SKINNY,FRANSEEN,WESCOTT NEEDLES

K962907 · Baxter Healthcare Corp · KNW · Oct 23, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962907
• Device Name: SKINNY,FRANSEEN,WESCOTT NEEDLES
• Applicant: Baxter Healthcare Corp
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment.

Device Story

Fine needle aspiration (FNA) needle consists of cannula and stylet assembly with handle; used for manual insertion into soft tissues (breast, liver, kidney, pancreas, lung); facilitates aspiration of fluid containing cells for diagnostic analysis or treatment monitoring; operated by clinicians in clinical settings.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, hemolysis, and pyrogenicity. Materials found acceptable.

Technological Characteristics

Cannula and stylet assembly with handle. Materials evaluated per ISO 10993-1 for biocompatibility. Manual operation.

Indications for Use

Indicated for patients requiring soft tissue fluid/cell aspiration for diagnostic evaluation or treatment monitoring; applicable to breast, liver, kidney, pancreas, and lung tissues.

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 Skinny Chiba Needle
• Hart Enterprises, Inc. Soft Tissue Needles

Submission Summary (Full Text)

{0}

K962907

Surgical Group

OCT 23 1996

Baxter Healthcare Corporation

1500 Waukegan Road

McGaw Park, Illinois 60085 USA

847.473.1500

FAX: [phone]

# Baxter

## XII. SMDA REQUIREMENTS

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
### FINE NEEDLE ASPIRATION NEEDLE

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

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

**Telephone:** [phone]

**Date Summary Prepared:** July, 1996

**Common Name:** Fine Needle Aspiration Needle

**Classification:** Class II per 21CFR § 876.1075

**Predicate Devices:**
Baxter Skinny Chiba Needle
Hart Enterprises, Inc. Soft Tissue Needles

**Description:**
The FNA needles are comprised of a cannula and stylet assembly connected to a handle for ease of insertion into soft tissues of the body.

19

{1}

X962907

Surgical Group

Baxter Healthcare Corporation

1500 Waukegan Road

McGaw Park, Illinois 60085 USA

847.473.1500

FAX: [phone]

# Baxter

## XII. SMDA REQUIREMENTS (continued)

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FINE NEEDLE ASPIRATION NEEDLE

**Intended Use:**

FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment.

**Substantial Equivalence:**

The Baxter FNA Needles are substantially equivalent to Baxter’s Skinny Chiba Needles and to the Hart Enterprises Soft Tissue Biopsy Needle in that:

- the intended use is the same
- the performance attributes are the same

**Summary of testing:**

The materials used in the fabrication of the FNA needles are evaluated through biological qualification safety tests as outlined ISO 10993, Part 1 - “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were Cytotoxicity, Sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, Hemolysis, and Pyrogenicity as required. These materials meet the requirements of the guidance and found to be acceptable for the intended use.