The AMT G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.

Device Description

The Applied Medical Technology, Inc. G-Tube Balloon Gastrostomy Feeding Device (AMT G-Tube) is made of silicone elastomer and is designed for enteral feeding in a gastrostomy tract. The device can be used as a replacement device through a mature stoma tract or for initial placement in a supported stoma tract. The device is offered in several French (FR) sizes ranging from 12 FR to 24 FR. On the shaft near the end is located a balloon which, when properly inflated acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The external bolster (preassembled on the AMT G-Tube) acts as a stabilizer to prevent inward migration. The device is sold as sterile and can be placed in an outpatient or home setting by a health care professional or care giver.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AMT G-Tube Balloon Gastrostomy Feeding Device, based on the provided FDA 510(k) summary:

This device is not an AI/ML powered device, therefore, sections 2-6 and 8-9 do not apply.

Acceptance Criteria and Reported Device Performance

Device Name: AMT G-Tube Balloon Gastrostomy Feeding Device

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implied/Stated)	Reported Device Performance (Summary)	Basis for Acceptance (Study Type)
Biocompatibility	ISO 10993-1, -3, -5, -6, -7, -10, -11	Met acceptance criteria for permanent contact (>30 days) with mucosal membrane and breached/compromised surfaces.	Met all applicable biocompatibility requirements.	Bench Testing
Sterilization	ANSI/AAMI/ISO 11135-1:2014	Sterility Assurance Level (SAL) of $10^{-6}$.	Validated to confirm a SAL of $10^{-6}$. Sterilization processing complies.	Bench Testing
	ISO 10993-7	Compliance with Ethylene Oxide Sterilization Residuals.	Complied with ISO 10993-7.	Bench Testing
Shelf Life	ASTM F1980	Evaluation of performance after simulated 3-year accelerated aging of packaging. Evaluation of performance of 50A durometer 18Fr TGJ assemblies after four years of accelerated aging. Evaluation of performance of 50A durometer 18Fr TGJ sprung tubing after four-year accelerated aging simulation.	Validated shelf life of three years.	Bench Testing
Bench Testing	AMT Design Specifications	Balloon Assembly Bond Peel/Tear Strength: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Balloon Burst: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Fill Valve Blow Out: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Fill Valve Pullout: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Flow Rate: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Leak Test: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Tubing Tensile Test to determine strength (at gastric holes): (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Minimum Overmold Bond Strength: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Stoma Pullout: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Tubing Cyclic and Tensile Test: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Main Strap Tensile Test: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Side Strap Tensile Test: (Specific values not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
	ASTM F2528-06	Balloon Integrity in Simulated Gastric Fluid: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Balloon volume maintenance: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Balloon size and shaft size: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Balloon concentricity: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Balloon integrity: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
	ISO 80369-3	Dimensional Verification: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Missed Connection Testing: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
	ISO 80369-20	Fluid leakage: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Stress cracking: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Resistance to separation from axial load: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Resistance to separation from unscrewing: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Resistance to overriding: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
		Disconnection by unscrewing: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
	ISO 11607-1:2019 and ISO 11607-2:2019	Packaging for terminally sterilized medical devices: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
	EN 1615:2000, EN 1618:1997	Leak Testing: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing
Safety - Pyrogenicity	USP 41-National Formulary (NF) 36: 2018 <151>	Pyrogenicity testing: (Specific requirements not provided, but implied to be met)	Met or exceeded all acceptance criteria.	Bench Testing

Study Information

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided document does not specify the sample sizes for the individual bench tests or the country of origin/provenance for the data. The studies performed were bench testing, meaning they were conducted in a laboratory setting rather than with human subjects, therefore, provenance like "country of origin" is less relevant than for clinical data. The tests are prospective in nature, as they are specifically designed to evaluate the performance of the manufactured device.

