(71 days)
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No
The device is a simple surgical blade accessory and the summary contains no mention of AI or ML.
No.
The device is a dermatome blade used for harvesting skin for grafting, which is a surgical procedure. While grafting can be part of a therapeutic process, the blade itself is a surgical instrument and not a device that directly performs a therapeutic function on its own.
No
Explanation: The device, a dermatome blade, is used to harvest skin for grafting. This is a surgical procedure, not a diagnostic one. It does not identify a disease, condition, or risk factor.
No
The device is a physical blade made of stainless steel, intended for use with a dermatome. It is described as a hardware accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to harvest a split thickness of skin from a donor site for grafting. This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body in vitro (outside the body).
- Device Description: The description details a surgical blade used with a dermatome, which is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.
Product codes (comma separated list FDA assigned to the subject device)
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Padgett Dermatome Blades
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
AUG 29 1996
f
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
-
- Contact Name
Timothy N. Thomas, Vice President, Regulatory Affairs and Quality Assurance DSP Worldwide Telephone: 508-677-6545
- Contact Name
-
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
1
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.