PLANET 55

K071472 · Larsen & Toubro Limited · MWI · Sep 21, 2007 · Cardiovascular

Device Facts

• Record ID: K071472
• Device Name: PLANET 55
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The PLANET 55 multi-parameter 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 /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, EtCO2 and FiCO2 readings. 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.

Device Story

PLANET 55 is a 4-channel multi-parameter patient monitor; inputs include ECG (3/5 lead), respiration, NIBP, temperature, SpO2, and CO2 sensors. Device processes physiological signals to display real-time waveforms and digital values (HR/PR, SpO2, RR, NIBP, temperature, EtCO2, FiCO2). Features include 24/48/72-hour tabular/graphical trends, NIBP trend storage (240 readings), and alarm recall (24 events). Operated by professional healthcare providers in clinical environments; includes thermal array recorder for printing. Connectivity options include USB, RS232, RS485, infrared remote, and Ethernet. Output provides continuous monitoring and adjustable alarm signals to assist clinicians in patient assessment and decision-making during bedside care or transport.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with international standards IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance). No clinical data provided.

Technological Characteristics

4-channel monitor with 8.4" TFT display. Parameters: ECG, Respiration, NIBP, Temperature, SpO2, CO2. Connectivity: USB, RS232, RS485, Infrared, Ethernet. Thermal array recorder. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for monitoring vital signs in adult, pediatric, and neonatal patients in clinical settings (bedside or intrahospital transport). Parameters include ECG, SpO2, respiration, temperature, NIBP, and CO2. 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

• PLANET 50 Patient Monitoring System (K043370)
• STAR 50 Patient Monitoring System (K051608)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. Above the company name is the text "K07 1472" in a handwritten font. The logo is a circle with the letters "L" and "T" inside.

SEP 2 1 2007

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : [phone]

E - Mail .

Ref :

30th March 2007 Page: 01 of 04

## 510(K) SUMMARY

(Per section 807.92 ©)

| 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 | [e-mail] | | |
| Date the summary was prepared | 30th March, 2007 | | |

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Image /page/1/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. Above the logo is the number 2071472. The logo consists of the letters L and T inside of a circle. Below the logo is the text "LARSEN & TOUBRO LIMITED" in bold.

- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : [phone]

E - Mail :

Ref : .

30th March 2007 Page: 02 of 04

| DEVICE | |
|---------------------|---------------------------|
| Trade name | PLANET 55 |
| 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# | PLANET 50 Patient Monitoring System (L&T Medical Equipments & systems) / K043370 STAR 50 Patient Monitoring System (L&T Medical Equipments & systems) / K051608 | | |

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Image /page/2/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. Above the logo is the text "KC71472". The logo consists of the letters "L" and "T" inside of a circle. Below the logo is the text "LARSEN & TOUBRO LIMITED" in bold.

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUC

Aysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 · Tel ; [phone]

E - Mail

Hef

30th March 2007 Page: 03 of 04

## DEVICE DESCRIPTION

PLANET 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, and CO2.

PLANET 55 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR, SpOz, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has selective 24\48\72 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. It has got optional communication features - USB, RS232, RS485 Infrared remote and Ethernet.

## INTENDED USE OF THE DEVICE

The PLANET 55 multi-parameter 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 /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, EtCO2 and FiCO2 readings.

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.

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Image /page/3/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of the letters L and T inside of a circle. Above the logo is the number KC71472.

LECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Complex, KlADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : [phone]

E - Mail

Rel

30th March 2007 Page: 04 Of 04

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

Device: Larsen & Toubro limited make PLANET 55 Patient Monitoring System. Predicate device:

- PLANET 50 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K043370
- STAR 50 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K051608

The parameters available with the Larsen & Toubro Limited make PLANET 55 Patient monitoring system are available with the predicate device - Larsen & Toubro Limited make PLANET 50 patient monitoring system & STAR 50 patient monitoring system (for 3/5L ECG, Respiration and Temperature).

Comparison of all the parameters of PLANET 55 to that of the predicate device 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

## Conclusion:

Based on the Technological characteristics of PLANET 55 and its comparison with that of predicate device Planet 50 and Star 50 (for 3/5L ECG, Respiration and Temperature), 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.

e.

(avindran)

(N Ravindr) Head - Design & Development

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2007

Larsen & Toubro LLC c/o Mr. Jay Y. Kogoma Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Rc: K071472

> Trade/Device Name: Planet 55 Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: September 5, 2007 Received: September 6, 2007

Dear Mr. Kogoma:

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 such 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.

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Page 2 - Mr. Jay Y. Kogoma

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 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/industry/support/index.html.

Sincerely vours.

Bfummermor fr

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

071472 510(k) Number (if known)

Device name: PLANET 55

Indication for use:

The PLANET 55 multi-parameter 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 /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, EtCO2 and FiCO2 readings.

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)

Blummmma
Sign Off

Division of Cardloya 510(k) Number

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