BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE

• K Number: K071745
• Device Name: BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
• Manufacturer: BAYLIS MEDICAL CO., INC.
• Date Cleared: 2007-07-19 ( 22 days)
• Product Code: GXI
• Regulation Number: 882.4725
• Type: Special
• Panel: NE
• Reference & Predicate Devices: K002389
• Predicate For: N/A

Intended Use

Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.

Device Description

The Baylis Pain Management Single-Use Probe is a sterile, single-use device that delivers Radiofrequency (RF) energy.

AI/ML Overview

The provided text is a 510(k) summary for the Baylis Pain Management Single-Use Probe. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested table and study details based on the input text. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Regulation Number and Section

§ 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).