TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

K063434 · Radiometer Basel AG · DQA · Jan 22, 2007 · Cardiovascular

Device Facts

• Record ID: K063434
• Device Name: TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
• Applicant: Radiometer Basel AG
• Product Code: DQA · Cardiovascular
• Decision Date: Jan 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO2, functional oxygen saturation SpO2 and pulse rate in adults and pediatrics.

Device Story

TOSCA 500 monitors transcutaneous PCO2 (tcPCO2), SpO2, and pulse rate using a single sensor applied to ear lobe, forehead, or cheek. PCO2 measurement uses Stow-Severinghaus electrochemical electrode; sensor heating induces local hyperemia to increase arterial blood supply. SpO2 and pulse rate measurement uses Masimo SET signal extraction technology; sensor contains red (660 nm) and infrared (880 nm) LEDs and a photodiode. Light absorption differences between oxygenated/reduced hemoglobin determine SpO2. Masimo SET decomposes pulsatile signals into arterial signal and noise components to calculate SpO2. Device includes integrated calibration unit for PCO2 sensor. Used in clinical settings; operated by healthcare professionals. Output displayed on monitor; assists clinicians in assessing patient respiratory and circulatory status. Benefits include continuous, non-invasive monitoring of gas exchange and oxygenation.

Clinical Evidence

Clinical studies performed on healthy adult volunteers under induced hypoxia. Compared forehead/cheek sensor measurements to arterial blood gas (co-oximeter) for SpO2 and to ear lobe measurements (validated against ECG) for pulse rate. Results confirmed specified saturation and pulse rate accuracy met. tcPCO2 values at forehead/cheek showed good correlation with ear lobe measurements.

Technological Characteristics

Stow-Severinghaus type electrochemical PCO2 electrode; optical pulse oximetry sensor (660nm/880nm LEDs). Patient contact materials tested per ISO-10993-1:1992 for prolonged contact (24h-30d). Integrated calibration unit for PCO2. Masimo SET signal extraction technology for SpO2/pulse rate. Fixation rings for forehead/cheek application.

Indications for Use

Indicated for simultaneous continuous monitoring of transcutaneous PCO2, functional oxygen saturation (SpO2), and pulse rate in adult and pediatric patients.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System (K043357)

Submission Summary (Full Text)

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K063434

## LINDE MEDICAL SENSORS AG

Equivalent Device:

#### RADIOMETER COPENHAGEN

## 510(k) Summary

| Submitted by: | Radiometer Basel AG<br>Austrasse 25<br>4051 Basel - Switzerland<br>Phone:<br>011 41 61 278 82 07<br>Fax:<br>011 41 61 278 81 81 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jean-Pierre Palma<br>CEO / Head of Mechanical Engineering / Regulatory Affairs |
| Date Summary prepared: | October 30, 2006 |
| Trade Name: | TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System |
| Common Name: | Cutaneous Gas Monitor / Pulse Oximeter |
| Classification Name: | Monitor Carbon Dioxide Cutaneous (73LKD) / Oximeter (74DQA) |
| Substantially | TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System |

# Description of the TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System

510(k) Number: K043357

The TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCQ2, functional oxygen saturation SpO2 and pulse rate, using a single sensor (TOSCA Sensor).

The system consists of a TOSCA Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCQz part of the sensor and also provides a storage facility for the sensor, and with the Masimo SET signal extraction technology for the calculation of the functional oxygen saturation and the pulse rate ; a TOSCA Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximelty sensor; supplies for the sensor preparation; supplies for the sensor attachment to the patient, and a gas mixture for the sensor calibration.

With the new TOSCA Fixation Rings 32mm (subject of this new 510(k)), the TOSCA sensor may be battled to the forehead or the cheek, and to other conventional mesuring sites for the for the for the for the for treacurement only measurement only.

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#### Intended Use

The TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO2, functional oxygen saturation SpO2 and pulse rate in adults and pediatrics.

#### Principles of Operation

The TOSCA 500 System is used for the simultaneous continuous monitoring of transcutaneous PCO2 functional oxygen saturation SpO2 and pulse rate, using a single sensor (TOSCA Sensor) applied to the ear lobe, the forehead, the cheek or other measuring sites for toPCO2 measurement only.

