(133 days)
No
The summary describes standard physiological monitoring and analysis features (ECG, SpO2, NIBP, etc.) and mentions specific algorithms for arrhythmia and ST detection, but does not use terms like AI, ML, deep learning, or describe any adaptive or learning capabilities. The reference to Mortara algorithms suggests the use of established, non-AI/ML signal processing techniques.
No
The device is described as a patient monitoring system for vital signs and does not mention any therapeutic function.
No
This device is a patient monitoring system, which provides continuous measurement of vital signs and physiological parameters. While it offers "Arrhythmia and ST detection," this is for monitoring and analysis of data, not for making a definitive diagnosis. The text explicitly states, "The user, responsible to interpret the monitored data made available, will be a professional health care provider." This indicates the device provides data for interpretation by a professional, rather than diagnosing a condition itself.
No
The device description explicitly mentions hardware components such as a 12.1" TFT display, a two-channel thermal array recorder, and various physical connections (USB, RS232, Ethernet), indicating it is a physical medical device system, not software-only.
Based on the provided information, the STAR 55 Model 100 multi-parameter Patient Monitoring system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The STAR 55 Model 100 directly monitors physiological parameters of the patient (ECG, SpO2, Respiration, Temperature, etc.) using sensors applied to the body. It does not analyze samples taken from the patient.
- The intended use and device description clearly state it's a patient monitoring system. Its purpose is to continuously track vital signs and provide real-time data about the patient's physiological state.
- There is no mention of analyzing biological samples. The parameters measured are directly related to the patient's body functions.
Therefore, the STAR 55 Model 100 falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STAR 55 Model 100 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/ 12 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, N2O, O2, EtAA and FiAA readings.
In addition, Star 55 Model 100 has got Arrhythmia and ST detection from 3L/5L/12L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients
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.
Product codes
MHX
Device Description
STAR 55 Model 100 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5/12 lead), Arrhythmia & ST analysis, Respiration, NIBP, IBP, Temperature, SpO2, CO2 & Gas monitoring,
STAR 55 Model 100 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 Blond Pressure (Systolic. Diastolic and Mean), Temperature, EtCO2, FiCO2, NoO. O2, EtAA and FiAA readings. It has selective 2448172 Hours tabular and graphical trends. It han special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facilius 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 fratures . USB, RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable aların limits as well as visible and audible alarm signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Pediatric or Neonatal patient. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients.
Intended User / Care Setting
professional health care provider. The monitor is not intended the home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
JUN - 5 2009
larsen & Toubro Limited
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Date: 20.04.2009 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, | ||
| Mysore – 570018, Karnataka, INDIA | |||
| Telephone | 91-821-2402561 | Fax | 91-821-2402468 |
| Contact Person | A.B.Deshpande | Title | Head – Quality Assurance & |
| Management Representative | |||
| E-Mail address | DeshpandeAB@myw.ltindia.com | ||
| Date the summary was prepared | 20th Apr 2009 |
Regal Off : L & T House, Ballard Estate, P O Box 278, Mumbai 400 001 . Phone . + S11:22;67525066 . For . +0 H22:67:525858 Website:www.LNTEBG.com
1
K090172
Larsen & Toubro Limited
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Date: 20.04.2009 Page: 02 of 04
| DEVICE | |
|---|---|
| Trade name | STAR 55 Model 100 |
| Common name | Patient Monitoring System |
| Classification name | Vital Signs Monitor |
| PREDICATE DEVICE IDENTIFICATION | ||
|---|---|---|
| CFR21 Section | 870.1025 | Product code (optional) |
| Classification panel | Cardiovascular | |
| Device Class | Class II | |
| Legally marketed Comparison Device / K# | STAR 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K080173Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp.) / K020550 | |
| MHX |
Regd. Off . I & 1 Nover, Bollard Estate . P.O. Box 278 . Phone . +91(22)67625056 . Fax . +91,22)6752665F Website , www.INTEBG.com
1
.21
2
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Date: 20.04 2009 Page: 04 of 04
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device: Larsen & Toubro limited make STAR 55 Model 100 Patient Monitoring System. Predicate device:
- STAR 55 Patient Monitoring System (L&T Medical Equipments & Systems) / ତ K080173
- Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope 0 Corp.) / K020550
The parameters available with the Larsen & Toubro Limited make STAR 55 Model 100 Patient monitoring system are available with the predicate device Datasepe Corp. make "Passport 2 Vital signs monitor with View 12 ECG Analysis Moditle" for 12 Lad ECG analysis & Larsen & Toubro Limited make STAR 55 Patient monitoring system for all other parameters.
The data acquired by 121. ECG Module is interpreted utilizing Mortara Instruments algorithm (cleared by FDA under notification numbers: K920627, K933143).
Comparison of all the parameters of STAR 55 Model 100 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:
ﺍﻟﻤﺘﺤﺪﺓ
Based on the Technological characteristics of STAR 55 Model 100 and its comparison with that of predicate devices Larsen & Toubro Limited believes that their (eviewice is substantially equivalent to this predicate Monitors and doesn't posses any additions rick is safety & effectiveness of the device.
Image /page/3/Picture/22 description: The image shows a black and white drawing of what appears to be a tree branch or root system. The lines are jagged and irregular, creating a sense of natural, organic growth. The image is simple, with no background or other elements to distract from the central subject.
(N Ravindran) Head - Design & Development
Rugd Off : L & T House Ballard Estate, F.O.Bcx 278, Mumbai 400 001 · Fhone : +3122/67525056 · F. + +91(22)67625658 Website - www.l.NTEBG.com
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest movement and flight. The overall design is simple and recognizable, conveying a sense of authority and purpose.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Larsen & Toubro Limited c/o Ms. Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114
Re: K090172
Trade/Device Name: Star 55 Model 100
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)
Regulatory Class: Class II Product Code: MHX Dated: May 6, 2009
Received: May 7, 2009
Dear Ms. Smith:
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 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 - Ms. Yolanda Smith
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
sume D. bumer
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
K090122 510(k) Number (if known)
Device name: STAR 55 Model 100
Indication for use:
The STAR 55 Model 100 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/ 12 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, N2O, O2, EtAA and FiAA readings.
In addition, Star 55 Model 100 has got Arrhythmia and ST detection from 3L/5L/12L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients
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)
ulla R. h. huse
(Division Sign-Off) Division of Cardiovascular Devices
510(K) Number_K090132
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