COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K

K111495 · Wilson-Cook Medical, Inc. · FBK · Jul 19, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K111495
• Device Name: COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Jul 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lessons, prior to excision with a snare or endoscopic device.

Device Story

Device is a kit assembled by end-user; components include handle with threaded piston/directional arrow, sterile needle cannula with integrated pressure gauge, and 10 cc syringe containing sterile water/sodium CMC mixture (optional blue colorant). Used in GI endoscopy; operated by physician. Principle: needle creates starter bleb below affected tissue; viscous gel injected into bleb to elevate tissue from muscle layer. Elevated bleb facilitates endoscopic dissection/resection using separately supplied electrosurgical device. Gel dissolves and passes naturally post-excision. Pressure gauge monitors for needle kinks/bends in tortuous anatomy. Benefits: viscous injectate maintains bleb elevation longer than saline, reducing risk of muscle layer involvement during resection.

Clinical Evidence

No clinical data. Evidence consists of pre-clinical bench testing and animal testing to verify biological safety of injection media and validate performance capabilities of the GI Endoscopic Injection Gel Kit against design criteria.

Technological Characteristics

Kit includes handle, needle cannula with integrated pressure gauge, and syringe with sodium CMC/water mixture. Sensing principle: mechanical pressure gauge for monitoring needle patency. Dimensions/form factor: endoscopic injection needle. Sterilization: sterile components. No software or electronic components.

Indications for Use

Indicated for submucosal lift of polyps or other gastrointestinal mucosal lesions in patients requiring endoscopic excision of such lesions.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• US Endoscopy Dual Lumen Injector Needle Snare (k040961)
• Cook Endoscopic Ultra Ultrasound Needle (k083330)

Submission Summary (Full Text)

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# (111495

## JUL 1 9 2011

### ATTACHMENT F: 510(k) Summary

SPONSOR:

CONTACT/SUBMITTER:

DATE OF SUBMISSION:

#### DEVICE:

Trade Name: Common Name: Classification:

#### PREDICATE DEVICES:

.TENDED USE:

#### DEVICE DESCRIPTION:

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

Marge Walls-Walker Senior Regulatory Specialist: Engineering [336] 744-0157 Ex. 6290

May 26, 2011

Gastroenterology Injection Needle

Cook GI Endoscopic Injection Gel Kit GI Endoscopic Injection Needle GI/GU Injection Needle, Class II FBK 21 CFR § 876.1500

US Endoscopy Dual Lumen Injector Needle Snare (k040961) Cook Endoscopic Ultra Ultrasound Needle (k083330)

This device is indicated for sub mucosal lift of polyps or other gastrointestinal mucosal lesions. prior to excision with a snare or endoscopic device

The proposed Cook Device is assembled by the end user from three component pieces: a handle with a threaded piston and directional arrow, a sterile needle cannula with an attached pressure gauge to track pressure in the event of needle kinks/bends in the tortuous GI anatomy and a sterile 10 cc syringe filled with a mixture of sterile water and sodium CMC. Blue colorant may or may . not be added to enhance endoscopic visibility. After creation of a starter bleb below affected tissue, the gel is then injected into the starter bleb. The bleb will then stay elevated from the muscle layer to allow for endoscopic dissection or resection with a separately supplied endoscopic electrosurgical device. After excision and retrieval of affected tissue, the bleb will dissolve and pass out of the body naturally.

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#### COMPARISON OF CHARACTERISITICS:

equivalent to the named predicates in terms of Intended Use, Indications for Use, performance characteristics tested, needle gauge, principle of operation and biocompatibility. No electrosurgical instrument is provided with the subject device to allow for the excision, but the removal of the bleb can be accomplished using one of the many existing technologies available,

Pre-clinical testing verified the biological safety of

the injection media and validated the performance

We believe the proposed device to be substantially

## PERFORMANCE DATA:

capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing. The IFU suggests a preliminary injection of saline to begin the bleb to reduce the inherent risk of all iniection needles for perforation/iniection into the muscularis. The subject device is meant to complement existing technologies for excision of GI tract tissue by creation of a visible bleb using a viscous injectate that is easily available, and effective. The viscosity of the subject gel overcomes the limitation of injection of saline and other low viscosity materials with respect to time the bleb remains elevated from the muscularis and other mechanical mucosal separation techniques that may result in muscle layer involvement.

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

Ms. Marge Walls-Walker Senior Regulatory Affairs Specialist Wilson Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Rd WINSTON-SALEM NC 27105

JUL 19 2011

Re: K111495

Trade/Device Name: Cook GI Endoscopic Injection Gel Kit Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: May 26, 2011 Received: May 31, 2011

Dear Ms. Walker:

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 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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm428674.htm

Sincerely yours,

Dukart Lemur MD

Herbert P. Lerner, M.D., Director (Acting) 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 Form

Indications for Use

510(k) Number (if known):

Device Name: Cook GI Endoscopic Injection Gel Kit

Indications for Use:

This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lessons, prior to excision with a snare or endoscopic device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Logu m Why
(Division Sign-Off)

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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __ K 111495