BIOPSY INTRODUCER NEEDLE

K963390 · Baxter Healthcare Corp · KNW · Oct 10, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963390
• Device Name: BIOPSY INTRODUCER NEEDLE
• Applicant: Baxter Healthcare Corp
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Biopsy Introducer Needles are devices that are used to guide procedural biopsy needles coaxially to the location of tissue masses or lesions located throughout the body.

Device Story

Biopsy introducer needle; used to guide procedural biopsy needles coaxially to tissue masses or lesions. Operated by clinicians in clinical settings. Facilitates accurate placement of biopsy needles to target sites; aids in tissue sampling procedures.

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

Coaxial needle design. Materials evaluated per ISO 10993-1 standards for biological safety.

Indications for Use

Indicated for guiding procedural biopsy needles coaxially to tissue masses or lesions throughout the body in patients requiring biopsy procedures.

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® TruGuide® Coaxial Needle

Submission Summary (Full Text)

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Surgical Group
Baxter Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085 USA
847.473.1500
FAX: [phone]
OCT 10 1996

# Baxter

## XII. SMDA REQUIREMENTS (continued)

K963390

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
### BIOPSY INTRODUCER NEEDLE

**Intended Use:**
Biopsy Introducer Needles are devices that are used to guide procedural biopsy needles coaxially to the location of tissue masses or lesions located throughout the body.

**Substantial Equivalence:**
The Baxter Biopsy Introducer Needle is substantially equivalent to the Bard® TruGuide® Coaxial Needle predicate device 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 Biopsy Introducer Needles were evaluated through appropriate biological qualification safety tests as identified in 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 tests and are found to be acceptable for the intended use.

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