MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE

K021991 · Syncro Medical Innovations, Inc. · KNT · Jul 18, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021991
• Device Name: MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
• Applicant: Syncro Medical Innovations, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

This catheter is inserted orally or trans-nasally directly into the small bowel and is intended to provide nutrition, fluids, and medications directly into the intestinal tract.

Device Story

MagnaFlow® is an enteral feeding tube for small bowel access. Device features a magnet embedded in the distal tip; an external magnet is used by a clinician to steer the catheter through the stomach pyloric sphincter into the duodenum. A reed switch proximal to the tip magnet detects proximity of the external magnet, triggering an LED light in the manifold to confirm capture. The device serves as a conduit for nutrition, fluids, and medications. Benefits include facilitated placement and reduced risk of tube misplacement complications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Enteral feeding tube with embedded distal tip magnet and reed switch for external magnetic guidance. Includes manifold with LED indicator for magnet capture. Sterilization and packaging are consistent with predicate standards.

Indications for Use

Indicated for pediatric, adult, or elderly patients unable to consume adequate oral diet. Used for small bowel feeding in patients with functioning gut requiring short- to moderate-term support, including post-trauma, post-surgical, burn, general trauma, high-risk patients prone to tube misplacement, and patients with malnutrition secondary to underlying disease.

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

• Flexiflo Magnetically Guided Enteral Feeding Tube (K972437)

Submission Summary (Full Text)

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# JUL 1 8 2002

Page 14

Premarket Notification Syncro Medical Innovations, Inc.

## XVI. 510(k) Summary

| Submitter: | Syncro Medical Innovations, Inc.<br>433 Cherry Street<br>Lower Level Suite #6<br>Macon, GA 31201 |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Sabry A. Gabriel, M.D.<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: Gabriel [e-mail] |
| Date summary prepared: | 6/14/02 |
| Device trade name: | MagnaFlow® Magnetically Guided Enteral Feeding Tube |
| Device common name: | Enteral Feeding Tube |
| Device classification<br>name: | Tube, Feeding at CFR 21 876.5980 |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | K972437: Flexiflo Magnetically Guided Enteral Feeding Tube |
| Description of device:<br>MagnaFlow® | The MagnaFlow® Magnetically Guided Enteral Feeding Tube<br>system is intended for direct placement in the small bowel.<br>The catheter functions as a conduit for enteral feeding for<br>patients who cannot consume an adequate diet orally. The<br>catheter has a magnet embedded in the distal tip, which<br>through the use of an external magnet aids in catheter<br>placement. When the external magnet is in close proximity to<br>the catheter tip, a reed switch (located proximal to tube tip<br>magnet) closes, causing an LED light (in manifold) to<br>illuminate. That light indicates when the external magnet has<br>captured the tube distal portion. The external magnet can steer<br>the catheter through the stomach pyloric sphincter into the<br>duodenum. |
| Intended use of the<br>device. | This catheter is inserted orally or trans-nasally directly into the<br>small bowel and is intended to provide nutrition, fluids, and<br>medications directly into the intestinal tract. |
| Technological<br>characteristics: | The proposed device has the same fundamental technological<br>characteristics of the predicate devices and similar design,<br>packaging, sterilization and labeling. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds or waves, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# (JUL 1 8 2002

Sabry A. Gabriel, M.D. CEO and President Syncro Medical Innovations, Inc. 433 Cherry Street Lower Level Suite #6 MACON GA 31201

Re: K021991 Trade/Device Name: MagnaFlow® Magnetically Guided Enteral Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: June 14, 2002

Received: June 18, 2002

Dear Dr. Gabriel:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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KO2 1991

Premarket Notification Syncro Medical Innovations, Inc. Page 8

### VIII. Indications for Use

The MagnaFlow® Magnetically Guided Enteral Feeding 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.

Concurrance of CRDH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use

David G. Stevenson