The Traditional Length GJ Feeding Device is indicated for use in adult, adolescent, children, and infants over 10kg 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 esophagectorny 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 Traditional Length GJ 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 surgically-created gastric stoma. The multi-lumen tubing is marked with a graduated scale and held in place by means of an inflatable internal retention balloon and a sliding external bolster. The external tri-port is overmolded onto the tubing and contains three ports: one large port for administering nutrition/medication in the jejunum labeled "JEJUNAL," one large port for gastric decompression/drainage labeled "GASTRIC," and one smaller port housing the balloon fill valve labeled "BAL."

The tri-port component of the Traditional Length GJ Feeding Device is offered in two variations: a legacy model and an ENFit® model designed to ISO 80369-3. Both variations of the device are identical except for the design of the tri-port component configurations.

The tri-port of the legacy model has two large silicone funnel ports, and a small port to fill 1. the retention balloon. The JEJUNAL and the GASTRIC ports have individual attached silicone straps and plugs intended to independently close each funnel when not in use. The BAL port houses a small, MR conditional balloon fill valve.
1. The tri-port of the ENFit® model has 2 large ports and one small port akin to the legacy model, but with a twist-lock thermoplastic male ENFit® connector housed in each the JEJUNAL and the GASTRIC funnel ports. The ENFit® connectors are compliant to ISO 80369-3. The JEJUNAL and the GASTRIC ENFit® ports have individual attached tethers and plugs intended to independently close each ENFit® port when not in use. The BAL port houses an MR safe balloon fill valve.

Both the legacy and the ENFit® variations of the Traditional Length GJ Feeding Device are offered in different French sizes. The gastric length of both variations of the Traditional Length GJ Feeding Device is adjustable, depending on where the sliding external bolster is placed along the multi-lumen tubing. Various jejunal lengths are available. The distal portion of only the 16Fr and 18Fr jejunal tubing contains an anti-kink design using a metal spring. At the distal end of every tube, a silicone tip is attached to the device through which a non-absorbable suture is attached. The Traditional Length GJ Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.

AI/ML Overview

The document provided is a 510(k) summary for a medical device called the "Traditional Length GJ Feeding Device". It describes the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted on the Traditional Length GJ Feeding Device. For each test, the general acceptance criterion is that the components and materials "met or exceeded design specifications established by AMT." The reported performance is that the device "meets all the acceptance criteria and performed comparable to or better than the primary predicate."

Therefore, a table can be constructed as follows:

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

The document mentions "various performance tests on the components" and bench tests. However, it does not explicitly state the sample sizes used for these tests. The data provenance is implied to be from bench testing conducted by AMT (Applied Medical Technology, Inc.), the manufacturer. No details about country of origin for the data or whether it's retrospective or prospective are relevant here as it's not a clinical study.

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

This information is not applicable as the evaluation involved bench testing and biocompatibility testing, not expert-adjudicated clinical data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

This information is not applicable as the evaluation involved bench testing and biocompatibility testing, which do not typically require adjudication for ground truth establishment.

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:

No MRMC comparative effectiveness study was done. The device is a physical medical device (feeding tube), not an AI-powered diagnostic or interpretive tool.

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

No standalone algorithm performance study was done. The device is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance testing cited is the design specifications established by AMT and the requirements of recognized standards (ISO and ASTM standards). For biocompatibility, the ground truth is compliance with the requirements of ISO 10993 series for biological evaluation.

8. The Sample Size for the Training Set:

This information is not applicable as there is no training set for a physical medical device applying for 510(k) clearance based on bench testing.

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

This information is not applicable for the same reason as above (no training set).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".

March 1, 2019

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

Re: K182804

Trade/Device Name: Traditional Length GJ Feeding Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: January 23, 2019 Received: January 28, 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 mav, 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 avare 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. 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. 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.

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.

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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

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Indications for Use

510(k) Number (if known) K182804

Device Name Traditional Length GJ 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)

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510(k) Summary

Traditional Length GJ 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: January 23, 2019

II. DEVICE INFORMATION:

Trade/Device Name: Traditional Length GJ Feeding Device Common Name: Gastrointestinal Tube Classification Name: Gastrointestinal tubes and accessories. (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 Traditional Length GJ Feeding Device is indicated for use in adult, adolescent, child, and infant patients over 10kg 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.