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 section is not applicable as the studies described are bench tests (biocompatibility, sterilization, shelf life, and various physical performance tests) and do not involve expert review or establishment of ground truth in the context of diagnostic interpretation. The "ground truth" for these tests is the objective measurement against established engineering, material, and safety standards (e.g., a specific tensile strength, absence of pyrogens, a confirmed SAL).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among human readers/experts, typically in diagnostic studies. The studies performed were bench tests against pre-defined engineering and safety standards.

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 section is not applicable. The device is a physical medical device (gastrostomy feeding tube), not an AI/ML powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical medical device and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the various performance tests (biocompatibility, sterilization, shelf life, and bench tests) is based on established industry standards, design specifications, and objective laboratory measurements. For instance, a confirmed Sterility Assurance Level ($10^{-6}$) is an objective measurement against a standard, not an expert consensus or pathology report. Similarly, meeting specific tensile strength, flow rate, or leak test criteria are objective measurements against defined engineering specifications.

8. The sample size for the training set:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set.

9. How the ground truth for the training set was established:
This section is not applicable as the device is a physical medical device and does not involve AI/ML that requires a training set and its associated ground truth establishment.

Summary

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December 18, 2023

Applied Medical Technology, Inc. Jennifer Hazou Regulatory Affairs Specialist 8006 Katherine Blvd. Brecksville, Ohio 44141

Re: K222846

Trade/Device Name: AMT G-Tube Balloon Gastrostomy Feeding Device Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT Dated: November 17, 2023 Received: November 17, 2023

Dear Jennifer Hazou:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222846

Device Name

AMT G-Tube Balloon Gastrostomy 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

AMT G-Tube Balloon Gastrostomy Feeding Device

I. SUBMITTER:

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

Contact Person: Jennifer Hazou - Regulatory Affairs Specialist Email: Jennifer.Hazou@appliedmedical.net Date Prepared: November 17, 2023

II. DEVICE INFORMATION:

Trade/Device Name: AMT G-Tube Balloon Gastrostomy Feeding Device Common Name: Gastrointestinal Tube and Accessories Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT

III. PREDICATE INFORMATION:

Predicate: K161413 (Low Profile Balloon Feeding Device; Applied Medical Technology, Inc.)

Secondary Predicate Device: K190923 (Salem Sump Dual Lumen Stomach Tube with ENFit Connection; Cardinal Health).

Tertiary Predicate Device: K971434 (AMT G-Tube Balloon Replacement Gastrostomy Feeding Device; Applied Medical Technology, Inc.)

** None of the predicate devices have been subject to design-related recalls.

IV. INDICATIONS FOR USE:

Applied Medical Technology, Inc. - 510(k) Submission AMT G-Tube Balloon Gastrostomy Feeding Device Section 5 - Page 5.1

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v. DEVICE DESCRIPTION:

The device is offered in several French (FR) sizes ranging from 12 FR to 24 FR. On the shaft near the end is located a balloon which, when properly inflated acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device. The external bolster (preassembled on the AMT G-Tube) acts as a stabilizer to prevent inward migration.

The device is sold as sterile and can be placed in an outpatient or home setting by a health care professional or care giver.

For G-Tubes without Enhanced Decompression Capabilities:

The device has a "Y" port on one end. On this end there are three openings. One for the luer syringe to fill the balloon (contains a fill valve in this opening). One for attaching external tubing for feeding. One for administering medication if required (also known as a med port). The Y-Port has flexible caps for closing off the feeding and med ports when not in use. The silicone balloon is bonded on the other end of the G-Tube and a separate channel through the tubing connects the balloon to the balloon filling port and valve. The balloon filling port contains the valve required to fill and deflate the balloon using a luer syringe.

