CHAIT CECOSTOMY CATHETER

K982500 · Cook, Inc. · KNT · Jan 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K982500
• Device Name: CHAIT CECOSTOMY CATHETER
• Applicant: Cook, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jan 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .

Device Story

The Chait Cecostomy Catheter is a low-profile, 'trap door' catheter designed for antegrade colonic flushing. It is inserted into a pre-established percutaneous tract into the cecum. The device consists of a 10.2 French urethane catheter with five pigtail curves and three distal sideports, a trap door fitting that sits flush against the abdominal wall, and a metal access adapter cannula. When not in use, a plastic plug locks into the trap door fitting. Clinicians use the device to instill fluids into the colon to promote bowel evacuation. The device is supplied sterile for single-use. It benefits patients by providing a controlled access point for managing fecal incontinence.

Clinical Evidence

The submission references clinical trials, tensile strength tests, and biocompatibility tests to support the safety and performance of the device. No specific quantitative clinical metrics (e.g., p-values, sensitivity) are provided in the summary document.

Technological Characteristics

Materials: Urethane. Dimensions: 10.2 French diameter, 20cm length. Design: Single lumen, five pigtail curves, three distal sideports, trap door fitting with plastic plug, metal access adapter cannula. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring management of fecal incontinence via antegrade colonic flushing through a percutaneously prepared cecostomy.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Ultrathane™ Biliary Drainage catheter with a COOK-Cope Type Loop (K851242)
• Ultrathane™ Nephrostomy Catheter with a COOK-Cope Type Loop (K851242)

Submission Summary (Full Text)

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510(k) Premarket Notification Chait Cecostomy Catheter COOK INCORPORATED

### Safety and Effectiveness Information

April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 [phone] July 17, 1998

| Device: | Trade Name: Chait Cecostomy Catheter |
|-------------------------------|--------------------------------------|
| Proposed Classification Name: | Introduction, Drainage Catheter |

### Predicate Devices:

The Chait Cecostomy Catheter is similar in terms of intended use, materials of construction, and technological characteristics to the predicate devices reviewed, the Ultrathane™ Biliary Drainage catheter with a COOK-Cope Type Loop and the Ultrathane™ Nephrostomy Catheter with a COOK-Cope Type Loop.

## Device Description

The Chait Cecostomy Catheter is a "trap door", low profile catheter which facilitates antegrade colonic flushing. The device is supplied sterile and is intended for one time use. A tract must be established through the abdomen into the cecum prior to placement of the trap door catheter. Accessories used in conjunction with this device include, but are not limited to, a metal stiffener, a wire guide, a connecting tube, a syringe and saline solution.

The device consists of a cecostomy catheter with a trap door attachment and an access adapter. The 10.2 French catheter is made of urethane and is manufactured with five (total) pigtail curves. The distal end of the catheter includes three sideports which are evenly spaced inside the fifth curve. The endhole is 0.038 inches in diameter. The total length of the catheter is 20cm.

The trap door fitting is also made of urethane and lies flat against the abdomen wall. It incorporates a plastic plug which locks securely into place when the catheter is not being accessed.

The access adapter is a metal cannula. The distal end of the cannula is curved and can be

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510(k) Premarket Notification Chait Cecostomy Catheter COOK INCORPORATED

attached to the trap door fitting as needed to fluids through the Chait Cecostomy Catheter and into the cecum. The proximal end of the cannula is designed with a large tapered fitting that will fit most taper tip syringes.

## Substantial Equivalence

COOK INCORPORATED currently markets two devices, the Ultrathane™ Nephrostomy Catheter with a COOK-Cope Type Loop and the Ultrathane™ Biliary Drainage Catheter with a COOK-Cope Type Loop, which are believed to be substantially equivalent to the catheter, subject of this submission. The Ultrathane Biliary Drainage Catheter is indicated for antegrade biliary drainage. The Ultrathane™ Nephrostomy Catheter is indicated for external urine drainage from the renal pelvis. Both devices are manufactured in either Ultrathane™ or polyurethane. These devices are classified as modified Preamendment devices and were also reviewed as substantially equivalent under K851242.

The Ultrathane™ Biliary Drainage Catheter is manufactured with a single lumen polyurethane tubing measuring 8.5, 10.2, 12.0, and 14.0 Fr. in outside diameter in a nominal 40cm length. The Ultrathane™ Nephrostomy Catheter is manufactured with a single lumen polyurethane tubing measuring 8.5, 10.2, 12.0, and 14.0 Fr. in outside diameter in a nominal 25cm length. The Chait Cecostomy Catheter will be manufactured with a single lumen urethane tubing measuring 10.2 Fr. in outside diameter and 20cm in length.

# Test Data

The Chait Cecostomy Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- જુન Clinical Trials
- જુન Tensile Strength Tests
- જીન Biocompatibility Tests

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a catheter which facilitates antegrade colonic flushing.

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

COOK INCORPORATED c/o Ms. April Lavender, RAC Vice President Regulatory Affairs 925 South Curry Pike P.O Box 489 Bloomington, Indiana 47402

Re: K982500 Chait Cecostomy Catheter Set Dated: October 28, 1998 Received: October 29, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT 21 CFR 876.5895/Procode: 78 EXD

Dear Ms. Lavender:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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COOK INCORPORATED Response to Request for Additional Information K982500 Chait Cecostomy Catheter

510(k) Number (if known): K982500

Device Name:

Chait Cecostomy Catheter

Indications for Use:

The Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The opening and is and maintained in a percutaneously prepared opening such as a cecostomy .

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use | <div> <svg height="15" width="15"> <path d="M4 10 L11 3" stroke="black" stroke-width="2"></path> </svg> </div> |
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| Use<br>(Per 21 CFR 801.109) | |

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| | Over-the-Counter |
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| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |

| 510(k) Number | K982500/S001 |
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