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 Description

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.

AI/ML Overview

Acceptance Criteria and Study for TOSCA 500 tcPCO2, SpO2 and Pulse Rate Monitoring System

Based on the provided text, the TOSCA 500 Monitoring System's acceptance criteria and the study proving its performance are focused on demonstrating substantial equivalence to a predicate device, particularly for the new fixation rings for forehead and cheek application. The document describes non-clinical and clinical tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "as intended" and meeting "specified accuracy," as well as "good correlation" with the predicate device.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
tcPCO2 Measurement (Forehead/Cheek)	Good correlation with predicate device (earlobe measurement).	"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." (Predicate device's earlobe tcPCO2 was validated against arterial blood gas values).
SpO2 Measurement (Forehead/Cheek)	Performs as intended and meets specified saturation accuracy.	"The results show that the TOSCA System performs as intended and that the specified saturation accuracy is met." (Compared to arterial blood samplings with a co-oximeter during induced hypoxia).
Pulse Rate Measurement (Forehead/Cheek)	Performs as intended and meets specified Pulse Rate accuracy.	"The results show that the TOSCA System performs as intended and that the specified Pulse Rate accuracy is met." (Compared to earlobe measurement of predicate device, which was validated against ECG heart rate).
Environmental, Electrical, EMC, Mechanical	Passed all applicable tests.	"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."
Biocompatibility	All patient contact materials pass for prolonged contact.	"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...All patient contacting material passed."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The exact number of "adult volunteers" for the non-clinical and clinical tests is not specified in the provided text. It simply states "on adults volunteers" and "healthy adults volunteers."
Data Provenance: The data for both non-clinical and clinical tests was generated prospectively in-house. The location is implied to be at Radiometer Basel AG, Switzerland, as the submission is from Basel and refers to "testing in house."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used or their qualifications for establishing ground truth.

For tcPCO2, the "predicate device by comparison with arterial blood gas values" implies a standard clinical method for ground truth, likely interpreted by medical professionals.
For SpO2, "arterial blood samplings with a co-oximeter" provides the ground truth, and co-oximetry is a standard laboratory method.
For Pulse Rate, "heart rate obtained by ECG" is the ground truth, a standard medical measurement.

While these methods represent established ground truths, the involvement of specific "experts" for adjudication or establishing ground truth related to the device's performance evaluation is not detailed.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned in the provided text for the test set results. The comparisons are made against established objective methods (arterial blood gas, co-oximeter, ECG), rather than subjective expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's performance against objective ground truths and a predicate device, not on human readers' improvement with or without AI assistance. The device is a monitoring system, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are essentially standalone performance evaluations. The TOSCA 500 Monitoring System's measurements (tcPCO2, SpO2, Pulse Rate) are directly compared to reference ground truth methods. There is no mention of a "human-in-the-loop" component to the device's measurement process itself; it's a device generating readings that are then used by practitioners.

7. The Type of Ground Truth Used

tcPCO2: Arterial blood gas values (indirectly, via validation of the predicate device's earlobe measurement).
SpO2: Laboratory co-oximeter measurements from arterial blood samplings.
Pulse Rate: Electrocardiogram (ECG) heart rate (indirectly, via validation of the predicate device's earlobe measurement).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. The TOSCA 500 system utilizes the "Masimo SET signal extraction technology" for SpO2 and pulse rate. The Masimo SET technology itself states that "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." This suggests that the Masimo SET algorithm was developed and validated on a dataset of healthy adult volunteers, but the size of that original dataset is not specified in this 510(k) summary. The current submission's studies serve as validation for the TOSCA 500 system incorporating this technology.

9. How the Ground Truth for the Training Set Was Established

For the Masimo SET technology incorporated into the device (which is where a "training set" might implicitly exist for its internal algorithms):

The ground truth for SpO2 was established by "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states."

For the specific TOSCA 500 studies (which are more akin to test sets given the focus on comparing to predicate/established methods):

Ground truth for these studies was established as described in point 7: arterial blood gas, co-oximeter, and ECG.

Summary

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K063434

LINDE MEDICAL SENSORS AG

Equivalent Device:

RADIOMETER COPENHAGEN

510(k) Summary

Submitted by:	Radiometer Basel AGAustrasse 254051 Basel - SwitzerlandPhone:011 41 61 278 82 07Fax:011 41 61 278 81 81
Contact:	Jean-Pierre PalmaCEO / 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).

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Page 1 of

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).