numbers: K920627, K933143)." This indicates that the core algorithm for 12-lead ECG interpretation is a previously cleared algorithm, implying its performance has been deemed acceptable in its prior clearances. However, no specific performance metrics for this device using that algorithm are provided in this document.

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

Sample Size: Not specified in the provided document.
Data Provenance: Not specified in the provided document.

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

Not specified in the provided document.

4. Adjudication method for the test set:

Not specified in the provided 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 type of study is not mentioned in the provided document. The device is a patient monitoring system, not primarily an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

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

The document mentions that the 12L ECG module uses "Mortara Instruments algorithm (cleared by FDA under notification numbers: K920627, K933143)." This implies that the algorithm itself had standalone performance evaluated for its initial clearance. However, this document does not present a standalone performance study specifically for the STAR 55 Model 100 using this algorithm; it relies on the predicate algorithm's prior clearance.

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

Not specified in the provided document. For patient monitoring systems, ground truth typically involves reference devices (e.g., a known accurate ECG machine for rhythm analysis, a calibrated thermometer for temperature).

8. The sample size for the training set:

Not specified in the provided document. As the device utilizes a previously cleared algorithm for specific functions (e.g., Mortara Instruments algorithm for ECG), the training data for that algorithm would have been part of its original clearance, but no details are provided here.

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

Not specified in the provided document. Similar to point 8, this would pertain to the original clearance of any algorithms incorporated, but is not detailed here.

Summary of available information related to acceptance and study:

The submission highlights compliance with international standards:

IEC 60601-1 Medical Electrical safety
IEC 60601-1-2 EMC compliance

The fundamental claim for clearance is substantial equivalence to predicate devices:

STAR 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K080173
Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp.) / K020550

The core argument for substantial equivalence relies on:

The parameters available with the STAR 55 Model 100 being available with the predicate devices.
The 12L ECG Module utilizing a previously FDA-cleared algorithm (Mortara Instruments algorithm: K920627, K933143).

Therefore, this 510(k) submission does not provide the detailed study results and acceptance criteria as outlined in your request. It rather demonstrates that the device's technological characteristics and intended use are similar to those of legally marketed predicate devices, and that it adheres to general safety and EMC standards.

Summary

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K090172

JUN - 5 2009

larsen & Toubro Limited

1 – BLOGTO JAL S KILECTRONICS DIVISION – LEETTRONIC PROMOCIA comments of the consideration and the country of the

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Date: 20.04.2009 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	20th Apr 2009

Regal Off : L & T House, Ballard Estate, P O Box 278, Mumbai 400 001 . Phone . + S11:22;67525066 . For . +0 H22:67:525858 Website:www.LNTEBG.com

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K090172

Larsen & Toubro Limited

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Date: 20.04.2009 Page: 02 of 04

DEVICE
Trade name	STAR 55 Model 100
Common name	Patient Monitoring System
Classification name	Vital Signs Monitor

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	870.1025	Product code (optional)
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device / K#	STAR 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K080173Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp.) / K020550
		MHX

Regd. Off . I & 1 Nover, Bollard Estate . P.O. Box 278 . Phone . +91(22)67625056 . Fax . +91,22)6752665F Website , www.INTEBG.com

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Date: 20.04.2009 Page: 03 of 04

DEVICE DESCRIPTION

INTENDED USE OF THE DEVICE

The STAR 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Nconatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead/ 12 lead/ 12 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, Fronz, FiCO2, N2O, O2, EtAA and FiAA readings.

In addition Star 55 Model 100 has got Arrhythmia and ST detection from 31/51/12L ECG measurements. The Arthythmia and ST analysis module is intended for 150 with Adult & Pediatric patients and is not intended for use with Neonatal patients.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjusiable alarm limits as well as visible and audible aların signals. The monitor is not intended the home use.

Regd. Off 1, 8 T House, Bellard Estate, P.O.Box 278, Mumbai 400 001 € Phone : +34122;p776256666 Website ' www.LNTESG com

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K090172

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Larsen & Tourro Limited

ELECTRICAL E ELECTPONICS DAUGION DELECTRANC PHOLDUL 17. No 33.00 Are Hollier 14 : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Date: 20.04 2009 Page: 04 of 04

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device: Larsen & Toubro limited make STAR 55 Model 100 Patient Monitoring System. Predicate device:

STAR 55 Patient Monitoring System (L&T Medical Equipments & Systems) / ତ K080173
Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope 0 Corp.) / K020550

The parameters available with the Larsen & Toubro Limited make STAR 55 Model 100 Patient monitoring system are available with the predicate device Datasepe Corp. make "Passport 2 Vital signs monitor with View 12 ECG Analysis Moditle" for 12 Lad ECG analysis & Larsen & Toubro Limited make STAR 55 Patient monitoring system for all other parameters.

The data acquired by 121. ECG Module is interpreted utilizing Mortara Instruments algorithm (cleared by FDA under notification numbers: K920627, K933143).

Comparison of all the parameters of STAR 55 Model 100 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:

ﺍﻟﻤﺘﺤﺪﺓ

Based on the Technological characteristics of STAR 55 Model 100 and its comparison with that of predicate devices Larsen & Toubro Limited believes that their (eviewice is substantially equivalent to this predicate Monitors and doesn't posses any additions rick is safety & effectiveness of the device.

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(N Ravindran) Head - Design & Development

Rugd Off : L & T House Ballard Estate, F.O.Bcx 278, Mumbai 400 001 · Fhone : +3122/67525056 · F. + +91(22)67625658 Website - www.l.NTEBG.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest movement and flight. The overall design is simple and recognizable, conveying a sense of authority and purpose.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Larsen & Toubro Limited c/o Ms. Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114

Re: K090172

Trade/Device Name: Star 55 Model 100

Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)

Regulatory Class: Class II Product Code: MHX Dated: May 6, 2009

Received: May 7, 2009

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

Sincerely yours,

sume D. bumer

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

K090122 510(k) Number (if known)

Device name: STAR 55 Model 100

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)

ulla R. h. huse

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number_K090132

Page 1 of 1

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.