STAR 55
Device Facts
| Record ID | K080173 |
|---|---|
| Device Name | STAR 55 |
| Applicant | Larsen & Toubro Limited |
| Product Code | MWI · Cardiovascular |
| Decision Date | Feb 8, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The STAR 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 intra-hospital transport 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 Capitography (82) 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.
Device Story
STAR 55 is an 8-channel multi-parameter patient monitor with a 12.1" TFT display. It processes physiological inputs including ECG (3/5 lead), respiration, NIBP, IBP, temperature, SpO2, CO2, and optional anesthetic gases. The device provides real-time waveform visualization and digital parameter readouts. It features 24/48/72-hour tabular/graphical trends, a 240-reading NIBP trend buffer, and an alarm recall facility for the last 24 events. A two-channel thermal array recorder allows for printing waveforms and trends. Connectivity options include USB, RS232, infrared remote, and Ethernet. Operated by professional healthcare providers in clinical environments, the device assists in patient assessment through adjustable alarm limits and visual/audible alerts, facilitating continuous monitoring and clinical decision-making.
Clinical Evidence
Bench testing only. The device was evaluated for compliance with international standards IEC 60601-1 and IEC 60601-1-2. No clinical data was provided.
Technological Characteristics
8-channel patient monitor with 12.1" TFT display. Parameters: ECG, Respiration, NIBP, IBP, Temp, SpO2, CO2, Gas. Connectivity: USB, RS232, 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 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
- STAR 50 Patient Monitoring System (K051608)
- PM 9000 Express Patient Monitor (K053234)
Related Devices
- K103686 — STAR 50 N · Larsen & Toubro Limited · Mar 15, 2011
- K082685 — GALAXY 55 · Larsen & Toubro Limited · Sep 26, 2008
- K071472 — PLANET 55 · Larsen & Toubro Limited · Sep 21, 2007
- K090172 — STAR 55 MODEL 100 · Larsen & Toubro Limited · Jun 5, 2009
- K051608 — STAR 50 MONITORING SYSTEM · Larsen & Toubro Limited · Jun 29, 2005
Submission Summary (Full Text)
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Image /page/0/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 printed in bold, uppercase letters.
K080173
pg 1 of 4
- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 ▪Tel : +91(821) 2402661 ● Fax : +91(821) 2402468
E - Maii :
Ref :
FEB - 8 2000
Date: 10.05.2007 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 | DeshpandeAB@myw.ltindia.com | | |
| Date the summary was prepared | 10th May, 2007 | | |
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Image /page/1/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" symbol enclosed in a circle. Below the symbol, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570,018 • Tel : +91(821) 2402561 • Fax : +91(821) 2402468
E - Mail :
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Date: 10.05.2007 Page: 02 of 04
| DEVICE | |
|---------------------|---------------------------|
| Trade name | STAR 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# | STAR 50 Patient Monitoring System (L&T Medical Equipments & systems) / K051608 PM 9000 Express Patient Monitor (Mindray Co., Ltd.) / K053234 | | |
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Image /page/2/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" intertwined inside. Below the symbol, the words "LARSEN & TOUBRO LIMITED" are written in bold, uppercase letters.
ECTRONICS DIVISION - ELECTRONI
Mysore Campus, KiADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail :
Ref :
Date: 10.05.2007 Page: 03 of 04
## DEVICE DESCRIPTION
STAR 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, Sp02, CO2 & Gas monitoring.
STAR 55 is a 8-channel monitor with 12.1" TFT 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, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA 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, 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 STAR 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 intra-hospital transport 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 Capitography (82) 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.
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Image /page/3/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. The logo consists of a circle with the letters "L" and "T" inside, and the words "LARSEN & TOUBRO LIMITED" written below the circle. The text is in a bold, sans-serif font.
ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Campus, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail :
Ref :
Date: 10.05.2007 Page: 04 Of 04
ring
## TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device: Larsen & Toubro limited make STAR 55 Patient Monitoring System. Predicate device:
- STAR 50 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K051608
- PM 9000 Express Patient Monitor (Make: Mindray Co., Ltd.) / K053234 t
The parameters available with the Larsen & Toubro Limited make STAR 55 Patient monitoring system are available with the predicate devices - Larsen & Toubro Limited make STAR 50 patient monitoring system & Mindray Co., Ltd. PM 9000 patient monitor for Gas monitoring.
Comparison of all the parameters of STAR 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 STAR 55 and its comparison with that of predicate devices Star 50 and PM 9000 Express for gas monitoring, 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.
(N Ravir Head - Design & Development
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 8 2008
Larsen & Toubro Ltd. c/o Mr. Ned Devine Sr. Staff Engineer Underwriter Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K080173
STAR 55 Regulation Number: 21 CFR 870.2300 Regulation Nàme: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: January 15, 2008 Received: January 24, 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.
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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 (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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
1,080173
510(k) Number (if known)
Device name: STAR 55
Indication for use:
The STAR 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 intract usingle transport 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, EtCO2, FiCO2, FiCO2, No 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)
(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K080173
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