The PLANET 55 multi-parameter 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 /5 lead), SpO2, Respiration, Temperature 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 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

PLANET 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, and CO2.

PLANET 55 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR, SpOz, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has selective 24\48\72 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features - USB, RS232, RS485 Infrared remote and Ethernet.

AI/ML Overview

Here's an analysis of the provided documents regarding the Larsen & Toubro Limited PLANET 55 Patient Monitoring system.

Please note: The provided documents (510(k) summary and FDA clearance letter) primarily focus on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way a new, novel AI/software medical device might. Therefore, some of the requested information (like specific performance metrics, sample sizes for test sets, expert qualifications, and MRMC studies) is not present in these documents as it wasn't the focus of this type of submission.

Acceptance Criteria and Reported Device Performance

The documents do not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the PLANET 55 monitor's various parameters. Instead, the "acceptance criteria" are implied by the process of demonstrating substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as those devices for its intended use.

The reported "device performance" is primarily qualitative, stating that the device offers the same parameters and functionality as the predicate devices.

Parameter Monitored	Implied Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (Qualitative)
ECG (3/5 lead)	Performs as safely and effectively as predicate devices for ECG monitoring.	Capable of displaying ECG, HR/PR.
Respiration	Performs as safely and effectively as predicate devices for respiration monitoring.	Capable of displaying Respiration, RR.
NIBP	Performs as safely and effectively as predicate devices for non-invasive blood pressure monitoring.	Capable of displaying Non-Invasive Blood Pressure (Systolic, Diastolic, Mean).
Temperature	Performs as safely and effectively as predicate devices for temperature monitoring.	Capable of displaying Temperature.
SpO2	Performs as safely and effectively as predicate devices for SpO2 monitoring.	Capable of displaying SpO2.
CO2 (Capnography)	Performs as safely and effectively as predicate devices for CO2 monitoring.	Capable of displaying CO2, EtCO2, FiCO2.
General Functionality	Meets safety and essential performance standards.	4-channel monitor with 8.4" TFT display, tabular/graphical trends (24/48/72 hours), NIBP trend (240 readings), Alarm Recall (24 patient alarms), 2-channel thermal array recorder, optional communication (USB, RS232, RS485, Infrared, Ethernet).

Study Details (Based on available information)

Table of Acceptance Criteria and Reported Device Performance: (Addressed above, largely qualitative based on substantial equivalence.)
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided documents. Substantial equivalence claims often rely on engineering testing and comparison to predicate device specifications rather than a distinct "test set" of patient data for performance validation in the way software algorithms use for efficacy.
- Data Provenance: Not applicable in the context of this submission, as it's not a study involving patient data to prove a novel performance claim. The submission relies on compliance to international standards and direct comparison of features and specifications with predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/mentioned. Ground truth establishment with experts is typical for diagnostic algorithms, not for monitoring systems seeking substantial equivalence based on technical specifications and established technology.
Adjudication method for the test set:
- Not applicable/mentioned.
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:
- No. This is a patient monitoring system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and was not conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a "patient monitoring system" with a human user (professional health care provider) responsible for interpreting the data. It is not an "algorithm only" device in the sense of AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence for a vital signs monitor typically involves:
  - Conformance to standards: Meeting established performance requirements detailed in relevant IEC standards (e.g., IEC 60601-1 Medical Electrical safety, IEC 60601-1-2 EMC compliance).
  - Bench testing: Verifying accuracy and functionality of individual parameters against calibrated reference equipment.
  - Comparison to predicate device specifications: Ensuring that the technical specifications and performance characteristics are equivalent.
The sample size for the training set:
- Not applicable/mentioned. This is not an AI/machine learning device that requires a "training set" of data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.

Summary of the Study provided in the 510(k) Summary:

The "study" presented in this 510(k) summary is a comparative analysis demonstrating substantial equivalence to predicate devices rather than a traditional clinical efficacy study.

