MICRO DIAMOND-POINT DISSECTION NEEDLES by DSP WORLDWIDE

The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are electrosurgical electrodes which are intended for use as accessories to electrosurgical devices to cut tissue (dissection) and control bleeding for general, plastic, and reconstructive surgery.

Device Description

The DSP Worldwide Suowden-Pencer Micro Diamond-Point™ Dissection Needles are inserted into the electrosurgical handpiece. As with all other electrosurgical electrodes, energy is applied to the tissuc with the highest concentration at the tip of the electrode. The Micro Diamond-Pointer Dissection Needles are provided in a variety of lengths and contigurations The electricie of a tungeten needlo rip inserted into a stainless steel sleeve. This needle assembly is then covered with two layers of heat shrink tubing for insulation. Micro Diamond-Point™ Dissection Needless are provided nonsterile, for single use only. Devices are provided three per package and require sterilization prior to use. Sterilization instructions are provided in device labeling.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) summary for a medical device (electrosurgical dissection needles) and primarily focuses on:

Device identification and contact information.
Device description and intended use.
Comparison to a predicate device to claim equivalence.

It does not include the kind of detailed study results or performance metrics you are asking for.

Summary

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K962544
SEP 2

510(k) Summary DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles (per 21 CFR 807.92)

1. Date of Preparation: September 12, 1996
1. Sponsor/Applicant : DSP Worldwide Snowden-Pencer 5175 South Royal Atlanta Drive Tucker, GA 30084

DSP Worldwide 600 Airport Road Fall River, MA 02720-4740

1. Contact Name: Mr. Timothy N. Thomas Vice President, Regulatory Affairs and Quality Assurance DSP Worldwide Telephone: 508-677-6545

Device Name:

Trade/Proprietary Name: Micro Diamond-Point™ Dissection Needles Common/Usual Name: Electrosurgical electrode Classification Name: Accessory to electrosurgical cutting and coagulation device

1. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed:
  Colorado MicroDissection Needle (K881763)

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Q. Device Description:

Intended Use:

The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are electrosurgical electrodes which are intended for use as accessories to electrosurgical devices to cut tissue (dissection) and control bleeding for general, plastic, and reconstructive surgery.

Comparison of Technological Characteristics:

The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are equivalent the Colorado MicroDissection Needles in design, materials, operational characteristics, and sterility. Any difference between devices is minor and raises no new issues of safety and offectiveness.

Addendum to K962544 ਰੇ। 19/96 Attachment 3 - Page 2 DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles

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.