STELLAR 300

{0}------------------------------------------------ 093017 # Larsen & Toubro Limited ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS - Mysore Canipus, KIADB Industrial Area, Hebbal - Hootegalli, Mysole - 570 018 - Tel. E · Mail : ત્ત્વના : APR 2 9 2010 21" Aug 2009 Page: 01 of 04 ### 510(K) SUMMARY (Per section 84) 1.491 € j . | 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 | | DeshpandeAB@myw.ltindia.com | | | Date the summary was prepared | | 12th Aug 2009 | | Regd, Off : L & T House, Ballard Estate, P O. Box 278, Mumbai 400 001 · Phone : +91(22)67525658 · Fax : +91(22)67525858 Website : www.LNTEBG.com {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a circle with two mirrored symbols inside. The symbols are stylized letters, possibly "L" and "T", connected in the middle. The letters are slightly distorted, and the overall image has a grainy texture. # larsen & Toubro Limited ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Mysore Campus, KIADB Industral Area, Hebbal - Hootegali, Mysore - 570 018 - Tel - 91 (821) 2402561 - Fax ' +91 (821) 2402458 E · Mail · મગ્ર : 21ª Aug 2009 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) | MWI | | Classification panel | Cardiovascular | | Device Class | Class II | | Legally marketed Comparison Device /<br>K# | STELLAR 404T Patient Monitoring<br>System (L&T Medical Equipments &<br>systems) / K060058 | Regd. Off:L. & T House. Ballard Estate, P.O.Bex 278, Mumbai 400 001 ● Phone: +9 (122)67525658 ● Fax: +9 (22)67525358 Wabsite . www LNTEBG.com {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo consisting of two stylized letters, likely 'L' and 'T', mirrored and placed side-by-side within a circle. The letters are designed with sharp, angular lines, giving them a modern and geometric appearance. The logo is rendered in black against a white background, creating a high-contrast image. The overall design is simple yet distinctive, suggesting a corporate or brand identity. ## ARSEN & Toubro Limited ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS Mysore Campus, KIADƏ Indusmal Area, Hebbai - Hoolagalli, Mysore - 570 018 + Tol - +91 (821) 2402661 · Fax : +91 (821) 2402468 E - Mail : Ref 215 Aug 2009 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 arrav recorder for printing of Tabular trends & wavelorms. STELLAR 300 have waveform display capability for Piethysmograph. It also displays the digital values of PR, SpO2_Non-Invasive Blood Pressure (Systolic. Displays Mean) and Temperature 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 adouls and rend for NIEP to store the last 100 readings. Allarm recall feature offers last 16 lam conditions. ### INTENDED USE OF THE DEVICE The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult or Pediatric patient's vital signs at the bedside or during intractor an transport along with the appropriate accessories mentioned / supplied with the with Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SpO3, 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 porable device, permits patient monitoring with adjustable alarm limits as well as vi piraond audifile alam signals. The monitor is not intended for houne use. Regd. Off : L & T House Bailard Estate, P.O.Eox 278, Mumbai 400 001 · Phone · +91(22)67525658 Website : www.LNTEBG.com {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo consisting of the letters 'LT' inside of a circle. The letters are stylized and appear to be connected. The logo is black and white and has a slightly distressed or vintage look. The image quality is somewhat low, with visible pixelation and artifacts. # larsen & Toubro Limited ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS Mysora Campus, KIADB Industrial Araa. Hebbal · Hootagali, Mysore · 570 018 · Tel · E - Mar : 后 21" Aug 2009 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 4047 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 oximery 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 alaring are STCLAR 40 15 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 STELLAR 404T has Adult & Neonate modes of operation whereas STELLAR 300 has only Adult mode of operation. STELEAR 300 has got TFT color display like STELLAR 404T. STELLAR 300 hass got thermal array recerder similar to that available in STELLAR 4047. Battery provided in STELLAR 300 is Lithium for, where as it is Lead acid battery in case of predicate device STELLAR 404T. Companison 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 EC 60601-1-2 Medical Electrical Equipment-EMC requirements & sale #### Conclusion: Based on the Technological characteristics of STELLAR 300 and its comparison with that of predicate device STELLAR 404T, Larsen & Toubro Limited believes had their ad vice is substantially equivalent to this predicate Monitor and doesn't pose any additional risk on safety & effectiveness of the device. (1) Ravindral Head - Design & Development Regd. Off : L & 1 House. Bailaid Estate, P O. Ecx 276, Mumbai 400 001 · Prose · +9 (122)67525658 · Fax · +91(22)67525658 Website : www. UNTEBG.com {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure on the right side. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged to follow the curve of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 APR 2 9 2010 Larsen & Toubro Limited c/o Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 K093017 Re: > Trade/Device Name: Stellar 300 Regulatory Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (Two) Product Code: MWI Dated: April 20, 2010 Received: April 21, 2010 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 (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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, W.Wod. 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 K093017 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 or Pediatric patient's vital signs at the bedside or during intra-hospital 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. 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 Eyaluation (ODE) W. Wess Page 1 of 1 510(k) Number K085301 Division of Cardiovascular Device