Transcutaneous measurement of PCO2 makes use of the fact that carbon dioxide gas is able to diffuse through body tissue and skin and can be detected by a sensor at the skin surface. By warming up the sensor, a local hyperemia is induced, which increases the supply of arterial blood to the dermal capillary bed below the sensor. The PCO2 part of the TOSCA sensor consists of a Stow-Severinghaus type electrode. PCO2 is measured by determining the pH of an electrolyte solution. A change in pH is proportional to the logarithm of the PCO2 change. The pH is determined by measuring the potential between a miniaturized glass pH electrode and an Ag(AgCl reference electrode. The electrolyte is provided within a thin hydrophilic spacer, which is placed over the sensor surface and is coupled to the skin via a highly gas permeable hydrophobic membrane. The sensor is calibrated in a gas of a known CO2 concentration. The slope (change of potential with PCO2) is preset in the sensor memory.

The principle of the SpO2 measurement is based on the difference in the light absorption characteristics of haemoglobin in its oxygenated and reduced forms. The SpO2 part of the TOSCA sensor consists of two light emitting diodes, a red (660 nm) and an infrared (880 nm), and a photodiode. The light originating from the diodes passes through the capillary bed and is redirected to the photo-detector by a light reflecting material (attachment clip or ring at the ear lobe) or by an underlying bone (at the forehead or cheek). The light received by the photo detector is converted to electrical signals which are analyzed by the monitor. The signals containing pulsatile components which are caused by variations in blood volume synchronous with cardiac action reflecting inflowing arterial blood and fluctuating absorbance of venous blood due to patient motion are analysed with the Masimo SET Signal Extraction Technology incorporated in the TOSCA 500 Monitor. Because oxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET signal processing decomposes the red and infrared pulsatile absorbance signals into an arterial signal plus a noise component and calculates the ratio of the arterial signals without noise. The ratio of the two arterial pulse added absorbance signals and its value is used to find the SpO2 saturation in an empirically derived equation in the Masimo Set software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states.

#### Environmental Testing

Applicable environmental, electrical, EMC and mechanical Testing per Reviewers Guidance for Premarket Submissions - November 1993 were performed and the TOSCA 500 Monitoring System passed all tests.

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#### Biocompatibility Testing

All patient contact materials were tested as Surface Devices with skin contact for prolonged contact duration (24 hours to 30 days) as defined in ISO-10993-1:1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests. All patient contacting material passed.

#### Non clinical tests performed that support a determination of substantial equivalence

The TOSCA Monitoring System, with the TOSCA Sensor applied to the forehead and to the cheek with the new TOSCA Fixation Rings was subjected to testing in house on adults volunteers. The tcPCO2 values measured with the TOSCA System at the cheek using the new TOSCA Fixation Rings were compared to the values measured at the ear lobe using an Attachment Clip (validated with the predicate device by companison with arterial blood gas values). The results show that a good correlation exists between the values measured at the forehead and at the cheek and the values measured at the ear lobe.

#### Clinical tests performed that support a determination of substantial equivalence

Clinical studies using the TOSCA Monitoring System, with the TOSCA Sensor applied to the forehead and to the cheek with the new TOSCA Fixation Rings, were performed on healthy adults volunteers subjected to induced hypoxia.

The arterial hemoglobin saturation values measured with the TOSCA System were compared to the values determined from arterial blood samplings with a co-oximeter. The results show that the TOSCA System performs as intended and that the specified saturation accuracy is met.

The Pulse Rate values measured with the TOSCA System at the forehead and at the cheek were compared to the values measured at the ear lobe using an Attachment Clip (validated with the predicate device by comparison with the heart rate obtained by ECG). The results show that the TOSCA System performs as intended and that the specified Pulse Rate accuracy is met.

### Conclusion

The results of the environmental, bench and clinical testing demonstrate that the TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System and accessories are safe, effective and performs as well as the predicated device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jean-Pierre Palma CEO/Head of Mechanical Engineering /Regulatory Affairs Radiometer Basel AG Austrasse 25 4051 Basel SWITZERLAND JAN 2 2 2007

Re: K063434

Trade/Device Name: TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Codc: DQA, DPZ and LKD Dated: November 8, 2006 Received: November 13, 2006

Dear Mr. Palma:

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.

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Page 2 - Mr. Palma

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. 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):

Device Name: TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System

Indications For Use:

The TOSCA 500 Monitoring System is designed for the simultaneous continuous monitoring of transcutaneous PCO₂, functional oxygen saturation SpO₂ and Pulse Rate in adults and pediatrics.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Martin John

msu rapinlogy, General Hospilal

K06 3434

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