18 GAUGE TRU-CUT BIOPSY NEEDLE

K960509 · Baxter Healthcare Corp · KNW · Apr 4, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960509
• Device Name: 18 GAUGE TRU-CUT BIOPSY NEEDLE
• Applicant: Baxter Healthcare Corp
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Indications for Use

The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation.

Device Story

18 gauge Tru-Cut Biopsy Needle; consists of cannula and stylet assembly with handle; used for soft tissue biopsy (breast, lung, lymph node, prostate); manual operation by clinician; device facilitates tissue sample collection for diagnostic evaluation.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 including USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization tests.

Technological Characteristics

18 gauge needle; cannula and stylet assembly; manual operation; materials evaluated per ISO 10993-1 biocompatibility standards.

Indications for Use

Indicated for patients requiring soft tissue diagnostic evaluation, including breast, lung, lymph node, and prostate tissue sampling.

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

• Baxter 14 Gauge Tru-Cut Biopsy Needle

Submission Summary (Full Text)

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k960509

APR - 4 1996

Surgical Group

Baxter Healthcare Corporation

1500 Waukegan Road

McGaw Park, Illinois 60085 USA

847.473.1500

FAX: [phone]

A

# Baxter

APR - 4 1996

# XII. SMDA REQUIREMENTS

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 18 GAUGE TRU-CUT BIOPSY NEEDLE

Manufacturer: Baxter Healthcare Corporation
Surgical Group
400 East Foster Road
Mannford, OK 74044

Regulatory Affairs Contact: Sharon Richter
Surgical Group
1500 Waukegan Road MPK
McGaw Park, IL 60085

Telephone: [phone]

Date Summary Prepared: January, 1996

Common Name: 18 Gauge Tru-Cut Biopsy Needle

Classification: Class II per 21CFR § 876.1075

Predicate Device: Baxter 14 Gauge Tru-Cut Biopsy Needle

Description: The 18 gauge Tru-Cut Biopsy needle is comprised of a cannula and stylet assembly connected to a handle for ease of insertion into the soft tissue.

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# XII. SMDA REQUIREMENTS (continued)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## 18 GAUGE TRU-CUT BIOPSY NEEDLE

**Intended Use:**
The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation.

**Substantial Equivalence:**
The Baxter 18 gauge Tru-Cut Biopsy Needle is substantially equivalent to Baxter’s 14 gauge Tru-Cut Biopsy Needle in that:
- the intended use is the same
- the performance attributes are the same

**Summary of testing:**
All materials used in the fabrication of this 18 gauge Tru-Cut Biopsy Needle were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization as required. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.