ROSS ENTERAL FEEDING TUBE

K972437 · Ross Products · FPD · Jan 26, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K972437
• Device Name: ROSS ENTERAL FEEDING TUBE
• Applicant: Ross Products
• Product Code: FPD · Gastroenterology, Urology
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. 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. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-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 external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel. The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.

Device Story

System consists of enteral feeding tube, external steering magnet, and pH tape. Magnet guides tube tip during placement into small bowel to facilitate enteral nutrition. pH tape used to verify tube location by measuring acidity/alkalinity of aspirated fluids. Used in clinical settings by healthcare providers for patients requiring nutritional support. Benefits include rapid, safe tube placement and reduced risk of misplacement complications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes a feeding tube, external steering magnet for guidance, and pH indicator tape for fluid acidity verification. Mechanical guidance principle. Class II device under 21 CFR 876.5980.

Indications for Use

Indicated for pediatric, adult, and elderly patients with a functioning gut requiring short- to moderate-term enteral feeding support due to inability to consume adequate oral diet. Includes post-trauma, post-surgical, burn, and malnourished patients, or those at high risk for tube misplacement.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the caduceus in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IAN 26 1998

Sanford W. Bigelow, Ph.D. Director, Medical Nutritional Regulatory Affairs Ross Products, Abbott Laboratories 625 Cleveland Avenue Columbus, Ohio 43215

Re: K972437 Flexflo Magnetically Guided Enteral Feeding Tube Regulatory Class: II Product Code: 78 FPD 21 CFR 876.5980 Dated: October 31, 1997 Received: November 4, 1997

Dear Dr. Bigelow:

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. 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 your device in the Federal Reqister.

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Page - 2 - Dr. Sanford W. Bigelow

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. I E 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/dsmamain.html".

Sincerely yours,

Robert D. Satting/

Lillian Yin, Ph.D. 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 Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. 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. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-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 external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel. ....... . - - - - - -

The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Satting

Division of Reproductive, Abdominal, ENT, and Radiological Devices 97243 510(k) Number _

Prescription Use ✓

OR Over-The-Counter Use

(Per 21 CFR 801.109)

972437