BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER

K962077 · C.R. Bard, Inc. · KNW · Jul 30, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962077
• Device Name: BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
• Applicant: C.R. Bard, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jul 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Device Story

Single-use, sterile, 2-part stainless steel cannula/stylet biopsy needle; spring-driven automatic mechanism. Used for percutaneous core tissue sampling of soft organs/tumors. Features modified angled distal sample notch to improve sample collection. Operated by clinicians during biopsy procedures. Output is a core tissue sample for diagnostic evaluation. Spacer component available for computed tomography guidance.

Clinical Evidence

Bench testing only. Comparison of sample quality between modified angled distal notch and standard radius distal notch showed no significant difference in tissue samples collected.

Technological Characteristics

Stainless steel 2-part cannula/stylet with plastic hubs; disposable; spring-driven automatic mechanism. Available in 12-20 gauge diameters and 10-30cm lengths. Features modified angled distal sample notch. Optional computed tomography spacer and etched tip. Sterile, non-pyrogenic.

Indications for Use

Indicated for percutaneous core biopsy of soft tissues including liver, kidney, prostate, spleen, lymph nodes, and soft tissue tumors. Contraindicated for use in bone.

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.

Predicate Devices

• Bard® Biopty-Cut® Biopsy Needle (K871390)
• Bard® Biopty-Cut® Biopsy Needle with Spacer (K910720)

Reference Devices

• Biopsy needles (K922939)

Submission Summary (Full Text)

{0}

K962077
JUL 30 1996
Bard Radiology Division
13183 Harland Dr., N.E.
Covington, GA 30209
BARD

# VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

## Submitter Information:

Submitter's Name: C. R. Bard, Inc., Radiology Division
Address: 13183 Harland Drive North East Covington, Georgia 30209
Phone Number: [phone] or 1-800-526-4455 extension 6411
Fax Number: [phone]
Contact Person: Carol Vierling
Contact Person's Address: 8195 Industrial Blvd. Covington, Georgia 30209
Date of Preparation: May 13, 1996

## Device Name:

Trade Name: Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Biopsy Needle with Spacer
Common/Usual Name: Biopsy Needle
Classification Name: Gastroenterology-urology biopsy instrument, needle

## Predicate Device Name:

Trade Name: Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Biopsy Needle with Spacer

## Device Description:

The Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Needle with Spacer are single-use biopsy needles.

## Intended Use:

The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

{1}

K962077

## Technological Characteristics Summary:

The Bard® Biopsy-Cut® Biopsy Needle and Bard® Biopsy-Cut® Needle with Spacer which are the subject of this Premarket Notification, have a modified sample notch. They are available in various gauges and lengths. The Bard® Biopsy-Cut® Needle with Spacer is packaged with a computed topography spacer.

## Performance Data Summary:

Testing confirms that the quality of the samples obtained with the modified notch needles are equivalent to the samples obtained from the standard sample notch needles.

51

{2}

# SECTION VI - TABLE 1
Characteristics of Equivalent Devices
Type of Instrument

| Characteristic | Bard® Biopsy-Cut® Biopsy Needle
510(k) #K871390 | CURRENT Bard® Biopsy-Cut® Needle with and without Spacer
510(k) #K910720 | PROPOSED Bard® Biopsy-Cut® Needle with and without Spacer |
| --- | --- | --- | --- |
| Indications for Use | Percutaneous biopsy of the liver, kidney, prostate, spleen, lymph nodes and different tumors. | Obtaining core biopsy, of various organs and tissues.¹ | Obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissues. It is not intended for use in bone.¹ |
| Needle Type | Sterile, non-pyrogenic, 2-part cannula/stylet, stainless steel with plastic hubs. | Sterile, non-pyrogenic, 2-part cannula/stylet, stainless steel with plastic hubs. | Sterile, non-pyrogenic, 2-part cannula/stylet, stainless steel with plastic hubs. |
| Reuse Status | Disposable, not intended for re-use. | Disposable, not intended for re-use. | Disposable, not intended for re-use. |
| Available Needle Diameters | 14,18, 20 gauge | 12,14,16,18,20 gauge | 12,14,16,18,20 gauge |
| Available Needle Lengths | 16, 20cm | 10, 16, 20cm (all gauges)
25, 30cm (16, 18 gauge) | 10, 16, 20cm (all gauges)
25, 30cm (16, 18 gauge) |
| Sample Notch Length | 17mm for 18 gauge
20mm for 14 gauge | 17mm² | 17mm for 12, 16, 18, 20 gauge
19mm for 14 gauge |
| Configuration of Sample Notch Ends | proximal = radius
distal = radius | proximal = radius
distal = radius | proximal = radius
distal³= angled |
| Centimeter Gradations on Cannula | None | Optional | Optional |
| Spacer Component | None | Optional | Optional |
| Etched Tip | None | Optional | Optional |

1. Indications for use were very general in #K910720. A subsequent 510(k) for biopsy needles, #K922939, included DFUs with more specific indications. These indications were used in the Biopsy-Cut Biopsy needle line.
2. #K910720 noted that the sample notch length was 17mm for all needles. It should have noted that the notch length is 17 or 19mm, depending on gauge size.
3. distal = angled is the only change proposed. Test results and report presented in Appendix B of this submission show no significant difference could be detected between the samples collected by a needle with an angled distal sample notch and samples collected by a needle with a radius distal sample notch.

Page 1 of 2

{3}

Page 2 of 2
K962077

# SECTION VI - TABLE 1
## Characteristics of Equivalent Devices
## Type of Instrument

| Characteristic | Bard® Biopsy-Cut® Biopsy Needle
510(k) #K871390 | CURRENT
Bard® Biopsy-Cut® Needle with and without Spacer
510(k) #K910720 | PROPOSED
Bard® Biopsy-Cut® Needle with and without Spacer |
| --- | --- | --- | --- |
| Number of Samples | 1 per fire | 1 per fire | 1 per fire |
| Mechanics of Action | Automatic, spring - driven | Automatic, spring - driven | Automatic, spring - driven |
| Mode of Action | Single puncture and sample | Single puncture and sample | Single puncture and sample |