For G-Tubes with Enhanced Decompression Capabilities:

The device has a "Y" port on one end. On this end there are three openings. One for the luer syringe to fill the balloon (contains a fill valve in this opening). When not utilizing the decompression capability of the device, the large, main port will be used for attaching external tubing/syringe for feeding and medication. When decompressing the stomach is required, this same large, main port will be attached to external suction for decompression. During decompression, the smaller side port on the "Y" port will open to provide make-up air to the stomach. The Y-Port has flexible caps for closing off the main and side ports when not in use. The silicone balloon is bonded along the tubing of the G-Tube, and a separate channel through the tubing connects the balloon to the balloon fill port and valve. The balloon fill port contains the valve required to fill and deflate the balloon using a luer syringe.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATES:

TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATE DEVICES
	Subject Device:	Predicate(K161413):	SecondaryPredicate(K190923):	Tertiary Predicate(K971434):
Device Classand ProductCode:	Class II; KNT	Class II; KNT	Class II; PIF, FEG	Class II; KNT
	Substantial Equivalence:	Same	Different	Same
Sterilization:	Sterile (Ethylene Oxide),single use only	Sterile (EthyleneOxide), single use only	Sterile (Ethylene Oxide),single use only	Sterile (Ethylene Oxide),single use only
	Substantial Equivalence:	Same	Same	Same
Prescription	Single use: PrescriptionOnly.	Single use:Prescription Only.	Single use: PrescriptionOnly.	Single use: PrescriptionOnly.
	Substantial Equivalence:	Same	Same	Same
Indications forUse:	The AMT G-Tube BalloonGastrostomy FeedingDevice is indicated to beused as a percutaneousgastrostomy tube. Thisdevice will assist inproviding nutritiondirectly into the stomachthrough a secured (initialplacement) or formed(replacement) stoma in ahuman patient, 10kg orabove, who is unable toconsume nutrition byconventional means. TheAMT G-Tube BalloonGastrostomy FeedingDevice can also delivermedication and allow fordecompression of thestomach.	The Low ProfileBalloon FeedingDevice is indicated foruse in patients whorequire long termfeeding, are unable totolerate oral feeding,who are at low risk foraspiration, requiregastric decompressionand/or medicationdelivered directly intothe stomach througha secured (initialplacement) or formed(replacement) stoma.The Low ProfileBalloon FeedingDevice is intended forall age groups.	The Salem Sump™ DualLumen Stomach Tubewith ENFit™ Connectionis intended for gastricdecompression andadministration ofnutrition, fluids andmedication. The deviceis intended for patientswith age of two andolder.	The AMT Balloon G-Tubeis to be used as apercutaneousreplacementgastrostomy tube for apatient with a well-established gastrostomytract. This device willassist in providingnutrition directly intothe stomach through anestablished stoma in ahuman patient who isunable to consumenutrition byconventional means.The AMT Balloon G-Tubecan also delivermedication and allow fordecompression of thestomach.
	Subject Device:	Predicate(K161413):	SecondaryPredicate(K190923):	Tertiary Predicate(K971434):
	Substantial Equivalence:	Similar	Similar	Similar
Intended Use:	To provide nutritiondirectly into the stomachthrough a secured (initialplacement) or formed(replacement) stoma in ahuman patient who isunable to consumenutrition by conventionalmeans. The device doesnot require endoscopy forremoval or replacement.	The Low ProfileBalloon FeedingDevice is indicated foruse in patients whorequire long termfeeding, are unable totolerate oral feeding,who are at low risk foraspiration, requiregastric decompressionand/or medicationdelivered directly intothe stomach througha secured (initialplacement) or formed(replacement) stoma.The Low ProfileBalloon FeedingDevice is intended forall age groups.	The Salem Sump™ DualLumen Stomach Tubewith ENFit™ Connectionis intended for gastricdecompression andadministration ofnutrition, fluids andmedication. The deviceis intended for patientswith age of two andolder.	To provide nutritiondirectly into the stomachthrough an establishedstoma in a humanpatient who is unable toconsume nutrition byconventional means. TheG-Tube BalloonReplacementGastrostomy FeedingDevice is meant to be areplacement device, notan initially placedfeeding tube. The devicedoes not requireendoscopy for removalor replacement. Thedevice is designed inseveral sizes toaccommodate thepediatric as well as theadult patient.
