PLANET 50 MONITORING SYSTEM

K043370 · Larsen & Toubro Limited · MWI · Feb 15, 2005 · Cardiovascular

Device Facts

• Record ID: K043370
• Device Name: PLANET 50 MONITORING SYSTEM
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The PLANET 50 multiparameter Patient Monitoring system is intended to monitor a single adult, pediatric or 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), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 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

PLANET 50 is a multiparameter patient monitor; inputs include ECG (3-lead), respiration, capnography (CO2), plethysmography, NIBP, and temperature sensors. Device processes signals to display real-time waveforms and digital values for HR/PR, SpO2, RR, NIBP (systolic, diastolic, mean), EtCO2, and FiCO2. Features include graded color-coded alarms, 24-hour tabular/graphical trends (except NIBP), and 16-event alarm recall. Optional two-channel thermal array recorder provides hard-copy trends and waveforms. Used in clinical settings (bedside or intra-hospital transport) by professional healthcare providers. Output allows clinicians to assess patient status and adjust care based on monitored vital signs. Benefits include continuous patient surveillance and timely notification of physiological changes via adjustable alarm limits.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparison of technological characteristics, parameter range/accuracy, and adherence to international safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27).

Technological Characteristics

TFT color display; 3-lead ECG, respiration, capnography, NIBP, temperature, and pulse oximetry sensing. Powered by two sealed lead-acid batteries. Weight: 5kg. Includes optional two-channel thermal array recorder. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-27 (ECG).

Indications for Use

Indicated for monitoring vital signs in adult, pediatric, or neonatal patients at the bedside or during intra-hospital transport. Parameters include ECG (3-lead), respiration, capnography (CO2), plethysmography, HR/PR, SpO2, NIBP, and temperature. Not intended 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

• Eagle 3000 patient Monitoring System (Marquette Electronic) (K952474)
• Vital signs monitor Model 8100 (CSI) (K001020)

Submission Summary (Full Text)

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FEB 1 5 2005

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## LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS

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Mysore Works, KIADB Industrial Area, Hebbal-Hootagalii, Mysore - 571 186 · Tel : (91) - 821 - 402561 · Fax : (91) - 821 - 402468

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25th April, 2004 Page : 01 of 04

### 510(K) SUMMARY

(Per section 807.92 O)

| 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 |
| E-Mail address | [e-mail] | | |
| Date the summary was prepared | April 25th,2004 | | |

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KC43370/S1
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# LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS

Mysore Works, KIADB Industrial Area, Hebbal-Hootagalli, Mysore - 571 186 • Tel : (91) - 821 - 402561 • Fax : (91) - 821 - 402468

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| DEVICE | |
|---------------------|---------------------------|
| Trade name | PLANET 50 |
| Common name | Patient Monitoring System |
| Classification name | Vital Signs Monitor |

| PREDICATE DEVICE IDENTIFICATION | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----|
| CFR21 Section | Product code (optional) | MWI |
| 870.2300 | | |
| Classification panel | Cardiovascular | |
| Device Class | Class II | |
| Legally marketed Comparison Device / K# | Eagle 3000 patient Monitoring System (Marquette Electronic) / K952474 Vital signs monitor Model 8100 (CSI) / K001020 | |

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K04337c/51

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- **ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS** -

Mysore Works, KIADB Industrial Aree, Hebbal-Hootagalli, Mysore - 571 186  •  Tel : (91) - 821 - 402561  •  Fax : (91) - 821 - 402462

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2500 April, 2004 Page : 03 of 04

### DEVICE DESCRIPTION

This PLANET 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3 lead), Respiration, Capnography, Temperature, NIBP and Pulse oximetry. with an optional inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.

PLANET 50 is a three channel monitor with waveform display capability for ECG (3 lead), Respiration, Capnography (CO2) and Plethysmograph. It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has graded and color coded alarms It has 24 hours tabular and graphical trends for all parameters except NIBP. It has special tabular trend for NIBP to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions.

### INTENDED USE OF THE DEVICE

The PLANET 50 multiparameter Patient Monitoring system is intended to monitor a single adult, pediatric or 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), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 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.

Regd. Off : L & T House, Ballard Estate, P. O. Box 278, Mumbai 400 001 ● Phone : [phone] / 82 · Fax : 91 - 22 · 262 0222

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### BRO LI

- **ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS** -

Mysore Works, KIADB Industrial Area, Hebbal-Hootagalli, Mysore - 571 186  • Tel : (91) - 821 - 402561  •  Fax : (91) - 821 - 402468 2500 April, 2004

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

Device : Larsen & Toubro limited make PLANET 50 Patient Monitoring System.

Predicate device :

Eagle 3000 patient Monitoring System (Marquette Electronic), K# K952474 Vital signs monitor Model 8100 (CSI), K# K001020

The parameters available with the Larsen & Toubro Limited make PLANET 50 Patient monitoring system (ECG-3 lead, Respiration, Temperature, NIBP, Capnography and Pulse oximetry) are also available with these predicate devices. The range and accuracy of the parameters & method of sensing are similar to the predicate devices. In PLANET 50 monitor audible & visual alarms are provided similar to those in the Predicate devices.

PLANET 50 has got TFT color display like CSI Model 8100. PLANET 50 has got thermal array recorder similar to that available in Marquette Eagle 3000. Weight of the PLANET 50 (5Kg) is less than that of the predicate devices. Battery (2 sealed lead acid) is provided in PLANET 50 monitor like that of the predicate device CSI Model 8100.

Comparison of all the parameters of PLANET 50 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 safety IEC 60601-1-2 EMC compliance IEC 60601-2-27 ECG safety

### Conclusion :

Based on the Technological characteristics of PLANET50 and its comparison with those of a predicate device CSI Model 8100 and Marquettee Eagle 3000 monitors, Larsen & Toubro Limited believes that their device is substantially equivalent to these Monitors and doesn't pose any additional risk on safety & effectiveness of the device.

(Mohan G.R.)
Head – Design & Development

Regd. Off : L & T House, Ballard Estate, P. O. Box 278, Mumbai 400 001  • Phone : [phone] / 82  •  Fax : 91 - 22 - 262 0223

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2005

Larsen & Toubro LTD c/o Mr. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K043370

Trade Name: PLANET 50 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: December 07, 2004 Received: December 08, 2004

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection b re(s) perceived is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prof to May 20, 1978, as secordance with the provisions of the Federal Food, DNIg. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Ac. (11ct) that to not requently of the general controls provisions of the Act. The I ou may, therefore, manel the Act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc a c roy ols. Existing major regulations affecting your device can may oc subject to such additions, 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. Ned Devine

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Blummenfor

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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### K043370/51

### Indications for Use

510(k) Number (if known): ' Ko43370

Device Name: PLANET 50

Indications for Use:

The PLANET 50 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), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, non-invasive blood pressure ( systolic, diastolic and mean) Temperature, EtCO2 and FiCO2 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.

Blummen

(Division Sign-Cit) Division of Cardiovascular Devices 510(k) Number_1043

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)