GALAXY 55

K082685 · Larsen & Toubro Limited · MWI · Sep 26, 2008 · Cardiovascular

Device Facts

• Record ID: K082685
• Device Name: GALAXY 55
• Applicant: Larsen & Toubro Limited
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2. Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO2. RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EICO2, FiCO2, NoO. O2, EtAA and FiAA 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

Galaxy 55 is a multi-parameter patient monitor for bedside use by professional healthcare providers. It acquires physiological signals including ECG (3/5 lead), respiration, NIBP, IBP, temperature, SpO2, CO2, and anesthetic gases. The device processes these inputs to display real-time waveforms and digital values (HR/PR, RR, blood pressure, gas concentrations) on an external 15"/17"/19" monitor. It features tabular/graphical trends (up to 72 hours), NIBP trend storage (240 readings), and alarm recall (last 24 alarms). It includes adjustable alarm limits with audible/visible alerts. Data can be printed via a two-channel thermal array recorder. Optional connectivity includes USB, RS232, infrared remote, and Ethernet. The device assists clinicians in continuous patient assessment, enabling timely clinical intervention based on monitored vital signs.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

8-channel multi-parameter monitor; supports ECG, SpO2, NIBP, IBP, Temp, CO2, and gas modules. Connectivity: USB, RS232, Infrared, Ethernet. Standards: IEC 60601-1 (Safety), IEC 60601-1-2 (EMC). Display: External 15"/17"/19".

Indications for Use

Indicated for monitoring vital signs of single adult, pediatric, or neonatal patients in clinical settings. Parameters include ECG, SpO2, respiration, temperature, capnography, NIBP, IBP, and gas monitoring. 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

• STAR 55 Patient Monitoring System (K080173)

Submission Summary (Full Text)

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# SEP 2 6 2008

## LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 = Tel : (91) - 821 - 2402561 ● Fax : (91) - 821 - 2402468

E - Mail :

Hei :

Date: 20.02.2008 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 | 91-821-2405439 | 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 | 20th Feb, 2008 | | |

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

23

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K082685
p2/4

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## LARSEN & TOUBRO LIMITED

- ELECTRICAL BUSINESS GROUP + ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 ▲ Tel : (91) - 821 - 2402561 ● Fax : (91) - 821 - 2402468

E · Mail :

મેદા :

Date: 20.02.2008 Page: 02 of 04

| DEVICE | |
|---------------------|---------------------------|
| Trade name | GALAXY 55 |
| 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# | STAR 55 Patient Monitoring System (L&T Medical Equipments & systems) / K 080173 | |

Regd. Off : L & T House, Ballard Estate, P. O. Box 278, Mumbai 400 001 ● Phone : [phone] / 82 ● Fax : 91 - 22 - 262 0223
Website : 20 - 201 - 1 - 2 - Website : www.intebg.

.

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Image /page/2/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. The logo consists of a stylized "LT" inside a circle above the company name. The text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.

ELECTRONICS DIVISION - ELECTRONIC PRODUC Mysore Campus, KIADB Industrial Area, Hebbal · Hootagalli, Mysore · 570 018 · Tel: [phone]

E · Mail :

Date: 20.02.2008 Page: 03 of 04

#### વિદ્યા :

### DEVICE DESCRIPTION

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

GALAXY 55 is a 8-channel monitor with 15"/17"/19" external monitor display capable of displaying ECG. Respiration. SpO2, CO2. digital values of HR/PR. SpO2, RR. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolie and Mean), Temperature, EiCO2. FiCO2. NoO. On, EiAA and FiAA readings. It has selective 24148172 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, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

### INTENDED USE OF THE DEVICE

The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2. Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, SpO2. RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean). Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EICO2, FiCO2, NoO. O2, EtAA and FiAA 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.

Regd. Off:L & T House, Ballard Estate, P.O.Box 278, Mumbai 400 001 ● Phone:[phone] ● Fax: [phone] Website : www.LNTEBG.com

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Image /page/3/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized symbol above the company name. The symbol is a circle with the letters 'L' and 'T' intertwined inside. The company name is written in bold, uppercase letters.

- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Area, Hebbal - Hoolagali, Mysore - 570 018 ● Tel : (91) - 821 - 24022661 ● Fax : (91) - 821 - 2402468

E - Mail :

ମ୍ପରା :

Date: 20.02.2008 Page: 04 Of 04

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

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

- STAR 55 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K 080173
The parameters available with the Larsen & Toubro Limited make GALAXY 55 Patient monitoring system are available with the predicate devices - Larsen & Toubro Limited make STAR 55 patient monitoring system

Comparison of all the parameters of GALAXY 55 to that of the predicate devices is given in the "Predicate device comparison table" 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 GALAXY 55 and its comparison with that of predicate devices Star 55, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitor and doesn't pose any additional risk on safety & effectiveness of the device.


(N Ravindran) Head - Design & Development

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2008

Larsen & Toubro Limited c/o Underwriters Laboratories, Inc. (Third Party Review) Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, IL 60062

Rc: K082685

Trade/Device Name: Galaxy 55 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: Scptember 2, 2008 Received: September 15, 2008

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. 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

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Page 2 - Mr. Ned Devine

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 yours,

Dura R. Holmes

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

510(k) Number (if known)

Device name: Galaxy 55

Indication for use:

The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HRPR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA 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)

Duna R. Jenkins

(Division Sign-Off) Division of Cardiovascular Devices

K082685 510(k) Number.

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