Applied Medical Technology, Inc. - 510(k) Submission Traditional Length GJ Feeding Device Section 5 - Page 5.1

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V. DEVICE DESCRIPTION:

The tri-port of the legacy model has two large silicone funnel ports, and a small port to fill 1. the retention balloon. The JEJUNAL and the GASTRIC ports have individual attached silicone straps and plugs intended to independently close each funnel when not in use. The BAL port houses a small, MR conditional balloon fill valve.
1. The tri-port of the ENFit® model has 2 large ports and one small port akin to the legacy model, but with a twist-lock thermoplastic male ENFit® connector housed in each the JEJUNAL and the GASTRIC funnel ports. The ENFit® connectors are compliant to ISO 80369-3. The JEJUNAL and the GASTRIC ENFit® ports have individual attached tethers and plugs intended to independently close each ENFit® port when not in use. The BAL port houses an MR safe balloon fill valve.

TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATEDEVICE
	Subject Device: Traditional Length GJ FeedingDevice	Predicate: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit (K123716)
Device Class andProduct Code:	II, KNT, PIF	II, KNT
	Substantial Equivalence:	Similar
TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATEDEVICE
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
Indications forUse:	The Traditional Length GJ Feeding Device is indicatedfor use in adult, adolescent, child, and infant patientsover 10kg 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 whom malnutritionalready exists, or may result, secondary to concurrentconditions.	The AMT Transgastric-Jejunal feeding tube isindicated for use in patients who cannotabsorb adequate nutrition through thestomach, who have intestinal motilityproblems, gastric outlet obstruction, severegastroesophageal reflux, are at risk ofaspiration, or in those who have had previousesophagectomy or gastrectomy.The use of this tube is also clinically indicatedwhen simultaneous gastric decompression andjejunal feeding are needed. This includespatients in whom malnutrition already exists,or may result, secondary to concurrentconditions.
	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 ofenteral nutrition into the distal duodenum orproximal jejunum.
	Substantial Equivalence:	Same
Principles ofOperation	• Deliver enteral nutrition directly into the smallintestine by enteral feeding pump.• Allow gastric decompression by gravity (leavingthe G plug open), or connect to low intermittentsuction.	• Deliver enteral nutrition directly into thesmall intestine by enteral feeding pump.• Allow gastric decompression by gravity(connect extension set to gastric port,leaving the plug open), or connect to lowintermittent suction.
	Substantial Equivalence:	Similar
TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATEDEVICE
Major DesignCharacteristics	Medical grade silicone construction Medical grade silicone tubing with graduated centimeter markings Sliding external bolster External tri-port adapter: Jejunal feeding port with strap/plug Gastric decompression port with strap/plug Balloon fill valve Inflatable silicone internal retention balloon Multiple Gastric and Jejunal exit ports Anti-kink enforced Jejunal portion (16Fr & 18Fr only) Tapered distal tip with suture MR Conditional	Medical grade silicone construction Medical grade silicone tubing External low-profile bolster: Jejunal feeding port with interlock and strap/plug Gastric decompression port with interlock and strap/plug Balloon fill valve Inflatable silicone internal retention balloon Multiple Gastric and Jejunal exit ports Anti-kink enforced Jejunal portion (16Fr & 18Fr only) Tapered distal tip with suture MR Conditional
	Substantial Equivalence:	Similar

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE: VI.

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Applied Medical Technology, Inc. – 510(k) Submission Traditional Length GJ Feeding Device

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As indicated above, minor differences exist between the Traditional Length GJ Feeding Device and the predicate device. These differences include:

External device profile/size: The subject device has a tri-port (overmold) attached to a standard length of adjustable gastric tubing available in various jejunal lengths while the primary predicate is not adjustable, but rather has a low-profile (overmold) bolster attached to various gastric and jejunal length configurations.
These minor design differences between the Traditional Length GJ Feeding Device (subject device) and the primary predicate (K123716) device do not raise different questions of safety and/or effectiveness from the predicate device. The intended use and indications for use remain the same between the Traditional Length GJ Feeding Device and the predicate device.

