(122 days)
No
The summary describes hardware updates and software versioning, but makes no mention of AI or ML technologies.
No
The device is described as a "Monitoring System" intended for "continuous monitoring" of physiological parameters (tcpCO₂, tcpO₂, SpO2, and pulse rate). This indicates it is for diagnostic or monitoring purposes, not for treating or preventing a disease or condition.
Yes
Explanation: The device is intended for continuous monitoring of physiological parameters (transcutaneous Carbon Dioxide, oxygen, oxygen saturation, and pulse rate), which are measurements used to assess a patient's health status and aid in the diagnosis or management of conditions. The "Intended Use / Indications for Use" section explicitly states its purpose for monitoring these parameters in various patient populations.
No
The device description explicitly details hardware components including a basic unit with a touch screen, two modules, calibration units, sensors, and application systems (earclip, fixation ring, double adhesive ring). While software is mentioned as being updated, the core device is a physical monitoring system with hardware components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The TCM CombiM and TCM TOSCA Monitoring Systems are described as devices for continuous monitoring of physiological parameters (tcpCO₂, tcpO₂, SpO₂) directly on the patient's skin (transcutaneous). This is an in vivo measurement, not an in vitro examination of a specimen.
- Intended Use: The intended use clearly states "continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure" and "oxygen saturation of arterial haemoglobin (SpO2) and pulse rate". These are measurements taken from the living body, not from a sample outside the body.
Therefore, the device falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure in neonates, pediatrics and adults not under gas anesthesia.
The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.
Product codes (comma separated list FDA assigned to the subject device)
LKD, DQA, DPZ, KLK, LPP
Device Description
The TCM TOSCA monitoring system and the TCM CombiM monitoring system are based on the TCM 4/40 Monitoring System (K043003) which consist of a basic unit that has touch screen and two modules. One module for the combined tcpO2/tcpCO2 monitoring and one for SpO2. Both new modules have an integrated calibration unit.
Both Sensors can be used with either earclip- or a conventional fixation ring application system. In addition the CombiM also comes with a double adhesive ring.
The software of the TCM 4/40 basic unit has been updated (to version 3.01) and two new modules have been developed to enable the use of the sensor technology from the TOSCA500 Monitoring System (K063434) and from the MicroGas 7650 rapid (K003943).
Thereby the SpO2 and tcpCO2 can be measured using the new TCM TOSCA module and the combined SpO2/tcpCO2 sensor of the TOSCA500 system.
The tcpO2 and tcpCO2 can be monitored using the new TCM CombiM module and the combined tcpOz/tcpCO2 sensor of the MicroGas 7650 rapid system. A new single tcpCO2 sensor can also be used with this module.
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
The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure in neonates, pediatrics and adults not under gas anesthesia.
The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.
Intended User / Care Setting
Not Found
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): 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.
TOSCA500 Monitoring System, K063434, MicroGas 7650 rapid, K003943, TCM 4/40 Monitoring System, K043003
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.
Not Found
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
§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.
(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.
0
510(k) Premarket Notification Submission
109315-9
510(k) Summary
For
FEB - 5 2010
TCM TOSCA/Combil Monitoring System
Manufacturer:
・・・
Radiometer Medical ApS Company Address: Åkandevej 21, DK-2700 Brønshøj, Denmark
Contact Information:
Radiometer Medical ApS Aakandevej 21 , DK-2700 Brønshøj Denmark Attn: Mrs. Jana S. Hellmann. Vice President RA/QA Phone +45 38273827 Fax: +4538272727 Email: jana.hellmann@radiometer.dk
Tom S. Hett
Date of Preparation:
August 31, 2009
・・
1
TCM TOSCA/CombiM Monitoring System
Device Name/Classification
- Trade name: ●
- (21 CFR 868.2480, product code LKD, DQA, DPZ)
- Trade name: . (21 CFR 868.2500, product code LKD, KLK, LPP)
Identification of Predicate Device
TOSCA500 Monitoring System, K063434 MicroGas 7650 rapid, K003943 TCM 4/40 Monitoring System, K043003
Instrument Description
The TCM TOSCA monitoring system and the TCM CombiM monitoring system are based on the TCM 4/40 Monitoring System (K043003) which consist of a basic unit that has touch screen and two modules. One module for the combined tcpO2/tcpCO2 monitoring and one for SpO2. . Both new modules have an integrated callbration unit
Both Sensors can be used with either earclip- or a conventional fixation ring application system. In addition the CombiM also comes with a double adhesive ring.
The software of the TCM 4/40 basic unit has been updated (to version 3.01) and two new modules have been developed to enable the use of the sensor technology from the TOSCA500 Monitoring System (K063434) and from the MicroGas 7650 rapid (K003943).
Thereby the SpO2 and tcpCO2 can be measured using the new TCM TOSCA module and the combined SpO2/tcpCO2 sensor of the TOSCA500 system.
The tcpO2 and tcpCO2 can be monitored using the new TCM CombiM module and the combined tcpOz/tcpCO2 sensor of the MicroGas 7650 rapid system. A new single tcpCO2 sensor can also be used with this module.
Device Intended Use
TCM TOSCA/CombiM Monitoring system
The TCM ComblM Monitoring Systems is Intended for continuous monitoring of transcutaneous Carbon Dloxide (tcpCO2), oxygen (tcpO2) partial pressure in neonates, pediatrics and adults not under gas anesthesia.
