GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111

K072787 · Syncro Medical Innovations, Inc. · KNT · Oct 31, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072787
• Device Name: GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
• Applicant: Syncro Medical Innovations, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 31, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The device is intended for direct placement into 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.

Device Story

Gabriel Blue Tube is an enteral feeding tube (11 Fr, 50" length) designed for small bowel placement. Device includes an internal stylet with a magnetic tip. An external steering magnet is used by a clinician to guide the tube tip into the duodenum. A reed switch and light indicator signal when the internal magnet is captured by the external magnet, facilitating safe and rapid placement. The tube acts as a conduit for enteral nutrition. Used in clinical settings for patients requiring short- to moderate-term feeding support. Benefits include reduced risk of tube misplacement and improved efficiency of placement.

Clinical Evidence

Bench testing only. Performance tests included tensile, flow, flexibility, and biocompatibility testing to demonstrate substantial equivalence.

Technological Characteristics

11 Fr, 50" (127cm) enteral feeding tube. Features internal stylet with magnetic tip and external steering magnet. Includes reed switch and light indicator for magnetic capture. Materials and design are identical to the predicate device.

Indications for Use

Indicated for pediatric, adult, or 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 high-risk patients prone to tube misplacement or malnutrition.

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

• Gabriel Blue Tube Magnetically Guided Feeding Tube (formerly MagnaFlow® Magnetically Guided Enteral Feeding Tube) (K021991)

Submission Summary (Full Text)

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K072787 R. lot 2

Special 510(k)

| Submitter: | Syncro Medical Innovations, Inc.<br>20 West Federal<br>Suite M-5B<br>Youngstown, OH 44503 | JC7 3 1 200 |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submission<br>Correspondent: | William G. McLain<br>President and Principal Consultant<br>Keystone Regulatory Services, LLC.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date summary prepared: | September 28, 2007 | |
| Device trade name: | Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube | |
| Device common name: | Feeding Tube | |
| Device classification name: | Tube, Feeding<br>78 KNT at 21 CFR Part 876.5980 | |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | Gabriel Blue Tube Magnetically Guided Feeding Tube (Formerly named<br>the MagnaFlow® Magnetically Guided Enteral Feeding Tube), K021991 | |
| Description of the device: | The Gabriel Blue Tube serves as a conduit through which enteral feeding<br>solutions are directly infused into the patient's small bowel. The device will<br>be marketed in one length (50" [127cm]) and one French size (11 Fr). The<br>feeding tube contains a stylet which has magnets attached to its tip. An<br>external magnet is used to capture the tip and guide the device to the<br>duodenum. A reed switch and light indicate when the magnet has been<br>captured and can be guided to its final location. | |
| Intended use of the device: | The device is intended for direct placement into the small bowel. The tube<br>functions as a conduit to facilitate enteral feeding, and may be used in<br>pediatric, adult or elderly patients who cannot consume an adequate diet<br>orally. Small bowel feeding may be indicated for patients with a<br>functioning gut who require short- to moderate-term feeding support, such<br>as post-trauma patients, post-surgical patients, burn patients, general<br>trauma patients, high-risk patients prone to tube misplacement<br>complications, and patients in whom malnutrition exists, or may result,<br>secondary to an underlying disease or condition.<br>The external steering magnet functions as a guidance tool to assist in the<br>safe, rapid placement of the feeding tube into the small bowel. | |
| Technological<br>characteristics: | The proposed device has the same technological characteristics as the<br>predicate device(s). | |

# SECTION 5. 510(K) SUMMARY

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K072787pc. dat2

:

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| Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube | | Special 510(k) |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Performance tests: | Tests were performed to demonstrate substantial equivalence in the following areas:<br>• Tensile<br>• Flow<br>• Flexibility<br>• Biocompatibility | |
| Conclusions: | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. | |

:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 3 1 2007

Syncro Medical Innovations, Inc. c/o Mr. William McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 LEOLA PA 17540

Re: K072787

Trade/Device Name: Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: September 28, 2007 Received: October 1, 2007

Dear Mr. McLain:

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 intentate 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 Fedral Food, Or to 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, isting 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 such 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 In addin

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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.

This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Nancy Brogdon

Nancv 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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K07278/B/of/

Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube

Special 510(k)

### SECTION 6. INDICATIONS FOR USE STATEMENT

510(k) Number:

K072787

Device Name:

Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube

Indications for Use: The Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube is intended for direct placement into 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 mainutrition exists, or may result, secondary to an underlying disease or condition.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Remmer

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

Syncro Medical Innovations, Inc.