STAR (LUNAR SERIES) MONITORING SYSTEM

K032867 · Larsen & Toubro Limited · MWI · Nov 10, 2003 · Cardiovascular

Device Facts

• Record ID: K032867
• Device Name: STAR (LUNAR SERIES) MONITORING SYSTEM
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The STAR (LUNAR SERIES) multiparameter 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 (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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

STAR (LUNAR Series) is a multiparameter patient monitor for bedside or intra-hospital transport use. It accepts inputs via sensors for ECG (3/5 lead), respiration, temperature, NIBP, pulse oximetry, and invasive blood pressure (2 channels). The device processes these signals to display real-time waveforms (ECG, plethysmograph, respiration, IBP) and digital values (HR/PR, SpO2, RR, NIBP, IBP, temperature) on a TFT color monitor. It features graded, color-coded audible and visual alarms with adjustable limits. Data management includes 24-hour tabular/graphical trends (except NIBP, which stores 240 readings) and recall of the last 16 alarm conditions. Professional healthcare providers operate the device to interpret patient status and make clinical decisions. Optional output includes printing via inkjet printer or chart recorder. The device is powered by sealed lead-acid batteries for portability.

Clinical Evidence

Bench testing only. Compliance with international standards IEC 60601-1 (Medical Electrical safety), IEC 60601-1-2 (EMC compliance), and IEC 60601-2-27 (ECG safety) was demonstrated to support safety and effectiveness.

Technological Characteristics

TFT color display; 4-channel waveform monitoring; 2-channel temperature and IBP; 3/5 lead ECG; sealed lead-acid battery power; portable form factor. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-27.

Indications for Use

Indicated for monitoring vital signs in adult, pediatric, or neonatal patients in clinical settings (bedside or intra-hospital 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

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

Submission Summary (Full Text)

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

NOV 1 0 2003

Image /page/0/Picture/1 description: The image shows a black and white logo. The logo consists of a circle with the letters 'L' and 'T' intertwined inside. Below the circle, there is a word in bold capital letters, but the word is cut off, so only 'TOUBRO' is visible.

K032867
page 1 of 4

# LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP . ELECTRONIC PRODUCTS -

Mysore Works. KIADB Industrial Area. Hebbal - Hoolagalli, Mysore - 571 186 • Tel · (91) - 821 - 402561 • Fax · (91) - 821 - 402468

E - Mail

Rel

7" October 2003 Page : 01

## 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 | 91-821-402561 | Fax | 91-821-402468 |
| Contact Person | A.B.Deshpande | Title | Head - Quality Assurance & customer<br>support |
| E-Mail address | [e-mail] | | |
| Date the summary was prepared | October 7,2003 | | |

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

Image /page/1/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circle with the letters "L" and "T" inside, and the words "LARSEN & TOUBRO LIMITED" are written below the circle. The text is in a bold, sans-serif font. The logo is black and white.

32867
page 2 of 4

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

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

E - Mall

વિભ

7" October 2003 Pagc : 02

| DEVICE | |
|---------------------|---------------------------|
| Trade name | STAR (LUNAR SERIES) |
| 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# | Eagle 3000 patient Monitoring System (Marquette Electronic) / K952474 Vital signs monitor Model 8100 (CSI) / K001020 | | |

Regd. Off : L & T House, Ballard Estate, P. O. Box 276, Mumbai 400 001 • Phone : [phone] / 82 • Fax : 91 - 22 • 262 0223 Website : www.Intebg.com

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

Image /page/2/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. The logo consists of a stylized symbol above the company name. The symbol appears to be two interlocking letter 'L's inside of a circle. The company name is written in bold, uppercase letters.

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS

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

E · Mail

Pet

7th October 2003 Page : 03

#### DEVICE DESCRIPTION

This STAR unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry and Invasive BP. STAR is a four channel monitor with waveform display capability for ECG (Lead I / II / III / V / AVL / AVF / AVR), Picthysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mcan) and Temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters cxccpt NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Print out of tabular trend and ECG waveform can be obtained through an optional inkjet printer or paper chart recorder.

#### INTENDED USE OF THE DEVICE

The STAR (LUNAR SERIES) multiparameter 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 (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration and Invasive Blood pressure (TBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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.

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

Image /page/3/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized circle with the letters "L" and "T" inside. Below the logo, the words "LARSEN & TOUBRO LIMITED" are written in bold, uppercase letters.

K032867
page 4 of 4

- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Tel : (91) - 821- 402561 . Fax : (91) - 821 . 402468 Mysore Works, KIADB Industrial Area

E - Mail

Rel .

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device : Larsen & Toubro limited make STAR(LUNAR series) 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 these predicate devices are available with the Larsen & Toubro Limited make STAR (LUNAR series) patient monitoring system (ECG-3/5 lead, Respiration, Temperature -- 2 channels, NIBP, Pulse oximetry and Invasive BP- 2 channels). The no. of channels, range and accuracy of the parameters & method of sensing are similar to the predicate devices. In STAR monitor audible & visual alarms are provided similar to those in the Predicate devices.

STAR has got TFT color display like CSI Model 8100. Weight is also comparable with that of Marquette Eagle 3000. Battery (2 sealed lead acid) is provided in STAR monitor like that of the predicate device CSI Model 8100.

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

#### Compliance to standards:

Testing were conducted, which demonstrate safety and effectiveness to the following international standards. 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 STAR (LUNAR scries) 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.

7th October 2003 Page : 04

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

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms, with the lines becoming wavy at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2003

Larsen & Toubro Ltd. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548

Re: K032867

Trade Name: STAR (LUNAR Series) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 29, 2003 Received: October 30, 2003

Dear Mr. Devine:

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.

{5}------------------------------------------------

Page 2 - Mr. Ned E. Devine, Jr.

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 (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. 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/dsma/dsmamain.html

Sincerely yours.

Degea map
L. Degea, M.D.

Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K032867

Page 1 of 1

### Indication for Use statement

510(k) Number (if known)

Device name: STAR (LUNAR series)

Indication for use:

The STAR (LUNAR SERIES) multiparameter 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 (Lead I / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER RPAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Medusa Mayer for BDE

ardiovascular Devices

510(k) number: k032867

Prescription Use (Per 21 CFR 801.109) OR

Over-the -counter-use