(37 days)
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No
The description focuses on the electrosurgical function and physical components, with no mention of AI or ML.
No
The device is used to conduct electrosurgical energy to tissue, which is a surgical tool, not a therapeutic device. It is meant to cut or coagulate tissue, not to treat a condition or disease.
No
Explanation: The device is described as an electrosurgical energy delivery device used for cutting or coagulation of tissue, operating with an electrosurgical unit or generator. Its function is therapeutic (delivering energy to tissue), not diagnostic (identifying or characterizing disease).
No
The device description explicitly details physical components such as a molded plastic housing, a mode switch, a cable, a plug, and an electrode. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's function is to "conduct monopolar electrosurgical energy... to the target tissue." This is a surgical tool used directly on the patient's body during a procedure.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device's purpose is to deliver energy for cutting or coagulating tissue.
Therefore, based on the provided information, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.
Product codes
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Device Description
This device has a molded plastic housing. The mode switch selects the appropriate electrosurgical function (CUT or COAG). Exiting the housing is a ten foot cable which has a standard 3-prong plug to connect to the generator. The electrode packaged with this pencil will be either a coated electrode or a regular bare electrode, and with or without a holster. TThis device is a single use, disposable. It is sold sterile.
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
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Key Metrics
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Predicate Device(s)
MegaDyne Medical Products, Inc pencils and electrodes, Valleylab pencils and electrodes, Conmed pencils and electrodes, E&M Engineering pencils
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
JAN 2 4 1997
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name/Address:
Drew D. Weaver Director of Regulatory Affairs MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Contact Person:
Same as above
Date Summary Prepared:
December 17, 1996
Device Name:
| Common Name: | Electrosurgical Device, Cutting and Coagulation & Accessories |
|---|---|
| Trade Name: | Not yet established |
| Classification (if known): | Class II, Tier II, 79GEI, General and Plastic Surgery, 21 CFR 878 4400 |
1
MegaDyne Medical Products, Inc. 510(k) Notification: Electrosurgical Device, Cutting and Coagulation & Accessories December 11, 1996 Page C.2
Predicate Devices:
MegaDyne Medical Products, Inc pencils and electrodes Valleylab pencils and electrodes Conmed pencils and electrodes E&M Engineering pencils
Applicant Device Description:
This device has a molded plastic housing. The mode switch selects the appropriate electrosurgical function (CUT or COAG). Exiting the housing is a ten foot cable which has a standard 3-prong plug to connect to the generator. The electrode packaged with this pencil will be either a coated electrode or a regular bare electrode, and with or without a holster. TThis device is a single use, disposable. lt is sold sterile.
Applicant Device Intended Use:
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.
Technological Characteristics:
This device is substantially equivalent in materials and operation to other pencils There are no new technological characteristics and already on the market. therefore no new questions of safety and effectiveness.
Performance Data:
MegaDyne voluntarily complies with ANSI/AAMI HF 18-1993