(14 days)
Not Found
No
The summary describes a standard multiparameter patient monitor with data display, trending, and alarms. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal processing and parameter calculation.
No
The device is a patient monitoring system designed to measure and display vital signs, not to deliver therapy.
No.
Explanation: The device is intended to monitor and display vital signs and parameters, which is a patient monitoring function. It explicitly states that "The user, responsible to interpret the monitored data made available, will be a professional health care provider," indicating that the device provides data for interpretation, rather than performing a diagnostic function itself.
No
The device description explicitly mentions hardware components such as an "external 14 inch RGB compatible VGA monitor" and an "optional Thermal recorder". It also describes monitoring various physiological parameters using sensors and accessories, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- This device is a patient monitor that directly measures physiological parameters from the patient's body (ECG, SpO2, blood pressure, respiration, temperature, CO2, anesthesia agents). It does not analyze samples taken from the patient.
The device's function is to monitor vital signs in vivo (within the living body), which is distinct from the in vitro (in glass/outside the body) nature of IVD devices.
N/A
Intended Use / Indications for Use
The Galaxy 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), Capnography (CO2) & Anesthesia agents. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA 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 (comma separated list FDA assigned to the subject device)
MWI
Device Description
This Galaxy unit is a multiparameter Patient monitor System with an external 14 inch RGB compatible VGA monitor (640X480 pixels). The parameters provided are ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Invasive BP and Anesthesia gas monitoring (AGM). AGM provides CO2, N2O and 5 anesthesia agents.
Galaxy is a four channel monitor with waveform display capability for ECG (Lead I / II / Sulaxy Is a returnality AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2), Capnography (CO2) & Anesthesia agents. It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Virastolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters and volor of or NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Galaxy has got an 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; 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KOG1816
Image /page/0/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" symbol enclosed in a circle, positioned above the company name. The text "LARSEN & TOUBRO LIMITED" is written in a bold, sans-serif font. The logo and text are both in black, set against a white background.
ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail :
Ref :
JUL 1 2 2005
14th Nov 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 |
| E-Mail address | DeshpandeAB@myw.ltindia.com | ||
| Date the summary was prepared | 14th Nov 2005 |
1
.
Image /page/1/Picture/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a stylized "LT" inside of a circle above the company name. The text "LARSEN & TOUBRO LIMITED" is written in bold, uppercase letters.
- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Complex. KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail :
Ref :
14" Nov 2005 Page : 02 of 04
| DEVICE | |
|---|---|
| Trade name | GALAXY |
| 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# | Patient Monitoring System – STAR | |
| 50 (Larsen & Toubro Limited), K# | ||
| K051608 Vamos Anesthetic Gas Monitor | ||
| (Draeger Medical), K# K012139 |
2
Image /page/2/Picture/1 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 written in bold, uppercase letters. The logo is simple and modern, and the text is clear and easy to read.
ECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalii, Mysore - 570 018 • Tel : +91 (821) 2402468
E - Mail :
Ref :
14th Nov 2005 Page : 03 of 04
DEVICE DESCRIPTION
This Galaxy unit is a multiparameter Patient monitor System with an external 14 inch RGB compatible VGA monitor (640X480 pixels). The parameters provided are ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry, Invasive BP and Anesthesia gas monitoring (AGM). AGM provides CO2, N2O and 5 anesthesia agents.
Galaxy is a four channel monitor with waveform display capability for ECG (Lead I / II / Sulaxy Is a returnality AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2), Capnography (CO2) & Anesthesia agents. It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Virastolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters and volor of or NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Galaxy has got an optional Thermal recorder for printing Tabular trends & waveforms.
INTENDED USE OF THE DEVICE
The Galaxy 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), Capnography (CO2) & Anesthesia agents. It can also display the digital values of HR/PR, SpO2, RR, (Solf Collection & Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA 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/1 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circular emblem with the letters "LT" inside. Below the emblem, the words "LARSEN & TOUBRO LIMITED" are written in bold, uppercase letters.
ELECTRONICS DIVISION - ELECTRONIC PRODUC
Mysore Complex, KIADB Industrial Area, Hebbal - Hootagali, Mysore - 570 018 • Tel : +91(821) 2402468
E - Mail :
Ref :
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device : Larsen & Toubro limited make GALAXY Patient Monitoring System.
Predicate device :
Patient Monitoring System - STAR 50, (Larsen & Toubro Limited), K# K051608 For Anesthesia Gas Monitoring - Vamos Anesthetic Gas Monitor (Draeger Medical), K# K012139
The parameters available with the predicate device Star 50 are available with the Larsen & Toubro Limited make GALAXY patient monitoring system (ECG-3/5 lead, Respiration, Temperature - 2 channels, NIBP, Pulse oximetry and Invasive BP- 2 channels). The no. of channels, range and accuracy of the parameters & method of sensing are similar to this predicate device -- Star 50. In GALAXY monitor audible & visual alarms are provided similar to those in the Predicate device - Star 50 In addition, the Anesthesia gas Monitoring provided in Vamos Anesthetic Gas Monitor is available with Larsen & Toubro Limited make GALAXY Patient monitor.
Comparison of all the parameters of GALAXY to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document. Compliance to standards: The following international standards are referred. Medical Electrical Equipment - General requirement for safety: IEC 60601-1 Medical Electrical Equipment General requirement for co-lateral standard Electromagnetic compatibility requirements & tests: IEC 60601-1-2 ECG compliance: IEC 60601-2-27 & AAMI EC 13 NIBP compliance: IEC 60601-2-30 & AAMI SP10
Conclusion:
Based on the Technological characteristics of GALAXY and its comparison with those of a predicate device STAR 50 and VAMOS Anesthetic Gas Monitor (for Anesthesia Gas Monitoring), 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.
effectiveness of the de
(N Ravindran
Head - Design & Development
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2006
Larsen & Toubro Limited c/o Mr. Daniel W. Lehtonen Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087
Re: K061816 Trade Name: Galaxy 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 27, 2006 Received: June 28, 2006
Dear Mr. Lehtonen:
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.
5
Page 2 - Mr. Daniel W. Lehtonen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised and i bermination that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I cuchar statutes and reguirements, including, but not limited to: registration and listing Compry with an all the requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 801), advertise (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. product radiation control po begin marketing your device as described in your Section 510(k) This letter will and will would began tial equivalence of your device of your device to a legally premarket noticated. " 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 of Compliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Oriece of Comptant on tification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
B/xmmman 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)
KOSIBIT
Device name: GALAXY
Indication for use:
The Galaxy 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 / AVL / AVF / AVR), Plethysmograph, Respiration, Invasive Blood pressure (IBP1 & IBP2), Capnography (CO)) & Anesthesia agents. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, EtAA and FiAA 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 X (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. bummer!
on Slan-Q Division of Cardlov 510íki Number
Page 1 of 1