(12 days)
No
The document describes a standard multi-parameter patient monitor with no mention of AI or ML capabilities. The functions described are typical for such devices and do not suggest the use of advanced algorithms for data analysis or interpretation beyond basic signal processing and alarm generation.
No
The device is described as a "multi-parameter Patient Monitoring system" intended to monitor vital signs, not to treat or diagnose a condition.
No.
The device is described as a "multi-parameter Patient Monitoring system" intended to monitor vital signs and provide readings and trends. While it provides "monitored data," it explicitly states that the user is "responsible to interpret the monitored data made available," implying it does not provide a diagnosis itself.
No
The device description explicitly states it is a "multiparameter Patient monitor System (TFT color monitor)" and lists various hardware components like ECG, Respiration, Temperature, NIBP, Pulse oximetry, Capnography, and Invasive BP. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the STAR 50 unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "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". This describes a device that monitors physiological parameters directly from the patient's body.
- Device Description: The description details the monitoring of parameters like ECG, Plethysmograph, Respiration, Invasive Blood Pressure, Capnography, NIBP, SpO2, Temperature, etc. These are all measurements taken from the patient, not from samples of bodily fluids or tissues.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which is the defining characteristic of an in vitro diagnostic device.
Therefore, the STAR 50 unit is a patient monitoring system, not an IVD.
N/A
Intended Use / Indications for Use
The STAR 50 unit is a 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 (Lead I / II/ III / V / AVL / AVF AVR), Plethysmograph, Respiration, Invasive Blood Pressure (IBP1 & IBP2) and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (systolic, diastolic and mean) and Temperature, EtCO2 and FiCO2 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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.
Product codes
MWI
Device Description
This STAR 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Capnography and Invasive BP.
STAR 50 is a four channel monitor with waveform display capability for ECG (Lead 1 / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2) and Capnography (CO2). It also displays the digital values of HRPR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters except NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. STAR 50 has got a optional Thermal recorder for printing Tabular trends & waveforms.
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
Intended User / Care Setting
professional health care provider. . . at the bedside or during intra-hospital transport
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
0
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 text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters. Underneath the company name, it says "ELECTRICAL BUSINESS GROUP · ELECTRONIC PRODUCTS".
Mysore Works, KIADB Industrial Area, Hebbal · Hoolagall, Mysore · 570 018 · Tel : (91) - 821 · 2402468
E - Mail
Ref .
JUN 2 9 2005
25th April. 2004 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 |
| E-Mail address | DeshpandeAB@myw.ltindia.com | ||
| Date the summary was prepared | April 25th, 2004 |
1
Image /page/1/Picture/1 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 capital letters. The text is bolded and in a sans-serif font.
- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -
Mysore Works, KIADB Industrial Area, Hebbal · Hootagalii, Mysore · 570 018 · Tel · (91) · 821 · 2402468
E · Mail
સિદ્ધા
25th April, 2004 Page : 02 of 04
| DEVICE | |
|---|---|
| Trade name | STAR 50 |
| 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 Patient Monitoring System - STAR, (Larsen & Toubro Limited), K# K032867 |
2
Image /page/2/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "L" and "T" enclosed in a circle. Below the logo, the words "LARSEN & TOUBRO LIMITED" are printed in bold, uppercase letters.
ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS
Mysore Works, KIADB Industrial Area, Hebbal · Hosore · 570 018 · Tel · (91) - 821 · 2402551 · Fax : (91) - 821 · 2402468
E - Mail
સ્દા
25th April. 2004 Page : 03 of 04
DEVICE DESCRIPTION
This STAR 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Capnography and Invasive BP.
STAR 50 is a four channel monitor with waveform display capability for ECG (Lead 1 / II / III / V / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2) and Capnography (CO2). It also displays the digital values of HRPR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters except NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. STAR 50 has got a optional Thermal recorder for printing Tabular trends & waveforms.
INTENDED USE OF THE DEVICE
The STAR 50 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, Invasive Blood pressure (IBP1 & IBP2) and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 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.
Website - www.mtcog.com
3
Image /page/3/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "L" and "T" enclosed in a circle. Below the logo, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.
-- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS --
Hootagalli, Mysore · 570 018 · Tel · (91) · 821 · 2402561 · Fax : (91) · 821 · 2402468 Mysore Works, KIADB Industnal Area, Hebbal
E - Mail
Rel
25" April, 2004 Page : 04 of 04
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device : Larsen & Toubro limited make STAR 50 Patient Monitoring System.
Predicate device :
Eagle 3000 patient Monitoring System (Marquette Electronic), K+ K952474 Vital signs monitor Model 8100 (CSI), K# K001020 Patient Monitoring System - STAR, (Larsen & Toubro Limited), K.# K032867
The parameters available with these predicate devices are available with the Larsen & Toubro Limited make STAR 50 patient monitoring system (ECG-3/5 lead, Respiration, Temperature - 2 channels, NIBP, Pulse oximetry, Capnography 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 50 monitor audible & visual alamis are provided similar to those in the Predicate devices.
STAR 50 has got TFT color display like CSI Model 8100. Weight is also comparable with that of Marquette Eagle 3000. Battery (2 scaled lead acid) is provided in STAR 50 monitor like that of the predicate device CSI Model 8100.
Comparison of all the parameters of STAR 50 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 IEC 60601-2-27 ECG safety
Conclusion :
Based on the Technological characteristics of STAR50 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.
(N Ravindran)
Head - Design & Development
Regd. Off : L & T House, Ballard Estate P. O. Box 278. Mumbar 400 001 · Phone : 261 6181 : 82 · 262 0223 Website : www.inteba.com
4
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Larsen & Toubro Ltd. c/o Mr. Ned Devine Intertek Testing Services NA, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K051608
Trade Name: STAR 50 Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor without Arrhythmia Detection and Alarms Regulatory Class: Class II (two) Product Code: MWI Dated: June 16, 2005 Received: June 17, 2005
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 for associo in 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 I ou may a 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 may or dayse to daen and 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 Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I DT b issum that your device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally i coclar suttates and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 807), adoling (21 OF RT & 007), govern 820); and if applicable, the electronic form in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comic of provision (crice as described in your Section 510(k) I mis letter will unow you to ough finding of substantial equivalence of your device to a legally premaired 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 If you desire specific acres at (240) 276-0295 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 may be obtained from the Other general mionination sturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bluminauer for
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): K05 1608
Device Name: STAR 50
Indications for Use:
The STAR 50 unit is a 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 (Lead I / II/ III / V / AVL / AVF AVR), Plethysmograph, Respiration, Invasive Blood Pressure (IBP1 & IBP2) and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (systolic, diastolic and mean) and Temperature, EtCO2 and FiCO2 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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.
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)
Blumena
Division Slan-Off Division of Cardiovascular Devices 510(k) Number