COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

K061937 · Cook Endoscopy · KNQ · Dec 1, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061937
• Device Name: COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
• Applicant: Cook Endoscopy
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Dec 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.

Device Story

Single lumen catheter with balloon mounted on distal tip; used for endoscopic dilation of esophageal strictures. Balloon is inflated with water to three distinct, progressively larger diameters to exert radial force on strictures. Device is supplied sterile for single use; not sold with inflation device. Operated by physicians in clinical settings. Benefits include mechanical dilation of esophageal narrowing to improve patient function.

Clinical Evidence

Bench testing only. Performance characteristics verified against FDA guidance for Urological Balloons.

Technological Characteristics

Single lumen catheter with inflatable balloon. Materials and biocompatibility verified. Sterile, single-use device. No electronic components or software.

Indications for Use

Indicated for endoscopic dilation of esophageal strictures in patients requiring such intervention.

Regulatory Classification

Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Special Controls

*Classification.* Class II (special controls). 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 Quantum T.T.C.Dilation Balloon (k935094)
• Microvasive RX Biliary Balloon Dilation Catheter (k001338)

Submission Summary (Full Text)

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K061937

DEC = ] 2006

## ATTACHMENT G : 510(k) Summary

Cook Endoscopy SPONSOR: 4900 Bethania Station Road Winston-Salem, NC 27105 Mabel L. Hunter CONTACT/SUBMITTER: Global Regulatory Affairs Specialist [336] -744-0157 Ex.6292 July 6, 2006 DATE OF SUBMISSION: Esophageal Dilation Balloon DEVICE: Cook Endoscopy Esophageal Dilation Balloon Trade Name: Esophageal Balloon Dilator Common Name: Dilator, Esophageal, Class II 78 KNQ Classification: 21 CFR § 876.5365 PREDICATE DEVICES: Wilson-Cook Quantum T.T.C.Dilation Balloon (k935094) Microvasive RX Biliary Balloon Dilation Catheter (k001338) Cook Endoscopy's Esophageal Dilation Balloon INTENDED USE: is intended to endoscopically dilate strictures of the esophagus. The proposed Cook Endoscopy Dilation Balloon DEVICE DESCRIPTION: is a single lumen catheter with a balloon mounted on the distal tip. The balloon is inflatable with water to three distinct and progressively larger size diameters to exert force on esophageal strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of esophageal strictures This device is supplied sterile and intended for single use. This balloon is not sold with inflation device. We believe the proposed device to be COMPARISON OF CHARACTERISTICS: substantially equivalent to the named predicates in terms of Intended Use, Indications for Use, performance characteristics tested, balloon diameter and length available and biocompatibility. Non-Clinical Testing was performed on characteristics of the balloon with respect to The PERFORMANCE DATA: FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC - 1 2006

Ms. Mabel L. Hunter Global Regulatory Affairs Specialist Cook Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K061937

Trade/Device Name: Cook Endoscopy Esophageal Dilation Balloon Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: October 30, 2006 Received: November 1, 2006

Dear Ms. Hunter:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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noting Public .

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 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:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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K06/937

## Indications for Use

510(k) Number (if known): __KD(@1937

Device Name: Cook Endoscopy Esophageal Dilation Balloon

Indications for Use:

The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Leger

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

Prescription Use Only
(Per 21 CFR § 801.109

OR

Over-the-Counter