REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360

K071764 · Obtech Medical Sarl · KNT · Oct 24, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071764
• Device Name: REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
• Applicant: Obtech Medical Sarl
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

Device Story

REALIZE™ Gastric Calibration Tube is a single-patient-use instrument for gastric/bariatric surgery. Device consists of 745 mm silicone tube with 38 F rounded, closed tip; includes inflatable balloon located 6.8 cm from distal tip and two suction/irrigation holes at distal end. Proximal end features check valve for syringe-based balloon inflation. Reference markings on shaft assist in positioning. Used by surgeons in OR to provide visible/tactile delineation of stomach antrum, decompress stomach, remove gastric fluid, and size gastric pouch. Device functions as mechanical aid during surgical procedures; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Silicone tube, 745 mm length, 38 F diameter. Features inflatable balloon, check valve, and suction/irrigation ports. Non-sterile, single-patient use. Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for patients undergoing gastric and bariatric surgical procedures requiring stomach antrum delineation, gastric decompression, fluid drainage, or gastric pouch sizing.

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

• COOK® Gastric Sizing Balloon Catheter
• BioEnterics® Gastric Balloon Suction Catheter

Submission Summary (Full Text)

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K071764

## 510(k) Summary

UCT 2 4 2007

Company Obtech Medical Sarl Chemin-Blanc LeLocle, Switzerland CH-2400

Contact Elizabeth Miller Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: [phone] [phone] Fax: Email: [e-mail]

Date Prepared June 28, 2007

Device Name Trade Name: REALIZE™ Gastric Calibration Tube Common or Usual Name: Gastrointestinal Tubes Tubes, Gastrointestinal (And Accessories) Classification Name: [21 CFR 876.5980 (KNT)]

COOK® Gastric Sizing Balloon Catheter Predicate Device BioEnterics® Gastric Balloon Suction Catheter

Device Description The REALIZETM Gastric Calibration Tube is a non-sterile, single patient use instrument consisting of a 745 mm long silicone tube with an approximate 38 F (12.7mm) rounded, closed tip. At the proximal end, the tube is equipped with a check valve which mates with a syringe used to fill a balloon located approximately 6.8 cm from the distal tip. At the distal end, the tube has two suction/irrigation holes that allow the removal of fluids and/ or irrigation during the procedure, if necessary. Reference markings are provided on the tube shaft, with the zero reference located approximately 39.6 cm from the proximal end of the balloon.

Indications for Use The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

Technological Characteristics The REALIZE™ Gastric Calibration Tube is similar to the design, function and materials of the predicate devices BioEnterics® Gastric Balloon Suction Catheter and COOK Gastric Sizing Balloon Catheter. The REALIZE™ Gastric Calibration Tube has the same indications for use as the predicates.

Performance Data Bench testing was performed to evaluate the performance of the intended use of the new device. The performance testing shows that the REALIZE™ Gastric Calibration Tube is equivalent to the BioEnterics® Gastric Balloon Suction Catheter.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 4 2007

Obtech Medical Sarl c/o Linda G. Hill, RAC Group Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road CINCINNATI OH 45242

Re: K071764

Trade/Device Name: REALIZE™ Gastric Calibration Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 11, 2007 Received: September 12, 2007

Dear Ms. Hill:

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 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Indications for Use
K071764

Device Name:

## REALIZE™ Gastric Calibration Tube

Indications for Use:

The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

(Posted November 13, 2003)

Helent Reman

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