WILSON-COOK ENDOSCOPIC CLIPPING DEVICE

K023903 · Wilson-Cook Medical, Inc. · PKL · Feb 20, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023903
• Device Name: WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

Device Story

Endoscopic clipping device; consists of introducer with locking handle and pre-loaded clip. Used by physicians during endoscopic procedures in the GI tract. Introducer deploys clip; clip remains in patient to achieve hemostasis or for marking. Disposable, sterile device. Clinical benefit: provides mechanical hemostasis for bleeding ulcers/defects and site marking.

Clinical Evidence

No clinical data. Evidence based on bench testing, specifically simulated use testing and biocompatibility testing, to demonstrate performance in accordance with intended use.

Technological Characteristics

Disposable, sterile endoscopic clipping device. Comprised of an introducer with a locking handle and a pre-loaded clip. Mechanical deployment mechanism. No software or electronic components.

Indications for Use

Indicated for patients requiring endoscopic marking or hemostasis in the GI tract, specifically for mucosal/submucosal defects < 3 cm in the upper GI tract, bleeding ulcers, arteries < 2 mm, and polyps < 1.5 cm in diameter. Contraindicated for the repair of GI tract lumenal perforations.

Regulatory Classification

Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Olympus Endoscopic Clipping Device (K990687)

Submission Summary (Full Text)

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#### RE: PREMARKET NOTIFICATION FOR THE WILSON-COOK ENDOSCOPIC CLIPPING DEVICE

N 023903

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 1.

pg 1 of 2

FEB 2 0 2003

## Submitted By:

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

## Device Description:

The Wilson-Cook Endoscopic Clipping Device is comprised of an introducer with a locking handle and one (1) pre-loaded clip. The introducer is used to deploy the clip and is not left in the patient. The clip is left in the patient to accomplish hemostasis.

| Trade Name: | Wilson-Cook Endoscopic Clipping Device |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Endoscopic Clipping Device |
| Classification Name/Code: | Clip, Hemostatic / MCH |
| Classification: | FDA has classified similar devices as Class II. This device<br>falls within the purview of the Gastroenterology and<br>Urology Device Panel. |
| Performance Standards: | To the best of our knowledge, performance standards<br>for this device do not exist. |
| Intended Use: | Used for endoscopic clip placement within the<br>gastrointestinal tract for the purpose of endoscopic<br>marking, hemostasis for mucosal/submucosal defects<br>less than 3 cm in the upper GI tract, bleeding ulcers,<br>arteries less than 2 mm, and polyps less than 1.5 cm in<br>diameter in the GI tract. This device is not intended for<br>the repair of GI tract lumenal perforations. |

## Predicate Device:

| PREDICATE<br>DEVICE | MANUFACTURER | DOCUMENT<br>CONTROL<br>NUMBER |
|---------------------------------------|----------------------|-------------------------------|
| Olympus Endoscopic<br>Clipping Device | Olympus America, Inc | K990687 |

## Substantial Equivalence:

The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.

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K023903 Py202

#### NOTIFICATION FOR THE WILSON-COOK ENDOSCOPIC RE: PREMARKET CLIPPING DEVICE

| DEVICE<br>CHARACTERISTIC | Wilson-Cook<br>Endoscopic Clipping<br>Device<br>[Subject of 510(K)] | Olympus<br>Endoscopic Clipping<br>Device |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Not assigned | K990687 |
| Intended Use | Used for endoscopic clip<br>placement within the<br>gastrointestinal tract for the<br>purpose of endoscopic<br>marking, hemostasis for<br>mucosal/ submucosal<br>defects less than 3 cm in<br>the upper GI tract, bleeding<br>ulcers, arteries less than 2<br>mm, and polyps less than<br>1.5 cm in diameter in the<br>GI tract. This device is not<br>intended for the repair of<br>GI tract lumenal<br>perforations. | Used for endoscopic clip<br>placement within the<br>gastrointestinal (GI) tract<br>for the purpose of<br>endoscopic marking,<br>hemostasis in the upper GI<br>tract for<br>mucosal/submucosal defects<br>< 3 cm, bleeding ulcers and<br>arteries < 2 mm, polyps <<br>1.5 cm in diameter, and<br>anchoring to affix jejunal<br>feeding tubes to the wall of<br>the small bowel. This device<br>is not intended for the<br>repair of GI tract. |
| Sterility | Sterile, Disposable | Sterile, Disposable |

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

# Discussion of Tests and Test Results:

The Wilson-Cook Endoscopic Clipping Device underwent simulated use testing and biocompatibility testing. Test results provide reasonable assurance the device will perform in accordance with its intended use.

# Conclusions Drawn from Tests:

Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Endoscopic Clipping Device meets the requirements for 510(k) substantial equivalence.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

Wilson-Cook Medical, Inc. GI Endoscopy Margaret J. Posner Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K023903

> Trade/Device Name: Wilson-Cook Endoscopic Clipping Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): November 16, 2002 Received (Date on orig SE ltr): November 22, 2002

Dear Margaret J. Posner,

This letter corrects our substantially equivalent letter of February 20, 2003.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 -

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 that FDA has made 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 19_ of _ 19

510(k) Number (if known): _K ○ノろイクフ

Device Name: __ Wilson-Cook Endoscopic Clipping Device

### Indications for Use:

Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/ submucosal defects less than 3 cm in the upper Gl tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter (Optional Format 1-2-96

David A. Syverson

(Division Sign-Off) Division of Reproductive, I and Radiological Devices 510(k) Number