GASTRIC LAVAGE VALVE

K990365 · T-Med Vac Corporation · KNT · Jul 26, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K990365
• Device Name: GASTRIC LAVAGE VALVE
• Applicant: T-Med Vac Corporation
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 26, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Talamonti "T" Valve is for use in gastric lavage to control the flow of stomach fluids

Device Story

Talamonti "T" Valve is a medical device used during gastric lavage procedures. It functions to control the flow of stomach fluids. The device is intended for prescription use by healthcare professionals in clinical settings. By regulating fluid flow, it assists in the management of gastric contents during lavage, facilitating the procedure for the clinician and potentially improving patient outcomes during gastric intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for patients requiring gastric lavage to control the flow of stomach fluids.

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

Sami Selim, Ph.D. Regulatory Med-Vac Corporation 1710 41st Avenue Kenasha, Wisconsin 53144

JUL 2 6 2000

Dear Dr. Selim:

Re:

K990365 Talamonti "T" Valve Dated: May 26, 2000 Received: June 2, 2000 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have a 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 (Agg). 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 age instructions agent national disc and adulteration.

If your device is classified (see above) into either 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 , inte 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 (1 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions: Failure to complywith the GMP regulation may result in regulatory action. In addition, FDA may publish futher announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou micht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions of 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 predication for your device and this, 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 and advertising of your device, please contact the Office of Compliance of [phone]. Also, please note the regulation and the c "Misbranding by reference to premarket notification" (21CFR 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 (30-1 his or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known): K990365

Device Name: Talamonti "T" Valve

Indications For Use:

The Talamonti "T" Valve is for use in gastric lavage to control the flow of stomach fluids

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices x990362 510(k) Number _