(149 days)
Circon ACMI VaporTrode™
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No
The summary describes a simple monopolar electrode for delivering radio frequency energy, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended for "ablation and coagulation of soft tissue," which are therapeutic actions to treat medical conditions.
No
The provided text states that the device is indicated for ablation and coagulation of soft tissue, which are therapeutic procedures. It is not described as a device used to identify or determine the nature of a disease.
No
The device description clearly states it is a "monopolar electrode designed to deliver radio frequency energy," indicating it is a hardware component, not software.
Based on the provided information, the Bard V-Max24 Roller Bar is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ablation and coagulation of soft tissue," which is a surgical procedure performed directly on a patient's body.
- Device Description: It's described as a "monopolar electrode designed to deliver radio frequency energy," which is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Bard V-Max24 Roller Bar is a therapeutic device used during surgery.
N/A
Intended Use / Indications for Use
The Bard V-Max24 Roller Bar is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes.
Product codes
Not Found
Device Description
The Bard V-Max24 Roller Bar is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrosurgical generator cleared for medical use.
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
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
Not Found
Predicate Device(s)
Circon ACMI VaporTrode™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
OCT - 9 1996
102
Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695
K961841
BARD
SECTION VI
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Information: A.
| Submitter's Name: | C. R. Bard, Inc. |
|---|---|
| Address: | 8195 Industrial Boulevard |
| Covington, Georgia 30209 | |
| Contact Person: | Evans Yi-Wen Wuu |
| Contact Person's Phone: | (770) 784-6946 |
| Contact Person's Fax: | (770) 784-6419 |
| Date of Preparation: | May 7, 1996 |
B. Device Name:
| Trade Name: | Bard V-Max²⁴ Roller Bar |
|---|---|
| Common / Usual Name: | Electrode, Electrosurgical |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
-
C. Predicate Device Name:
Trade Name: Circon ACMI VaporTrode™ -
D. Device Description:
The Bard V-Max24 Roller Bar is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrosurgical generator cleared for medical use.
E. Intended Use:
The Bard V-Max24 Roller Bar is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes.
1
F. Technological Characteristics Summary:
Table VI.1 provides a tabulated comparison of the technological characteristics of the Bard V-Max24 Roller Bar versus the predicate device.
2 : 72
| Table VI.1: Comparison Summary of Technological Characteristics | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------------------------------------------- |
| Comparison Topic | Bard V-Max24 Roller Bar | Circon ACMI VaporTrode
(Predicate Device) |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Indications
or
Intended Use | (Indications)
The Bard V-Max24 Roller Bar is
indicated for ablation and
coagulation of soft tissue and is
intended for use with
compatible resectoscopes. | (Intended Use)
Used with compatible
resectoscopes for vaporization
and coagulation of tissue. |
| Resectoscope
Compatibility | Examples of resectoscope
compatibility include Circon
ACMI (both USA and Classic
series), Wolf, Storz and
Olympus resectoscope. | Models available for Circon
ACMI (both USA and Classic
series) resectoscope. |
| Electrode Tip | Surface finished (smooth,
grooved, etc.) metal roller. | Grooved metal roller. |
| Body
Construction | Conductive wire jacketed with
polymer insulator tubing and
further jacketed with distal
stainless steel outer shaft. | Conductive wire jacketed with
polymer insulator tubing and
further jacketed with distal
stainless steel outer shaft. |
| Proximal
Construction | Conductive contact compatible
with specific resectoscopes. | Conductive contact compatible
with specific resectoscopes. |
| Stabilizer | On applicable models. | On both models. |