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.

Device Description

The MagnaFlow® Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The catheter functions as a conduit for enteral feeding for patients who cannot consume an adequate diet orally. The catheter has a magnet embedded in the distal tip, which through the use of an external magnet aids in catheter placement. When the external magnet is in close proximity to the catheter tip, a reed switch (located proximal to tube tip magnet) closes, causing an LED light (in manifold) to illuminate. That light indicates when the external magnet has captured the tube distal portion. The external magnet can steer the catheter through the stomach pyloric sphincter into the duodenum.

AI/ML Overview

The provided information pertains to a 510(k) premarket notification for a medical device called the MagnaFlow® Magnetically Guided Enteral Feeding Tube. This notification primarily focuses on establishing substantial equivalence to a predicate device already on the market (Flexiflo Magnetically Guided Enteral Feeding Tube, K972437).

Based on the provided text, there is no specific study described that proves the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven device. The document is a regulatory submission for a physical medical device (an enteral feeding tube) and focuses on describing its design, intended use, and substantial equivalence to a previously approved device. It does not detail clinical performance metrics, accuracy, sensitivity, or specificity as would be relevant for a diagnostic or AI device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission focuses on describing the device and its equivalence to a predicate, not on specific performance metrics against defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. As no such performance study is detailed, there's no mention of a test set, sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. This criterion is relevant for studies evaluating diagnostic accuracy, which is not the focus of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided.

5. 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:

This information is not provided. This type of study is relevant for AI-assisted diagnostic devices, which the MagnaFlow® is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided. The MagnaFlow® is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided.

8. The sample size for the training set:

This information is not provided.

9. How the ground truth for the training set was established:

This information is not provided.

Summary of what is provided regarding the device's characteristics and equivalence:

Device Trade Name: MagnaFlow® Magnetically Guided Enteral Feeding Tube
Device Common Name: Enteral Feeding Tube
Device Classification Name: Tube, Feeding at CFR 21 876.5980
Legally Marketed Predicate Device: K972437: Flexiflo Magnetically Guided Enteral Feeding Tube
Description of Device: The MagnaFlow® system is an enteral feeding tube for direct placement in the small bowel. It features a magnet embedded in the distal tip and a reed switch that closes to illuminate an LED light when an external magnet is in close proximity. This external magnet aids in steering the catheter through the stomach pyloric sphincter into the duodenum.
Intended Use: Inserted orally or trans-nasally into the small bowel to provide nutrition, fluids, and medications. For pediatric, adult, or elderly patients who cannot consume an adequate diet orally. Indications include post-trauma, post-surgical, burn patients, general trauma, high-risk patients prone to tube misplacement, and malnourished patients.
Technological Characteristics: The submission states that the proposed device has the "same fundamental technological characteristics of the predicate devices and similar design, packaging, sterilization and labeling." This is the primary "proof" for substantial equivalence in a 510(k) for this type of device – demonstrating that it is essentially the same as a device already cleared for market, rather than proving performance against novel acceptance criteria.

In conclusion, the provided text is a 510(k) summary for a physical medical device. It establishes substantial equivalence to a predicate device, which is the regulatory pathway for market clearance in this context. It does not contain the detailed performance study information typically associated with AI or diagnostic device submissions that would address the acceptance criteria as requested in the prompt.

Summary

{0}------------------------------------------------

JUL 1 8 2002

Page 14

Premarket Notification Syncro Medical Innovations, Inc.

XVI. 510(k) Summary

Submitter:	Syncro Medical Innovations, Inc.433 Cherry StreetLower Level Suite #6Macon, GA 31201
Contact person:	Sabry A. Gabriel, M.D.Phone: (478)301-4093Fax: (478)301-2045e-mail: Gabriel sa@mercer.edu
Date summary prepared:	6/14/02
Device trade name:	MagnaFlow® Magnetically Guided Enteral Feeding Tube
Device common name:	Enteral Feeding Tube
Device classificationname:	Tube, Feeding at CFR 21 876.5980
Legally marketed devicesto which the device issubstantially equivalent:	K972437: Flexiflo Magnetically Guided Enteral Feeding Tube
Description of device:MagnaFlow®	The MagnaFlow® Magnetically Guided Enteral Feeding Tubesystem is intended for direct placement in the small bowel.The catheter functions as a conduit for enteral feeding forpatients who cannot consume an adequate diet orally. Thecatheter has a magnet embedded in the distal tip, whichthrough the use of an external magnet aids in catheterplacement. When the external magnet is in close proximity tothe catheter tip, a reed switch (located proximal to tube tipmagnet) closes, causing an LED light (in manifold) toilluminate. That light indicates when the external magnet hascaptured the tube distal portion. The external magnet can steerthe catheter through the stomach pyloric sphincter into theduodenum.
Intended use of thedevice.	This catheter is inserted orally or trans-nasally directly into thesmall bowel and is intended to provide nutrition, fluids, andmedications directly into the intestinal tract.
Technologicalcharacteristics:	The proposed device has the same fundamental technologicalcharacteristics of the predicate devices and similar design,packaging, sterilization and labeling.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{3}------------------------------------------------

KO2 1991

Premarket Notification Syncro Medical Innovations, Inc. Page 8

VIII. Indications for Use

Concurrance of CRDH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

David G. Stevenson

Regulation Number and Section

§ 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.