The TCM TOSCA Monitoring Systems Is intended for continuous monitoring of transcutaneous Carbon Dloxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.
2
TCM TOSCA/CombiM Monitoring System
Medical device to which equivalence is claimed:
TOSCA500 Monitoring System, K063434 MicroGas 7650 rapid, K003943 TCM 4/40 Monitoring System, K043003
Please do refer to enclosed drawing the inter relationship with the new device and the predicate devices.
Comparison to Predicate Device:
Table 1 Comparison of features for TCM CombiM and Predicate Device
TCM CombiM compared to TCM4
| Area | TCM4 | TCM CombiM | Substantial |
|---|---|---|---|
| Indications for use | The TCM4 Monitoring | ||
| System is intended for | |||
| continuous | |||
| transcutaneous | |||
| monitoring of oxygen | |||
| and carbon dioxide | |||
| partial pressures. It is | |||
| indicated for use on | |||
| neonates, | |||
| pediatrics, and adults | |||
| not under gas | |||
| anesthesia | The TCM CombiM | ||
| monitoring system | |||
| is Intended for | |||
| continuous | |||
| transcutaneous | |||
| monitoring of | |||
| carbon dioxide | |||
| (tcpC02) and | |||
| oxygen (tcp02) | |||
| partial pressures. It | |||
| is Indicated for use | |||
| on neonates, | |||
| pediatrics and | |||
| adults not under | |||
| gas anesthesia | YES | ||
| Gas Measurement | |||
| parameters | tcpO2,tcpCO2 | tcpO2,tcpCO2 | YES |
| Basic unit HW (CPU + | |||
| controller) | TCM 4/40 ETX Basic | ||
| Unit | TCM 4/40 ETX | ||
| Basic Unit | YES | ||
| Module | TCM 4/40 Module | TCM CombiM | |
| Module | YES*1 | ||
| Operating system | Microsoft CE 5.0 | Microsoft CE 5.0 | YES |
| Basic unit SW | V3.0 | V3.0 | YES |
3
TCM TOSCA/CombiM Monitoring System
Table 2 Comparison of features for TCM TOSCA and Predicate Device
TCM TOSCA compared to TCM40
| Area | TCM40 | TCM Tosca | Substantial |
|---|---|---|---|
| Indications for use | The TCM40 Monitoring | ||
| System is intended for | |||
| continuous | |||
| transcutaneous | |||
| monitoring of oxygen | |||
| and carbon dioxide | |||
| partial pressures as | |||
| well as of oxygen | |||
| saturation of arterial | |||
| hemoglobin and pulse | |||
| rate. It is Indicated for | |||
| use on neonates, | |||
| pediatrics, and adults | |||
| not under gas | |||
| anesthesia. | The TCM TOSCA | ||
| monitoring system | |||
| Is Intended for | |||
| continuous | |||
| transcutaneous | |||
| monitoring of | |||
| carbon dioxide | |||
| (tcpC02) partial | |||
| pressures, oxygen | |||
| saturation of arterial | |||
| hemoglobin (Sp02) | |||
| and pulse rate. It is | |||
| indicated for use on | |||
| pediatrics and | |||
| adults not under gas | |||
| anesthesia. | YES*1 | ||
| Gas Measurement | |||
| parameters | tcpO2, tcpCO2 | tcpCO2 | YES*1 |
| SpO2 Technology | Nellcor OEM | Massimo OEM | YES*2 |
| Basic unit HW (CPU + | |||
| controller) | |||
| Module | TCM 4/40 ETX Basic | ||
| Unit | |||
| TCM 4/40 Module | TCM 4/40 ETX | ||
| Basic Unit | |||
| TCM CombiM | |||
| Module | YES | ||
| YES*3 | |||
| Operating system | Microsoft CE 5.0 | Microsoft CE 5.0 | YES |
| Basic unit SW | V3.0 | V3.0 | YES |
ICM TOSCA / Tosca 500
| 1
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Conclusion
The products listed in the tables are substantially equivalent based on their Indications for use and performance characteristics.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jana Hellmann Vice President, Regulatory Affairs/Quality Assurance Radiometer Medical ApS Åkandevej 21 Brønshøj, DK-2700 DENMARK
FEB - 5 2010
Re: K093154
Trade/Device Name: TCM TOSCA/CombiM Monitoring System Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (PcCO2) Monitor Regulatory Class: II Product Code: LKD, DQA, DPZ, KLK, LPP Dated: January 21, 2010 Received: January 25, 2010
Dear Ms. Hellmann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Ms. Hellmann
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.html 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
fac
Anthony D. Watson, B.Ś., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): N/A
Class II Devices:
Device Names: TCM TOSCA/CombiM Monitoring System
Indication for Use:
The TCM CombiM Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO₂), oxygen (tcpO₂) partial pressure in neonates, pediatrics and adults not under gas anesthesia.
The TCM TOSCA Monitoring Systems is intended for continuous monitoring of transcutaneous Carbon Dioxide (tcpCO2), oxygen saturation of arterial haemoglobin (SpO2) and pulse rate in pediatrics and adults.
Prescription Use __ × (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
L. Schullbert
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 093154 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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