GILTECH PLUS CONNECTING TUBE SET

K983624 · Giltech Plus, Inc. · KDH · Mar 18, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983624
• Device Name: GILTECH PLUS CONNECTING TUBE SET
• Applicant: Giltech Plus, Inc.
• Product Code: KDH · Gastroenterology, Urology
• Decision Date: Mar 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.

Device Story

Giltech Plus Connecting Tube Set comprises various tubing configurations including insufflation, suction/irrigation, and urinary extension sets. Device functions as physical conduit for connecting two medical devices. Used in clinical settings by healthcare professionals. Prohibited for intravenous or intramuscular applications. Benefits include facilitating fluid or gas transport between compatible medical equipment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Tubing sets for medical device interconnection. Materials and specifications not detailed. Non-electronic, mechanical device.

Indications for Use

Indicated for use as insufflation tubing, suction/irrigation tubing, urinary extension tubing, or general tubing to connect two medical devices. Contraindicated for intravenous or intramuscular transmission of gas or liquid.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 1009

Mr. William J. Giliam President Giltech Plus, Inc. P.O. Box 728 Milford, Pennsylvania 18337

K983624 Re: Trade Name: Giltech Plus Connecting Tube Set Regulatory Class: II Product Code: KDH Dated: January 13, 1999 Received: January 19, 1999

Dear Mr. Giliam:

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 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). 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 requirement, 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.

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## Page 2 - Mr. William J. Giliam

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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## "INDICATIONS FOR USE"

Page __ 1 of

510(k) Number (if known): __K983624

Device Name: Giltech Plus Connecting Tube Set

Indications For Use:

The Giltech Plus Connecting Tube Sets will consist of:

(a) Insufflation Tubing Sets

(b) Suction / Irrigation Sets

(c) Urinary Extension Tubing

(d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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ral Restorativ

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)