MICROGAS 7650 TRANSCUTANEOUS MONITOR

• K Number: K991644
• Device Name: MICROGAS 7650 TRANSCUTANEOUS MONITOR
• Manufacturer: LINDE MEDICAL SENSORS AG
• Date Cleared: 1999-05-21 ( 8 days)
• Product Code: KLK
• Regulation Number: 868.2500
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A

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.

Device Description

Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.

AI/ML Overview

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:

1. Table of acceptance criteria and reported device performance: Not provided in K991644.
2. Sample size for test set and data provenance: Not provided in K991644.
3. Number of experts and qualifications for ground truth: Not provided in K991644.
4. Adjudication method for test set: Not provided in K991644.
5. MRMC comparative effectiveness study: Not applicable/not provided as no new studies were conducted.
6. Standalone performance study: Not applicable/not provided as no new studies were conducted.
7. Type of ground truth used: Not provided in K991644.
8. Sample size for training set: Not applicable/not provided as no new studies were conducted.
9. How ground truth for training set was established: Not applicable/not provided as no new studies were conducted.

Regulation Number and Section

§ 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.