TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

K032291 · Linde Medical Sensors AG · DOA · Aug 24, 2004 · Clinical Toxicology

Device Facts

• Record ID: K032291
• Device Name: TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
• Applicant: Linde Medical Sensors AG
• Product Code: DOA · Clinical Toxicology
• Decision Date: Aug 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Linde Tosca System provides continuous monitoring of transcutaneous PCO2, SpO2, and pulse rate. Device utilizes single ear-lobe sensor containing Stow-Severinghaus-type electrochemical electrode for PCO2 and optical pulse oximetry sensor for SpO2. PCO2 measurement involves sensor heating to induce local hyperemia, increasing arterial blood supply to dermal capillary bed. SpO2 measurement relies on differential light absorption of oxygenated vs. reduced hemoglobin. System includes monitor with integrated calibration unit, sensor, and gas mixture for calibration. Used in clinical settings; operated by healthcare professionals. Output provides real-time physiological data to assist clinicians in patient status assessment and decision-making.

Clinical Evidence

Clinical testing demonstrated that the Tosca system meets performance requirements for PCO2, SpO2, and pulse rate monitoring. Bench testing included electrical, mechanical, and EMC testing per IEC 60601 and biocompatibility testing per ISO-10993-1:1992 for prolonged skin contact (24 hours to 30 days). All tests passed.

Technological Characteristics

System uses Stow-Severinghaus-type electrochemical electrode for PCO2 and optical sensor for SpO2. Patient-contact materials tested per ISO-10993-1:1992. Integrated calibration unit provides automatic calibration. Form factor includes monitor and ear-lobe sensor. Connectivity/software details not specified beyond integrated monitor functionality.

Indications for Use

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

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• MicroGas 7650 Transcutaneous Monitor (K003943)
• Kontron Pulse Oximeter 7840 (K890299)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 2 4 2004

K032291

#### Section 20 - 510(k) Summary

| Submitted By: | Linde Medical Sensors AG<br>Austrasse 25<br>4051 Basel - Switzerland<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jean-Pierre Palma<br>Head of Mechanical<br>Engineering/Regulatory Affairs |
| Date Summary Prepared: | July 18, 2003 |
| Trade Name: | Tosca PCO2, SpO2 and Pulse Rate<br>Monitoring System |
| Common/Classification Name: | Cutaneous Gas Monitor / Pulse<br>Oximeter<br>Monitor Carbon Dioxide Cutaneous<br>(73LKD) / Oximeter (74DQA) |
| Substantially Equivalent Device: | MicroGas 7650 Transcutaneous Monitor<br>(K003943)<br>Kontron Pulse Oximeter 7840<br>(K890299) |

# Description of the Tosca PCO2, SpO2 and Pulse Rate Monitoring System

The Linde Tosca 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 system consist of a TOSCA Monitor equipped with an integrated calibration unit which allows a fully automatic calibration and also provides a storage facility for the sensor; a TOSCA Sensor comprising the elements of an electrochemical Stow-Severinghaus-type carbon dioxide sensor and of an optical pulse oximetry sensor; supplies for the sensor preparation; supplies for the sensor attachment at the ear lobe; and a gas mixture for the sensor calibration.

#### Intended Use

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

20-1 Linde Medical Sensors AG 510(k) Premarket Notification Tosca PCQ2, SpO2 and Pulse Rate Monitoring System July 18, 2003

{1}------------------------------------------------

# Principles of Operation

The Linde Tosca 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.

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 portion of the Tosca sensor consists of a Stow-Severinghaus type electrode.

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 monitor calculates the percentage of oxygen saturation, i.e., the ratio of oxygenated haemoglobin to total haemoglobin. It does this by measuring the absorption of selected wavelengths of light passing through a sample of living tissue, for example an ear lobe.

# Electrical, Mechanical and EMC Testing

Electrical, Mechanical and EMC Testing per IEC 60601 was performed and the Tosca Monitoring System passed all tests.

## 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.

## Clinical Testing

The results of the clinical testing demonstrate that the Tosca PCO2, SpO2and Pulse Rate Monitoring System and accessories meet the performance requirements.

## Conclusions

All test results demonstrate that the Tosca PCO2, SpO2 and Pulse Rate Monitoring System and accessories are safe, effective and performs as well as the predicated devices, the MicroGas 7650 Transcutaneous Monitor and the Kontron Pulse Oximeter 7840.

{2}------------------------------------------------

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human figures, possibly symbolizing health, services, and the human element of the department's mission. The text is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Mr. Jean-Pierre Palma Head of Mechanical Engineering/Regulatory Affairs Linde Medical Sensors AG Austrasse 25 CH-4051 Basel SWITZERLAND

Re: K032291

Trade/Device Name: TOSCA PCO2 SpO2 and Pulse Rate Monitoring System Regulation Number: 870.2700, 868.2480 Regulation Name: Oximeter Cutaneous Carbon Dioxide (PcCO2 Regulatory Class: II Product Code: DOA, LKD Dated: August 6, 2004 Received: August 9, 2004

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 equirements 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. 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 mean that 1471 may Federal statutes and regulations administered by other Federal agencies. of the Her of any reathan the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 ce return in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) rms letter notification. The FDA finding of substantial equivalence of your device to a premainted predicated. For 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), 11 you desire specific at 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 may obtain 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/dsma/dsmamain.html

Sincerely yours,

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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K032291

Device Name: TOSCA PCO2, SpO2 and Pulse Rate Monitoring System

Indications For Use:

The Linde TOSCA System is designed for the simultaneous continuous The Linde TOGOA Of transcutaneous PCO2, functional oxygen saturation SpO2 and Pulse Rate in adults and pediatrics.

× 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)

Clive Mason

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
K032291
510(k) Number:

Page 1 of