INSTINCT ENDOSCOPIC HEMOCLIP

K132809 · Wilson-Cook Medical, Inc. · PKL · Oct 25, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132809
• Device Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Special
• 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

Instinct Endoscopic Hemoclip is a sterile, single-use mechanical device for endoscopic tissue approximation and hemostasis. Consists of a stainless steel and nitinol clip attached to a 230 cm introducer (nylon, stainless steel, nitinol). Operated by a physician via endoscope (minimum 2.8 mm accessory channel). Device deployed to clip tissue; provides mechanical hemostasis or marking. Benefits include controlled bleeding and tissue marking during GI procedures. MR Conditional per ASTM F2503.

Clinical Evidence

Bench testing only. Non-clinical performance testing for visual verification and tensile strength demonstrated the device met performance requirements.

Technological Characteristics

Materials: stainless steel, nitinol, nylon. 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 clip placement in the GI tract for marking, hemostasis of mucosal/submucosal defects <3 cm (upper GI), bleeding ulcers, arteries <2 mm, and polyps <1.5 cm. Contraindicated for 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

• Disposable Hemostasis Clip (K121505)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo for Cook Medical. The word "COOK" is in large, bold letters at the top of the logo. Below the word "COOK" is a rectangular box with the word "MEDICAL" inside. The background of the logo is white, and the text is black.

COOK ENDOSCOPY 4900 BETHANIA STATION ROAD winston-salem, nc 27105 U.5.A. ●HDNS・336.744.0157 10LL ++16- 800.245.4707 WWW.COOKMEDICAL.COM

### 510(k) Summary

| | 510(k) Summary | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy | OCT 25 2013 |
| Address: | 4900 Bethania Station Road<br>Winston-Salem, North Carolina 27105 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Contact: | Scottie Fariole, Manager, Regulatory Communications | |
| Date: | October 24, 2013 | |
| Trade Name: | Instinct Endoscopic Hemoclip | |
| Common Name: | Hemostasis Clip | |
| Classification Name: | Hemorrhoidal ligator, Gastroenterology-Urology (21 CFR 876.4400, Product Code FHN) | |
| Legally Marketed Devices: | Disposable Hemostasis Clip (K121505) | |
| Description of the Device: | The Instinct Endoscopic Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Instinct Endoscopic Hemoclip is 230 cm long. The deployed clip portion of the Instinct Endoscopic Hemoclip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol. | |
| 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 Gl tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the Gl tract. This device is not intended for the repair of Gl tract lumenal perforations. | |
| Technological Characteristics: | The Instinct Endoscopic Hemoclip has similar technological characteristics to the Disposable Hemostasis Clip (K121505) in terms of general design and function but differs in terms of component design. The deployed clip portion of the device is MR Conditional per ASMT F2503. | |

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### Performance Data:

Performance testing consisting of non-clinical bench testing for visual verification and tensile strength demonstrates that the Instinct Endoscopic Hemoclip met the performance requirements to fulfill the intended use of the device. The device is substantially equivalent to the currently cleared predicate device.

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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. Cook Endoscopy Scottie Fariole Manager, Regulatory Communications 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K132809 Trade/Device Name: Instinct Endoscopic Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE Itr): October 3, 2013 Received (Date on orig SE ltr): October 4, 2013

Dear Scottie Fariole,

This letter corrects our substantially equivalent letter of October 25, 2013.

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

Beniamin 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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#### Indications for Use

510(k) Number (if known): K132809

Device Name: Instinct Endoscopic Hemoclip

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)

## Benjamin R. Fisher -S 2013.10.25 16:37:16 -04'00'

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