WILSON-COOK ULTRASOUND BIOPSY NEEDLE

K013356 · Wilson-Cook Medical, Inc. · FCG · Oct 19, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013356
• Device Name: WILSON-COOK ULTRASOUND BIOPSY NEEDLE
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Oct 19, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope.

Device Story

The Wilson-Cook Ultrasound Biopsy Needle is a sterile, single-use device designed for soft tissue biopsy. It is used in conjunction with an ultrasound endoscope, which provides ultrasound guidance for needle placement. The device features a side-cutting needle configuration and an echogenic tip to enhance visibility under ultrasound. It is operated by a clinician during endoscopic procedures to obtain tissue samples for diagnostic purposes. The device is a modification of previous designs, utilizing a PEEK sheath and a Nitinol (Titanium Nickel) stylet. The device is intended to assist in the diagnosis and staging of lesions by facilitating accurate tissue sampling.

Clinical Evidence

No clinical data. Substantial equivalence is supported by design verification, dimensional/functional testing, and biocompatibility assessment of patient-contacting materials.

Technological Characteristics

Biopsy needle with side-cutting configuration and echogenic tip. Materials: PEEK sheath, Nitinol (Titanium Nickel) stylet. Sterile, single-use, disposable. Operates via manual insertion through the accessory channel of an ultrasound endoscope. No electronic components or software.

Indications for Use

Indicated for soft tissue biopsy performed via the accessory channel of an ultrasound endoscope.

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

• ProAct Biopsy Needle (K926559/A)
• Wilson-Cook Ultrasound Needle (K934356)

Submission Summary (Full Text)

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# OCT 1 9 2001

### RE: SPECIAL 510(K): DEVICE MODIFICATION FOR THE WILSON-COOK ULTR BIOPSY NEEDLE

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

# Submitted By:

Wilson-Cook Medical Inc. 4900 Bethania Station Road & 5951 Grassy Creek Boulevard Winston-Salem, NC 27105

### Device Description:

The Wilson-Cook Modified Ultrasound Biopsy Needle is used for soft tissue biopsy through the accessory channel of an ultrasound endoscope. This device is supplied sterile and intended for single use only.

| Trade Name: | Wilson-Cook Ultrasound Biopsy Needle |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Ultrasound Biopsy Needle |
| Classification Name/Code: | Set, Biopsy Needle and Needle, GU, 78 FCG |
| Classification: | FDA has classified similar devices as Class II, as<br>per 21 CFR § 876.1075. This device falls within<br>the purview of the Gastroenterology and Urology<br>Device Panel. |
| Performance Standards: | To the best of our knowledge, performance<br>standards for this device do not exist. |
| Intended Use: | Used for soft tissue biopsy through the accessory<br>channel of an ultrasound endoscope. |

### Predicate Device:

| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL<br>NUMBER |
|----------------------------------|--------------------------|----------------------------|
| ProAct Biopsy Needle | ProAct Ltd. | K926559/A |
| Wilson-Cook Ultrasound<br>Needle | Wilson-Cook Medical Inc. | K934356 |

## Substantial Equivalence:

The Wilson-Cook Modified Ultrasound Biopsy Needle is substantially equivalent to the referenced predicate devices with respect to design, materials of construction and intended use.

Biopsy Needle in the side-cutting This device is identical to the ProAct configuration of the needle, as well as the echogenic needle tip. In addition, both of these devices operate in the same manner in order to obtain biopsies.

The modified Ultrasound Biopsy Needle and the predicate Wilson-Cook Ultrasound Needle are both used endoscopically, employing ultrasound technology to quide the needle. The patient-contacting materials of these devices differ slightly, with the sheath of the predicate being polytetrafluoroethylene and the sheath of the modified device being PEEK. In addition, the stylet of the predicate is comprised of ANSI Grade 304 Stainless Steel while the modified device stylet is comprised of Titanium Nickel (Nitinol). Applicable biocompatibility data is included.

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K06 3356
Page 2 of 2

### RE: SPECIAL 510(K): DEVICE MODIFICATION FOR THE WILSON-COOK ULTR BIOPSY NEEDLE

| DEVICE<br>CHARACTERISTIC | Wilson-Cook Modified<br>Ultrasound Biopsy<br>Needle<br>[Subject of Special<br>510(k)] | ProAct Biopsy<br>Needle<br>(K926559/A) | Predicate<br>Wilson-Cook<br>Ultrasound Needle<br>(K934356) |
|--------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for soft tissue<br>biopsy through the<br>accessory channel of an<br>ultrasound endoscope. | Used for<br>percutaneous,<br>intra-operative, or<br>through a<br>laparoscope<br>biopsies. | Used for aspiration<br>biopsy to diagnose<br>and stage GI lesions,<br>providing sampling<br>by employing<br>ultrasound<br>technology to guide<br>the needle. |
| Sterility | Sterile, Disposable | Sterile, Disposable | Sterile, Disposable |

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

# Biocompatibility:

Reasonable assurance of biocompatibility for the patient-contacting materials has been established through a history of use in similar patient-contacting medical devices and as applicable biocompatibility test results.

# Design Control/Risk Analysis/Design Verification:

Design Control, Risk Analysis, Design Verification activities for the subject of this special 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21 CFR Part 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element/production controls to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, dimensional and functional testing to ensure the performance and design integrity of this product line were conducted. A l l results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2001

Re: K013356

Trade/Device Name: Wilson-Cook Ultrasound Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II

Product Code: 78 FCG Dated: September 28, 2001 Received: October 10, 2001

Dear Ms. Posner:

Ms. Margaret J. Posner

Wilson-Cook Medical

GI Endoscopy

Regulatory Affairs Specialist

4900 Bethania Station Road

WINSTON-SALAM NC 27105

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your booker only of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read of acrease a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ 12__ of ___ 12__

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ____Wilson-Cook Ultrasound Biopsy Needle

Indications for Use:

Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope.

(Please do not Write Below This Line – Continue on another Page, if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block; vertical-align:top;">✓</div> | OR | Over-The-Counter |
|----------------------|----------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

Nancy C Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K013356 |
|---------------|---------|
|---------------|---------|