(48 days)
Not Found
No
The summary describes a standard electrosurgical electrode and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is intended to provide electrocautery, which is a therapeutic intervention using electricity to cauterize tissue.
No
The device description and intended use indicate it is an electrosurgical electrode for electrocautery, which is a therapeutic (treatment) function, not a diagnostic one.
No
The device description explicitly states it is a "reusable electrode," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocautery over a large surface" by practitioners. This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "reusable electrode for use in monopolar electrosurgical accessories." This is a surgical tool, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device is clearly intended for therapeutic use (electrocautery) during a surgical procedure.
N/A
Intended Use / Indications for Use
Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.
Product codes
Not Found
Device Description
The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
practitioners
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
510(k) Summary Fusion Medical Technologies, Inc. Ball Tip Electrode
MAY - 5 1997
| 1. | Sponsor: | Fusion Medical Technologies, Inc.
1615 Plymouth Street
Mountain View, CA 94043 |
| ---- | ---------- | -------------------------------------------------------------------------------------- |
|---|
Contact Person:
Debera Brown Vice President, Regulatory and Clinical Affairs
-
- Device Name:
.
- Device Name:
:
| Trade Name: | To Be Determined |
|---|---|
| Common/Usual Name: | Electrosurgical Electrode |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories |
-
Identification of the Predicate or Legally Marketed Devices to Which Equivalence 3. is being Claimed:
Electrosurgical Electrode by Premier Dental Products -
- Device Description:
The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories.
- Device Description:
-
ડ. Intended Use:
Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.
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- б. A Statement of How the Technological Characteristics of the Device Compare to Those of the Predicate or Legally Marketed Device.
| Parameter | Fusion Ball Tip Electrode | Premier Dental Electrode
K923332 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use by
practitioners in a manner
identical to similar
electrosurgical electrodes of
this type presently in
commercial distribution. It
is intended to provide
electrocautery over a large
surface. | Intended for use by
practitioners in a manner
identical to similar
electrosurgical electrodes of
this type presently in
commercial distribution. It
is intended for cutting and
coagulation of tissue. |
| Use Profile | Provided Sterile; reusable
after cleaning and autoclave
sterilization | Provided non-sterile; first
use and reuse after
autoclave or ETO
sterilization |
| Compatibility | Standard 3/32 inch (2.4
mm) shaft fits most
electrosurgery chucks and
pencils | 44 different configurations
provided, all standard 3/32
shaft to fit most
electrosurgery chucks and
pencils |
| Material Composition | Stainless Steel shank,
Polyphenylsulfone for
insulation, 99% Pure Silver
as electrode tip | Stainless Steel shank,
Korvex 4X Teflon TFE heat
shrinkable tubing, Type 304
stainless steel electrode tip |
| Sterilization | Provided sterile by gamma
irradiation for first use | Provided non-sterile, must
be sterilized by user before
first use |
| Biocompatibility | Materials used in other
medical devices; ISO
10993-1 | Materials used in other
devices |
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