STELLAR 404 MONITORING SYSTEM

K042560 · Larsen & Toubro Limited · MWI · Oct 6, 2004 · Cardiovascular

Device Facts

• Record ID: K042560
• Device Name: STELLAR 404 MONITORING SYSTEM
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The STELLAR 404 two parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during 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) 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

STELLAR 404 is a 2-parameter patient monitor; inputs include NIBP and pulse oximetry sensors; processes signals to display plethysmograph waveforms and digital values for PR, SpO2, and NIBP (systolic, diastolic, mean); features graded color-coded alarms, 12-hour tabular/graphical trends for SpO2, and 100-reading NIBP trend storage; includes optional thermal array recorder for printing; operated by professional healthcare providers in clinical settings; provides real-time monitoring and alarm recall (last 16 events) to assist clinical decision-making; portable design supports intrahospital transport.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) confirmed.

Technological Characteristics

TFT color display; Lithium-ion battery; thermal array recorder; NIBP and pulse oximetry sensing; audible/visual alarms; weight <4kg; portable form factor; IEC 60601-1 and IEC 60601-1-2 compliant.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring vital sign monitoring (PR, SpO2, NIBP) at bedside or during intrahospital 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

• PLANET patient Monitoring System (K032871)

Submission Summary (Full Text)

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

OCT 2004

K042560
P 1/4-

Image /page/0/Picture/2 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of the letters L and T inside of a circle. Below the logo, the words "LARSEN & TOUBRO LIMITED" are written in all caps. The text is bolded and in a sans-serif font.

Powai Works, Saki Vihar Road, P. O. Box 8901, Mumbai-400 072 • Tel. : [phone] / 11

Ref :

:

.

E-mail :

2501 April, 2004 Page : 01 of 04

8

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

Regd. Off. : L&T House, Ballard Estate, P.O. Box 278, Mumbai 400 001 • Tel.: [phone] • Fax : [phone]

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

Image /page/1/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of the letters 'L' and 'T' intertwined within a circle. Below the logo, the text 'LARSEN & TOUBRO LIMITED' is written in bold, uppercase letters.

Powai Works, Saki Vihar Road, P. O. Box 8901, Mumbai-400 072 • Tel. : [phone] / 11

:

.

Rel :

.

:

E-mail :

25th April, 2004 Page : 02 of 04

| DEVICE | |
|---------------------|---------------------------|
| Trade name | STELLAR 404 |
| Common name | Patient Monitoring System |
| Classification name | Vital Signs Monitor |

| PREDICATE DEVICE IDENTIFICATION | | |
|-----------------------------------------|-------------------------------------------------------------------------------|-------------------------|
| CFR21 Section | 870.2300 | Product code (optional) |
| Classification panel | Cardiovascular | MWI |
| Device Class | Class II | |
| Legally marketed Comparison Device / K# | PLANET patient Monitoring System (L&T Medical Equipments & systems) / K032871 | |

Regd. Off. : L&T House, Ballard Estate, P.O. Box 278, Mumbai 400 001 • Tel.: [phone] • Fax : [phone]

.

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

Image /page/2/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" inside of a circle. Below the logo, the text "LARSEN & TOUBRO LIMITED" is written in all caps.

Powai Works, Saki Vihar Road, P. O. Box 8901, Mumbal-400 072 • Tel. : [phone] / 11

Ref :

E-mail :

25th April, 2004 Page : 03 of 04

## DEVICE DESCRIPTION

This STELLAR 404 unit is a 2 parameter Patient monitor System (TFT color monitor) with NIBP and Pulse oximetry with an optional inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.

STELLAR 404 has waveform display capability for Plethysmograph. It also displays the digital values of PR, SpO2 and Non-Invasive Blood Pressure (Cystolic, Diastolic and Mean) readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.

## INTENDED USE OF THE DEVICE

The STELLAR 404 2 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 parameter includes Piethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) 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. : 1.&T House, Ballard Estate, P.O. Box 278, Mumbai 400 001 · Tel.: [phone] · Fax : [phone]

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

Image /page/3/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circle with the letters "L" and "T" inside. Below the circle, the words "LARSEN & TOUBRO LIMITED" are written in all caps. The text is bolded and in a sans-serif font.

Powai Works, Saki Vihar Road, P. O. Box 8901, Mumbai-400 072 · Tel. : [phone] / 11

Rel :

E-mail :

25th April, 2004 Page : 04 Of 04

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

Device : Larsen & Toubro limited make STELLAR 404 Patient Monitoring System. Predicate device:

PLANET patient Monitoring System (Make: L&T Medical Equipments & systems) / K032871

The parameters available with the Larsen & Toubro Limited make STELLAR 404 Patient monitoring system (NIBP and Pulse oximetry) 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 404 monitor audible & visual alarms are provided similar to that in the Predicate device.

STELLAR 404 has got TFT color display like PLANET. STELLAR 404 has got thermal array recorder similar to that available in PLANET. Weight of the STELLAR 404 (4Kg maximum) is less than that of the predicate device. Battery provided in STELLAR 404 is Lithium ion, where as it is Lead acid battery in case of predicate device PLANET.

Comparison of all the parameters of STELLAR 404 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

### Conclusion:

Based on the Technological characteristics of STELLAR 404 and its comparison with that of predicate device PLANET, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitor and doesn't pose any additional risk on safetx & effectiveness of the device.

(Mohan G:R)
Head - Design & Development

Regd. Off. : L&T House, Ballard Estate, P.O. Box 278, Mumbai 400 001 • Tel.: [phone] • Fax : [phone]

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

Image /page/4/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2004

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

Re: K042560

Trade Name: STELLAR 404 Patient Monitoring System 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 21, 2004 Received: September 21, 2004

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to togally to togal Device Amendments, or to commerce prior to May 20, 1978, the examine
devices that have been reclassified in accordance with the provisions of the Federal Food, DNAA de vices may been results in a mot require approval of a premarket approval application (PMA). allu Cosmetic Act (71ct) that do not requent to the general controls provisions of the Act. The I ou may, dicroro, market are act include requirements for annual registration, listing of general controls provisions of as tice, 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.

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

Page 2 – Mr. Ned Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a bevice complies with other requirements of the Act that I DA has made a decommanding administered by other Federal agencies. You must or any I oderal statutes and registements, including, but not limited to: registration and listing (21 Comply with an the Act 31equirements, 01); good manufacturing practice requirements as set CTN in the quality systems (QS) of Art 807), go critical (21), and if applicable, the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin mainer of substantial equivalence of your device to a legally prematics notification: "The PDF intentigestication 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 If you desire specific arrestiance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whoording of reference to your responsibilities under the Act may be obtained from the Other general informational 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,

B. Ziminor for
B. Ziminor, MD

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

510(k) Number (if known): K042560

Device Name: STELLAR 404

Indications for Use:

The STELLAR 404 two parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during 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) 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.

Blumiman
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KOUNS

> 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)