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K Number
K982744
Device Name
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH AND WITHOUT HOLSTER, MODELS SB 312PB, SB 312 PBH
Manufacturer
NEW DEANTRONICS TAIWAN, LTD.
Date Cleared
1998-09-11

(36 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 the survey of the comments of and stricel overant Electrosurgicul accousery. Thanks of high-frequency electrical current.

Device Description

Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a medical device: "New Deantronics Taiwan, Limited Model SB 312 PB and SB 32 PBH Disposable Hand Switching Pencil, Push Button, Two Piece Body, With and Without Holster."

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/ML device submission would. This is a traditional medical device submission from 1998, and the FDA's review process at that time, and for this type of device, focused on "substantial equivalence" to a predicate device, rather than detailed performance metrics and studies as might be found for more complex or novel technologies today.

Therefore, I cannot provide the requested information. The document 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 (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
  • "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the primary "acceptance criterion" was substantial equivalence, which is a regulatory standard, not a performance metric defined by a specific study with statistical endpoints. There's no mention of performance studies, sample sizes, experts for ground truth, or MRMC studies in this document.

§ 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.