(56 days)
No
The summary describes a standard multi-parameter patient monitor with basic vital sign monitoring and display capabilities. There is no mention of AI, ML, or any advanced analytical features that would suggest the use of such technologies.
No
The device is a patient monitoring system, which monitors vital signs but does not provide therapy or treatment.
Yes
The device is a diagnostic device because its intended use is to monitor vital signs and present the monitored data to a professional healthcare provider for interpretation, which aids in diagnosing a patient's condition.
No
The device description explicitly states it is a "multi-parameter Patient Monitoring System (TFT color monitor)" and mentions hardware components like a built-in thermal array recorder and the ability to connect to an inkjet printer, indicating it is a hardware device with integrated software.
Based on the provided information, the PLANET multiparameter Patient Monitoring system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PLANET system, as described, directly monitors physiological parameters of a living patient (ECG, SpO2, NIPB, Temperature) using sensors applied to the body.
- The intended use and device description clearly state that it monitors a patient's vital signs at the bedside or during transport. This is in vivo monitoring, not in vitro testing of samples.
- There is no mention of analyzing biological samples or using reagents.
Therefore, the PLANET multiparameter Patient Monitoring system falls under the category of patient monitoring devices, which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
The PLANET 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. It can also display the digital values of HR/PR, SpO2, non-invasive blood pressure (systolic, diastolic and mean) and temperature 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. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.. The monitor is not intended for home use.
Product codes
74 DRT, MWI
Device Description
PLANET is a multi-parameter Patient Monitoring System (TFT color monitor) with ECG (3 lead),Temperature,NIPB, and pulse oximetry)with an optional built-in two channel thermal array recorder which can record online data (ECG waveform and plethysmograph) along with numerical values of other parameters.
PLANET is a three channel monitor with waveform display capability for ECG (3 lead), cascade and plethysmograph. It also displays the digital values of heart rate, pulse rate, SpO2, non-invasive blood pressure (systolic, diastolic and mean) and temperature readings. It has graded and color coded alarms. It has 24 hours tabular and graphical trends for ECG, SpO2 and temperature. It has special tabular trend for NIPB to store the last 240 readings. Alarm recall feature offers last 16 alarm conditions. Printout of tabular trend and ECG waveform can be obtained through an optional inkjet printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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 / bedside or during intra-hospital transport
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Marquette Medical, Eagle 3000 K952474, Criticare, CSI Model 8100 K001020
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
| NOV 1 0 2003 | 510(k) Summary
(As required by 21 CFR 807.92) | K 032871
page 1 of 2 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Submitted by: | Harry P. Gugnani
L&T Medical Systems
1821 Walden Office Square, Ste 400
Schaumberg, IL 60173 | |
| Date of Summary: | August 18, 2003 | |
| Device Name: | PLANET Monitoring System | |
| Common Name: | Cardiac Monitor | |
| Classification Name: | Monitor, Cardiac Incl. Cardio-tachometer & Rate Alarm | |
| Regulation Number: | 21 CFR 870.2300 | |
| Product Code: | 74 DRT | |
| Predicate Devices: | Marquette Medical, Eagle 3000 K952474
Criticare, CSI Model 8100 K001020 | |
| Device Description: | PLANET is a multi-parameter Patient Monitoring System
(TFT color monitor) with ECG (3 lead),Temperature,NIPB,
and pulse oximetry)with an optional built-in two channel
thermal array recorder which can record online data (ECG
waveform and plethysmograph) along with numerical
values of other parameters.
PLANET is a three channel monitor with waveform display
capability for ECG (3 lead), cascade and plethysmograph.
It also displays the digital values of heart rate, pulse rate,
SpO2, non-invasive blood pressure (systolic, diastolic and
mean) and temperature readings. It has graded and color
coded alarms. It has 24 hours tabular and graphical trends
for ECG, SpO2 and temperature. It has special tabular trend
for NIPB to store the last 240 readings. Alarm recall feature
offers last 16 alarm conditions. Printout of tabular trend and
ECG waveform can be obtained through an optional inkjet
printer. | |
| Intended Use: | The PLANET multi-parameter Patient Monitoring system | |
| K032871
page 2 of 2 | | |
| transport along with the appropriate accessories
mentioned/supplied with the unit. Vital signs parameters
include ECG (3 lead), Plethysmograph. It can also display
the digital values of HR/PR, SpO2, non-invasive blood
pressure (systolic, diastolic and mean) and temperature
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. It does not transmit
alarms or arrhythmias, and does not have arrhythmia
detection capabilities.. The monitor is not intended for
home use | | |
| Technological
Characteristics: | The parameters available with the PLANET Patient
monitoring system (ECG-3 lead, Temperature, NIBP 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 monitor audible & visual alarms are provided
similar to those in the Predicate devices.
PLANET has TFT color display as does the CSI Model
8100. Planet has thermal array recorder similar to that
available in Marquette Eagle 3000. Weight of the
PLANET is less than that of the predicate devices. Battery
(2 sealed lead acid) is provided in PLANET monitor like
that of the predicate devices CSI Model 8100. | |
| Compliance to standards: | Testing was conducted to demonstrate safety and
effectiveness to the following international standards:
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 PLANET and
its comparison with the predicate devices CSI Model 8100
and the Marquette Eagle 3000 monitors, Larsen & Toubro
Limited believes their device is substantially equivalent to
these Monitors and does no pose any additional risk to the
safety and effectiveness of the device | |
is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital
i U
1
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2003
Larsen & Toubro Ltd. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548
Re: K032871
Trade Name: PLANET Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 27, 2003 Received: October 28, 2003
Dear Mr. Devine:
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.
3
Page 2 - Mr. Ned E. Devine, Jr.
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
CTefan Mayr
Bram D. 7 uckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Indication for Use statement
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
KO32871
Device name : PLANET
Indication for use :
The PLANET multiparameter 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. It can also display the digital values of HR/PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature 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 arrhythmia provided is only a rate related arrhythmia without alarms. The monitor is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER RPAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Metka May for BDZ
(Division Sign-Off)
Division: Cardiovascular Devices
510(k) number 2032871
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -counter-use