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K Number
K972846
Device Name
BMC RF CANNULA
Manufacturer
BAYLIS MEDICAL CO., INC.
Date Cleared
1998-07-17

(350 days)

Product Code
GXI
Regulation Number
882.4725
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BMC RF Cannula is intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain.

Device Description

BMC RF Cannula

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for the BMC RF Cannula, indicating that the device is substantially equivalent to a predicate device for its stated indications for use in radio-frequency (RF) heat lesion procedures for pain relief.

Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

§ 882.4725 Radiofrequency lesion probe.

(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).