The Linde 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 Linde TOSCA 500 Monitoring System is designed for the simultaneous continous monitoring of transcutaneous PCO2 functional oxygen saturation SpO2 and pulse rate, using a single sensor (Tosca Sensor) applied to the ear lobe.

The system consists of a Tosca Monitor equipped with an integrated calibration unit which allows a fully automatic calibration of the PCO2 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 oximetry sensor; supplies for the sensor preparation; supplies for the sensor attachment at the ear lobe; and a gas mixture for the sensor calibration.

AI/ML Overview

Here's an analysis of the provided text regarding the Linde TOSCA 500 Monitoring System, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the PCO2, SpO2, or Pulse Rate measurements. Instead, it makes general statements about the device's performance. The "Substantially Equivalent Device" (K032291) is referenced, implying that the acceptance criteria are likely aligned with the performance demonstrated by that predicate device. However, without access to the predicate device's documentation, specific numerical criteria cannot be extracted from this submission.

Measurement Type	Acceptance Criteria (Not explicitly stated in this document)	Reported Device Performance (as stated)
Transcutaneous PCO2	Implied to be comparable to predicate device performance.	"The results show that the TOSCA System performs as intended and that a good correlation exists between transcutaneous PCO2 and arterial blood gas values."
Functional SpO2	Implied to be comparable to predicate device performance.	"The results show that the TOSCA System performs as intended and that the specified saturation accuracy is met."
Pulse Rate	Implied to be comparable to predicate device performance.	(Not explicitly stated for pulse rate in the same detail as PCO2 and SpO2, but implied by the overall "performs as intended" statement.)

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

PCO2 Clinical Studies:
- Sample Size: Not explicitly stated. The text mentions "adults and infants."
- Data Provenance: Clinical comparative studies. The country of origin is not specified but is implicitly European given the submitter's address (Basel, Switzerland). It is a prospective study as it refers to "clinical comparative studies...were performed."
SpO2 Clinical Studies:
- Sample Size: Not explicitly stated. The text mentions "healthy adults volunteers."
- Data Provenance: Clinical studies. The country of origin is not specified but implicitly European. It is a prospective study as it refers to "clinical studies...were performed."
SpO2 Algorithm (Masimo SET):
- Sample Size: Not explicitly stated for specific a number, but generally mentioned as "healthy adult volunteers."
- Data Provenance: "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." The origin of this foundational data for Masimo SET is not specified by geographical location, but it underlies the SpO2 performance. This would be prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. For the PCO2 and SpO2 clinical studies, the ground truth was established by:

PCO2: Arterial blood gas values. These would typically be analyzed by trained laboratory personnel.
SpO2: Arterial blood samplings with a co-oximeter. These would also be analyzed by trained laboratory personnel.

The "experts" in this context would be the medical professionals (e.g., physicians, nurses, lab technicians) responsible for collecting and analyzing the arterial blood gas and co-oximetry data, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the PCO2 or SpO2 clinical studies. The ground truth (arterial blood gas and co-oximeter readings) are typically objective measurements from laboratory equipment, not subjective assessments requiring adjudication like image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was performed as this device is a monitoring system directly measuring physiological parameters, not an AI or CAD (Computer-Aided Detection/Diagnosis) system that assists human readers in interpreting complex data like medical images. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device's performance is effectively standalone. The clinical studies (comparing transcutaneous PCO2 to arterial blood gas, and TOSCA SpO2 to co-oximeter SpO2) are designed to assess the accuracy of the device's measurements directly against a gold standard, without human intervention in the device's measurement process itself. The "algorithm" for SpO2 (Masimo SET Signal Extraction Technology) is an integral part of the device's standalone operation.

7. The Type of Ground Truth Used

Transcutaneous PCO2: Arterial blood gas values. This is a recognized gold standard for measuring blood PCO2.
Functional Oxygen Saturation (SpO2): Arterial blood samplings with a co-oximeter. Co-oximetry is considered a gold standard for measuring arterial oxygen saturation.
Pulse Rate: Not explicitly detailed, but generally derived from the same optical sensor as SpO2, and the ground truth would typically be from an ECG or another validated pulse measurement method. The submission does not detail the pulse rate ground truth specifically but implies it performed as intended.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the TOSCA 500 itself in the machine learning sense. The Masimo SET technology, which is incorporated into the TOSCA 500, did use human blood studies to develop its look-up table and algorithms. For Masimo SET:

Sample Size: Not explicitly stated as a number, but generally mentioned as "healthy adult volunteers."
Data Provenance: "human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states."

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

For the foundational Masimo SET technology (which informs the SpO2 measurements of the TOSCA 500):

Ground Truth Establishment: "laboratory co-oximeter on healthy adult volunteers in induced hypoxia states." The co-oximeter measurements served as the ground truth against which the optical signals were correlated to develop the SpO2 look-up tables and algorithms.

