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.

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.

AI/ML Overview

This document is a 510(k) summary for the "PLANET 50" Patient Monitoring System by Larsen & Toubro Limited. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as typically found in clinical trials for AI/ML devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) cannot be extracted directly from this type of regulatory submission. The document emphasizes compliance with safety standards and similarity in technological characteristics and performance ranges to predicate devices.

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy). Instead, it relies on the concept of substantial equivalence to predicate devices. The performance is assessed by confirming that the PLANET 50's parameters, ranges, and sensing methods are similar to those of the predicate devices.

Parameter/Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (PLANET 50)
ECG	Similar to predicate devices (Eagle 3000, Model 8100)	3-lead ECG, Waveform display capable
Respiration	Similar to predicate devices	Waveform display capable
Capnography (CO2)	Similar to predicate devices	Waveform display capable
Plethysmograph	Similar to predicate devices	Waveform display capable
HR/PR (Heart Rate/Pulse Rate)	Digital values displayed, similar range/accuracy to predicate devices	Digital values displayed, similar range/accuracy to predicate devices
SpO2 (Pulse Oximetry)	Digital values displayed, similar range/accuracy to predicate devices	Digital values displayed, similar range/accuracy to predicate devices
NIBP (Non-Invasive Blood Pressure)	Digital values for Systolic, Diastolic, Mean; similar range/accuracy to predicate devices	Digital values for Systolic, Diastolic, Mean; similar range/accuracy to predicate devices
Temperature	Digital values displayed, similar range/accuracy to predicate devices	Digital values displayed, similar range/accuracy to predicate devices
EtCO2 and FiCO2	Digital values displayed, similar range/accuracy to predicate devices	Digital values displayed, similar range/accuracy to predicate devices
Alarms	Audible & visual alarms, graded and color-coded, adjustable limits, alarm recall	Graded and color-coded alarms, adjustable limits, visible and audible signals, 16 alarm recall
Trends	Tabular and graphical trends available (predicate specific)	24 hours tabular and graphical trends for all parameters except NIBP; special tabular trend for NIBP (240 readings)
Display	TFT color display (like CSI Model 8100)	TFT color display
Recorder	Thermal array recorder (like Marquette Eagle 3000)	Inbuilt two-channel thermal array recorder
Power Source	Battery (like CSI Model 8100)	Battery (2 sealed lead acid)
Safety Compliance	IEC 60601-1, IEC 60601-1-2	Complies with IEC 60601-1, IEC 60601-1-2
ECG Safety Compliance	IEC 60601-2-27	Complies with IEC 60601-2-27

The overarching "acceptance criterion" is that "The range and accuracy of the parameters & method of sensing are similar to the predicate devices."

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

This information is not provided in the document. As a substantial equivalence submission, it relies on comparison to previously cleared devices rather than new clinical data from a test set.

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)

This information is not provided as there is no mention of a clinical test set requiring expert ground truth establishment.

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

This information is not provided as there is no mention of a clinical test set requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a patient monitoring system, not an AI diagnostic tool.

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

This is not applicable as the device is a hardware patient monitoring system, not a standalone algorithm.

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

This is not applicable in the context of this 510(k) submission, as it focuses on demonstrating technological equivalence to predicate devices and compliance with safety standards rather than establishing a new clinical ground truth for a novel diagnostic or therapeutic algorithm.

8. The sample size for the training set

This information is not provided and is not applicable as the device is a patient monitor, not an AI/ML system that undergoes a "training" phase with data.

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

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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FEB 1 5 2005

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LARSEN & TOUBRO LIMITED

ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS

Mysore Works, KIADB Industrial Area, Hebbal-Hootagalii, Mysore - 571 186 · Tel : (91) - 821 - 402561 · Fax : (91) - 821 - 402468

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E-Mall :

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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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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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

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ELECTRICAL BUSINESS GROUP - ELECTRONIC PRODUCTS -

Mysore Works, KIADB Industrial Aree, Hebbal-Hootagalli, Mysore - 571 186  •  Tel : (91) - 821 - 402561  •  Fax : (91) - 821 - 402462

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DEVICE DESCRIPTION

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.

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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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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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.

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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

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K043370/51

Indications for Use

510(k) Number (if known): ' Ko43370

Device Name: PLANET 50

Indications for 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)

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).