Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)

• K Number: K221815
• Device Name: Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)
• Manufacturer: Baisheng Medical Co., Ltd.
• Date Cleared: 2022-11-23 ( 154 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dr, OBS-Di, OBS-De) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator. The device is disposable and supplied sterile with an electrode tip.

The Electrosurgical Pencil (OBS-Dt, OBS-Ds, OBS-Ds, OBS-Da) is used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with an electrosurgical generator, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Device Description

Not Found

AI/ML Overview

This FDA clearance document is for an Electrosurgical Pencil and does not contain information about acceptance criteria or a study proving device performance as typically expected for AI/ML-enabled devices. The document is a 510(k) clearance letter, which determines substantial equivalence to a predicate device, rather than providing detailed performance data derived from clinical studies with specific acceptance criteria that would typically be seen for a new technology or diagnostic AI/ML device.

Therefore, I cannot provide the requested information in the format given because the input document does not contain:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: There is no mention of test sets, data, or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of ground truth establishment.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone performance study was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on the regulatory clearance process for a medical device (electrosurgical pencil) based on substantial equivalence to existing products, rather than a detailed performance study for an AI/ML algorithm.

Regulation Number and Section

§ 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.