(56 days)
Not Found
No
The summary describes a standard multiparameter patient monitor and does not mention any AI or ML capabilities.
No
The device is a patient monitoring system that measures and displays vital signs and is not described as providing treatment.
No
Explanation: The device is a patient monitoring system that measures and displays vital signs. It is intended to monitor a patient's condition, not to diagnose a disease or condition. The user is responsible for interpreting the monitored data.
No
The device description explicitly states it is a "multiparameter Patient monitor System (TFT color monitor)" and lists various hardware components like ECG leads, sensors for respiration, temperature, NIBP, pulse oximetry, and invasive BP. It also mentions the capability to connect to an optional inkjet printer or paper chart recorder. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, 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.
- Device function: The STAR (LUNAR SERIES) multiparameter Patient Monitoring system monitors vital signs directly from the patient's body (ECG, respiration, blood pressure, temperature, pulse oximetry). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states monitoring a patient's vital signs at the bedside or during transport. It does not mention any analysis of biological samples.
Therefore, this device falls under the category of patient monitoring equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The STAR (LUNAR SERIES) 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 and Invasive Blood pressure (IBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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 STAR unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry and Invasive BP. STAR is a four channel monitor with waveform display capability for ECG (Lead I / II / III / V / AVL / AVF / AVR), Picthysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mcan) and Temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters cxccpt NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Print out of tabular trend and ECG waveform can be obtained through an optional inkjet printer or paper chart recorder.
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)
Testing were conducted, which demonstrate safety and effectiveness to the following international standards. IEC 60601-1 Medical Electrical safety IEC 60601-1-2 EMC compliance IEC 60601-2-27 ECG safety
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
NOV 1 0 2003
Image /page/0/Picture/1 description: The image shows a black and white logo. The logo consists of a circle with the letters 'L' and 'T' intertwined inside. Below the circle, there is a word in bold capital letters, but the word is cut off, so only 'TOUBRO' is visible.
K032867
page 1 of 4
LARSEN & TOUBRO LIMITED
ELECTRICAL BUSINESS GROUP . ELECTRONIC PRODUCTS -
Mysore Works. KIADB Industrial Area. Hebbal - Hoolagalli, Mysore - 571 186 • Tel · (91) - 821 - 402561 • Fax · (91) - 821 - 402468
E - Mail
Rel
7" October 2003 Page : 01
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 | 91-821-402561 | Fax | 91-821-402468 |
| Contact Person | A.B.Deshpande | Title | Head - Quality Assurance & customer |
| support | |||
| E-Mail address | DeshpandeAB@myw.ltindia.com | ||
| Date the summary was prepared | October 7,2003 |
1
Image /page/1/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of a circle with the letters "L" and "T" inside, and the words "LARSEN & TOUBRO LIMITED" are written below the circle. The text is in a bold, sans-serif font. The logo is black and white.
32867
page 2 of 4
ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -
Mysore Works. KIADB Industrial Area. Hebbal - Hoolagali, Mysore - 571 186 ● Tel · (91) - 821 - 402561 ● Fax : (91) · 821 - 402468
E - Mall
વિભ
7" October 2003 Pagc : 02
| DEVICE | |
|---|---|
| Trade name | STAR (LUNAR SERIES) |
| 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 |
Regd. Off : L & T House, Ballard Estate, P. O. Box 276, Mumbai 400 001 • Phone : 261 8181 / 82 • Fax : 91 - 22 • 262 0223 Website : www.Intebg.com
2
Image /page/2/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. The logo consists of a stylized symbol above the company name. The symbol appears to be two interlocking letter 'L's inside of a circle. The company name is written in bold, uppercase letters.
ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS
Mysore Works, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 571 186 ● Tel : (91) - 821 - 402468
E · Mail
Pet
7th October 2003 Page : 03
DEVICE DESCRIPTION
This STAR unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3/5 lead), Respiration, Temperature, NIBP, Pulse oximetry and Invasive BP. STAR is a four channel monitor with waveform display capability for ECG (Lead I / II / III / V / AVL / AVF / AVR), Picthysmograph, Respiration and Invasive Blood pressure (IBP1 & IBP2). It also displays the digital values of HR/PR, SpO2, RR, Non-Invasive & Invasive Blood Pressure (Systolic, Diastolic and Mcan) and Temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for all parameters cxccpt NIBP. For NIBP the last 240 readings tabular trend can be seen. Display of last 16 alarm conditions is possible in alarm recall mode. Print out of tabular trend and ECG waveform can be obtained through an optional inkjet printer or paper chart recorder.
INTENDED USE OF THE DEVICE
The STAR (LUNAR SERIES) 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 and Invasive Blood pressure (TBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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 circle with the letters "L" and "T" inside. Below the logo, the words "LARSEN & TOUBRO LIMITED" are written in bold, uppercase letters.
K032867
page 4 of 4
- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -
Tel : (91) - 821- 402561 . Fax : (91) - 821 . 402468 Mysore Works, KIADB Industrial Area
E - Mail
Rel .
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device : Larsen & Toubro limited make STAR(LUNAR series) Patient Monitoring System.
Predicate device :
Eagle 3000 patient Monitoring System (Marquette Electronic), K# K952474 Vital signs monitor Model 8100 (CSI), K# K001020
The parameters available with these predicate devices are available with the Larsen & Toubro Limited make STAR (LUNAR series) 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 the predicate devices. In STAR monitor audible & visual alarms are provided similar to those in the Predicate devices.
STAR has got TFT color display like CSI Model 8100. Weight is also comparable with that of Marquette Eagle 3000. Battery (2 sealed lead acid) is provided in STAR monitor like that of the predicate device CSI Model 8100.
Comparison of all the parameters of STAR to that of the predicate devices is given in the "Substantial Equivalence Equipment comparison" document.
Compliance to standards:
Testing were conducted, which demonstrate safety and effectiveness to the following international standards. 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 STAR (LUNAR scries) 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.
7th October 2003 Page : 04
4
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 circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around a stylized symbol. The symbol consists of three curved lines that resemble a person with outstretched arms, with the lines becoming wavy at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2003
Larsen & Toubro Ltd. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548
Re: K032867
Trade Name: STAR (LUNAR Series) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 29, 2003 Received: October 30, 2003
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.
5
Page 2 - Mr. Ned 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 (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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours.
Degea map
L. Degea, M.D.
Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 1 of 1
Indication for Use statement
510(k) Number (if known)
Device name: STAR (LUNAR series)
Indication for use:
The STAR (LUNAR SERIES) 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 and Invasive Blood pressure (IBP1 & IBP2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive & 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER RPAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Medusa Mayer for BDE
ardiovascular Devices
510(k) number: K032867
Prescription Use (Per 21 CFR 801.109) OR
Over-the -counter-use