(184 days)
No
The summary describes a standard vital signs monitor with alarm handling and mentions compliance with performance and safety standards, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is described as a "Monitoring System" designed for "monitoring of vital parameters," which indicates it is a diagnostic or observational device, not one that provides therapy.
No
The device is described as a "Monitoring System" for "monitoring of vital parameters" and does not mention diagnosis. Monitoring vital signs is for observation, not to make a medical diagnosis.
No
The device description explicitly states it is powered via mains connection, internal battery, and external power input, indicating it includes hardware components beyond just software.
Based on the provided text, the Monitoring System ARGUS LCM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living organism (in vitro).
- ARGUS LCM Function: The description clearly states that the ARGUS LCM is for the monitoring of vital parameters directly from the patient (ECG, blood pressure, temperature, CO2, SpO2). These are measurements taken in vivo (within the living organism).
- No Mention of Sample Analysis: The text does not mention the collection or analysis of any biological samples.
Therefore, the ARGUS LCM falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:
- ECG: Heartrate, Respiration Rate ・
- Invasive Blood Pressure: systolic, diastolic and mean pressure -
- Temperature: temperature ー
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
- CO2, etCO2 and CO2ins -
- SpO2: SpO2 and pulse rate -
There is alarm handling for all parameters except temperature.
The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.
The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:
- ECG: Heartrate, Respiration Rate .
- Invasive Blood Pressure: systolic, diastolic and mean pressure -
- Temperature: temperature -
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
- CO2, etCO2 and CO2ins and respiration rate. -
- SpO2: SpO2 and pulse rate
There is alarm handling for all parameters except temperature.
The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.
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
Not Found
Intended User / Care Setting
Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal 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)
The Argus LCM Monitoring and associated accessories have been tested and found to comply with recognized national and international performance, safety and electromagnetic compatibility standards for medical devices and product specifications listed in the Argus LCM labeling.
A risk analysis, identifying potential hazards and documenting mitigation of the hazards. has been developed and verified/validated as part of SCHILLER AG. product development procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K031557, K990966, K021090, K012216, K022084
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510 K Summary of Safety and Effectiveness
according to 21 CFR 807.92
MAY 1 9 2006
- A1 . Address
SCHILLER AG Altgasse 68 CH-6341 Baar Switzerland
Contact Name: Tel: Date:
Mr. Markus Buetler 001 41 41 766 4252 02." May 2006
Device Name A2
| 1. Trade Name: | Argus LCM (Basic / Plus) |
|---|---|
| 2. Common Name: | Monitoring System |
Legally Marketed Device A3
Legally Marketed Device to which this submitted device is compared:
| ARGUS PB-1000 System | K012226 |
|---|---|
| Cardiovit AT-102 | K031557 |
A4 Intended Use
The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:
- ECG: Heartrate, Respiration Rate .
- Invasive Blood Pressure: systolic, diastolic and mean pressure -
- Temperature: temperature -
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
- CO2, etCO2 and CO2ins and respiration rate. -
- SpO2: SpO2 and pulse rate
There is alarm handling for all parameters except temperature.
The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.
The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
1
K053207
P2/4
Table of Comparison (1) A5
| | Argus PB-1000 System
(K012226) | ARGUS LCM |
|---------------------------|-----------------------------------|-------------------|
| Dimensions: | 210x115x45mm | 290x275x180mm1) |
| Weight: | 980 g | 4.6 kg / 9.2lbs2) |
| Environmental Conditions: | | |
| Operating temperature | +10° - 40° C | same |
| Storage temperature | -10° - +50° C | same |
| Relative humidity | 25% - 95%
(non condensing) | same |
Discussion of Differences:
None of the above differences (1 or 2) can be considered as safety relevant differences.
We consider the submitted device to be as safe and effective as the Predicate ARGUS PB-1000 (K 012226) device.
