The Micro Transgastric-Jejunal Feeding Device is inchildren and adults who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.

The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Device Description

The AMT Micro Transgastric-Jejunal feeding device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a gastric stoma. The tube in held in place (within the stoma tract) by means of an inflatable balloon and a low-profile external bolster. The external bolster contains two ports; one labeled "JEJUNAL" (glow green) and one labeled "GASTRIC" (white). Incorporated within each port is a one-way valve which is opened by attaching the appropriate AMT Extension Set. AMT Extension Sets are color coded and connect to the feeding and drainage ports. The JEJUNAL (glow green) port is used for feeding into the small intestine. The GASTRIC (white) port is used to drain the stomach with the use of low intermittent suction or gravity drainage. A third port labeled "BAL" is used to inflate and deflate the balloon.

The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical targets. Instead, it describes various performance tests conducted on the Micro Transgastric-Jejunal Feeding Device to demonstrate conformance to applicable recognized standards and comparability to the predicate device.

Therefore, I cannot populate a table of acceptance criteria with reported device performance or describe a study that proves the device meets specific numerical acceptance criteria.

However, I can extract information about the types of tests performed and the general conclusion regarding device performance.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted, specific numerical acceptance criteria and reported device performance are not provided in the document. The text broadly states that the device "meets all the acceptance criteria and performed comparable to or better than the primary predicate."

Therefore, the table would look like this, indicating the lack of specific data in the provided document:

Acceptance Criteria (Specific Numerical Targets)	Reported Device Performance (Specific Numerical Results)
Not specified in the document	Not specified in the document; generally stated as "met all acceptance criteria and performed comparable to or better than the primary predicate."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified. The document mentions "various performance tests on the components" and lists types of tests, but does not provide the number of units or samples tested for each.
Data Provenance: The tests were conducted internally by AMT ("AMT conducted various performance tests") and are bench tests. The document does not specify a country of origin for the data or whether it's retrospective or prospective, though bench testing is inherently prospective for the specific tests performed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable for performance bench testing. Ground truth, in the context of expert review, is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) where human experts determine the correct outcome. The tests described are physical performance tests (e.g., strength, flow rate).

4. Adjudication Method for the Test Set:

Not applicable for performance bench testing. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers or experts when establishing ground truth. This is not relevant to objective physical performance measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document explicitly states: "F. Clinical Study: Clinical testing was NOT performed." MRMC studies involve human readers and clinical cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The device is a physical medical device (a feeding tube), not an algorithm or software. The document explicitly states: "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" would be the physical measurement standards and design specifications established by AMT and defined by the listed ISO and ASTM standards. The device's performance was compared against these established technical benchmarks.

8. The Sample Size for the Training Set:

Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As a physical device, there is no "training set" or "ground truth for a training set" in the context of AI/ML.

Summary of Device Performance Study (as described):

The manufacturer, Applied Medical Technology, Inc. (AMT), conducted various bench tests on the components of the Micro Transgastric-Jejunal Feeding Device. These tests aimed to demonstrate conformance to applicable recognized standards and to compare the device's performance to its primary predicate (AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit, K123716).

Tests performed included:

Testing per AMT Design Specifications:
- Balloon Assembly Bond Peel/Tear Strength
- Balloon Burst
- Fill Valve Blow Out
- Fill Valve Pullout
- Flow Rate
- Leak Test
- Tensile Test to remove jejunal interlock
- Tensile Test to remove gastric interlock
- Tensile Test to tear tubing at jejunal hole
- Tensile Test to tear tubing at gastric hole
- Minimum Overmold External Bolster Bond Strength
- Stoma Pullout
- Tubing Tensile Test
- Gastric Strap Tensile Test
- Jejunal Strap Tensile Test
Testing per ASTM F2528-06 (Standard for Gastrostomy and Jejunostomy Feeding Tubes):
- Balloon Integrity in Simulated Gastric Fluid
- Balloon volume maintenance
- Balloon size and shaft size
- Balloon concentricity
- Balloon integrity
Testing per ISO 80369-20 (Small-bore connectors for liquids and gases in healthcare applications):
- Fluid leakage
- Stress cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
Testing per ASTM F2052 (Magnetic Resonance Safety):
- Magnetically induced displacement force
Testing per ASTM F2119 (Magnetic Resonance Safety):
- MR image artifact
Testing per ASTM F2182 (Magnetic Resonance Safety):
- Radio frequency induced heating
Biocompatibility Testing following ISO 10993 standards (Parts 1, 3, 5, 6, 7, 10, 11, 12, 17) for permanent contact with mucosal membranes and breached/compromised surfaces.

