(69 days)
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No
The document describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities.
No.
The device is a patient monitoring system used to measure and display vital signs, not to treat a medical condition.
No
The device is a patient monitoring system that displays vital signs but does not interpret or diagnose conditions based on those measurements. The "Intended Use" states that 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 mentions hardware components like a "TFT color monitor," "optional inbuilt two channel thermal array recorder," and various sensors for vital signs. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the PLANET 50 multi-parameter Patient Monitoring system is not an In Vitro Diagnostic (IVD) 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 PLANET 50 system directly monitors physiological parameters of a living patient (ECG, respiration, blood pressure, SpO2, temperature, CO2) using sensors attached to the body.
- The intended use and device description clearly state that it monitors a patient's vital signs at the bedside or during transport. This involves direct patient contact and measurement of physiological signals, not analysis of biological samples.
- The parameters measured (ECG, Respiration, Capnography, Temperature, NIBP, SpO2) are all in-vivo measurements.
Therefore, the PLANET 50 system falls under the category of patient monitoring devices, which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
The PLANET 50 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), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, non-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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
This PLANET 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3 lead), Respiration, Capnography, Temperature, NIBP and Pulse oximetry. with an optional inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
PLANET 50 is a three channel monitor with waveform display capability for ECG (3 lead), Respiration, Capnography (CO2) and Plethysmograph. It also displays the digital values of HR/PR, SpO2, RR, Non-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. It has special tabular trend for NIBP to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult, pediatric or neonatal
Intended User / Care Setting
professional health care provider. The monitor is not intended for home use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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FEB 1 5 2005
Image /page/0/Picture/1 description: The image shows a logo consisting of the letters 'L' and 'T' intertwined within a circle. The letters are stylized with sharp, angular lines, giving them a modern and geometric appearance. The logo is presented in black against a white background, creating a high contrast and making it easily recognizable. The overall design is simple yet distinctive, suggesting a corporate or brand identity.
LARSEN & TOUBRO LIMITED
ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS
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Mysore Works, KIADB Industrial Area, Hebbal-Hootagalii, Mysore - 571 186 · Tel : (91) - 821 - 402561 · Fax : (91) - 821 - 402468
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E-Mall :
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25th April, 2004 Page : 01 of 04
510(K) SUMMARY
(Per section 807.92 O)
| 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 |
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Image /page/1/Picture/0 description: The image shows a black and white logo of Larsen & Toubro (L&T). The logo consists of the letters 'L' and 'T' interlocked within a circle. The 'L' is on the left side, and the 'T' is on the right side, with both letters sharing a common horizontal line. The logo is simple and modern, representing the company's brand identity.
KC43370/S1
P 2/4
LARSEN & TOUBRO LIMITED
ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS
Mysore Works, KIADB Industrial Area, Hebbal-Hootagalli, Mysore - 571 186 • Tel : (91) - 821 - 402561 • Fax : (91) - 821 - 402468
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E-Mail :
25th April, 2004 Page : 02 of 04
| DEVICE | |
|---|---|
| Trade name | PLANET 50 |
| 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# | Eagle 3000 patient Monitoring System (Marquette Electronic) / K952474 Vital signs monitor Model 8100 (CSI) / K001020 |
2
K04337c/51
$\mathbb{P}^{3/4}$
Image /page/2/Picture/2 description: The image shows a logo consisting of the letters "L" and "T" intertwined within a circle. The "L" is positioned on the upper left, while the "T" is on the lower right. The letters are bold and connected, creating a unified design within the circular border.
- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -
Mysore Works, KIADB Industrial Aree, Hebbal-Hootagalli, Mysore - 571 186 • Tel : (91) - 821 - 402561 • Fax : (91) - 821 - 402462
Ref :
E-Mail :
2500 April, 2004 Page : 03 of 04
DEVICE DESCRIPTION
This PLANET 50 unit is a multiparameter Patient monitor System (TFT color monitor) with ECG(3 lead), Respiration, Capnography, Temperature, NIBP and Pulse oximetry. with an optional inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
PLANET 50 is a three channel monitor with waveform display capability for ECG (3 lead), Respiration, Capnography (CO2) and Plethysmograph. It also displays the digital values of HR/PR, SpO2, RR, Non-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. It has special tabular trend for NIBP to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions.
INTENDED USE OF THE DEVICE
The PLANET 50 multiparameter 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 parameters include ECG (3 lead), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-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.
Regd. Off : L & T House, Ballard Estate, P. O. Box 278, Mumbai 400 001 ● Phone : 261 8181 / 82 · Fax : 91 - 22 · 262 0222
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E-Mage : 04 Of 04
Image /page/3/Picture/1 description: The image shows a logo consisting of the letters 'L' and 'T' inside of a circle. The letters are stylized and appear to be connected. The logo is black and white and has a simple, clean design.
BRO LI
- ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -
Mysore Works, KIADB Industrial Area, Hebbal-Hootagalli, Mysore - 571 186 • Tel : (91) - 821 - 402561 • Fax : (91) - 821 - 402468 2500 April, 2004
Ref :
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
Device : Larsen & Toubro limited make PLANET 50 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 the Larsen & Toubro Limited make PLANET 50 Patient monitoring system (ECG-3 lead, Respiration, Temperature, NIBP, Capnography and Pulse oximetry) are also available with these predicate devices. The range and accuracy of the parameters & method of sensing are similar to the predicate devices. In PLANET 50 monitor audible & visual alarms are provided similar to those in the Predicate devices.
PLANET 50 has got TFT color display like CSI Model 8100. PLANET 50 has got thermal array recorder similar to that available in Marquette Eagle 3000. Weight of the PLANET 50 (5Kg) is less than that of the predicate devices. Battery (2 sealed lead acid) is provided in PLANET 50 monitor like that of the predicate device CSI Model 8100.
Comparison of all the parameters of PLANET 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 PLANET50 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.
(Mohan G.R.)
Head – Design & Development
Regd. Off : L & T House, Ballard Estate, P. O. Box 278, Mumbai 400 001 • Phone : 261 8181 / 82 • Fax : 91 - 22 - 262 0223
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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2005
Larsen & Toubro LTD c/o Mr. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K043370
Trade Name: PLANET 50 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: December 07, 2004 Received: December 08, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection b re(s) perceived is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prof to May 20, 1978, as secordance with the provisions of the Federal Food, DNIg. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Ac. (11ct) that to not requently of the general controls provisions of the Act. The I ou may, therefore, manel the Act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc a c roy ols. Existing major regulations affecting your device can may oc subject to such additions, 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 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 may be obtained 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,
Blummenfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K043370/51
Indications for Use
510(k) Number (if known): ' Ko43370
Device Name: PLANET 50
Indications for Use:
The PLANET 50 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), Plethysmograph Respiration and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, non-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.
Blummen
(Division Sign-Cit) Division of Cardiovascular Devices 510(k) Number_1043
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)