(8 days)
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.
Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.
The provided document for K991644, the MicroGas 7650 Transcutaneous Monitor, does not include acceptance criteria or a study proving the device meets acceptance criteria.
Instead, the submission states:
- 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."
This means that the current K991644 submission obtained clearance based on substantial equivalence to a previously approved device (Kontron MicroGas 7650, PMA P810037) and did not present new performance data for acceptance criteria. To find the information requested, one would need to refer to PMA P810037.
Therefore, I cannot populate the table or answer the subsequent questions based on the provided text for K991644, as this information is explicitly stated to be in a separate, referenced document (PMA P810037).
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided in K991644.
- Sample size for test set and data provenance: Not provided in K991644.
- Number of experts and qualifications for ground truth: Not provided in K991644.
- Adjudication method for test set: Not provided in K991644.
- MRMC comparative effectiveness study: Not applicable/not provided as no new studies were conducted.
- Standalone performance study: Not applicable/not provided as no new studies were conducted.
- Type of ground truth used: Not provided in K991644.
- Sample size for training set: Not applicable/not provided as no new studies were conducted.
- How ground truth for training set was established: Not applicable/not provided as no new studies were conducted.
{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 AGAustrasse 254051 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)
§ 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.