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K Number
K101372
Device Name
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
Manufacturer
BAYLIS MEDICAL CO., INC.
Date Cleared
2010-08-10

(85 days)

Product Code
GXI
Regulation Number
882.4725
Type
Special
Panel
NE
Reference & Predicate Devices
K092337
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The DuoCool Pain Management Probe (probe model number: OSP-17-180-20; kit model number: OSK-17-180-20) is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

Device Description

The DuoCool Pain Management Probe is a sterile, single-use probe used to deliver Radio-Frequency (RF) energy while being cooled.

AI/ML Overview

This document is a 510(k) summary for the DuoCool Pain Management Probe. It establishes substantial equivalence to a predicate device and does not contain acceptance criteria or study results that demonstrate the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence rather than detailed performance study data against acceptance criteria.

§ 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).