STAR 55 MODEL 100

K090172 · Larsen & Toubro Limited · MHX · Jun 5, 2009 · Cardiovascular

Device Facts

• Record ID: K090172
• Device Name: STAR 55 MODEL 100
• Applicant: Larsen & Toubro Limited
• Product Code: MHX · Cardiovascular
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Multi-parameter patient monitor; inputs include ECG (3/5/12 lead), SpO2, respiration, NIBP, IBP, temperature, CO2, and optional gas modules. Device processes physiological signals to display real-time waveforms and digital values; performs arrhythmia and ST-segment analysis. Used in clinical settings (bedside/intra-hospital transport) by professional healthcare providers. Features 12.1" TFT display, alarm management, and thermal array recorder for printing trends/waveforms. Connectivity includes USB, RS232, infrared remote, and Ethernet. Output allows clinicians to track patient status, adjust alarm limits, and make informed clinical decisions based on monitored vital signs and automated analysis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and compliance with international standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

8-channel monitor with 12.1" TFT display. Parameters: ECG, SpO2, Respiration, NIBP, IBP, Temp, CO2, Gas. Connectivity: USB, RS232, IR, Ethernet. Thermal array recorder. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC). ECG analysis utilizes Mortara Instruments algorithm.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring continuous vital sign monitoring at bedside or during intra-hospital transport. Arrhythmia and ST detection features are indicated for adult and pediatric patients only; contraindicated for neonatal patients. Not for home use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• STAR 55 Patient Monitoring System (K080173)
• Passport 2 Vital signs monitor with View 12 ECG Analysis Module (K020550)

Reference Devices

• Mortara Instruments ECG algorithm (K920627, K933143)

Submission Summary (Full Text)

{0}------------------------------------------------

K090172

**JUN - 5 2009**

# larsen & Toubro Limited

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

lar - er Canque RP PS hebstad Area Healingally Kiyson - 520 018 e Tel - 191182 n 202551 a 1 - 1 m - 1 m - 1 m - 1 m - 1 m - 1 m - 1 - 1 m - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

r

. - -

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,<br>Mysore – 570018, Karnataka, INDIA | | |
| Telephone | 91-821-2402561 | Fax | 91-821-2402468 |
| Contact Person | A.B.Deshpande | Title | Head – Quality Assurance &<br>Management Representative |
| E-Mail address | [e-mail] | | |
| 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

{1}------------------------------------------------

# K090172

# Larsen & Toubro Limited

S M-F- DI.ECTEICAL & FLECTROINGS CAMPION FELECTRONS PAGON THE FOR THE CONTRA

on H Stationer Clause, Meller Honlight Children + 516 918 @ Tell - 49 435. 1 - 1 control cour 11 14 14 11 11 11

: 【ミニッ

发电子

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 . [phone] . Fax . +91,22)6752665F Website , www.INTEBG.com

1

.21

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular logo with a stylized design. The design features a horizontal line across the center, with abstract shapes above and below it. The shapes are not clearly defined, but they appear to be geometric. The logo has a rough, textured outline, giving it a slightly distressed appearance.

#### Tousro | mitted LARSEN &

ELECTPICAL & SLECTPORICS CHASION FELECTRING FRODUCT I ------------------------------------------------------------------------------------------------------------------------

ADE Comsenar Arca 1941 an 1942 parti Moscal - 570-648 < Tel - 1993, contr

1. 142.

్రాప

Date: 20.04.2009 Page: 03 of 04

## 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.

## 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

20

{3}------------------------------------------------

K090172

Image /page/3/Picture/1 description: The image shows a circular logo with a stylized lightning bolt running through the center. The lightning bolt appears to be formed by two mirrored 'L' shapes. There is some text above the lightning bolt, but it is too blurry to read. The logo has a slightly rough, hand-drawn appearance.

# Larsen & Tourro Limited

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

Cases >

િત્રમ

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.

Image /page/3/Picture/22 description: The image shows a black and white drawing of what appears to be a tree branch or root system. The lines are jagged and irregular, creating a sense of natural, organic growth. The image is simple, with no background or other elements to distract from the central subject.

(N Ravindran) Head - Design & Development

Rugd Off : L & T House Ballard Estate, F.O.Bcx 278, Mumbai 400 001 · Fhone : +3122/67525056 · F. + [phone] Website - www.l.NTEBG.com

{4}------------------------------------------------

## 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.

{5}------------------------------------------------

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 [phone] or [phone] 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

{6}------------------------------------------------

# Indications for Use

K090122 510(k) Number (if known)

Device name: STAR 55 Model 100

Indication for use:

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.

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