COOK GASTRIC SIZING BALLOON CATHETER

K030841 · Cook, Inc. · KNT · Jul 11, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030841
• Device Name: COOK GASTRIC SIZING BALLOON CATHETER
• Applicant: Cook, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

Device Story

Flexible 18 French silicone gastric catheter; 55cm length with centimeter markings (10cm-50cm). Used in gastric/bariatric surgery by physicians. Provides visible/tactile delineation of stomach cardia; enables gastric decompression, fluid drainage, and gastric pouch sizing via inflatable balloon. Device provides physical feedback to surgeon during procedure to assist in surgical decision-making and anatomical assessment.

Clinical Evidence

Bench testing only. Testing included analysis of cuff burst volume, cuff diameter over time, cuff pressure/diameter at various inflation volumes, and biocompatibility. No clinical data provided.

Technological Characteristics

Silicone catheter; 18 French diameter; 55cm length; centimeter markings (10-50cm). Features inflatable balloon for sizing and suction lumen for drainage. Non-powered, manual device.

Indications for Use

Indicated for patients undergoing gastric and bariatric surgical procedures requiring gastric pouch sizing and gastric fluid drainage/removal.

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

• Gastric Balloon Suction Catheter (K002838)

Submission Summary (Full Text)

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510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED

K030841 Page 1 of 2

# Safety and Effectiveness Information

Carol Zwissler Submitted By: Requlatory Affairs Coordinator COOK INCORPORATED 750 Daniels Way PO Box 489 Bloomington, IN 47402 [phone] March 11, 2003 Trade Name: Cook Gastric Sizing Balloon Catheter Device: (KNT)

Proposed Classification Name: Gastrointestinal Tube and Accessories

# Predicate

The Cook Gastric Sizing Balloon Catheter is similar in terms Device: of intended use, materials of construction and technological characteristics to the Gastric Balloon Suction Catheter marketed by BioEnterics.

# Device Description:

The Cook Gastric Sizing Balloon Catheter is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the cardia of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch. The silicone catheter is 18 French and 55cm long with centimeter markings every centimeter from 10cm to 50cm.

# Indications for Use:

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove qastric fluid.

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KOSATI

510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED

K030841 Page 2 of 2

#### Substantial Equivalence

The Cook Gastric Sizing Balloon Catheter is similar to another gastric balloon: the Gastric Balloon Suction Catheter, marketed by BioEnterics, which was found substantially equivalent under DC# K002838.

The similar indications for use, materials of construction and the technological characteristics of the Cook Gastric Sizing Balloon Catheter as compared to the predicate device support a determination of substantial equivalency.

#### Test Data

The Cook Gastric Sizing Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

- Analysis of Cuff Burst Volume .
- Analysis of Cuff Diameter Over Time ●
- Analysis of Cuff Pressure and Diameter at Various Inflation Volumes .
- . Biocompatibility

The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for it use as a gastric sizing balloon.

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Image /page/2/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a symbol that resembles an abstract representation of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2003

Ms. Carol Zwissler Regulatory Affairs Coordinator Cook Incorporated P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K030841

Trade/Device Name: Gastric Sizing Balloon Catheter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: June 17, 2003 Received: June 18, 2003

Dear Ms. Zwissler:

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 (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 fairther 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon
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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510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED

Device Name: Gastric Sizing Balloon Catheter

Indications for Use:

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

Over-the-Counter-Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030841