DERMTOME BLADE

K962371 · Dsp Worldwide · GFD · Aug 29, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962371
• Device Name: DERMTOME BLADE
• Applicant: Dsp Worldwide
• Product Code: GFD · General, Plastic Surgery
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.

Device Story

Stainless steel blade; accessory to Padgett dermatomes; secures to dermatome head via nut; oscillates in horizontal plane to harvest split-thickness skin grafts; single-use; disposable; sterile; gamma-sterilized; used by surgeons in clinical/surgical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel construction; oscillating blade mechanism; single-size; gamma sterilization; Tyvek/polypropylene packaging.

Indications for Use

Indicated for use as an accessory to Padgett type dermatomes to harvest split-thickness skin grafts from donor sites.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Padgett Dermatome Blades

Submission Summary (Full Text)

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AUG 29 1996
K962371

# 510(k) Summary

## DSP Worldwide Snowden-Pencer Dermatome Blade
*(per 21 CFR 807.92)*

1. Date of Preparation
June 18, 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
Timothy N. Thomas, Vice President, Regulatory Affairs and Quality Assurance
DSP Worldwide
Telephone: [phone]

4. Device Name
Trade/Proprietary Name: Dermatome blade
Common/Usual Name: Padgett dermatome blade
Classification Name: Accessory to Padgett Dermatome

5. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed:
Padgett Dermatome Blades

DSP Worldwide Snowden-Pencer - Dermatome Blade 510(k) 6/18/96 Page D-1

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6. Device Description

The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization.

7. Intended Use

The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.

8. Comparison of Technological Characteristics

The DSP Worldwide Snowden-Pencer Dermatome Blade is equivalent to other currently marketed Padgett type dermatome blades in design, materials, operational characteristics, and sterility. Any difference between devices is minor and raises no new issues of safety and effectiveness.

DSP Worldwide Snowden-Pencer - Dermatome Blade 510(k) 6/18/96 Page D-2