DISPOSABLE HEMOSTASIS CHIP

K121505 · Wilson-Cook Medical Inc./Cook Endoscopy · PKL · Aug 31, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121505
• Device Name: DISPOSABLE HEMOSTASIS CHIP
• Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Aug 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is 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

Disposable Hemostasis Clip is a sterile, single-use endoscopic device. It consists of a stainless steel and nitinol clip attached to an introducer (nylon, stainless steel, nitinol). Used by physicians during endoscopic procedures to place clips within the GI tract for marking or hemostasis. Compatible with endoscopes having a minimum 2.8 mm accessory channel. The clip is deployed from the introducer to approximate tissue. Benefits include effective management of bleeding ulcers, small polyps, and mucosal defects. The device is MR Conditional per ASTM F2503.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing demonstrating that the device meets performance requirements.

Technological Characteristics

Materials: stainless steel and nitinol (clip); nylon, stainless steel, and nitinol (introducer). Dimensions: 230 cm length. Compatibility: endoscopes with >= 2.8 mm accessory channel. MR Conditional per ASTM F2503. Single-use, sterile.

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. 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

• Wilson-Cook Endoscopic Clipping Device (K023903)

Submission Summary (Full Text)

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of 2 COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHOHE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

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AUG 3 1 2012

121505

## 5. 510(k) Summary

| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 4900 Bethania Station Road<br>Winston-Salem, North Carolina 27105 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Scottie Fariole, Global Regulatory Affairs Specialist |
| Date: | May 18, 2012 |
| Trade Name: | Disposable Hemostasis Clip |
| Common Name: | Hemostasis Clip |
| Classification Name: | Hemorrhoidal ligator, Gastroenterology-Urology (21 CFR 876.4400,<br>Product Code MND) |
| Legally Marketed Devices: | Wilson-Cook Endoscopic Clipping Device (K023903) |
| Description of the Device: | The Disposable Hemostasis Clip is a sterile, single use device that<br>consists of a metal clip that detaches from the introducer to<br>maintain approximation of tissue to achieve hemostasis in the<br>gastrointestinal tract. The device is compatible with endoscopes<br>with a minimum accessory channel of 2.8 mm. The Disposable<br>Hemostasis Clip is 230 cm long. The deployed clip portion of the<br>Disposable Hemostasis Clip is stainless steel and nitinol while the<br>introducer is nylon, stainless steel and nitinol. |
| Intended Use: | This device is used for endoscopic clip placement within the<br>gastrointestinal tract for the purpose of endoscopic marking,<br>hemostasis for mucosal/submucosal defects less than 3 cm in the<br>upper GI tract, bleeding ulcers, arteries less than 2 mm, and<br>polyps less than 1.5 cm in diameter in the GI tract. This device is<br>not intended for the repair of GI tract lumenal perforations. |
| Technological Characteristics: | The Disposable Hemostasis Clip has similar technological<br>characteristics to the Wilson-Cook Endoscopic Clipping Device<br>(K023903) in terms of general design and function but differs in<br>terms of materials, dimensions, clip geometry and handle<br>operation. Additionally, the deployed clip portion of the device is<br>MR Conditional per ASMT F2503. |

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### Performance Data:

Performance testing consisting of non-clinical bench testing demonstrates that the Disposable Hemostasis Clip met the performance requirements to fulfill the intended use of the device. The device is substantially equivalent to currently cleared predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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. / Cook Endoscopy Scottie Fariole Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K121505

Trade/Device Name: Disposable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): August 21, 2012 Received (Date on orig SE ltr): August 22, 2012

Dear Scottie Fariole,

This letter corrects our substantially equivalent letter of August 31, 2012.

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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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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### 4. Indications for Use

510(k) Number (if known): K121505

Device Name: _ Disposable Hemostasis Clip

Indications for Use:

This device is 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.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard Leuu

inn Sidne tive, Gastro-Renal, and S10/k) Numr

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