	Substantial Equivalence:	Similar	Similar	Similar
Principles ofOperation	The device features a bi-lumen silicone tubeovermolded on one endwith a silicone Y-portthrough which nutritionand medication may bedelivered. Opposite the Y-port, the tubing is definedon one end with aninflatable silicone balloonthat acts as an internalbolster to preventoutward migration of thedevice.Along the tubing,between the Y-port and	The device features abi-lumen siliconetube overmolded onone end with a low-profile siliconebolster throughwhich nutrition andmedication may bedelivered, by way ofpolycarbonateinterlock. Oppositethe bolster, thetubing is tipped onone end with aspecial silicone tip,bonded directly to aninflatable silicone	One lumen is used as theprimary channel fornutrition and medicationdelivery, while thesecond lumen serves asa vent channel andallows make-up air to bedrawn into the stomachwhen GastricDecompression isperformed through theprimary lumen –reducing the chance thatthe suction causesulceration of the mucosaof the stomach wall	The device features a bi-lumen silicone tubeovermolded on one endwith a silicone Y-portthrough which nutritionand medication may bedelivered. Opposite the Y-port, the tubing istipped on one end withan inflatable siliconeballoon that acts as aninternal bolster toprevent outwardmigration of the device.Along the tubing,between the Y-port and
TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATE DEVICES
	Subject Device:	Predicate(K161413):	SecondaryPredicate(K190923):	Tertiary Predicate(K971434):
	external bolster that ispositioned snug to theabdomen to preventinward migration.Those configurations thatfeature EnhancedDecompression are madewith tri-lumen tubing andadditional tubing lengthdistal to the balloon,creating a "sump" toreach the dependentportion of the stomachand providing a lumen thefull length of the device toallow make-up air to bedrawn into the stomachwhen GastricDecompression isperformed through theprimary lumen - reducingthe chance that thesuction causes ulcerationof the mucosa of thestomach wall during LowIntermittent Wall Suction.	balloon that acts asan internal bolster toprevent outwardmigration of thedevice.	during Low IntermittentWall Suction.	external bolster that ispositioned snug to theabdomen to preventinward migration.
	Substantial Equivalence:	Similar	Similar	Similar
DesignSimilarities	1. Devices have direct access to stomach.2. All devices have the ability to decompress the stomach.3. All devices have the ability to administer feeding solutions and medications directly into the stomach.4. All devices are offered in various French sizes for adult and pediatric use.
	Subject Device:	Predicate(K161413):	SecondaryPredicate(K190923):	Tertiary Predicate(K971434):
DesignDifferences	1. The G-Tube and low-profile devices are anchored in the stomach with a silicone retention balloon, while the Salem Sump device is not anchored.2. The G-Tube and low-profile devices directly access the stomach via a stoma tract, while the Salem Sump device is a naso/orogastric device.3. The G-Tube and low-profile devices are predominately made of silicone, while the Salem Sump device is predominately made of polyvinyl chloride (PVC).4. The G-Tube with Enhanced Decompression Capabilities and the Salem Sump utilize a dedicated "vent" lumen to allow make-up air to enter the stomach during decompression to allow for more effective gastric decompression while those G-Tube configurations without Enhanced Decompression features as well as the low-profile device do not feature a dedicated vent lumen.5. The G-Tube devices have a sliding external bolster to help secure the device within the patient, while the Salem Sump and low-profile devices do not have a sliding component.6. The low-profile device is configured in fixed lengths to be selected for certain abdominal wall thicknesses while the other devices are adjustable across a range of patient anatomy.