Conclusion of the study: The document states that the Micro Transgastric-Jejunal Feeding Device "meets all the acceptance criteria and performed comparable to or better than the primary predicate." No animal studies or clinical studies were performed. The specific numerical data from these tests that support this conclusion are not included in the provided text.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 29, 2019

Applied Medical Technology, Inc. Joy Tubero Regulatory Affairs Specialist 8006 Katherine Boulevard Brecksville, OH 44141

Re: K183508

Trade/Device Name: Micro Transgastric-Jejunal Feeding Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: February 25, 2019 Received: February 27, 2019

Dear Joy Tubero:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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/tray. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

Page 2

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark J. Antonino -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K183508

Device Name Micro Transgastric-Jejunal Feeding Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

✘ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

Micro Transgastric-Jejunal Feeding Device

I. SUBMITTER:

Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 Phone: 440-717-4000 Fax: 440-717-4200

Contact Person: Joy Tubero - Regulatory Affairs Specialist Email: joy.tubero@appliedmedical.net Date Prepared: December 14, 2018

II. DEVICE INFORMATION:

Trade/Device Name: Micro Transgastric-Jejunal Feeding Device Common Name: Gastrointestinal Tube Classification Name: Gastrointestinal Tube And Accessories Regulation Number: 21 CFR 876.5980 Product Code: KNT, PIF Regulatory Class: II Review Panel: Gastroenterology and Urology

III. PREDICATE INFORMATION:

Primary Predicate: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit (K123716)

The predicate device has not been subject to design-related recalls. .

INDICATIONS FOR USE: IV.

The Micro Transgastric-Jejunal Feeding Device is indicated for use in adult, adolescent, child, and infant patients over 6kg who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.

{4}------------------------------------------------

V. DEVICE DESCRIPTION:

The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.

TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THEPREDICATE DEVICES
	Subject Device: Micro Transgastric-Jejunal FeedingDevice	Predicate: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit (K123716)
Device Class andProduct Code:	II, KNT, PIF	II, KNT
	Substantial Equivalence:	Same
Sterilization:	Sterile (Ethylene Oxide), single use only.	Sterile (Ethylene Oxide), single use only.
	Substantial Equivalence:	Same
Prescription	Single use: Prescription Only	Single use: Prescription Only
	Substantial Equivalence:	Same
MRI SafetyInformation	Labeled MR Conditional	Labeled MR Conditional
	Substantial Equivalence:	Same
TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THEPREDICATE DEVICES
	Subject Device: Micro Transgastric-Jejunal FeedingDevice	Predicate: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit (K123716)
Indications forUse:	The Micro Transgastric-Jejunal Feeding Device isindicated for use in adult, adolescent, child, and infantpatients over 6kg who cannot absorb adequate nutritionthrough the stomach, who have intestinal motilityproblems, gastric outlet obstruction, severegastroesophageal reflux, are at risk of aspiration, or inthose who have had previous esophagectomy orgastrectomy.The use of this tube is also clinically indicated whensimultaneous gastric decompression and jejunal feedingare needed. This includes patients in whommalnutrition already exists, or may result, secondary toconcurrent conditions.	The AMT Transgastric-Jejunal feeding tube isindicated for use in patients who cannot absorbadequate nutrition through the stomach, who haveintestinal motility problems, gastric outletobstruction, severe gastroesophageal reflux, are atrisk of aspiration, or in those who have hadprevious esophagectomy or gastrectomy.The use of this tube is also clinically indicatedwhen simultaneous gastric decompression andjejunal feeding are needed. This includes patientsin whom malnutrition already exists, or may result,secondary to concurrent conditions.
	Substantial Equivalence:	Similar
Intended Use:	Provide simultaneous gastric decompression/drainageand delivery of enteral nutrition into the distalduodenum or proximal jejunum.	Provide simultaneous gastricdecompression/drainage and delivery of enteralnutrition into the distal duodenum or proximaljejunum.
	Substantial Equivalence:	Same
Sizes:	• Tube Diameter: larger proximal-gastric Fr size, smallerdistal-jejunal Fr size	• Tube Diameter: entire length of device is one Frsize
	Substantial Equivalence:	Similar
Principles ofOperation	• Deliver enteral nutrition directly into the smallintestine by enteral feeding pump.• Allow gastric decompression by gravity (connectextension set to gastric port, leaving the plug open), orconnect to low intermittent suction.	• Deliver enteral nutrition directly into the smallintestine by enteral feeding pump.• Allow gastric decompression by gravity (connectextension set to gastric port, leaving the plugopen), or connect to low intermittent suction.
	Substantial Equivalence:	Same
TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THEPREDICATE DEVICES
	Subject Device: Micro Transgastric-Jejunal FeedingDevice	Predicate: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit (K123716)
Major DesignCharacteristics	Medical grade silicone and polyurethaneconstruction External low-profile bolster: Jejunal feeding port with interlock andstrap/plug Gastric decompression port with interlock andstrap/plug Balloon fill valve Anti-reflux duckbill valves to help prevent leakage Inflatable silicone internal retention balloon Gastric and jejunal exit ports Anti-kink enforced Jejunal tubing Tapered distal tip Radiopaque barium sulfate to aid in visualization MR Conditional Sold as part of a kit with accessories	Medical grade silicone construction External low-profile bolster: Jejunal feeding port with interlock andstrap/plug Gastric decompression port with interlockand strap/plug Balloon fill valve Anti-reflux duckbill valves to help preventleakage Inflatable silicone internal retention balloon Gastric and Jejunal exit ports Anti-kink enforced Jejunal portion of tubing(16Fr & 18Fr only) Tapered distal tip with suture Radiopaque barium sulfate to aid invisualization MR Conditional Sold as part of a kit with accessories
	Substantial Equivalence:	Similar

