(84 days)
Not Found
No
The summary describes a simple electrosurgical electrode and does not mention any AI or ML components or functionalities.
No
The device is an accessory to electrosurgical devices used for cutting tissue and controlling bleeding, rather than providing a therapeutic effect itself.
No
Explanation: The device is an electrosurgical electrode used to cut tissue and control bleeding, which are therapeutic functions, not diagnostic.
No
The device description clearly describes a physical electrosurgical electrode made of tungsten and stainless steel, covered with heat shrink tubing. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an electrosurgical electrode used to "cut tissue (dissection) and control bleeding for general, plastic, and reconstructive surgery." This describes a surgical tool used directly on a patient's tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description details a physical electrode designed to deliver electrical energy for surgical purposes. It does not describe any components or processes related to analyzing biological samples.
Therefore, the DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles are surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
Not Found
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K962544
SEP 2
510(k) Summary DSP Worldwide Snowden-Pencer Micro Diamond-Point™ Dissection Needles (per 21 CFR 807.92)
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- Date of Preparation: September 12, 1996
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- 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: 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
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- Identification of the predicate or legally marketed device(s) to which equivalence is being claimed:
Colorado MicroDissection Needle (K881763)
- Identification of the predicate or legally marketed device(s) to which equivalence is being claimed:
1
Q. 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.
- 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