The PLANET 55 Model 100 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 /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, EtC02, and FiC02 readings.

In addition, PLANET 55 Model 100 has Arrhythmia and ST detection from 3L / 5L ECG measurements. The Arthythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal Patients.

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 Model 100 is a Multi-parameter patient monitoring system for continuous monitoring of the physiological parameter ECG (3/5 lead), Arrhythmia & ST analysis, Respiration, NIBP, Temperature, SpO2 and CO2.

PLANET 55 Model 100 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, Sp02, CO2 digital values of HR/PR, Spo2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, FiCO2, FCO2, FCO2 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 first 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 i.e. USB, RS232, Infrared remote and Ethernet. The unit comes with adjustable alarm limits as well as visible and audible alarm signals.

AI/ML Overview

The provided text describes the Larsen & Toubro Limited PLANET 55 Model 100 Patient Monitoring System, a multi-parameter device. However, it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

The document is a 510(k) summary for premarket notification to the FDA. It primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The document does not provide a table detailing specific acceptance criteria (e.g., accuracy ranges for heart rate, SpO2, NIBP) or corresponding reported device performance values. It states that the device is "substantially equivalent" to predicate devices, implying similar performance, but quantitative data is not provided.

2. Sample Size for the Test Set and Data Provenance:

Missing. No specific test set sample size is mentioned for evaluating the new PLANET 55 Model 100.
Missing. Data provenance (country of origin, retrospective/prospective) is not discussed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Missing. The document does not describe any expert-established ground truth for a test set. This type of information would typically be found in a detailed performance study.

4. Adjudication Method:

Missing. No adjudication method is described, as there's no mention of a ground truth establishment process involving multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Missing. There is no mention of an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device described (patient monitor) is not an AI-assisted diagnostic tool in the sense that would typically involve a MRMC study.

6. Standalone (Algorithm Only) Performance Study:

Missing. While the device has algorithms for Arrhythmia and ST analysis, the document does not present a standalone performance study report for these algorithms with specific metrics (e.g., sensitivity, specificity) against a ground truth. It relies on the substantial equivalence argument to predicate devices which presumably have established performance.

7. Type of Ground Truth Used:

Missing. As no specific performance study against a defined ground truth for the PLANET 55 Model 100 is provided, the type of ground truth used is not stated. For vital signs monitors, ground truth often involves comparison to reference devices or direct physiological measurements.

8. Sample Size for the Training Set:

Missing. The document does not mention any training set or its sample size. This would typically be relevant for machine learning-based devices, but the PLANET 55 Model 100 is presented as a traditional vital signs monitor relying on established algorithms rather than novel AI/ML models that require extensive training data.

9. How Ground Truth for the Training Set Was Established:

Missing. Since no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary of available information:

Device Name: PLANET 55 Model 100
Intended Use: Multi-parameter patient monitoring system for continuous monitoring of physiological parameters (ECG, Respiration, NIBP, Temperature, SpO2, CO2), including Arrhythmia & ST analysis. Intended for Adult, Pediatric, or Neonatal patients at bedside or during intra-hospital transport, not for home use. Used by professional healthcare providers.
Predicate Devices:
- PLANET 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K071472
- Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp) / K020550
Regulatory Status: Substantially Equivalent to predicate devices, Class II, Product Code MHX (Arrhythmia detector and alarm).
Standards Compliance: IEC 60601-1 (Medical Electrical Safety) and IEC 60601-1-2 (EMC compliance).

Conclusion:

The provided document serves as a 510(k) summary for regulatory submission, focusing on demonstrating substantial equivalence to already marketed devices. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, ground truth methodologies, or expert involvement that your request specifies for the device itself. Such granular data would typically be found in separate, more detailed technical or clinical performance reports that form part of the full 510(k) submission but are not included in this public summary.

Summary

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K090443
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Larsen & Toubro Limited

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Mysore Campor), KADB Industral Area: Hebbal - Hoolagali, Mysolo - Tel: - 911821) 2405000 - Fax - 91 (821) 2402468

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JUN - 5 2009

Date: 05.01.2009 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	91-821-2405439	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	05.01.2009

Regd. Off:L & T House, Ballard Eslate. P O. Box 278, Mumbai 400 00 ● Phone: #91(22)67525858
1181 +91(22)675258 Website:www.LNTEBG.com

. . . . . . . . . .

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Larsen & Toubro Limited

--- ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS --

Mysore Campu's. KIADB Industrial Area. Hebbal - Hoctagall. Mysore - 570 0118 - Tel: +91 (821) 2405000 - Fax: - 91 (821) 2402468

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	DEVICE
Trade name	PLANET 55 Model 100
Common name	Patient Monitoring System
Classification name	Vital Signs Monitor

PREDICATE DEVICE IDENTIFICATION
CFR21 Section	870.1025	Product code	MHX
Classification panel	Cardiovascular
Device Class	Class II
Legally marketed Comparison Device / K#	PLANET 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K071472 Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp) / K020550

Regd. Off:L & T House. Ballard Estate, P.O. Box 278. Munisi 400 001 ◆ Phone:+9 1(22)67525656 ● Fax: +9 1(22)67525856 • Website : www.LNTEBG.com :

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Image /page/2/Picture/0 description: The image shows a logo consisting of two stylized letters, likely 'L' and 'T', enclosed within a circle. The letters are designed with a geometric, angular style, giving them a modern and somewhat abstract appearance. The logo has a textured or slightly pixelated look, possibly due to the image quality or the original design. The overall impression is a simple yet distinctive mark, suitable for branding purposes.

