STELLAR 300

K103763 · Larsen & Toubro Limited · MWI · Mar 11, 2011 · Cardiovascular

Device Facts

• Record ID: K103763
• Device Name: STELLAR 300
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Mar 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable 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

STELLAR 300 is a 3-parameter patient monitor; inputs include NIBP, pulse oximetry, and temperature sensors. Device processes signals to display real-time waveforms (plethysmograph) and digital values for PR, SpO2, NIBP (systolic, diastolic, mean), and temperature. Features include graded color-coded alarms, alarm recall (last 16 conditions), and trend storage (2/12-hour tabular/graphical trends; 100 NIBP readings). Integrated thermal array recorder prints trends and waveforms. Operated by professional healthcare providers at bedside or during intrahospital transport. Output allows clinicians to assess patient status and adjust alarm limits. Benefits include continuous vital sign monitoring and historical data review for clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) confirmed.

Technological Characteristics

TFT color display; thermal array recorder; Lithium-ion battery. Parameters: NIBP, Pulse Oximetry, Temperature. Standards: IEC 60601-1, IEC 60601-1-2. Portable form factor.

Indications for Use

Indicated for monitoring vital signs (PR, SpO2, NIBP, Temperature, Plethysmograph) in adult, pediatric, and neonate patients. For use by professional healthcare providers in clinical settings (bedside or intrahospital 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

• STELLAR 404T Patient Monitoring System (K060058)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a black and white logo of Larsen & Toubro (L&T). The logo consists of the letters 'L' and 'T' interlocked within a circle. The letters are stylized with a bold, geometric design, and the overall impression is one of strength and engineering prowess.

K103763

MAR 1 1 2011

08th Sep 2010 Page: 01 of 04

## 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 | 8th Sep 2010 | | |

L&T Medical Equipment & Systems, Larsen & Toubro Limited Mysore Campus, Gate No. 5, Plot No. 358-360, KIADB Industrial Area, Hebbal, Mysore - 570 018. INDIA Tel : [phone] Fax : + 91 821 2407001. ClC Toll free: 1800-200-5858, 1800-233-5858 www.LNTMEDICAL.com

Registered Office: L&T House, N. M. Marg Ballard Estate Mumbai 400 001, India | C

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

Image /page/1/Picture/7 description: The image shows a logo consisting of the letters 'L' and 'T' intertwined within a circle. The 'L' is stylized with a sharp, angular design, and the 'T' is similarly styled to complement the 'L'. The logo has a bold, simple design, making it easily recognizable.

8th Sep 2010 Page: 02 of 04

| DEVICE | |
|---------------------|---------------------------|
| Trade name | STELLAR 300 |
| Common name | Patient Monitoring System |
| Classification name | Vital Signs Monitor |

| PREDICATE DEVICE IDENTIFICATION | | |
|-----------------------------------------|-------------------------------------------------------------------------------------|-------------------------|
| CFR21 Section | 870.2300 | Product code (optional) |
| Classification panel | Cardiovascular | |
| Device Class | Class II | |
| Legally marketed Comparison Device / K# | STELLAR 404T Patient Monitoring System (L&T Medical Equipments & systems) / K060058 | |
| | | MWI |

L&T Medical Equipment & Systems, Larsen & Toubro Limited Mysore Campus, Gate No. 5, Plot No. 358-360, KIADB Industrial Area, Hebbal, Mysore - 570 018. INDIA Tel : [phone] Fax : + 91 821 2407001. ClC Toll free: 1800-200-5858, 1800-233-5858 www.LNTMEDICAL.com .

.

・・.

Registered Office: L&T House, N. M. Marg Ballard Estate Ballard Estate
Mumbai 400 001, India QD

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

Image /page/2/Picture/11 description: The image shows a logo with the letters 'L' and 'T' inside of a circle. The 'L' is on the left side of the circle, and the 'T' is on the right side. The letters are stylized and bolded. The logo is black and white.

80 Sep 2010 Page: 03 of 04

### DEVICE DESCRIPTION

This STELLAR 300 unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.

STELLAR 300 have waveform display capability for Plethysmograph. It also displays Meen of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Displays Mean) and Temperatire readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.

## INTENDED USE OF THE DEVICE

The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Piethysmograph. It can also display the digital walues of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings.

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

L&T Medical Equipment & Systems, Larsen & Toubro Limited Mysore Campus, Gate No. 5, Plot No. 358-360, KIADB Industrial Area, Hebbal, Mysore - 570 018. INDIA Tel : [phone] Fax : + 91 821 2407001. ClC Toll free: 1800-200-5858, 1800-200-585888 www.LNTMEDICAL.com

Registered Office: L&T House, N. M. Marq Ballard Estate Mumbai 400 001, India رو

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

8th Sep 2010 Page: 04 Of 04

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

Device: Larsen & Toubro limited make STELLAR 300 Patient Monitoring System. Predicate device:

STELLAR 404T Patient Monitoring System (Make: L&T Medical Equipments & systems) / K060058

The parameters available with the Larsen & Toubro Limited make STELLAR 300 Patient monitoring system (NIBP, Pulse oximetry and Temperature) are also available with the predicate device. The range and accuracy of the parameters & method of sensing are similar to the predicate devices. In STELLAR 300 monitor audible & visual alams are provided similar to that in the Predicate device.

STELLAR 300 has got TFT color display like STELLAR 404T. STELLAR 300 has got thermal array recorder similar to that available in STELLAR 404T. Battery provided in STELLAR 300 is Lithium ion, which is same as that of predicate device STELLAR 404T.

STELLAR 300 device with Adult & Pediatric mode is already FDA approved -K093017. In this submission, Neonate mode is added to STELLAR 300.

Comparison of all the parameters of STELLAR 300 to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document.

## Compliance to standards:

The following international standards are referred.

IEC 60601-1 Medical Electrical Equipment-General requirement for safety IEC 60601-1-2 Medical Electrical Equipment-EMC requirements & tests

### Conclusion:

Based on the Technological characteristics of STELLAR 300 and its comparison with that of predicate device STELLAR 404T, 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

L&T Medical Equipment & Systems, Larsen & Toubro Limited Mysore Campus, Gate No. 5, Plot No. 358-360, KIADB Industrial Area, Hebbal, Mysore - 570 018. INDIA Tel : [phone] Fax : + 91 821 2407001. CIC Toll free: 1800-200-5858, 1800-233-5558 www.LNTMEDICAL.com

Registered Office: L&T House, N. M. M. Marq Ballard Estate Mumbai 400 001, India 22

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

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

Larsen & Toubro Limited c/o Mr. E.J. Smith Smith Associates 1468 Harwell Ave Crofton, MD 21114

MAR 1 1 201

Re: K103763

Trade/Device Name: Stellar 300 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: 74 MWI Dated: March 2, 2011 Received: March 4, 2011

Dear Mr. 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 – 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 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

umer R. Vahmer

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

510(k) Number (if known):

510(k) Number (if known):

Device name: STELLAR 300

Indication for use:

The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the benside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also disolay the digital wallus of PR, SpO2, Non-Invasive Blood Pressure (Systolic Diastolic and Mean) and Temperature readings.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable 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)

uma t2. volumer

. ·

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K103763

Page 1 of 1