(48 days)
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.
The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories.
This 510(k) premarket notification for the Fusion Ball Tip Electrode does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in the context of an AI/ML device. The provided text describes a medical device, specifically an electrosurgical electrode, and compares its technological characteristics to a predicate device for the purpose of demonstrating substantial equivalence.
Therefore, the following requested information cannot be extracted or inferred from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document focuses on technological characteristics for substantial equivalence, not performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is mentioned.
- The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is mentioned.
The document is a traditional 510(k) submission focused on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, indications for use, and material composition, rather than performance against specific acceptance criteria relevant to AI/ML or diagnostic performance.
{0}------------------------------------------------
510(k) Summary Fusion Medical Technologies, Inc. Ball Tip Electrode
MAY - 5 1997
| 1. | Sponsor: | Fusion Medical Technologies, Inc.1615 Plymouth StreetMountain 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 andAccessories |
-
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.
046
me
{1}------------------------------------------------
- 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 ElectrodeK923332 |
|---|---|---|
| Indications for Use | Intended for use bypractitioners in a manneridentical to similarelectrosurgical electrodes ofthis type presently incommercial distribution. Itis intended to provideelectrocautery over a largesurface. | Intended for use bypractitioners in a manneridentical to similarelectrosurgical electrodes ofthis type presently incommercial distribution. Itis intended for cutting andcoagulation of tissue. |
| Use Profile | Provided Sterile; reusableafter cleaning and autoclavesterilization | Provided non-sterile; firstuse and reuse afterautoclave or ETOsterilization |
| Compatibility | Standard 3/32 inch (2.4mm) shaft fits mostelectrosurgery chucks andpencils | 44 different configurationsprovided, all standard 3/32shaft to fit mostelectrosurgery chucks andpencils |
| Material Composition | Stainless Steel shank,Polyphenylsulfone forinsulation, 99% Pure Silveras electrode tip | Stainless Steel shank,Korvex 4X Teflon TFE heatshrinkable tubing, Type 304stainless steel electrode tip |
| Sterilization | Provided sterile by gammairradiation for first use | Provided non-sterile, mustbe sterilized by user beforefirst use |
| Biocompatibility | Materials used in othermedical devices; ISO10993-1 | Materials used in otherdevices |
047
§ 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.