PLANET MONITORING SYSTEM by LARSEN & TOUBRO LIMITED

The PLANET 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 (3 lead), Plethysmograph. It can also display the digital values of HR/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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.

Device Description

PLANET is a multi-parameter Patient Monitoring System (TFT color monitor) with ECG (3 lead),Temperature,NIPB, and pulse oximetry)with an optional built-in two channel thermal array recorder which can record online data (ECG waveform and plethysmograph) along with numerical values of other parameters. PLANET is a three channel monitor with waveform display capability for ECG (3 lead), cascade and plethysmograph. It also displays the digital values of heart rate, pulse rate, SpO2, non-invasive blood pressure (systolic, diastolic and mean) and temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for ECG, SpO2 and temperature. It has special tabular trend for NIPB to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions. Printout of tabular trend and ECG waveform can be obtained through an optional inkjet printer.

AI/ML Overview

The provided text is a 510(k) summary for the PLANET Monitoring System, a multi-parameter patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with standards, rather than presenting a detailed study proving performance against specific acceptance criteria for AI/ML features.

Therefore, the requested information elements such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not present in the provided document. This type of information is typically required for AI/ML device submissions, which were not the focus of this 2003 submission for a traditional patient monitor.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "The range and accuracy of the parameters & method of sensing are similar to the predicate devices." It also lists compliance with several international standards. However, specific numerical acceptance criteria (e.g., accuracy +/- X% for heart rate) and reported performance values are not provided within this summary for specific vital signs parameters. The table below reflects the general claims made about similarity and compliance.

Acceptance Criteria (Inferred/General)	Reported Device Performance
Parameters (ECG, Temp, NIBP, SpO2) available	All listed parameters are available.
Range of parameters similar to predicate devices	Stated as "similar to the predicate devices."
Accuracy of parameters similar to predicate devices	Stated as "similar to the predicate devices."
Method of sensing similar to predicate devices	Stated as "similar to the predicate devices."
Audible & visual alarms similar to predicate devices	Stated as "similar to those in the Predicate devices."
Compliance with IEC 60601-1 Medical Electrical safety	Testing was conducted to demonstrate safety and effectiveness to this standard.
Compliance with IEC 60601-1-2 EMC Compliance	Testing was conducted to demonstrate safety and effectiveness to this standard.
Compliance with IEC 60601-2-27 ECG safety	Testing was conducted to demonstrate safety and effectiveness to this standard.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document focuses on technological similarities and compliance with engineering standards, not on clinical performance studies with test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This is relevant for AI/ML performance evaluation, which is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. This is relevant for AI/ML performance evaluation, which is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is a traditional patient monitor without AI assistance described in the 510(k) summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is a traditional patient monitor without a standalone algorithm as defined for AI/ML.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. Ground truth for AI/ML training/testing is not part of this submission's summary. The "ground truth" for this device would be considered the physical measurements from validated sensors/methods, and the document implies these are similar to predicate devices.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable/Not provided. There is no mention of a training set.

Summary

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NOV 1 0 2003	510(k) Summary(As required by 21 CFR 807.92)	K 032871page 1 of 2
Submitted by:	Harry P. GugnaniL&T Medical Systems1821 Walden Office Square, Ste 400Schaumberg, IL 60173
Date of Summary:	August 18, 2003
Device Name:	PLANET Monitoring System
Common Name:	Cardiac Monitor
Classification Name:	Monitor, Cardiac Incl. Cardio-tachometer & Rate Alarm
Regulation Number:	21 CFR 870.2300
Product Code:	74 DRT
Predicate Devices:	Marquette Medical, Eagle 3000 K952474Criticare, CSI Model 8100 K001020
Device Description:	PLANET is a multi-parameter Patient Monitoring System(TFT color monitor) with ECG (3 lead),Temperature,NIPB,and pulse oximetry)with an optional built-in two channelthermal array recorder which can record online data (ECGwaveform and plethysmograph) along with numericalvalues of other parameters.PLANET is a three channel monitor with waveform displaycapability for ECG (3 lead), cascade and plethysmograph.It also displays the digital values of heart rate, pulse rate,SpO2, non-invasive blood pressure (systolic, diastolic andmean) and temperature readings. It has graded and colorcoded alarms. It has 24 hours tabular and graphical trendsfor ECG, SpO2 and temperature. It has special tabular trendfor NIPB to store the last 240 readings. Alarm recall featureoffers last 16 alarm conditions. Printout of tabular trend andECG waveform can be obtained through an optional inkjetprinter.
Intended Use:	The PLANET multi-parameter Patient Monitoring system
K032871page 2 of 2
transport along with the appropriate accessoriesmentioned/supplied with the unit. Vital signs parametersinclude ECG (3 lead), Plethysmograph. It can also displaythe digital values of HR/PR, SpO2, non-invasive bloodpressure (systolic, diastolic and mean) and temperaturereadings.
The user, responsible to interpret the monitored data madeavailable, will be a professional health care provider. Thedevice, which can also be used as a portable device, permitspatient monitoring with adjustable alarm limits as well asvisible and audible alarm signals. It does not transmitalarms or arrhythmias, and does not have arrhythmiadetection capabilities.. The monitor is not intended forhome use
TechnologicalCharacteristics:	The parameters available with the PLANET Patientmonitoring system (ECG-3 lead, Temperature, NIBP andPulse oximetry) are also available with these predicatedevices. The range and accuracy of the parameters &method of sensing are similar to the predicate devices. InPLANET monitor audible & visual alarms are providedsimilar to those in the Predicate devices.PLANET has TFT color display as does the CSI Model8100. Planet has thermal array recorder similar to thatavailable in Marquette Eagle 3000. Weight of thePLANET is less than that of the predicate devices. Battery(2 sealed lead acid) is provided in PLANET monitor likethat of the predicate devices CSI Model 8100.
Compliance to standards:	Testing was conducted to demonstrate safety andeffectiveness to the following international standards:IEC 60601-1 Medical Electrical safetyIEC 60601-1-2 EMC ComplianceIEC 60601-2-27 ECG safety
Conclusion:	Based on the Technological characteristics of PLANET andits comparison with the predicate devices CSI Model 8100and the Marquette Eagle 3000 monitors, Larsen & ToubroLimited believes their device is substantially equivalent tothese Monitors and does no pose any additional risk to thesafety and effectiveness of the device

is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

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: K032871

Trade Name: PLANET Monitoring System 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 27, 2003 Received: October 28, 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.

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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 (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 (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 vours.

CTefan Mayr

Bram D. 7 uckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Indication for Use statement

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

KO32871

Device name : PLANET

Indication for use :

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER RPAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Metka May for BDZ

(Division Sign-Off)
Division: Cardiovascular Devices

510(k) number 2032871

Prescription Use (Per 21 CFR 801.109)

Over-the -counter-use

Regulation Number and Section

§ 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).