(30 days)
No
The device description focuses on mechanical and magnetic guidance, with no mention of AI or ML algorithms for image processing, decision making, or other functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is used to facilitate enteral feeding in patients who cannot consume an adequate diet orally, providing nutritional support and treating malnutrition.
No
The device is an enteral feeding tube used to deliver nutrients directly to the small bowel; it does not measure, analyze, or interpret data for diagnostic purposes.
No
The device description clearly outlines physical components including a feeding tube, stylet with magnets, and an external magnet, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Gabriel Blue Tube is a physical device that is inserted into the body (specifically the small bowel) to deliver enteral feeding solutions. It is a conduit for delivering nutrients, not a test performed on a sample.
- Intended Use: The intended use clearly states it is for "direct placement into the small bowel" to "facilitate enteral feeding." This is a therapeutic and supportive function, not a diagnostic one.
The device description and performance studies also focus on the physical properties and functionality of the tube itself (tensile strength, flow, flexibility, biocompatibility), which are typical for medical devices intended for insertion and delivery, not for diagnostic tests.
N/A
Intended Use / 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.
Product codes
KNT
Device Description
The Gabriel Blue Tube serves as a conduit through which enteral feeding solutions are directly infused into the patient's small bowel. The device will be marketed in one length (50" [127cm]) and one French size (11 Fr). The feeding tube contains a stylet which has magnets attached to its tip. An external magnet is used to capture the tip and guide the device to the duodenum. A reed switch and light indicate when the magnet has been captured and can be guided to its final location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bowel
Indicated Patient Age Range
pediatric, adult or elderly patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed to demonstrate substantial equivalence in the following areas: • Tensile • Flow • Flexibility • Biocompatibility
The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.
0
K072787 R. lot 2
Special 510(k)
| Submitter: | Syncro Medical Innovations, Inc.
20 West Federal
Suite M-5B
Youngstown, OH 44503 | JC7 3 1 200 |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submission
Correspondent: | William G. McLain
President and Principal Consultant
Keystone Regulatory Services, LLC.
Phone: 717-656-9656
Fax: 717-656-3434
Email: bill.mclain@keystoneregualtory.com | |
| 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
78 KNT at 21 CFR Part 876.5980 | |
| Legally marketed devices
to which the device is
substantially equivalent: | Gabriel Blue Tube Magnetically Guided Feeding Tube (Formerly named
the MagnaFlow® Magnetically Guided Enteral Feeding Tube), K021991 | |
| Description of the device: | The Gabriel Blue Tube serves as a conduit through which enteral feeding
solutions are directly infused into the patient's small bowel. The device will
be marketed in one length (50" [127cm]) and one French size (11 Fr). The
feeding tube contains a stylet which has magnets attached to its tip. An
external magnet is used to capture the tip and guide the device to the
duodenum. A reed switch and light indicate when the magnet has been
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
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. | |
| Technological
characteristics: | The proposed device has the same technological characteristics as the
predicate device(s). | |
SECTION 5. 510(K) SUMMARY
1
K072787pc. dat2
:
.
| Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube | Special 510(k) | |
|---|---|---|
| Performance tests: | Tests were performed to demonstrate substantial equivalence in the following areas: | |
| • Tensile | ||
| • Flow | ||
| • Flexibility | ||
| • Biocompatibility | ||
| Conclusions: | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. |
:
2
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
3
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 (800) 638-2041 or (240) 276-3150 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
4
K07278/B/of/
Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube
Special 510(k)
SECTION 6. INDICATIONS FOR USE STATEMENT
510(k) Number:
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.