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K Number
K982743
Device Name
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-14

(39 days)

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

Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.

Device Description

Model SB 313 PB and SB 313 PBH Disposable Hand Switching Pencil, Push Button, One Piece Body. With and Without Holster

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a disposable hand switching pencil for electrosurgery. It is not a study and, therefore, does not contain information about acceptance criteria, device performance, ground truth, or study methodologies.

Here's why the requested information cannot be extracted from this document:

  • Nature of the Document: This is a regulatory approval letter based on "substantial equivalence" to a predicate device. It confirms the device can be legally marketed but does not provide the underlying performance data or study details that led to that determination.
  • Lack of Study Details: The letter explicitly states, "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the FDA compared the new device's characteristics (design, materials, indications for use) to a previously approved predicate device, not necessarily by conducting a new clinical study with specific acceptance criteria and performance metrics.
  • Focus on Equivalence: The primary purpose of a 510(k) submission is to demonstrate substantial equivalence, not to prove meeting specific performance criteria through a detailed clinical trial or rigorous AI validation study.

Therefore, I cannot provide any of the requested information (acceptance criteria table, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) because this document does not contain that type of technical performance and study data.

§ 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.