PLANET 55, MODEL 100

{0}------------------------------------------------ Image /page/0/Figure/0 description: The image shows a logo with a circle surrounding two stylized letters that appear to be 'L's. The 'L's are mirrored and connected in the center, creating a symmetrical design within the circle. The logo has a textured or slightly rough appearance, possibly indicating it's from a scanned or low-resolution source. K090443 P1/4 # Larsen & Toubro Limited --------------------------------------------------------------------------------------------------------------- i : : 1. 1 : : : . . : . Mysore Campor), KADB Industral Area: Hebbal - Hoolagali, Mysolo - Tel: - 911821) 2405000 - Fax - 91 (821) 2402468 #### 后,协副 નિર્ણ . · . . . . . . : . . . : # JUN - 5 2009 : Date: 05.01.2009 Page: 01 of 04 ### 510(K) SUMMARY . (Per section 807.92 (") | <b>CONTACT DATA</b> | | | | |-------------------------------|--------------------------------------------------------------------------------|-------|---------------------------------------------------------| | Submitter's Name | Larsen & Toubro Limited | | | | Address | KIADB Industrial Area, Hebbal Hootagalli,<br>Mysore - 570018. Karnataka. INDIA | | | | Telephone | 91-821-2405439 | 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 | 05.01.2009 | | | : Regd. Off:L & T House, Ballard Eslate. P O. Box 278, Mumbai 400 00 ● Phone: #91(22)67525858 1181 +91(22)675258 Website:www.LNTEBG.com . . . . . . . . . . . (, {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the letters 'L' and 'T' inside of a circle. The two letters are stylized and appear to be connected. The logo is black and white and has a simple design. The letters are bold and easy to read. p.214 # Larsen & Toubro Limited --- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -- Mysore Campu's. KIADB Industrial Area. Hebbal - Hoctagall. Mysore - 570 0118 - Tel: +91 (821) 2405000 - Fax: - 91 (821) 2402468 1 E · Mar : . Carlos Career States ・ . : · Rel : ි Page: 02 of 04 . The same · : : | | DEVICE | |---------------------|---------------------------| | Trade name | PLANET 55 Model 100 | | Common name | Patient Monitoring System | | Classification name | Vital Signs Monitor | | PREDICATE DEVICE IDENTIFICATION | | | | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----| | CFR21 Section | 870.1025 | Product code | MHX | | Classification panel | Cardiovascular | | | | Device Class | Class II | | | | Legally marketed Comparison Device / K# | PLANET 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K071472 Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp) / K020550 | | | Regd. Off:L & T House. Ballard Estate, P.O. Box 278. Munisi 400 001 ◆ Phone:+9 1(22)67525656 ● Fax: +9 1(22)67525856 • Website : www.LNTEBG.com : {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo consisting of two stylized letters, likely 'L' and 'T', enclosed within a circle. The letters are designed with a geometric, angular style, giving them a modern and somewhat abstract appearance. The logo has a textured or slightly pixelated look, possibly due to the image quality or the original design. The overall impression is a simple yet distinctive mark, suitable for branding purposes. # LARSEN & TOUBRO LIMITED ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS Mysore Cambus, KIADB Industrial Area, Heabal - Hootagati, Mysole - 570 018 · Tel - 191 (621) 240546R E · Mall માં છે. Date: 05.01.2009 Page: 03 of 04 #### DEVICE DESCRIPTION Planet 55 Model 100 is a Multi-parameter patient monitoring system for confinuous monitoring of the physiological parameter ECG (3/5 lead). Arrhythmia & ST analysis, Respiration. NIBP. Temperature, SpO2 and CO2. PLANET 55 Model 100 is a 4-channel monitor with 8,4" TFT display capable of displaying ECG. Respiration. Sp02. CO2 digital values of HR/PR. Spo2. Righton-Invasive Blood Pressure (Systolic, Diastolic and Mean). Temperature, FiCO2, FCO2, FCO2 readings. It has selective 24148172 Hours tabilitar and graphical trends. It has special feature of NIBP having a trend of storing lust 240 readings. It has Altrin Recal first with last 24 patient alarms details. It has a wo-chamel thermal array receint for printing of Tabular trends & waveforms. It has got-optional communication features i USB. RS232. Infrared remote and Ethernet. The get options comments with adjustable alàrm fimits as well as visible and audible alarm signals. ## INTENDED USE OF THE DEVICE The PLANET 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 thring 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 and Capnography (CO2). It can also display the digital values of HRPR, SpO2, RR. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EiCO2, and FiCO2 readings. In addition, PLANET 55 Model 100 has got Archythmia and ST detection from 31. / 51. ECG measurements. The Arthythmia and ST refection for the crime for all . 31. - 51. All 1 and i Adult & Pediatric patients and is not intended for use with Neonarda Micheed The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with alle alarm limits as well us sisible and audible alarm signals. The monitor is not included by nome use. Regd. Off:L & T House. Ballard Estate, P.O. Box 278, Mimbral 400 00 · Phone:+9 (22)67525656 · Fax:+91(22)67525858 · Fax:+91(22)675256 Website : www LNTEBG.com {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo consisting of two stylized letters, 'L' and 'T', enclosed within a circle. The 'L' and 'T' are designed with sharp angles and lines, giving them a modern and geometric appearance. The logo has a black and white color scheme, with the letters and circle outlined in black against a white background. The overall design is simple, clean, and easily recognizable. # & Toubro Limitt ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS Mysore Campais, KADB Industrial Area, Heibai · Hootagali, Mysore · 570 018 · Tel: · 4911821) 2405000 · Fax: · 91 (82 ) 2402466 乐 · Maui . 14rd : Date: 05 01 .2009 Page: 04 01 01 01 01 ### TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE Device: Larsen & Toubro limited make PLANET 55 Model 100 Patient Monitoring System. #### Predicate device: - � PLANET 55 Patiem Monitoring System (Make: L&T Medical Equipments & Systems) / K071472. - Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope o Corp) : K020550. : The parameters available with the Larsen & Toubro Limited make PLANET 55 Model 100 Patient monitoring system are available with the predicate devices "Passport 2 Vital signs monitor with 12 ECG Analysis Module" for Arrhythmia & ST analysis and Larsen & Toubro Limited make PLANET 55 patient monitoring system for other parameters. Comparison of the parameters of PLANET 55 Model 100 to that of the predicate device is given in the "Predicate device comparison table" document. #### Compliance to standards: The following international standards are referred. IEC 60601-1 Medical Electrical safety IFC 60601-1-2 EMC compliance #### Conclusion: Based on the Technological characteristics of PLANET 55 Model 100 and its comparison with that of predicate devices 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) (N. Ravindran) Head - Design & Development Regd. Off : L & T House, Ballard Estate, P.O. Box 273, Mumbei 400 001 · Phone : 191(22)67525856 Website : www.LNTEBG.com {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### JUN - 5 2009 Larsen & Toubro Limited c/o Ms. Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114 #### Re: K090443 Trade/Device Name: PLANET 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 (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/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 (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. Žuckerman, 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) Device name: PLANET 55 Model 100 Indication for use: The PLANET 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), SpO2, Respiration, Temperature and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtC02, and FiC02 readings. In addition, PLANET 55 Model 100 has Arrhythmia and ST detection from 3L / 5L ECG measurements. The Arthythmia 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) H.R.M. D.D. for B Zuckerman ardiovascular Devices **510(k) Number** K090443 Page 1 of 1 19