The STAR 55 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), 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.

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 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, Sp02, CO2 & Gas monitoring.

STAR 55 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 Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings. It has selective 24\48\72 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

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The provided document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and compliance with general safety standards, rather than presenting a specific performance study with detailed acceptance criteria.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a dedicated study for the STAR 55. Instead, it relies on demonstrating that "The parameters available with the aLarsen & Toubro Limited make STAR 55 Patient monitoring system are available with the predicate devices - aLarsen & Toubro Limited make STAR 50 patient monitoring system & Mindray Co., Ltd. PM 9000 patient monitor for Gas monitoring."

The "Conclusion" states: "Based on the Technological characteristics of STAR 55 and its comparison with that of predicate devices Star 50 and PM 9000 Express for gas monitoring, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitors and doesn't pose any additional risk on safety & effectiveness of the device."

This implies that the acceptance criterion for the STAR 55's performance is that it performs similarly to the predicate devices across all measured parameters, and the reported device performance is that it meets this unstated, but implied, substantial equivalence.

Without explicit values from the document, a table cannot be fully constructed. However, if we interpret "acceptance criteria" as "compliance with predicate device functionality," then the table would look something like this:

Parameter Monitored	Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
ECG	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Respiration	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
NIBP	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
IBP	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Temperature	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
SpO2	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
CO2	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Gas Monitoring	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Display	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Trends	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Alarm Recall	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Recorder	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Communication	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent
Alarms	Functionality comparable to predicate devices (STAR 50, PM 9000)	Substantially equivalent

2. Sample Size for the Test Set and Data Provenance

The document does not provide details of a specific clinical performance study with a test set, sample size, or data provenance. The assessment is based on a comparison of technological characteristics with predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no clinical study with ground truth established by experts is described. The assessment is based on comparison to existing legally marketed devices.

4. Adjudication Method

Not applicable, as no clinical study requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The document describes a comparison to predicate devices, not a study evaluating human reader performance with and without AI assistance.

6. Standalone Performance Study

A standalone performance study, as typically understood for an algorithm or AI, is not described. The document focuses on the device as a whole system and its equivalence to other patient monitors. However, the compliance to standards like IEC 60601-1 Medical Electrical safety and IEC 60601-1-2 EMC compliance implies that standalone technical performance evaluations (e.g., accuracy of parameter measurements, electrical safety) were conducted, but the details of these tests are not provided in this summary.

7. Type of Ground Truth Used

The concept of "ground truth" in the context of clinical images or advanced algorithms is not applicable here. The "truth" for this submission is the established performance and safety of the predicate devices. The claim is that the new device's technological characteristics are equivalent, implying its performance is also equivalent.

8. Sample Size for the Training Set

Not applicable, as this device is a hardware patient monitoring system, not an AI/ML algorithm that typically requires a training set.

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

Not applicable for the same reason as point 8.

Summary

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

K080173
pg 1 of 4

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

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

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FEB - 8 2000

Date: 10.05.2007 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	10th May, 2007

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ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570,018 • Tel : +91(821) 2402561 • Fax : +91(821) 2402468

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Date: 10.05.2007 Page: 02 of 04

DEVICE
Trade name	STAR 55
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#	STAR 50 Patient Monitoring System (L&T Medical Equipments & systems) / K051608 PM 9000 Express Patient Monitor (Mindray Co., Ltd.) / K053234

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ECTRONICS DIVISION - ELECTRONI

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

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DEVICE DESCRIPTION

STAR 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, Sp02, CO2 & Gas monitoring.

INTENDED USE OF THE DEVICE

The STAR 55 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), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of Capitography (82) Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings.

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Image /page/3/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. The logo consists of a circle with the letters "L" and "T" inside, and the words "LARSEN & TOUBRO LIMITED" written below the circle. The text is in a bold, sans-serif font.

ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

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

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Date: 10.05.2007 Page: 04 Of 04

ring

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

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

STAR 50 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K051608
PM 9000 Express Patient Monitor (Make: Mindray Co., Ltd.) / K053234 t

The parameters available with the Larsen & Toubro Limited make STAR 55 Patient monitoring system are available with the predicate devices - Larsen & Toubro Limited make STAR 50 patient monitoring system & Mindray Co., Ltd. PM 9000 patient monitor for Gas monitoring.

Comparison of all the parameters of STAR 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 STAR 55 and its comparison with that of predicate devices Star 50 and PM 9000 Express for gas monitoring, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitors and doesn't pose any additional risk on safety & effectiveness of the device.

(N Ravir Head - Design & Development

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 8 2008

Larsen & Toubro Ltd. c/o Mr. Ned Devine Sr. Staff Engineer Underwriter Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062

Re: K080173

STAR 55 Regulation Number: 21 CFR 870.2300 Regulation Nàme: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: January 15, 2008 Received: January 24, 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.

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Page 2 - Mr. Ned Devine

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 (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. 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,

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

1,080173

510(k) Number (if known)

Device name: STAR 55

Indication for use:

The STAR 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intract usingle transport 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, EtCO2, FiCO2, FiCO2, No EtAA and FiAA readings.

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)

(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K080173

Page 1 of 1

2 est

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).