(154 days)
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.
Not Found
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:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: There is no mention of test sets, data, or their origin.
- 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.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
- If a standalone performance study was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- 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.
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November 23, 2022
Baisheng Medical Co., Ltd. Sylvia Dong Regulatory Affairs Specialist No.11, Fusheng Road, Xinhui District, Jiangmen, Guangdong, Jiangmen, 529100 China
Re: K221815
Trade/Device Name: Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-D1, OBS-Da) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 29, 2022 Received: September 30, 2022
Dear Sylvia Dong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) 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)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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.