BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)

K962425 · Radi Medical Systems AB · GAA · Sep 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962425
• Device Name: BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
• Applicant: Radi Medical Systems AB
• Product Code: GAA · General, Plastic Surgery
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is indicated for use for biopsy of bone lesions.

Device Story

Coaxial bone biopsy system; consists of cannula with sharp cutting edge and eccentric drill bit. Drill tip protrudes beyond cannula; eccentric design forces drill to wobble during rotation, creating hole larger than cannula outer diameter. Facilitates advancement of cannula into bone; cannula remains as fixed guiding path after drill removal. Allows multiple sampling or treatment access without repeated CT localization. Used in clinical settings by physicians; manual operation. Benefits: simplified biopsy procedure; reduced need for repeated imaging.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: brass, solder, biocompatible components. Design: coaxial cannula (14G/15G) and eccentric drill bit. Manual operation; no energy source. Non-sterile/sterile status not specified.

Indications for Use

Indicated for patients requiring biopsy of bone lesions.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Angiomed Osty-Cut Bone Biopsy Needle

Submission Summary (Full Text)

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RADI MEDICAL SYSTEMS
K962425
SEP 11 1996
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: Radi Medical Systems AB
Address: Palmbladsgatan 10
S-754 50 Uppsala, Sweden
Phone: [phone]
Fax: [phone]
Contact Person: Per Egnelöv
Date of Preparation: June 11, 1996

B. Device Name:

Trade Name: Bonopty™ Coaxial Bone Biopsy Syswith Eccentric Drill
Common Name: Bone biopsy system
Classification Names: Set, biopsy needle and needle, gastro-urology

C. Predicate Device Names:

Trade Names: Angiomed Osty-Cut Bone Biopsy Needle

D. Device Description:

The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a cannula with a sharp cutting edge and a drill bit (drill) that fits into the cannula. When the biopsy system is assembled, the tip of the drill protrudes beyond the cutting edge of the cannula. The distal tip of the drill has two cutters which do not align with the center line of the drill, as would a conventional drill. During drilling, the eccentric drill tip functions like a guide and forces the drill to wobble in the hole, with the drill tip as a center of rotation. Therefore, the hole created is larger than the outer diameter of the cannula of the needle assembly thus making it easy to advance the cannula over the drill until the cannula is anchored in the bone. Then the drill can be removed and the cannula left in the bone, mounted as a fixed guiding path to facilitate sampling with different biopsy needles or to allow further treatment, without the need to obtain localizing CT scans for each biopsy.

VI.1

RADI MEDICAL SYSTEMS AB
Palmbladsgatan 10
Skandinaviska Forskilda

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RADI MEDICAL SYSTEMS

The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a Penetration Set, a Biopsy Set and an optional Extended Drill.

The Penetration Set consists of one Penetration Cannula with stylet (OD 14G, ID 15G, Length 95mm), one Drill (OD 15G, Length 122mm), one Depth Gauge (adjustable length) and one Reference Guide.

The Biopsy Set consists of one Biopsy Cannula with Stylet (OD 15G, ID 18G, Length 160mm), one Ejector Pin, one Depth Gauge (adjustable length) and one Reference Guide.

The Extended Drill (OD 15G, ID 18G, Length 160mm) is optional.

E. Intended Use:

The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is indicated for use for biopsy of bone lesions.

F. Technical Characteristics:

The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is situated of biocompatible materials. Most of the materials used in the construction are typical for similar accessories. These include brass and solder.

VI.

Address

Telefon/ Telephone

Telefax

Telex

Bank

Bankgiro/ Banking account

Postgiro/ Postal account

RADI MEDICAL SYSTEMS AB