TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM

K093154 · Radiometer Medical Aps · LKD · Feb 5, 2010 · Anesthesiology

Device Facts

• Record ID: K093154
• Device Name: TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
• Applicant: Radiometer Medical Aps
• Product Code: LKD · Anesthesiology
• Decision Date: Feb 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2480
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

TCM TOSCA/CombiM Monitoring System is a multi-parameter monitor based on the TCM 4/40 platform. It utilizes two new modules—TCM CombiM and TCM TOSCA—to integrate sensor technologies from the TOSCA500 and MicroGas 7650 rapid systems. The device processes transcutaneous gas signals (tcpO2, tcpCO2) and SpO2/pulse rate data. Sensors are applied via earclips, fixation rings, or double adhesive rings. The system features a touchscreen interface for clinician operation in clinical settings. Output provides real-time physiological monitoring to assist healthcare providers in assessing patient respiratory and oxygenation status, facilitating clinical decision-making for non-anesthetized patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, intended use, and performance comparisons to predicate devices.

Technological Characteristics

System consists of a basic unit (TCM 4/40 ETX) with touchscreen and two modules (TCM CombiM, TCM TOSCA). Operates on Microsoft CE 5.0. Uses transcutaneous electrochemical sensors for gas monitoring and SpO2 technology (Masimo OEM for TOSCA). Connectivity via integrated calibration units. Sensors support earclip or fixation ring application.

Indications for Use

Indicated for continuous monitoring of tcpCO2 and tcpO2 in neonates, pediatrics, and adults not under gas anesthesia (CombiM); and continuous monitoring of tcpCO2, SpO2, and pulse rate in pediatrics and adults (TOSCA).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TOSCA500 Monitoring System (K063434)
• MicroGas 7650 rapid (K003943)
• TCM 4/40 Monitoring System (K043003)

Submission Summary (Full Text)

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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 [phone] Fax: [phone] Email: [e-mail]

Tom S. Hett

Date of Preparation:

August 31, 2009

・・

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## 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.

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# 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<br>System is intended for<br>continuous<br>transcutaneous<br>monitoring of oxygen<br>and carbon dioxide<br>partial pressures. It is<br>indicated for use on<br>neonates,<br>pediatrics, and adults<br>not under gas<br>anesthesia | The TCM CombiM<br>monitoring system<br>is Intended for<br>continuous<br>transcutaneous<br>monitoring of<br>carbon dioxide<br>(tcpC02) and<br>oxygen (tcp02)<br>partial pressures. It<br>is Indicated for use<br>on neonates,<br>pediatrics and<br>adults not under<br>gas anesthesia | YES |
| Gas Measurement<br>parameters | tcpO2,tcpCO2 | tcpO2,tcpCO2 | YES |
| Basic unit HW (CPU +<br>controller) | TCM 4/40 ETX Basic<br>Unit | TCM 4/40 ETX<br>Basic Unit | YES |
| Module | TCM 4/40 Module | TCM CombiM<br>Module | YES*1 |
| Operating system | Microsoft CE 5.0 | Microsoft CE 5.0 | YES |
| Basic unit SW | V3.0 | V3.0 | YES |

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# 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<br>System is intended for<br>continuous<br>transcutaneous<br>monitoring of oxygen<br>and carbon dioxide<br>partial pressures as<br>well as of oxygen<br>saturation of arterial<br>hemoglobin and pulse<br>rate. It is Indicated for<br>use on neonates,<br>pediatrics, and adults<br>not under gas<br>anesthesia. | The TCM TOSCA<br>monitoring system<br>Is Intended for<br>continuous<br>transcutaneous<br>monitoring of<br>carbon dioxide<br>(tcpC02) partial<br>pressures, oxygen<br>saturation of arterial<br>hemoglobin (Sp02)<br>and pulse rate. It is<br>indicated for use on<br>pediatrics and<br>adults not under gas<br>anesthesia. | YES*1 |
| Gas Measurement<br>parameters | tcpO2, tcpCO2 | tcpCO2 | YES*1 |
| SpO2 Technology | Nellcor OEM | Massimo OEM | YES*2 |
| Basic unit HW (CPU +<br>controller)<br>Module | TCM 4/40 ETX Basic<br>Unit<br>TCM 4/40 Module | TCM 4/40 ETX<br>Basic Unit<br>TCM CombiM<br>Module | YES<br>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

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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -----------<br>I was connect and a<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------<br>- FAR - -<br>-<br>------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>The first of the county of the county of the county of the county of<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----- | 1<br>-------------<br> |

### Conclusion

The products listed in the tables are substantially equivalent based on their Indications for use and performance characteristics.

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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.

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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 [phone] or [phone] 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

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# 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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