| LCM
Plus | LCM
Basic | Module | Description | Reference | Standards |
|-------------|--------------|--------|----------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------|
| X | X | System | Schiller AT-102 | K031557, Schiller
AT-102 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-4 |
| X | | ECG | Schiller AT-102 | K031557, Schiller
AT-102 | IEC 60601-1
IEC 60601-2-2 |
| | X | ECG 3p | New Schiller ECG
Hardware amplifier
Amplifier Firmware
Filtering
Algorithm | K031557, Schiller
AT-102 | IEC 60601-1
IEC 60601-2-2 |
| X | X | SPO2 | Masimo OEM SpO2
Module MS-7 | K990966, Masimo
SET 2000 | Verification and
Test Documer |
| X | X | SPO2 | Nellcor OEM SpO2 Module
MP-100 | K021090, Nellcor N-
550 Pulse Oximeter | Verification and
Test Documer |
| X | X | NIBP | Schiller NIBP Module
ARGUS PB-1000 | K012216, Schiller
ARGUS PB-1000
System | IEC 60601-2-3 |
| X | X | Temp. | Schiller Temperature
Module ARGSU PB-1000 | K012216, Schiller
ARGUS PB-1000
System | EN 12470-4 |
| X | X | CO2 | Welch Allyn OEM CO2
Module LC101 | K022084, Welch
Allyn Atlas Monitor | Specifications
Declaration |
| X | X | IBP | Schiller IBP Module
ARGUS PB-1000 | K012216, Schiller
ARGUS PB-1000
System | IEC 60601-2-3 |
Table of Comparison (2)
2
B1 Non-Clinical Tests
-
- Electrical Safety and Reliability:
The device has been tested to be in accordance with the following standards: EN 60601-1:1990: Safety of Medical Electrical Equipment part 1, General requirements. IEC60601-1-2: Electromagnetic Compatibility Test, Electrostatic Discharge, Radio Frequency Electromagnetic Field, Fast Transients. IEC60601-2-27:1996 Particular Requirements for the safety of electrocardiographic monitoring equipment.
- Electrical Safety and Reliability:
IEC60601-2-30:1995 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. IEC60601-2-34:1995 Particular requirements for the safety of the blood pressure monitoring equipment. IEC60601-2-49:2001 Particular Requirements for the safety of multifunction patient monitoring equipment EN865:1997 Pulse Oximeters-Particular Requirements
All tests are passed.
4) Data related to software quality
SCHILLER has reviewed its software development process following the guideline * reviewer guidance for computer controlled medical devices undergoing 510 (k) review". Device software requirements, software structure chart, software development, software revision/ modification, software identification, software verification, validation and testing are described in the data attached.
B2 Clinical Tests
n.a.
B3 Summary of Performance Testing:
The Argus LCM Monitoring and associated accessories have been tested and found to comply with recognized national and international performance, safety and electromagnetic compatibility standards for medical devices and product specifications listed in the Argus LCM labeling.
A risk analysis, identifying potential hazards and documenting mitigation of the hazards. has been developed and verified/validated as part of SCHILLER AG. product development procedures. SCHILLER AG Quality System conforms to 21 CFR 820 and is Certified to ISO 9001:2000 and ISO 13485:2003
3
Conclusion
As stated above, SCHILLER AG conclusion is that the Argus LCM Monitoring is safe, effective, comply with the appropriate medical device standards and equivalent to the Argus PB-1000 System (K012226) and Cardiovit AT-102 (K031557) currently on the market.
Baar (Switzerland) 02™ May 2006
A. Bi. Ree
Markus Buetler SCHILLER AG Quality Assurance and Regulatory Affairs Manager
Section and Career of
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2006
Mr. Markus Buetler Quality and Regulatory Department Schiller AG Altgasse 68 Baar, ZG, Switzerland 6341
Re: K053207
Trade/Device Name: Argus, Model LCM 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: November 11, 2005 Received: November 16, 2005
Dear Mr. Buetler:
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 10 mo beared or 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. Markus Buetler
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of acribed alla I termination that your device complies with other requirements of the Act that I Dr Amal statutes and regulations administered by other Federal agencies. You must or any I caster that to t'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 (21 CFR Part 807), accems (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. product faction control provided in arketing your device as described in your Section 510(k) I mis lotter will and w Jown FDA finding of substantial equivalence of your device to a legally premated predicated with 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 If you active 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 other general 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 yours,
Duna R. hochner
Image /page/5/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines, possibly resembling a stylized letter or a unique design. The lines are thick and dark, suggesting they were drawn with a pen or marker. The overall impression is abstract and artistic.
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
510(k) Number (If know): KOS3207
Device Name: Argus LCM
Indications for Use:
The Monitoring System ARGUS LCM is for the monitoring of vital parameters such as:
- ECG: Heartrate, Respiration Rate ・
- Invasive Blood Pressure: systolic, diastolic and mean pressure -
- Temperature: temperature ー
- Non Invasive Blood Pressure: systolic, diastolic and mean pressure -
- CO2, etCO2 and CO2ins -
- SpO2: SpO2 and pulse rate -
There is alarm handling for all parameters except temperature.
The ARGUS LCM is powered via the normal mains connection 230V/110V, and using an internal battery and an external power input.
The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
SCHILLER AG
Altgasse 68
341 Baar/Switzerland
10////0√
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
ovascular Devices
510(k) Number K053207