(172 days)
The Bard Coagulating Resector is indicated for resection and coagulation of soft tissue and is intended for use with compatible resectoscopes.
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.
This document is a 510(k) summary for the Bard Coagulating Resector, an electrosurgical electrode. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed statistical outcomes.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text because the document describes a regulatory submission for a medical device based on technological characteristics and intended use comparison to existing devices, not a clinical trial with performance metrics.
Specifically:
- A table of acceptance criteria and the reported device performance: Not available. The document provides a comparison of technological characteristics with predicate devices (Table VI.1) but does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance data from a clinical study.
- Sample size used for the test set and the data provenance: Not applicable, as no test set from a clinical study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable, as no test set is described.
- 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 device is a surgical electrode, not an AI-powered diagnostic tool, and no MRMC study or AI component is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical surgical tool, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no ground truth for performance evaluation is described.
- The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable, as there is no mention of a training set.
The provided text focuses on the device's description, intended use, and a comparison of its technological characteristics with predicate devices to demonstrate substantial equivalence, which is a common pathway for 510(k) clearance for medical devices without the need for extensive clinical performance studies.
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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.
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K9625-38 p202
Table VI.1 Comparison Summary of Technological Characteristics
| ComparisonTopic | Bard CoagulatingResector | Microvasive Wedge™ElectrosurgicalResection Device(Predicate Device) | CIRCON ACMIRight Angle CuttingLoop Electrode(Predicate Device) |
|---|---|---|---|
| IndicationsorIntended Use | (Indications)The Bard CoagulatingResector is indicatedfor resection andcoagulation of softtissue and is intendedfor use withcompatibleresectoscopes. | (Intended Use)Intended for cuttingand coagulation duringresection. To be usedwith compatibleresectoscopes. | (Intended Use)Intended for cutting(resection). To be usedwith compatibleresectoscopes. |
| ResectoscopeCompatibility | Examples ofresectoscopecompatibility includeCIRCON ACMI (bothUSA and Classicseries), Wolf, Storz(both Single andDouble stem), andOlympusresectoscope. | Models available forCIRCON ACMI USAseries and Storz (Singlestem) resectoscopes. | Fits compatibleCIRCON ACMIresectoscopes. |
| Electrode Tip | Metal loop. | Metal loop. | Wire loop. |
| BodyConstruction | Conductive wirejacketed with black(polymer) insulatortubing and furtherjacketed with distalstainless steel outershaft. | Conductive wirejacketed with polymerinsulator tubing. | Conductive wirejacketed with polymerinsulator tubing. |
| ProximalConstruction | Conductive contactcompatible withspecific resectoscopes. | Conductive contactcompatible withspecific resectoscopes. | Conductive contactcompatible withspecific resectoscopes. |
| Stabilizer | On applicable models. | On all models. | On all models. |
§ 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).