(30 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube based on the provided document:
This 510(k) submission is a "Special 510(k)", which is used for modifications to a legally marketed device where the modifications do not affect the intended use or fundamental scientific technology of the device. Consequently, the provided information focuses on performance tests confirming the substantial equivalence of the modified device to its predicate, rather than a de novo clinical study with extensive details about ground truth establishment, reader studies, or training sets typical of entirely new AI/ML devices.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Tests Conducted) |
|---|---|
| Mechanical Integrity | Tensile |
| Flow Dynamics | Flow |
| Physical Characteristics | Flexibility |
| Biocompatibility | Biocompatibility |
Conclusion: The results of the laboratory tests demonstrated that the device is as safe and effective as the legally marketed predicate devices. This implies the new device met performance benchmarks inherent to the predicate device's established safety and effectiveness.
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample sizes for each performance test (Tensile, Flow, Flexibility, Biocompatibility). It refers to "Tests were performed," indicating internal laboratory testing.
- Data Provenance: The tests were "laboratory tests," implying internal testing conducted by the manufacturer, Syncro Medical Innovations, Inc. No information is provided regarding the country of origin for the data or whether it was retrospective or prospective in terms of patient data, as these tests are primarily materials and functional performance evaluations rather than patient-based clinical trials.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in the context of this 510(k) submission. "Ground truth" in this scenario would relate to the established engineering specifications and benchmarks for the physical and biological properties of the feeding tube. These are typically defined by industry standards and regulatory requirements, not by expert consensus on clinical images or diagnoses.
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Adjudication Method for the Test Set:
- Not applicable. The "adjudication method" is typically relevant for studies involving human interpretation or clinical endpoints, where discrepancies between evaluators need to be resolved. For material and functional performance tests, results are typically quantitative and compared against predefined specifications.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This type of study is not relevant for a device like a magnetically guided enteral feeding tube, which is a physical medical device and not an AI/ML diagnostic tool or software.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm or AI system.
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The type of ground truth used:
- For this device, the "ground truth" for the performance tests would be established engineering specifications, material standards, and regulatory requirements for tensile strength, flow rate, flexibility, and biocompatibility. These are objective measurements compared against predefined limits or against the performance of the legally marketed predicate device.
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The sample size for the training set:
- Not applicable. There is no training set mentioned or implied as this is a physical medical device being evaluated for substantial equivalence based on its physical properties and performance, not an AI/ML model.
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How the ground truth for the training set was established:
- Not applicable, as no training set exists for this type of device submission.
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K072787 R. lot 2
Special 510(k)
| Submitter: | Syncro Medical Innovations, Inc.20 West FederalSuite M-5BYoungstown, OH 44503 | JC7 3 1 200 |
|---|---|---|
| SubmissionCorrespondent: | William G. McLainPresident and Principal ConsultantKeystone Regulatory Services, LLC.Phone: 717-656-9656Fax: 717-656-3434Email: 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, Feeding78 KNT at 21 CFR Part 876.5980 | |
| Legally marketed devicesto which the device issubstantially equivalent: | Gabriel Blue Tube Magnetically Guided Feeding Tube (Formerly namedthe MagnaFlow® Magnetically Guided Enteral Feeding Tube), K021991 | |
| Description of the device: | The Gabriel Blue Tube serves as a conduit through which enteral feedingsolutions are directly infused into the patient's small bowel. The device willbe marketed in one length (50" [127cm]) and one French size (11 Fr). Thefeeding tube contains a stylet which has magnets attached to its tip. Anexternal magnet is used to capture the tip and guide the device to theduodenum. A reed switch and light indicate when the magnet has beencaptured 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 tubefunctions as a conduit to facilitate enteral feeding, and may be used inpediatric, adult or elderly patients who cannot consume an adequate dietorally. Small bowel feeding may be indicated for patients with afunctioning gut who require short- to moderate-term feeding support, suchas post-trauma patients, post-surgical patients, burn patients, generaltrauma patients, high-risk patients prone to tube misplacementcomplications, 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 thesafe, rapid placement of the feeding tube into the small bowel. | |
| Technologicalcharacteristics: | The proposed device has the same technological characteristics as thepredicate 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:• 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. |
:
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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 (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
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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:
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.
§ 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.