LARSEN & TOUBRO LIMITED

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Cambus, KIADB Industrial Area, Heabal - Hootagati, Mysole - 570 018 · Tel - 191 (621) 240546R

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Date: 05.01.2009 Page: 03 of 04

DEVICE DESCRIPTION

Planet 55 Model 100 is a Multi-parameter patient monitoring system for confinuous monitoring of the physiological parameter ECG (3/5 lead). Arrhythmia & ST analysis, Respiration. NIBP. Temperature, SpO2 and CO2.

PLANET 55 Model 100 is a 4-channel monitor with 8,4" TFT display capable of displaying ECG. Respiration. Sp02. CO2 digital values of HR/PR. Spo2. Righton-Invasive Blood Pressure (Systolic, Diastolic and Mean). Temperature, FiCO2, FCO2, FCO2 readings. It has selective 24148172 Hours tabilitar and graphical trends. It has special feature of NIBP having a trend of storing lust 240 readings. It has Altrin Recal first with last 24 patient alarms details. It has a wo-chamel thermal array receint for printing of Tabular trends & waveforms. It has got-optional communication features i USB. RS232. Infrared remote and Ethernet. The get options comments with adjustable alàrm fimits as well as visible and audible alarm signals.

INTENDED USE OF THE DEVICE

The PLANET 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or thring intra-hospital 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 HRPR, SpO2, RR. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EiCO2, and FiCO2 readings.

In addition, PLANET 55 Model 100 has got Archythmia and ST detection from 31. / 51. ECG measurements. The Arthythmia and ST refection for the crime for all . 31. - 51.
All 1 and i Adult & Pediatric patients and is not intended for use with Neonarda Micheed

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with alle alarm limits as well us sisible and audible alarm signals. The monitor is not included by nome use.

Regd. Off:L & T House. Ballard Estate, P.O. Box 278, Mimbral 400 00 · Phone:+9 (22)67525656 · Fax:+91(22)67525858
· Fax:+91(22)675256 Website : www LNTEBG.com

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Image /page/3/Picture/0 description: The image shows a logo consisting of two stylized letters, 'L' and 'T', enclosed within a circle. The 'L' and 'T' are designed with sharp angles and lines, giving them a modern and geometric appearance. The logo has a black and white color scheme, with the letters and circle outlined in black against a white background. The overall design is simple, clean, and easily recognizable.

& Toubro Limitt

ELECTRICAL & ELECTRONICS DIVISION - ELECTRONIC PRODUCTS

Mysore Campais, KADB Industrial Area, Heibai · Hootagali, Mysore · 570 018 · Tel: · 4911821) 2405000 · Fax: · 91 (82 ) 2402466

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Date: 05 01 .2009 Page: 04 01 01 01 01

TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Device: Larsen & Toubro limited make PLANET 55 Model 100 Patient Monitoring System.

Predicate device:

� PLANET 55 Patiem Monitoring System (Make: L&T Medical Equipments & Systems) / K071472.
Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope o Corp) : K020550.

: The parameters available with the Larsen & Toubro Limited make PLANET 55 Model 100 Patient monitoring system are available with the predicate devices "Passport 2 Vital signs monitor with 12 ECG Analysis Module" for Arrhythmia & ST analysis and Larsen & Toubro Limited make PLANET 55 patient monitoring system for other parameters. Comparison of the parameters of PLANET 55 Model 100 to that of the predicate device is given in the "Predicate device comparison table" document.

Compliance to standards:

The following international standards are referred. IEC 60601-1 Medical Electrical safety IFC 60601-1-2 EMC compliance

Conclusion:

Based on the Technological characteristics of PLANET 55 Model 100 and its comparison with that of predicate devices 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.

(N. Ravindran)

Head - Design & Development

Regd. Off : L & T House, Ballard Estate, P.O. Box 273, Mumbei 400 001 · Phone : 191(22)67525856 Website : www.LNTEBG.com

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2009

Larsen & Toubro Limited c/o Ms. Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114

Re: K090443

Trade/Device Name: PLANET 55 Model 100 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: MHX Dated: May 6, 2009 Received: May 7, 2009

Dear Ms. Smith:

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 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 - Ms. Yolanda Smith

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

Bram D. Žuckerman, 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

510(k) Number (if known)

Device name: PLANET 55 Model 100

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)

H.R.M. D.D. for B Zuckerman

ardiovascular Devices

510(k) Number K090443

Page 1 of 1

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.