(106 days)
Baylis Pain Management Generator - TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.
The Baylis Pain Management Generator - TD is a modification of the previously 510(k) cleared Baylis Pain Management Generator -TD (510(k): K031950). The modification includes the addition of a multi-radiofrequency (Multi-RF) mode to create multiple lesions during neurological lesion procedures. The generator is used with its accessory, the Multi-RF cable that connects 1 to 4 radiofrequency probes to facilitate multiple monopolar RF lesions at a given time.
This document is a 510(k) summary for the Baylis Pain Management Generator - TD. It describes a modification to an already cleared device, primarily the addition of a multi-radiofrequency (Multi-RF) mode. The summary focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving performance against new acceptance criteria for the modified device.
Therefore, the provided text does not contain the information requested to fill out a table of acceptance criteria, reported device performance, details of a study with sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.
The 510(k) process for this device type typically relies on demonstrating that the modified device has the same intended use and fundamental scientific technology as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. Often, this is supported by bench testing and sometimes animal studies, but not necessarily by extensive human clinical trials with specific acceptance criteria that would generate the kind of data requested in your prompt.
Here's what can be extracted from the document:
- Device Name: Baylis Pain Management Generator - TD
- Modification: Addition of a multi-radiofrequency (Multi-RF) mode to create multiple lesions during neurological lesion procedures.
- Intended Use: To create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. (Identical to the predicate device).
- Predicate Device: Baylis Pain Management Generator - TD (K031950)
- Basis for Approval: Substantial equivalence to the predicate device, with the claim that the fundamental scientific technology is the same and the indications for use are identical.
The following information is NOT available in the provided text:
- A table of acceptance criteria and reported device performance.
- Details of a study proving the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number/qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance study.
- Type of ground truth used.
- How ground truth for a training set was established.
This is a common characteristic of 510(k) submissions for device modifications; the focus is on a comparison to an already approved device rather than a de novo demonstration of efficacy against novel criteria with new clinical studies.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.