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATES:

{5}------------------------------------------------

SECTION – 5

{6}------------------------------------------------

As indicated above, minor differences exist among the Micro Transgastric-Jejunal Feeding Device and the predicate devices. These differences include:

. Tubing Material: The subject device tubing is composed of silicone and polyurethane while the predicate tubing is constructed of silicone tubing.
Size: The subject device is offered with a distal/jejunal Fr size of tubing that is smaller than that of the proximal/gastric Fr size whereas the Fr size is consistent throughout the entire length of the predicate device.

These minor design differences between the Micro Transgastric-Jejunal Feeding Device (subject device), and the predicate (K123716) do not raise different questions of safety and/or effectiveness from the predicate or the reference device. The intended use and indications for use remain the same between the Micro Transgastric-Jejunal Feeding Device and the predicate device.

VII. PERFORMANCE DATA:

A. Biocompatibility Testing: Following a Biological Evaluation Plan, the Micro Transgastric-Jejunal Feeding Device has been tested for biocompatibility based on the applicable sections of the following standards:
ISO 10993-1: 2009 Biological Evaluation of Medical Devices ●

{7}------------------------------------------------

Part 1: Evaluation and testing within a risk management process
ISO 10993-3: 2014 Biological Evaluation of Medical Devices ● - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices . - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-6: 2016 Biological Evaluation of Medical Devices . - Part 6: Test for local effects after implantation.
. ISO 10993-7: 2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization.
. ISO 10993-11:2006 Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological Evaluation of Medical Devices ● - Part 12: Sample preparation and reference materials
ISO 10993-17:2002 Biological Evaluation of Medical Device ● - Part 17: Sample preparation and reference materials

In accordance with a Biological Evaluation Plan, a Biological Risk Assessment was completed on the patient contacting materials and it was determined that the Micro Transgastric-Jejunal Feeding Device met the acceptance criteria for permanent contact (greater than 30 days) with mucosal membrane and breached/compromised surfaces.

B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device.
C. Electromagnetic Compatibility & Electrical Safety: There are NO electronic components related in any way to this device.

D. Performance Testing:

AMT conducted various performance tests on the components contained within the Micro Transgastric-Jejunal Feeding Device. Testing found that all components and materials met or exceeded design specifications established by AMT.

Bench tests have been carried out to demonstrate conformance to applicable recognized standards, as well as to compare performance to the predicate. The tests carried out are outlined below.

Testing per AMT Design Specifications:
- Balloon Assembly Bond Peel/Tear Strength O
- Balloon Burst O
- Fill Valve Blow Out O
- Fill Valve Pullout O

{8}------------------------------------------------

Flow Rate O
Leak Test O
Tensile Test to remove jejunal interlock O
Tensile Test to remove gastric interlock O
Tensile Test to tear tubing at jejunal hole O
O Tensile Test to tear tubing at gastric hole
Minimum Overmold External Bolster Bond Strength O
Stoma Pullout O
Tubing Tensile Test O
Gastric Strap Tensile Test O
Jejunal Strap Tensile Test O
Testing per ASTM F2528-06: ●
- Balloon Integrity in Simulated Gastric Fluid O
- Balloon volume maintenance O
- Balloon size and shaft size O
- Balloon concentricity O
- Balloon integrity O
. Testing per ISO 80369-20:
- Fluid leakage O
- Stress cracking O
- o Resistance to separation from axial load
- Resistance to separation from unscrewing O
- O Resistance to overriding
- O Disconnection by unscrewing
Testing per ASTM F2052:
- Magnetically induced displacement force O
Testing per ASTM F2119: ●
- o MR image artifact
Testing per ASTM F2182:
- Radio frequency induced heating O

The Micro Transgastric-Jejunal Feeding Device meets all the acceptance criteria and performed comparable to or better than the primary predicate.

E. Animal Study: Animal testing was NOT performed.
F. Clinical Study: Clinical testing was NOT performed. Clinical evidence gathered from independent organizations has been included in the submission.

VIII. Conclusion:

{9}------------------------------------------------

The Micro Transgastric-Jejunal Feeding Device can be found substantially equivalent to the predicate device cleared under K123716 in intended use, performance, and principles of operation. The minor design differences between the subject device and the legally marketed predicate do not raise different questions of safety and/or efficacy, and the information submitted in this application demonstrates that the subject device is at least as safe and effective as the current legally marketed device.

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.