Applied Medical Technology, Inc. – 510(k) Submission AMT G-Tube Balloon Gastrostomy Feeding Device Section 5 - Page 5.3

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Applied Medical Technology, Inc. – 510(k) Submission AMT G-Tube Balloon Gastrostomy Feeding Device Section 5 – Page 5.4

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TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE PREDICATE DEVICES

VII. PERFORMANCE DATA:

A. Biocompatibility Testing: Following a Biological Evaluation Report, the AMT G-Tube Balloon Gastrostomy Feeding Device was tested for biocompatibility based on the applicable sections of the following standards:
. ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10993-3 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: Tests 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 10993-11:2017 Biological Evaluation of Medical Devices --Part 11: Tests for Systemic Toxicity

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

Applied Medical Technology, Inc. - 510(k) Submission AMT G-Tube Balloon Gastrostomy Feeding Device Section 5 - Page 5.6

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B. Performance Testing:

1. Sterilization

Testing has been completed to evaluate the sterilization process for the subject device, and is outlined below:

Testing per ANSI/AAMI/ISO 11135-1:2014
- Sterilization process validation o
Testing per ISO 10993-7:
- Part 7: Ethylene Oxide Sterilization Residuals O

The subject device is ethylene oxide sterilized, and has been validated to confirm a Sterility Assurance Level (SAL) of 106. The sterilization processing complies with the standards.

2. Shelf Life

Applicable shelf life testing was conducted in accordance with the following:

. Testing in accordance with ASTM F1980:
- Evaluation of the performance of the Traditional GJ device after a simulated O 3-year accelerated aging of packaging
Testing in accordance with ASTM F1980-16:
- Evaluation of the performance of 50A durometer 18Fr TGJ assemblies after O four years of accelerated aging
- o Evaluation of the performance of 50A durometer 18Fr TGJ sprung tubing after a four-year accelerated aging simulation

Testing indicates that the subject device has a validated shelf life of three years.

3. Bench Testing

Bench tests have been carried out to demonstrate conformance to applicable recognized standards and to assure reliable design and performance under the specified testing parameters according to predetermined criteria. All testing was performed to ensure conformity to ISO 14971 (application of risk management to medical devices). The tests carried out included:

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

Applied Medical Technology, Inc. - 510(k) Submission AMT G-Tube Balloon Gastrostomy Feeding Device Section 5 - Page 5.7

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Fill Valve Pullout o
Flow Rate O
Leak Test O
Tubing Tensile Test to determine strength (tested at gastric holes (for O configurations with Enhanced Decompression Capabilities))
Minimum Overmold Bond Strength O
Stoma Pullout O
Tubing Cyclic and Tensile Test O
Main Strap Tensile Test O
Side Strap Tensile Test O
Testing per ASTM F2528-06
- Balloon Integrity in Simulated Gastric Fluid O
- O Balloon volume maintenance
- Balloon size and shaft size o
- Balloon concentricity o
- Balloon integrity O
Testing per ISO 80369-3 ●
- Dimensional Verification o
- Missed Connection Testing 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 ISO 11607-1:2019 and ISO 11607-2:2019 ●
- o Packaging for terminally sterilized medical devices
Testing per EN 1615:2000, EN 1618:1997 o Leak Testing
Testing per (USP) 41-National Formulary (NF) 36: 2018 <151> ●
- o Pyrogenicity testing

The subject device met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate.

C. Animal Study: Animal testing was NOT performed.
D. Clinical Study: Clinical testing was NOT performed.

Applied Medical Technology, Inc. – 510(k) Submission AMT G-Tube Balloon Gastrostomy Feeding Device Section 5 - Page 5.8

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E. CONCLUSION:

The AMT G-Tube Balloon Gastrostomy Feeding Device can be found substantially equivalent to the predicate device cleared under K161413 in intended use, performance, and principles of operation. The design differences between the subject device and the predicate device do not raise different questions of safety and/or efficacy, and the information submitted in the application demonstrates that the subject device is at least as safe and effective as the predicate 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.