(115 days)
Not Found
No
The document describes a standard multi-parameter patient monitor with data display, trending, and alarm features, but makes no mention of AI or ML capabilities.
No
The device monitors vital signs and physiological parameters; it does not provide any therapeutic treatment or intervention.
Yes
Explanation: The device monitors vital signs and physiological parameters, and the user (a professional healthcare provider) interprets the monitored data. This data helps in the assessment and diagnosis of a patient's condition.
No
The device description explicitly mentions hardware components such as an 8.4" TFT display, a two-channel thermal array recorder, and optional communication features like USB, RS232, RS485, Infrared remote, and Ethernet. It also refers to "appropriate accessories mentioned / supplied with the unit," implying physical components beyond software.
Based on the provided information, the PLANET 55 multi-parameter Patient Monitoring system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PLANET 55 Function: The PLANET 55 monitors physiological parameters directly from the patient's body (ECG, SpO2, Respiration, Temperature, NIBP, CO2). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it monitors vital signs at the bedside or during intrahospital transport. This is direct patient monitoring, not laboratory testing of samples.
Therefore, the PLANET 55 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 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.
Product codes
MWI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric or neonatal
Intended User / Care Setting
professional health care provider. The monitor 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
§ 870.2300 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Larsen & Toubro Limited. Above the company name is the text "K07 1472" in a handwritten font. The logo is a circle with the letters "L" and "T" inside.
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 |
1
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 |
2
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.
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.
INTENDED USE OF THE DEVICE
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.
3
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.
e.
(avindran)
(N Ravindr) Head - Design & Development
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
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.
5
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
6
Indications for Use
071472 510(k) Number (if known)
Device name: PLANET 55
Indication for use:
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.
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
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