(397 days)
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.
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.
The acceptance criteria and device performance are described in the "Clinical Testing" section ({1}).
1. Table of acceptance criteria and reported device performance:
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Testing Results | System meets performance requirements for PCO2, SpO2, and Pulse Rate. | "The results of the clinical testing demonstrate that the Tosca PCO2, SpO2and Pulse Rate Monitoring System and accessories meet the performance requirements." ({1}) |
| Overall Device Performance | Safe, effective, and performs as well as predicate devices. | "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." ({1}) |
The document does not explicitly list numerical acceptance criteria or detailed results from the clinical testing. It states a general conclusion that the device meets performance requirements.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text does not specify the sample size used for the clinical test set or the data provenance (country of origin, retrospective/prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This document describes a medical device for monitoring physiological parameters (PCO2, SpO2, Pulse Rate), not an AI-assisted diagnostic or interpretive tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the performance of the "Tosca PCO2, SpO2 and Pulse Rate Monitoring System" as a whole, which includes the sensor and monitor. This would be considered the standalone performance of the device itself for its intended function (continuous monitoring of PCO2, SpO2, and pulse rate). It's not an "algorithm only" study as it involves hardware and sensor technology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for the clinical testing. For physiological monitoring devices like this, ground truth would typically come from:
- Reference standard devices: Comparing the Tosca system's readings for PCO2, SpO2, and pulse rate against established, highly accurate reference measurement methods (e.g., arterial blood gas analysis for PCO2, CO-oximetry for SpO2, or ECG for pulse rate).
- Clinical observation: Assessing the device's ability to accurately reflect a patient's physiological state as determined by other clinical assessments.
Given the nature of the device, it's highly probable that a comparison against established reference methods was used, however, this is an inference, not explicitly stated.
8. The sample size for the training set:
This information is not provided in the document. The document describes clinical testing, implying validation or verification, rather than the development and training of a learning algorithm.
9. How the ground truth for the training set was established:
This information is not provided, as the document does not mention a "training set" in the context of machine learning or AI development.
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AUG 2 4 2004
Section 20 - 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 MechanicalEngineering/Regulatory Affairs |
| Date Summary Prepared: | July 18, 2003 |
| Trade Name: | Tosca PCO2, SpO2 and Pulse RateMonitoring System |
| Common/Classification Name: | Cutaneous Gas Monitor / PulseOximeterMonitor Carbon Dioxide Cutaneous(73LKD) / Oximeter (74DQA) |
| Substantially Equivalent Device: | MicroGas 7650 Transcutaneous Monitor(K003943)Kontron Pulse Oximeter 7840(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
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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.
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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.
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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 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
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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
§ 862.3320 Digoxin test system.
(a)
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.(b)
Classification. Class II.