(120 days)
The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.
The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.
The TCM4/40 Monitoring Systems essentially consist in a monitor unit, a combined oxygen/carbon dioxide interface module along with the combined electrodes assembly and (for the TCM40 only) an oxygen saturation/pulse module with a selection of three sensors.
The provided 510(k) Premarket Notification for the Radiometer Copenhagen TCM4/40 Monitoring Systems does not contain a typical study with acceptance criteria and reported device performance in the way a clinical trial or algorithm performance study would.
Instead, the submission relies on compliance with established consensus standards for medical devices and existing predicate devices to demonstrate safety and effectiveness. Therefore, many of the requested data points (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training) are not applicable or explicitly stated in this type of submission.
Here's an attempt to answer your questions based only on the provided text, indicating when information is not present:
Acceptance Criteria and Study Details for Radiometer TCM4/40 Monitoring Systems
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are framed in terms of compliance with regulatory standards for medical devices. The "reported device performance" is implicitly that it meets the requirements of these standards.
| Acceptance Criteria (from Standards) | Reported Device Performance |
|---|---|
| IEC-60601-1:1988 (General safety) | Compliant |
| IEC-60601-1-2:2001 (EMC) | Compliant |
| IEC-60601-2-23:1999 (Transcutaneous monitoring safety and essential performance) | Compliant |
| IEC-60601-3-1:1996 (Transcutaneous O2/CO2 essential performance) | Compliant |
| EN-865:1997 (Pulse oximeter requirements) | Compliant |
| IEC-60601-1-8:2003 (Alarm systems) | Compliant |
2. Sample size used for the test set and the data provenance
Not applicable. No specific "test set" in the context of a clinical performance study with patient data is mentioned. The evaluation relies on compliance with standards. The document explicitly states: "Based upon the extensive use of consensus standards covering all aspects of safety and performance, no clinical evaluation was deemed necessary to assess the product performance levels."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described, as no clinical performance study was deemed necessary.
4. Adjudication method for the test set
Not applicable. No test set requiring expert adjudication is described.
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
Not applicable. This device is a monitoring system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device's monitoring capabilities. The "standalone" performance is established through its compliance with the listed consensus standards for transcutaneous oxygen/carbon dioxide monitoring and pulse oximetry. The exact performance metrics (e.g., accuracy, precision) as measured against these standards are not detailed in this summary, but the conclusion is that the device "performs up to the requirements of the relevant international consensus standards."
7. The type of ground truth used
For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's safety and effectiveness is the requirements specified within the cited international consensus standards. The device's design and testing were assessed against these established engineering and performance criteria.
8. The sample size for the training set
Not applicable. The device's technological characteristics are adaptations of existing, previously cleared devices (TCM400, TCM3, OxiMAX N-550). There's no mention of a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. No training set is described. The device's development appears to be based on established engineering principles and components from predicate devices, validated against consensus standards.
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510(k) Premarket Notification; TCM4/40; K043003
RADIOMETER COPENHAGEN
February 16, 2005
MAR ] - 2005
510(k) Summary - TCM4/40 Monitoring Systems
| Submitter: | Radiometer Medical ApS |
|---|---|
| Address: | Åkandevej 21, DK-2700 Brønshøj, Denmark |
| Phone: | +45 3827.3827 |
| Fax: | +45 3827.2736 |
| Contact Person: | Pierre Pelletier |
| Trade Name: | TCM4/40 Monitoring Systems |
|---|---|
| Common name: | Transcutaneous pO2/pCO2/SpO2/pulse monitoring system |
| Classification Names: | 21CFR§868.2500: Monitor, Oxygen, Cutaneous |
| 21CFR§868.2480: Monitor, Carbon Dioxide, Cutaneous | |
| 21CFR§870.2700: Oximeter | |
| Predicate Devices: | TCM400 Monitoring System |
| TCM3 Monitoring System | |
| OxiMAX N-550 Pulse Oximetry System | |
| TOSCA PCO2, SpO2 and Pulse Rate Monitoring System | |
| Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040) | |
| MicroGas 7650 Transcutaneous Monitor | |
| Siemens Transcutaneous TpO2/CO2 Gas Module |
Device Description
The TCM4/40 Monitoring Systems essentially consist in a monitor unit, a combined oxygen/carbon dioxide interface module along with the combined electrodes assembly and (for the TCM40 only) an oxygen saturation/pulse module with a selection of three sensors.
Intended use
The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.
The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia.
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RADIOMETER COPENHAGEN
February 16, 2005
Technological characteristics
The monitoring unit (including software, cabinet, touch screen, electronic controls, power supply and battery) is an adaptation of Radiometer's TCM400 Monitoring System, with only one combined tcp02/tcpCO2 electrode and (for the TCM40 only) one pulse/SoO2 sensor (the TCM400 has up to 6 separate tcg0> electrodes). The combined tcp02/tcpCO2 electrode is identical to the electrode used in Radiometer's previous generation TCM3 Monitoring System. The pulse/SpO2 sensors are identical to the sensors used with Puritan Nellcor Bennett's OxiMAX N-550 Pulse Oximetry System.
Safety and performance evaluation studies
In order to ensure TCM4/40 Monitoring Systems is safe and effective for its intended use, it has been designed and tested to the requirements of the following standards:
- . IEC-60601-1:1988 Medical electrical equipment - Part 1: General requirements for safety
- IEC-60601-1-2:2001 . Medical Electrical Equipment - Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC-60601-2-23:1999 . Medical electrical equipment - Part 2-23: Particular reguirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
- IEC-60601-3-1:1996 . Medical Electrical Equipment Part 3-1: Essential performance requirements for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
- EN-865:1997 . Pulse oximeters - Particular requirements
. IEC-60601-1-8:2003
Medical electrical equipment - Part 1-8: General requirements for safety Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems
Based upon the extensive use of consensus standards covering all aspects of safety and performance, no clinical evaluation was deemed necessary to assess the product performance levels.
Conclusions from safety and performance evaluation studies
Compliance with the requirements in the above-named safety and performance standards demonstrates that the TCM4/40 Monitoring Systems are state-of-the-art transcutaneous oxygen/carbon dioxide monitors and pulse oximeters that have the necessary safety mechanisms and performs up to the requirements of the relevant international consensus standards.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle's head and neck, rendered in black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle design. The text is in a sans-serif font and is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 - 2005
Mr. Pierre Pelletier Regulatory Affairs Manager Radiometer Medical ApS Åkandevej 21, Brønshøj Denmark DK-2700
Re: K043003
Trade/Device Name: TCM4/40 Monitoring Systems Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (PcCO2) Monitor Regulatory Class: II Product Code: LKD, LPP, KLK, DQA Dated: January 20, 2005 Received: January 24, 20045
Dear Mr. Pelletier:
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 Ecderal Register.
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Page 2 - Mr. Pelletier
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 vour 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-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
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 STATEMENT
510(k) Number (if known): K043003
TCM4/40 Monitoring Systems Device Name:
Indications for Use:
The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and The TCM4 Monitoring System is mended for continued for use on neonates, pediatrics, and adults not under gas anesthesia.
The TCM40 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide partial pressures as well as of oxygen saturation of arterial hemoglobin and pulse Carbon uloxide partial pressures as well as of thyger of the mot under gas anesthesia.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and the comments of the comments of the comments of the comments of the comments of the comments of
Cicia Fowler
sion Sign-O
son of Anesthesiology, General Hospital.
action Control. Dental Devices
in Number
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§ 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.