(71 days)
The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.
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.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies. The document only describes a dermatome blade, its intended use, and claims equivalence to a predicate device.
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AUG 29 1996
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510(k) Summary DSP Worldwide Snowden-Pencer Dermatome Blade (per 21 CFR 807.92)
- Date of Preparation 1.
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
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- Contact Name
Timothy N. Thomas, Vice President, Regulatory Affairs and Quality Assurance DSP Worldwide Telephone: 508-677-6545
- Contact Name
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Device Name 4.
Trade/Proprietary Name: Dermatome blade Common/Usual Name: Padgett dermatome blade Classification Name: Accessory to Padgett Dermatome -
Identification of the predicate or legally marketed device(s) to which equivalence 5. is being claimed:
Padgett Dermatome Blades
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Device Description 6.
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.
- Comparison of Technological Characteristics 8.
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.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.