SURE CORE BIOPSY KIT

K963813 · Interventional Concepts, Inc. · KNW · Mar 20, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963813
• Device Name: SURE CORE BIOPSY KIT
• Applicant: Interventional Concepts, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Mar 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Indications for Use

The Sure-Core Biopsy Electrode is both a manual core cutting device and a monopolar electrosurgical device that is used to cut soft tissue for the purpose of obtaining a biopsy sample.

Device Story

Sure-Core Biopsy Electrode Kit includes locator needle, locator wire, soft tissue dilator, and monopolar electrosurgical core cutting electrode. Device used by physicians in surgical procedures to obtain soft tissue biopsy samples. Manual core cutting via distal stainless steel blade; monopolar electrosurgical wire used to sever/detach core sample from surrounding tissue. Physician-controlled operation. Benefits include improved core detachment compared to manual-only biopsy devices.

Clinical Evidence

No clinical data provided; safety and effectiveness based on design and intended use equivalence to existing biopsy and electrosurgical devices.

Technological Characteristics

Components: locator needle, locator wire, soft tissue dilator, monopolar electrosurgical electrode. Distal tip: stainless steel cutting blade. Energy source: monopolar electrosurgical generator. Manual operation.

Indications for Use

Indicated for obtaining soft tissue core biopsy samples.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Reference Devices

• ABBI (Advanced Breast Biopsy Instrumentation)
• Aaron Medical monopolar electrosurgical electrodes
• Unimed Surgical monopolar electrosurgical electrodes
• Weck monopolar electrosurgical electrodes

Submission Summary (Full Text)

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Interventional Concepts, Inc.

MAR 20 1997 K963813

# 510(K) SAFETY AND EFFECTIVENESS SUMMARY

Date: September 20, 1996

Prepared By: William McPherson

Common/Ususal Name: Monopolar Electrosurgical Electrode

Proprietary Name: Sure Core Biopsy Electrode

Classification: Class II

Description: The Sure-Core Biopsy Electrode Kit consists of four components: a locator needle, a locator wire, a soft tissue dilator, and the Sure-Core electrosurgical core cutting electrode. The Sure Core Biopsy Electrode is both a manual core cutting device and a monopolar electrosurgical device that is used to cut soft tissue for the purpose of obtaining a biopsy sample. The distal tip is a sharp stainless steel cutting blade which cores the tissue distal to the end of the dilator. The most difficult aspect of obtaining a true core biopsy is the detachment of the core from the remaining tissue. The Sure-Core Biopsy Electrode overcomes this obstacle by means of a monopolar electrosurgical wire. The electrosurgical wire cuts the tissue perpendicular to the distal blade.

Substantial Equivalence: The Sure Core Biopsy Electrode and accessory items are substantially equivalent to numerous currently marketed soft tissue biopsy devices in both design features and intended use. The Sure Core Biopsy Electrode has similar design features as the needle assembly for the ABBI (Advanced Breast Biopsy Instrumentation) except that the ABBI is computer controlled and the Sure Core Biopsy Electrode is a physician controlled surgical procedure. In addition, the Sure Core Biopsy Electrode is a monopolar electrosurgical electrode. The core tissue sample is detached or severed from the remaining tissue by activation of this feature. Again, numerous monopolar electrosurgical electrodes are currently marketed by Aaron Medical, Unimed Surgical, and Weck for cutting and coagulation of soft tissue.

Conclusion: The Sure Core Biopsy Electrode Kit and asseccory components are safe and effective for the intended purpose of obtaining soft tissue core biopsy samples.

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