(11 days)
Not Found
No
The summary describes a standard multi-parameter patient monitor with basic vital sign measurements, trend display, and alarms. There is no mention of AI, ML, or any advanced analytical capabilities that would suggest the use of such technologies.
No.
It is a patient monitoring system that measures and displays vital signs, not a device intended to treat or resolve a medical condition.
No.
The document describes the device as a patient monitoring system that measures vital signs and displays their values, but it does not explicitly state that it is used to make a diagnosis.
No
The device description explicitly states it is a "3 parameter Patient monitor System (TFT color monitor)" with an "inbuilt two channel thermal array recorder," indicating it is a hardware device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The STELLAR 404T is a patient monitoring system that measures vital signs directly from the patient's body (SpO2, NIBP, Temperature, Pulse Rate). It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor a patient's vital signs at the bedside or during transport, not to perform laboratory tests on biological samples.
The device description and intended use clearly indicate that it is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STELLAR 404T 3 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 Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature 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.
Product codes
MWI
Device Description
This STELLAR 404T unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
STELLAR 404T has waveform display capability for Plethysmograph. It also displays the digital values of PR, SpO2. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.
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, bedside or during intrahospital transport. The monitor is not intended for 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 (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
JAN 20 2006
K060058
P1/4
Image /page/0/Picture/2 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circular emblem with the letters "L" and "T" intertwined inside the circle. Below the emblem, the text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.
- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagali, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail ·
Ref .
2154 May, 2005 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 | 21st May,2005 |
1
Image /page/1/Picture/0 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 bold, uppercase letters. The logo and text are all in black.
- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402661 • Fax : +91(821) 2402468
E - Mail :
Ref :
2154 May, 2005 Page : 02 of 04
| DEVICE | |
|---|---|
| Trade name | STELLAR 404T |
| 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# | PLANET patient Monitoring System (L&T Medical Equipments & systems) / K032871 STELLAR 404 Patient Monitoring System (L&T Medical Equipments & systems) / K042560 |
2
Image /page/2/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circular emblem with the letters "L" and "T" intertwined inside the circle. Below the emblem, the words "LARSEN & TOUBRO LIMITED" are written in bold, uppercase letters.
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail
Ref :
2151 May, 2005 Page : 03 of 04
DEVICE DESCRIPTION
This STELLAR 404T unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
STELLAR 404T has waveform display capability for Plethysmograph. It also displays the digital values of PR, SpO2. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. 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 404T 3 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 Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature 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.
3
Image /page/3/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" symbol enclosed in a circle above the company name. The text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.
ELECTRICAL & ELECTRONICS DIVISION - FI ECTRONIC PRODUCTS
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 • Tel : +91(821) 2402661 • Fax : +91(821) 2402468
E - Mail :
Ref :
21 56 May, 2005 Page : 04 Of 04
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device : Larsen & Toubro limited make STELLAR 404T Patient Monitoring System. Predicate device:
- PLANET patient Monitoring System (Make: L&T Medical Equipments & . systems) / K032871
- STELLAR 404 Patient Monitoring System (Make: L&T Medical Equipments & . systems) / K042560
The parameters available with the Larsen & Toubro Limited make STELLAR 404T Patient monitoring system (NIBP, Pulse oximetry and Temperature) 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 404T monitor audible & visual alarms are provided similar to that in the Predicate device.
STELLAR 404T has got TFT color display like PLANET. STELLAR 404T has got thermal array recorder similar to that available in PLANET. Battery provided in STELLAR 404T is Lithium ion, where as it is Lead acid battery in case of predicate device PLANET.
Comparison of all the parameters of STELLAR 404T 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 Equipment-General requirement for safety
IEC 60601-1-2 Medical Electrical Equipment-EMC requirements & tests
Conclusion:
Based on the Technological characteristics of STELLAR 404T 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 safety & effectiveness of the device.
(N Ravindran)
Head – Design & Development
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with three intertwined strands, representing health, services, and human well-being. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2006
Larsen & Toubro Ltd. c/o Mr. Neil E. Devine Jr. Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719
Re: K060058
Trade Name: Stellar 404T Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: January 6, 2006 Received: January 9, 2006
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. Iisling 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.
5
Page 2 - Mr. Neil E. Devine, Jr.
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 (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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bfimmerman 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
Korovice 510(k) Number (if known)
Device name: STELLAR 404T
Indication for use :
The STELLAR 404T - three 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 Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature 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.
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 RPAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Kimmuna
on Sign-Off) Division of Cardlove : 10(g) Number
Page 1 of 1