WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE

K961897 · Wilson-Cook Medical, Inc. · FCG · Jan 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K961897
• Device Name: WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jan 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle is used for aspiration biopsy in the biliary system, and if desired for the introduction of other biopsy instruments.

Device Story

Device consists of double lumen tubing, 22 gauge needle, and proximal hubs; designed for insertion through endoscope accessory channel over .035” wire guide. Operates by positioning side ramp below biopsy site; needle advanced to aspirate cells via 20 cc syringe. Needle removable post-aspiration, allowing inner catheter to remain for introduction of secondary biopsy instruments. Used by physicians in clinical settings during endoscopic procedures. Benefits include dual-functionality for aspiration and subsequent instrument delivery.

Clinical Evidence

Bench testing only. Samples subjected to visual, dimensional, and functional analysis per internal standard operating procedures. All samples met test specifications. No clinical data provided.

Technological Characteristics

Materials: Polytetrafluoroethylene (PTFE) catheter, 304 stainless steel needle. Dimensions: 200 cm length, 10 French introduction catheter, 6 French tip, 5 French inner catheter. 22 gauge needle. 2-lumen design. Sterilization: Ethylene Oxide (EO) validated to SAL 10⁻⁶.

Indications for Use

Indicated for patients requiring aspiration biopsy within the biliary system.

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

• Wilson-Cook Biliary and Gastric Aspiration Needle (K895900)

Submission Summary (Full Text)

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Page 12 of 14
JAN 29 1997
K961897
P1072

# RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK BILIARY INTRODUCER with ASPIRATION BIOPSY NEEDLE

## J. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitted By:

Wilson-Cook Medical Inc.
4900 Bethania Station Road
Winston-Salem, NC 27105

### Device Description:

The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle consists of double lumen tubing, a 22 gauge needle and proximal hubs. This device is designed for insertion through the accessory channel of an endoscope, and may be placed over a previously positioned .035” wire guide. The catheter is advanced through the accessory channel, positioning the side ramp below the biopsy site. The needle is advanced and cells are aspirated using a 20 cc syringe. After cell collection, if desired, the needle can be removed, leaving the inner catheter in place for the introduction of other conventional biopsy instruments.

**Trade Name:** Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle
**Common/Usual Name:** Aspiration Biopsy Needle
**Classification Name:** Set, Biopsy Needle and Needle, Gastro-Urology 78FCG
**Classification:** FDA has classified similar devices as Class II, per 21 CFR § 876.1075. This device falls within the purview of the Gastroenterology and Urology Devices Panel.

**Performance Standards:** To the best of our knowledge, performance standards for this device do not exist.

**Sterility:** Validated EO cycle, following the AAMI Overkill Method to SAL 10⁻⁶.

### Intended Use:

The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle is used for aspiration biopsy in the biliary system, and if desired for the introduction of other biopsy instruments.

### Predicate Device:

| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL NUMBER |
| --- | --- | --- |
| Wilson-Cook Biliary and Gastric Aspiration Needle | Wilson-Cook Medical Inc. | K895900 |

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K961897
P292

# RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK BILIARY INTRODUCER with ASPIRATION BIOPSY NEEDLE

## J. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

| DEVICE CHARACTERISTIC | WILSON-COOK BILIARY INTRODUCER with ASPIRATION BIOPSY NEEDLE [Subject of 510(K)] | WILSON-COOK BILIARY & GASTRIC ASPIRATION NEEDLES (K895900) |
| --- | --- | --- |
| Intended Use | Needle aspiration biopsy in the biliary system and if desired introduction of biopsy instruments. | Needle aspiration biopsy in the biliary system. |
| Introducer Catheter/Sheath | Polytetrafluoroethylene | Polytetrafluoroethylene |
| Needle | 304 Stainless Steel | 304 Stainless Steel |
| French Size | Introduction Catheter: 10 French
Introduction Catheter Tip: 6 French
Inner Catheter (Needle): 5 French | 7 French |
| Length | 200 cm | 190 cm |
| Needle Gauge | 22 GA | 22 GA |
| Needle Extension | 7 mm | 7.5 mm |
| Number of Lumens | 2 | 1 |
| Sterility | Sterile, disposable | Sterile, disposable |

## Testing:

Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices.

The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle has been subjected to our internal standard operating procedures for product qualification and process validation. Samples were subjected to visual, dimensional and functional analysis. All samples were deemed acceptable, in that test specifications were met.