MICRO DIAMOND-POINT DISSECTION NEEDLES

K962544 · Dsp Worldwide · JOS · Sep 20, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962544
• Device Name: MICRO DIAMOND-POINT DISSECTION NEEDLES
• Applicant: Dsp Worldwide
• Product Code: JOS · General, Plastic Surgery
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Electrosurgical accessory; tungsten needle tip in stainless steel sleeve; heat shrink tubing insulation. Inserted into electrosurgical handpiece; energy applied to tissue via needle tip for cutting and coagulation. Used in general, plastic, and reconstructive surgery. Operated by surgeons. Provided nonsterile; requires user sterilization. Single-use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tungsten needle tip; stainless steel sleeve; heat shrink tubing insulation. Electrosurgical energy source. Various lengths/configurations. Nonsterile; requires user sterilization.

Indications for Use

Indicated for use in general, plastic, and reconstructive surgery for tissue cutting (dissection) and hemostasis (bleeding control) via electrosurgical devices.

Regulatory Classification

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.

Predicate Devices

• Colorado MicroDissection Needle (K881763)

Submission Summary (Full Text)

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K962544 SEP 20 1996

# 510(k) Summary

## DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles

### (per 21 CFR 807.92)

1. Date of Preparation: September 12, 1996

2. Sponsor/Applicant:
DSP Worldwide Snowden-Pencer
5175 South Royal Atlanta Drive
Tucker, GA 30084

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

3. Contact Name:
Mr. Timothy N. Thomas
Vice President, Regulatory Affairs and Quality Assurance
DSP Worldwide
Telephone: [phone]

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

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

Addendum to K962544 9/12/96 Attachment 3 - Page 1
DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles

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508-643-2217 MED.DEV. CONSULTANTS
625 P04/04 SEP 19 '96 15:24

6. Device Description:

The DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are inserted into the electrosurgical handpiece. As with all other electrosurgical electrodes, energy is applied to the tissue with the highest concentration at the tip of the electrode. The Micro Diamond-Point™ Dissection Needles are provided in a variety of lengths and configurations. The electrode consists of a tungsten needle tip 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.

7. 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.

8. 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 effectiveness.

Addendum to K962544 9/19/96 Attachment 3 - Page 2
DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles