MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

K990863 · Ross Product Div. Abbott Laboratories · KNT · Apr 6, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990863
• Device Name: MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
• Applicant: Ross Product Div. Abbott Laboratories
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 6, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Flexiflo PolyG Gastrostomy Tube is intended for gastric placement through a mature gastrocutaneous fistula, or one created during a Stamm or Witzel procedure. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Enteral feeding may be indicated for patients with a functioning gut who require short- to long-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.

Device Story

FlexiFlo PolyG Gastrostomy Tube functions as a conduit for enteral feeding or gastric decompression. Device is placed through a mature gastrocutaneous fistula or via Stamm/Witzel procedure. Used in clinical settings for patients unable to maintain adequate oral nutrition. Tube facilitates delivery of nutritional support or evacuation of gastric contents. Operated by healthcare professionals. Benefits include maintenance of nutritional status in patients with functioning gastrointestinal tracts.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gastrostomy tube for enteral feeding and gastric decompression. Form factor is a tube designed for placement through a gastrocutaneous fistula. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for pediatric, adult, and elderly patients with a functioning gut requiring short- to long-term enteral feeding or gastric decompression due to inability to consume adequate oral diet, including post-trauma, post-surgical, burn, and malnourished patients.

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

APR 6 1999

Sanford W. Bigelow, Ph.D. Director, Medical Nutritional Regulatory Affairs ROSS PRODUCTS DIVISION ABBOTT LABORATORIES 625 Cleveland Avenue Columbus, Ohio 43215-1724

Re: K990863

Modification to FlexiFlo PolyG® Gastrostomy Tube Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dated: March 15, 1999 Received: March 16, 1999

Dear Dr. Bigelow:

We have reviewed vour 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning

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Page 2 - Dr. Sanford W. Bigelow

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 the 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,

David A. Leipson

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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## VIII. INDICATIONS FOR USE

The Flexiflo PolyG Gastrostomy Tube is intended for gastric placement through a mature gastrocutaneous fistula, or one created during a Stamm or Witzel procedure. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Enteral feeding may be indicated for patients with a functioning gut who require short- to long-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990863