(8 days)
P810037
P810037
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not suggest the use of such technologies.
No.
The device measures partial pressures of oxygen and carbon dioxide but does not directly treat or provide therapy.
Yes
The device is intended to measure the partial pressure of oxygen and carbon dioxide, which are used to evaluate or determine a medical condition (respiratory status) of an infant. Therefore, it serves a diagnostic purpose.
No
The device description explicitly mentions a "sensor attached to the surface of the infant's skin," indicating a hardware component is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device measures the partial pressure of oxygen and carbon dioxide through the skin of an infant. This is a measurement taken directly from the living body, not from a sample of bodily fluid or tissue that has been removed from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The Linde Transcutaneous Monitor is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.
Product codes
73 KLK
Device Description
Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous layer of the skin
Indicated Patient Age Range
infant
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MicroGas 7650 is exactly the same device as the MicroGas 7650 distributed by Kontron Instruments under PMA P810037. Both devices are manufactured by Linde Medical Sensors AG of Basel, Switzerland.
Because there are no differences other than labeling between the Linde MicroGas 7650 and the Kontron MicroGas 7650, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to PMA number P810037 for this data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P810037
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2500 Cutaneous oxygen (PcO2) monitor.
(a)
Identification. A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control 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.
0
MAY 21 330
LINDE MEDICAL SENSORS AG
Linde
Appendix 4
510(k) Summary
MicroGas 7650 Transcutaneous Monitor - Summary of Safety and Effectiveness
Company:
| Address: | Linde Medical Sensors AG
Austrasse 25
4051 Basel - Switzerland |
|------------|----------------------------------------------------------------------|
| Telephone: | 011 41 61 278 82 07 |
| Telefax: | 011 41 61 278 81 81 |
Contact Person:
Jean-Pierre Palma (Regulatory Affairs)
Trade Name:
MicroGas 7650 Transcutaneous Monitor
Common Name:
Cutaneous Blood Gas Monitor
Intended Use:
The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.
Description of the Device:
Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.
Clinical and Non-Clinical Tests of Equivalency:
The MicroGas 7650 is exactly the same device as the MicroGas 7650 distributed by Kontron Instruments under PMA P810037. Both devices are manufactured by Linde Medical Sensors AG of Basel, Switzerland.
Because there are no differences other than labeling between the Linde MicroGas 7650 and the Kontron MicroGas 7650, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to PMA number P810037 for this data.
P.E.A.
Dr. Patrick Eberhard R&D Manager May 17, 1999
Austrasse 25
CH-4051 Basel
Telefon +41 (0)61 278 81 11
Telefax +41 (0)61 278 81 81
1
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing the head, body, and tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1999
Mr. Jean-Pierre Palma Linde Medical Sensors AG Austrasse 25 CH-4051 Basel SWITZERLAND
Re: K991644 MicroGas 7650 Transcutaneous Monitor Regulatory Class: II (two) Product Code: 73 KLK Dated: May 11, 1999 Received: May 13, 1999
Dear Mr. Palma:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Paqe 2 - Mr. Jean-Pierre Palma
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page ﻠﺴ of 1
510(k) Number (if known): K991644
Device Name: MicroGas 7650 Transcutaneous Monitor
Indications For Use:
The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arth. A. Liabosoli
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
Prescription Use \ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)