STAR 50 N

K103686 · Larsen & Toubro Limited · MWI · Mar 15, 2011 · Cardiovascular

Device Facts

• Record ID: K103686
• Device Name: STAR 50 N
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Mar 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Star 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unpin Vital signs parameters include ECG (3 lead / 5 lead), SpO2, Respiration, Temperature, external optional Capnography (CO₂). 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, EyCO2, and FiCO2. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

STAR 50N is a 6-channel multi-parameter patient monitor; inputs include ECG (3/5 lead), respiration, NIBP, IBP, temperature, SpO2, and optional external CO2. Device processes physiological signals to display real-time waveforms and digital values for HR/PR, SpO2, RR, NIBP (systolic/diastolic/mean), IBP (systolic/diastolic/mean), temperature, EtCO2, and FiCO2. Features include 168-hour tabular/graphical trends, 240-reading NIBP trend, and 24-alarm recall. Operated by professional healthcare providers in clinical settings (bedside/intra-hospital transport). Includes thermal array recorder, adjustable alarm limits, and visual/audible alerts. Connectivity options include USB, Wi-Fi, and Ethernet for integration with L&T Central Nursing Station (Skyline 55) or external displays. Output allows clinicians to assess patient status and make informed clinical decisions; benefits include continuous monitoring and timely intervention via alarm notifications.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison to predicate devices and compliance with international safety and EMC standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

6-channel multi-parameter monitor with 10.4" TFT display. Parameters: ECG, Respiration, NIBP, IBP, Temperature, SpO2, CO2. Connectivity: USB, Wi-Fi (optional), Ethernet. Thermal array recorder. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring continuous monitoring of vital signs (ECG, SpO2, Respiration, Temperature, NIBP, IBP, and optional CO2) at the bedside or during intra-hospital transport. Not for home use.

Regulatory Classification

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.

Predicate Devices

• STAR 55 Patient Monitoring System (K080173)
• Stellar 300 Patient Monitoring System (K093017)

Submission Summary (Full Text)

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21st January 2011 Page: 01 of 04

## MAR 1 5 2011

K103686 7/5

## 510(K) SUMMARY

(Per section 807.92 ©)

| CONTACT DATA | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name | Larsen & Toubro Limited |
| Address | L&T Medical Equipment & Systems,<br>Mysore Campus, Gate No.5, Plot No. 358-360,<br>KIADB Industrial Area, Hebbal,<br>Mysore – 570018, Karnataka, INDIA |
| Telephone | 91-821-2407200 |
| Fax | 91-821-2407001 |
| Contact Person | A.B.Deshpande |
| Title | Head – QA & Regulatory Affairs |
| E-Mail address | [e-mail] |
| Date the summary was prepared | 21 ^st January 2011 |

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21st January 2011 Page: 02 of 04

K103686 ネス/5

| DEVICE | |
|---------------------|---------------------------|
| Trade name | STAR 50N |
| 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 55 Patient Monitoring System<br>(L&T Medical Equipments &<br>systems) / K080173<br>• Stellar 300 Patient Monitoring<br>System (L&T Medical Equipments &<br>systems) / K093017 | | |

215t January 2011

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

:

and the comments of the country

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Page: 03 of 04

03/5

#### DEVICE DESCRIPTION

STAR 50N is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, SpO2 and external CO2 (optional).

STAR 50N is a 6-channel monitor with 10.4" 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 and FiCO2 readings. It has 168 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. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It has got optional communication features - USB, Wi/Fi (optional) and Ethernet. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display

#### INTENDED USE OF THE DEVICE

The STAR 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, external optional Capnography (CO2). It can also display the digital values of HR/PR, SpO₂, RR, Non-Invasive Blood Pressure (Systolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, and FiCO2. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display.

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

21st January 2011 Page: 04 Of 04

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### TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

#### Predicate Devices:

| | | Company Name Name Name Trade Name - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
|---------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Larsen & Toubro LTD | Star 55 | K080173 |
| Larsen & Toubro LTD | Stellar 300 | K09301- |

#### Predicate device:

Star 55 is a Multi parameter patient monitor used as a predicate device for all the parameters of Star 50N Multi parameter patient monitor, except for NIBP parameter.

Stellar 300 is a three parameter (NIBP, SpO2 & single channel Temperature) patient monitor used as a predicate device for 'NIBP parameter' of Star 50N Multi parameter patient monitor.

Comparison of all the parameters of STAR 50N to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document.

| Parameter | Star 50N | Star 55 |
|-------------------------------|----------|---------|
| 510(k) Number | | K080173 |
| Alarms | Same | Same |
| ECG | Same | Same |
| Respiration | Same | Same |
| Temperature | Same | Same |
| Pulse Oximetry | Same | Same |
| IBP (Invasive Blood Pressure) | Same | Same |
| Capnography | Same | Same |

#### Summary of Critical Parameters

| Parameter | Star 50N | Stellar 300 |
|---------------|----------|-------------|
| 510(k) Number | | K093017 |
| NIBP | Same | Same |

#### Compliance to standards:

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

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#### Conclusion:

Based on the Technological characteristics of STAR 50N and its comparison with that of predicate devices Star 55 and Stellar 300, 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 Ravindran) Head – Design & Development

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services. The symbol consists of three curved lines that converge at the bottom.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Larsen & Turbo Limited c/o Mr. E. J. Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, MD 21114

MAR 1 5 2011

K103686 Re:

Trade/Device Name: Star 50N Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: February 25, 2011 Received: February 28, 2011

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your 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 for use stated in the endrooms) to trggers and ment date of the Medical Device Amendments, or to commerce pror to May 20, 2011 11:12 in accordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). and Cosmotion For (11et) that be novice, subject to the general controls provisions of the Act. The r ou may, merelore, manner of the Act include requirements for annual registration, listing of general controlly provisions of nactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your derree is elassified (200 a00 - )
it may be subject to additional controls. Existing major regulations affecting your device can be It inay be subject to additional controllars, 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. E. J. 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 (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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

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 Form

#### Indications for Use

510(k) Number (if known): K103686

Device Name: Star 50N

Indications for Use:

The Star 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unpin Vital signs parameters include ECG (3 lead / 5 lead), SpO2, Respiration, Temperature, external optional Capnography (CO₂). 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, EyCO2, and FiCO2.

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence/of CDRH, Office of Device Evaluation (ODE)

fer B Zuckerman Page*1*of*1*
(Division Sign-Off)
3/15/2011
Division of Cardiovascular Devices
510(k) Number K103686