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K Number
K233615
Device Name
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1
Manufacturer
Baisheng Medical Co., Ltd.
Date Cleared
2024-01-08

(56 days)

Product Code
GEI,ODR
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator. the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Device Description

Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a. GBS-Db 4030c. GBS-Db 4030. GBS-Db 4040c. GBS-Db 4040. GBS-Dm 1030bc. GBS-Db 1031bc. GBS-Dm 1030b. GBS-Db 1031b. GBS-Dm 1130bc. GBS-Db 1131bc. GBS-Dm 1130b. GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1130nc, GBS-Db 1131nc, GBS-Dm 1130n, GBS-Db 1131n, GBS-Dm 2030c, GBS-Db 2031c, GBS-Dm 2030, GBS-Db 2031, GBS-Dm 2130c, GBS-Dm 2130, GBS-Db 2131, GBS-Dm 3030c, GBS-Db 3031c, GBS-Dm 3030, GBS-Db 3031, GBS-Dm 3130, GBS-Db 3131, GBS-Dm 3130c, GBS-Db 3131c. GBS-Db 2131c)

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The text is a formal letter from the FDA regarding a 510(k) premarket notification for "Electrosurgical Pads," confirming substantial equivalence to legally marketed predicate devices. It discusses regulatory matters, such as general controls provisions, additional controls for Class II/III devices, and various regulations (Quality System regulation, MDR, etc.). The indications for use for the electrosurgical pads are also described.

There is no mention of:

  • A table of acceptance criteria or reported device performance.
  • Sample sizes for test sets or data provenance.
  • Number/qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for training sets.
  • How ground truth for training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

§ 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.