(172 days)
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 "resection and coagulation of soft tissue," which are therapeutic actions.
No.
The device is used for resection and coagulation of soft tissue, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "monopolar electrode designed to deliver radio frequency energy," which is a hardware component.
Based on the provided information, the Bard Coagulating Resector is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resection and coagulation of soft tissue" within the body, used with resectoscopes. This is a surgical procedure performed in vivo (within a living organism).
- Device Description: It's a monopolar electrode delivering radio frequency energy for surgical purposes.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Bard Coagulating Resector does not involve the analysis of biological samples outside the body.
Therefore, the Bard Coagulating Resector is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bard Coagulating Resector is indicated for resection and coagulation of soft tissue and is intended for use with compatible resectoscopes.
Product codes
Not Found
Device Description
The Bard Coagulating Resector 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
soft tissue
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
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)
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
Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695
DEC 1 7 1996
K962538 P1022
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.
- A. Submitter's Information:
| 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: | June 25, 1996 |
- B. Device Name:
| Trade Name: | Bard Coagulating Resector |
|---|---|
| Common / Usual Name: | Electrode, Electrosurgical |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories |
- C. Predicate Device Name:
| Trade Name: | Microvasive® (Boston Scientific Corporation) |
|---|---|
| Wedge™ Electrosurgical Resection Device | |
| Trade Name: | CIRCON ACMI Right Angle Cutting Loop |
| Electrode |
-
Device Description: D.
The Bard Coagulating Resector is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrosurgical generator cleared for medical use. -
Intended Use: E.
480-06
The Bard Coagulating Resector is indicated for resection and coagulation of soft tissue and is intended for use with compatible resectoscopes.
- F. Technological Characteristics Summary:
Table VI.1 provides a tabulated comparison of the technological characteristics of the Bard Coagulating Resector versus the two predicate devices.
1
K9625-38 p202
Table VI.1 Comparison Summary of Technological Characteristics
| Comparison
Topic | Bard Coagulating
Resector | Microvasive Wedge™
Electrosurgical
Resection Device
(Predicate Device) | CIRCON ACMI
Right Angle Cutting
Loop Electrode
(Predicate Device) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Indications
or
Intended Use | (Indications)
The Bard Coagulating
Resector is indicated
for resection and
coagulation of soft
tissue and is intended
for use with
compatible
resectoscopes. | (Intended Use)
Intended for cutting
and coagulation during
resection. To be used
with compatible
resectoscopes. | (Intended Use)
Intended for cutting
(resection). To be used
with compatible
resectoscopes. |
| Resectoscope
Compatibility | Examples of
resectoscope
compatibility include
CIRCON ACMI (both
USA and Classic
series), Wolf, Storz
(both Single and
Double stem), and
Olympus
resectoscope. | Models available for
CIRCON ACMI USA
series and Storz (Single
stem) resectoscopes. | Fits compatible
CIRCON ACMI
resectoscopes. |
| Electrode Tip | Metal loop. | Metal loop. | Wire loop. |
| Body
Construction | Conductive wire
jacketed with black
(polymer) insulator
tubing and further
jacketed with distal
stainless steel outer
shaft. | Conductive wire
jacketed with polymer
insulator tubing. | Conductive wire
jacketed with polymer
insulator tubing. |
| Proximal
Construction | Conductive contact
compatible with
specific resectoscopes. | Conductive contact
compatible with
specific resectoscopes. | Conductive contact
compatible with
specific resectoscopes. |
| Stabilizer | On applicable models. | On all models. | On all models. |