VII. PERFORMANCE DATA:

A. Biocompatibility Testing: Following a Biological Evaluation Plan, the Traditional Length GJ 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 - 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

Applied Medical Technology, Inc. - 510(k) Submission Traditional Length GJ Feeding Device Section 5 - Page 5.4

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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 Traditional Length GJ 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 Traditional Length GJ 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
- Flow Rate O
- Leak Test O
- Tensile Test to tear tubing at jejunal holes O
- Tensile Test to tear tubing at gastric holes O
- Minimum Overmold Tri-Port Bond Strength O
- Stoma Pullout O
- Tubing Tensile Test O
- Suture Pullout 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

Applied Medical Technology, Inc. - 510(k) Submission Traditional Length GJ Feeding Device

Section 5 - Page 5.5

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Balloon volume maintenance O
Balloon size and shaft size O
Balloon concentricity O
Balloon integrity O
Testing per ISO 80369-20: ●
- O Fluid leakage
- Stress cracking O
- Resistance to separation from axial load O
- Resistance to separation from unscrewing O
- Resistance to overriding O
- Disconnection by unscrewing O
Testing per ASTM F2052:
- Magnetically induced displacement force O
Testing per ASTM F2213:
- Magnetically induced torque O
Testing per ASTM F2119:
- MR image artifact o
Testing per ASTM F2182:
- Radio frequency induced heating O

The Traditional Length GJ 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:

The Traditional Length GJ Feeding Device can be found substantially equivalent to the primary 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.

Test	Acceptance Criteria	Reported Device Performance
Testing per AMT Design Specifications	Components met or exceeded design specifications	Met or exceeded design specifications
Balloon Assembly Bond Peel/Tear Strength	Met or exceeded design specifications	Met or exceeded design specifications
Balloon Burst	Met or exceeded design specifications	Met or exceeded design specifications
Fill Valve Blow Out	Met or exceeded design specifications	Met or exceeded design specifications
Fill Valve Pullout	Met or exceeded design specifications	Met or exceeded design specifications
Flow Rate	Met or exceeded design specifications	Met or exceeded design specifications
Leak Test	Met or exceeded design specifications	Met or exceeded design specifications
Tensile Test to tear tubing at jejunal holes	Met or exceeded design specifications	Met or exceeded design specifications
Tensile Test to tear tubing at gastric holes	Met or exceeded design specifications	Met or exceeded design specifications
Minimum Overmold Tri-Port Bond Strength	Met or exceeded design specifications	Met or exceeded design specifications
Stoma Pullout	Met or exceeded design specifications	Met or exceeded design specifications
Tubing Tensile Test	Met or exceeded design specifications	Met or exceeded design specifications
Suture Pullout Tensile Test	Met or exceeded design specifications	Met or exceeded design specifications
Gastric Strap Tensile Test	Met or exceeded design specifications	Met or exceeded design specifications
Jejunal Strap Tensile Test	Met or exceeded design specifications	Met or exceeded design specifications
Testing per ASTM F2528-06	Conformance to applicable recognized standards	Conformed to applicable recognized standards
Balloon Integrity in Simulated Gastric Fluid	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Balloon volume maintenance	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Balloon size and shaft size	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Balloon concentricity	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Balloon integrity	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Testing per ISO 80369-20	Conformance to applicable recognized standards	Conformed to applicable recognized standards
Fluid leakage	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Stress cracking	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Resistance to separation from axial load	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Resistance to separation from unscrewing	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Resistance to overriding	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Disconnection by unscrewing	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Testing per ASTM F2052	Conformance to applicable recognized standards	Conformed to applicable recognized standards
Magnetically induced displacement force	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Testing per ASTM F2213	Conformance to applicable recognized standards	Conformed to applicable recognized standards
Magnetically induced torque	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Testing per ASTM F2119	Conformance to applicable recognized standards	Conformed to applicable recognized standards
MR image artifact	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Testing per ASTM F2182	Conformance to applicable recognized standards	Conformed to applicable recognized standards
Radio frequency induced heating	Conformed to applicable recognized standards	Conformed to applicable recognized standards
Biocompatibility	Met acceptance criteria for permanent contact with mucosal membrane and breached/compromised surfaces	Met acceptance criteria for permanent contact with mucosal membrane and breached/compromised surfaces