Objective: To show that the PLANET 55 Patient Monitoring System is substantially equivalent to legally marketed predicate devices (PLANET 50 Patient Monitoring System and STAR 50 Patient Monitoring System).
Methodology:
- Direct comparison of technological characteristics (parameters monitored, features) of the PLANET 55 with the identified predicate devices.
- Stated compliance to international standards: IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).
- The submission includes a "Substantial Equivalence Equipment comparison" document, which would detail feature-by-feature and specification-by-specification comparisons, but this document itself is not provided here.
Conclusion: Larsen & Toubro Limited believes that the PLANET 55 is substantially equivalent to its predicate monitors and "doesn't pose any additional risk on safety & effectiveness of the device."

In essence, the "study" for this type of device is a comprehensive engineering and regulatory comparison to show that the new device is as safe and effective as existing, legally marketed devices for the same intended use.

Summary

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SEP 2 1 2007

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402468

E - Mail .

Ref :

30th March 2007 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 &Management Representative
E-Mail address	DeshpandeAB@myw.ltindia.com
Date the summary was prepared	30th March, 2007

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Image /page/1/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. Above the logo is the number 2071472. The logo consists of the letters L and T inside of a circle. Below the logo is the text "LARSEN & TOUBRO LIMITED" in bold.

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS -

Mysore Complex, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402468

E - Mail :

Ref : .

30th March 2007 Page: 02 of 04

DEVICE
Trade name	PLANET 55
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#	PLANET 50 Patient Monitoring System (L&T Medical Equipments & systems) / K043370 STAR 50 Patient Monitoring System (L&T Medical Equipments & systems) / K051608

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Image /page/2/Picture/0 description: The image shows the logo of Larsen & Toubro Limited. Above the logo is the text "KC71472". The logo consists of the letters "L" and "T" inside of a circle. Below the logo is the text "LARSEN & TOUBRO LIMITED" in bold.

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUC

Aysore Campus, KIADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 · Tel ; +91(821) 2402468

E - Mail

Hef

30th March 2007 Page: 03 of 04

DEVICE DESCRIPTION

PLANET 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, and CO2.

INTENDED USE OF THE DEVICE

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Image /page/3/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. The logo consists of the letters L and T inside of a circle. Above the logo is the number KC71472.

LECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Complex, KlADB Industrial Area, Hebbal - Hootagalli, Mysore - 570 018 • Tel : +91(821) 2402468

E - Mail

Rel

30th March 2007 Page: 04 Of 04

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device: Larsen & Toubro limited make PLANET 55 Patient Monitoring System. Predicate device:

PLANET 50 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K043370
STAR 50 patient Monitoring System (Make: L&T Medical Equipments & . systems) / K051608

The parameters available with the Larsen & Toubro Limited make PLANET 55 Patient monitoring system are available with the predicate device - Larsen & Toubro Limited make PLANET 50 patient monitoring system & STAR 50 patient monitoring system (for 3/5L ECG, Respiration and Temperature).

Comparison of all the parameters of PLANET 55 to that of the predicate device 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

Conclusion:

Based on the Technological characteristics of PLANET 55 and its comparison with that of predicate device Planet 50 and Star 50 (for 3/5L ECG, Respiration and Temperature), Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitors and doesn't pose any additional risk on safety & effectiveness of the device.

(avindran)

(N Ravindr) Head - Design & Development

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2007

Larsen & Toubro LLC c/o Mr. Jay Y. Kogoma Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Rc: K071472

Trade/Device Name: Planet 55 Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: September 5, 2007 Received: September 6, 2007

Dear Mr. Kogoma:

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. Jay Y. Kogoma

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 from the Division of Small Manufacturers, International 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 vours.

Bfummermor fr

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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Indications for Use

071472 510(k) Number (if known)

Device name: PLANET 55

Indication for use:

Prescription Use V (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 PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummmma
Sign Off

Division of Cardloya 510(k) Number

Page 1 of 1

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).