SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE

K110005 · Syncro Medical Innovations, Inc. · KNT · Aug 4, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110005
• Device Name: SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
• Applicant: Syncro Medical Innovations, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Aug 4, 2011
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Syncro-Blue Tube™ functions as a conduit to facilitate enteral feeding, and may be used in the pediatric, adult or elderly patient who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with 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

Enteral feeding tube; 8 Fr diameter; 60cm length. Input: external steering magnet used during placement. Mechanism: stylet with distal reed switch and magnets; reed switch connects to external LED/battery pack; LED illuminates when near steering magnet to confirm position. Output: visual LED signal for clinician. Usage: clinical setting; operated by physician. Stylet removed post-placement; tube is MRI safe. Benefit: assists safe, rapid small bowel placement; reduces risk of misplacement complications.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included tensile, aspiration, flow, magnet capture, flexibility, column strength, pushability, biocompatibility, simulated use, radiopacity, LED turn-on distance, and connector compatibility.

Technological Characteristics

Enteral feeding tube; 8 Fr, 60cm. Features stylet with distal reed switch and magnets. Energy source: battery-powered external LED pack. Guidance: magnetic attraction to external steering magnet. Biocompatible materials. MRI safe after stylet removal.

Indications for Use

Indicated for pediatric, adult, or elderly patients requiring short- to moderate-term enteral feeding support due to inability to consume adequate oral diet. Applicable for patients with functioning gut, including 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 Enteral Feeding Tube (K072787)

Submission Summary (Full Text)

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K110005
Pg. 1 of 2

Syncro-Blue Tube, The Magnetically Guided Enteral Feed Tube

Special 510(k)

| SECTION 6. 510(K) SUMMARY | | AUG - 4 2011 |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | Syncro Medical Innovations, Inc.<br>20 West Federal<br>Suite M-5B<br>Youngstown, OH 44503 | |
| 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: | December 31, 2010 | |
| Device trade name: | Syncro-Blue Tube, The 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 Enteral Feeding Tube cleared<br>under K072787 | |
| Description of the device: | The Syncro-Blue Tube serves as a conduit through which enteral feeding<br>solutions are directly infused into the patient's small bowel. The modified<br>device will be marketed in one length (23.6" [60cm]) and one French size<br>(8 Fr). During placement of the tube, an external magnet is used to assist<br>the physician in placing the tube into the small bowel. The Syncro-Blue<br>Tube has a stylet with a reed switch positioned near its distal tip. The reed<br>switch is connected by wires to an external LED/battery pack that lights in<br>response to the presence of the external steering magnet. The reed<br>switch is located at the distal end of the stylet. The distal tip of the stylet<br>contain magnets which are attracted to the steering magnet. When the<br>tube is positioned, the stylet is removed from the device, making the<br>Syncro-Blue Tube MRI Safe. | |
| Intended use of the device: | The Syncro-Blue Tube™ functions as a conduit to facilitate enteral<br>feeding, and may be used in the pediatric, adult or elderly patient who<br>cannot consume an adequate diet orally. Small bowel feeding may be<br>indicated for patients with functioning gut who require short- to moderate-<br>term feeding support, such as post-trauma patients, post-surgical patients,<br>burn patients, general trauma patients, high-risk patients prone to tube<br>misplacement complications, and patients in whom malnutrition exists, or<br>may result, 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. | |

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Special 510(k)

Technological characteristics:

Performance tests:

The proposed device has the same technological characteristics as the predicate device(s).

Tests were performed to demonstrate substantial equivalence in the following areas:

- Tensile .
. I

- . Aspiration, Flow
- . Magnet Capture / Magnetic guidance
- Flexibility / Column Strength / Pushability .
- 4 Biocompatibility
- Simulated use. .
- Radiopacity .
- LED Turn-on Distance .
- Connector Compatibility Testing .

## Conclusions:

The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Syncro Medical Innovations, Inc. % William G. McLain, RAC President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 LEOLA PA 17540

AUG - 4 2011

Re: K110005

Trade/Device Name: Syncro-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: July 2, 2011 Received: July 5, 2011

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 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 111 (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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely, yours,

[signature]

ert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## SECTION 7. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Indications for Use:

KI10005

Syncro-Blue Tube Magnetically Guided Enteral Feeding Tube

The Syncro-Blue Tube™ functions as a conduit to facilitate enteral feeding, and may be used in the pediatric, adult or elderly patient who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with functioning gut who require short- to moderate-term feeding support, such as posttrauma 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.

Prescription Use V (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)

Hulst Leum

Reproductive, Gastro-Rer