(105 days)
Not Found
No
The document describes a standard multi-parameter patient monitor with vital sign measurements and basic analysis (Arrhythmia and ST detection). There is no mention of AI, ML, or any related concepts in the intended use, device description, or the sections specifically checked for these terms. The analysis features described are typical of traditional signal processing algorithms used in patient monitoring.
No
The device is a patient monitoring system designed to measure and display vital signs, not to treat or cure a disease or condition.
No
This device is a patient monitoring system that displays vital signs and provides arrhythmia/ST detection, but it explicitly states the user is "responsible to interpret the monitored data" and that it is "not intended for home use." This indicates it provides data for diagnosis rather than making a diagnosis itself.
No
The device description explicitly details hardware components such as an 8.4" TFT display, a two-channel thermal array recorder, and various communication features (USB, RS232, Infrared remote, Ethernet). It is described as a "Multi-parameter patient monitoring system" which implies a physical device with integrated hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The PLANET 55 Model 100 is a patient monitoring system that measures physiological parameters directly from the patient's body (in vivo). It uses sensors and electrodes applied to the patient to monitor vital signs like ECG, SpO2, Respiration, Temperature, NIBP, and Capnography.
- Intended Use: The intended use clearly states it's for monitoring a patient's vital signs at the bedside or during intra-hospital transport. It does not mention the analysis of biological specimens.
Therefore, the PLANET 55 Model 100 falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MHX
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, SpO2, CO2 digital values of HR/PR, Spo2, Righton-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 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 device comes with adjustable alarm limits as well as visible and audible alarm signals.
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 patient's vital signs. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal Patients.
Intended User / Care Setting
professional health care provider. The device is intended for use at the bedside or during intra-hospital transport and 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Figure/0 description: The image shows a logo with a circle surrounding two stylized letters that appear to be 'L's. The 'L's are mirrored and connected in the center, creating a symmetrical design within the circle. The logo has a textured or slightly rough appearance, possibly indicating it's from a scanned or low-resolution source.
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
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Date: 05.01.2009 Page: 01 of 04
510(K) SUMMARY
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(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 |
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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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Image /page/1/Picture/0 description: The image shows a logo with the letters 'L' and 'T' inside of a circle. The two letters are stylized and appear to be connected. The logo is black and white and has a simple design. The letters are bold and easy to read.
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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 | |
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| 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)
(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
6
Indications for Use
510(k) Number (if known)
Device name: PLANET 55 Model 100
Indication for use:
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.
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
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