Summary

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

K043357

LINDE MEDICAL SENSORS AG

Image /page/0/Picture/3 description: The image shows the word "Linde" in a stylized, cursive font. The "L" has a large, decorative swirl at the top, and the rest of the letters are connected in a flowing script. The word is in black and stands out against a white background.

510(k) Summary

Submitted by:	Linde Medical Sensors AGAustrasse 254051 Basel - SwitzerlandPhone: 011 41 61 278 82 07Fax: 011 41 61 278 81 81
Contact:	Jean-Pierre PalmaHead of Mechanical Engineering / Regulatory Affairs
Date Summary prepared:	October 20, 2004
Trade Name:	TOSCA 500 PCO2, SpO2 and Pulse Rate Monitoring System
Common Name:	Cutaneous Gas Monitor / Pulse Oximeter
Classification Name:	Monitor Carbon Dioxide Cutaneous (73LKD) / Oximeter (74DQA
Substantially Equivalent Device:	Tosca PCO2, SpO2 and Pulse Rate Monitoring System510(k) Number: K032291

Description of the TOSCA 500 PCO2, SpO2 and Pulse Rate Monitoring System

Intended Use

The Linde 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 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.

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

Transcutaneous measurement of PCO2 makes use of the fact that carbon dioxide gas is able to Transculanced medical one skin and can be detected by a sensor at the skin surface. By ulliuse through body trouc and allin and is induced, which increases the supply of arterial blood warming up the ochoor, a Usak of the sensor. The PCO2 part of the Tosca sensor consists of a to the deman capillary bod bolow the 60% is measured by determining the pH of an electrolyte Stow-Oc vehinghade type Sloothoodional to the logarithm of the PCO2 change. The pH is solution. A change in pr r is proponial to ween a miniaturized glass pH electrode and an Ag/AgCl delemined by modouning the povided within a thin hydrophilic spacer, which is placed over the sensor surface and is coupled to the skin via a highly gas permeable hydrophobic over the sensor sunded and 10 couple 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 The principle of the Open model 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 School online of two light originating from the diodes passes through the ear lobe and is redirected at the opposite side by a light reflecting material. 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.

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 500 Monitoring System was subjected to bench testing that determined the transcutaneous PCO2 performances according to IEC 60601-2-23 and IEC 60601-3-1.

The TOSCA 500 Monitoring System was subjected to bench testing using a simulator that determined the saturation and pulse rate performance accuracies under the ranges specified.

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

Clinical tests performed that support a determination of substantial equivalence

Clinical comparative studies between transcutaneous PCO2 and arterial blood gas values, using the TOSCA Monitoring System were performed on adults and infants. The results show that the TOSCA System performs as intended and that a good correlation exists between trancutaneous PCO2 and arterial blood qas values.

Clinical studies using the TOSCA Monitoring System were performed on healthy adults volunteers subjected to induced hypoxia measuring the arterial hemoglobin saturation values and comparing these values 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.

Conclusion

The results of the environmental, bench and clinical testing demonstrate that the TOSCA 500 PCO2 SpO2 and Pulse Rate Monitoring System and accessories are safe, effective and performs as well as the predicated device.

Austrasse 25 Teleton +41 1016 : 278 81 13 CH-4051 Base Telefax +41 (0)61 278 81 81

{3}------------------------------------------------

MAR 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jean-Pierre Palma Mr. Jour Prochanical Engineering/Regulatory Affairs Linde Medical Sensors AG Austrasse 25 Basel, 4051 SWITZERLAND

Re: K043357

R043337
Trade/Device Name: TOSCA 500 PCO2, SpO2 and Pulse Rate Monitoring System Regulation Number: 870.2710 Regulation Name: Ear Oximeter Regulatory Class: II Product Code: DPZ, LKD Dated: February 4, 2005 Received: February 7, 2005

Dear Mr. Palma:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your and have determined the device is substantially equivalent (for the fererenced above and have and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the Federal I 60a; Drag, Drag, therefore, market the device, subject to the general approvisions 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 (1 Writ), it may of 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.

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

Page 2 – Mr. Ferguson

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA $ Issualics of a substition of extent of ther requirements
mean that FDA has made a determination that your devices Federal agencies mean that FDA has made a decemination that your and inistered by other Federal agencies.
of the Act or any Federal statutes and regulations and mited to: registration of the Act or any Federal statues and reginations, but not limited to: registration
You must comply with all the Act's requirements, including, but not ice You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CPK Part 807), labelling (21 OFF Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 821); and if requirements as set form in the quality systems (Sections 531-542 of the Act);
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) I his letter will anow you to begin malies.ing your alence of your device to a
premarket notification. The FDA finding of substantial equivalence and this and premarket notification. The PDA maing of cases and the 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), If you desire specific atvice for your de need on the more in the regulation prease contact the Other or Comphanes and (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 Division of 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutie Michie md.

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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: TOSCA 500 PCO2, SpO2 and Pulse Rate Monitoring System

Indications For Use:

The Linde 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)

726-16727 con of Andrew : clogy, General Hospital, Insusion Contral, Denell Devices . 19(3) Number ___

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.