The AMT Suture Delivery System is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

Device Description

The Suture Delivery System is a sterile, single use suturing device designed to pass suture percutaneously through tissues in order to anchor the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters. The non-absorbable suture meets requirements established by the United Stated Pharmacopeia (USP) for non-absorbable surgical suture. The suture is provided pre-loaded in a hand-held, manually operated, disposable suture application device. Only the suture and the anti-splay component are intended to remain in place while the wall of the viscous adheres to the abdominal wall; all other components of the delivery system are removed completely and discarded.

AI/ML Overview

The provided text describes a 510(k) submission for the "AMT Suture Delivery System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance criteria in a clinical setting.

Therefore, the information you are requesting about acceptance criteria and a study proving those criteria are met, particularly regarding AI performance, human reader improvement with AI, training set details, and ground truth establishment, is not present in this document. This document describes a traditional medical device (suture delivery system) and its regulatory clearance process through the FDA, which does not involve AI or the kind of performance studies typically associated with AI-driven devices.

Here's a breakdown of what is available related to performance, and why the other information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes performance testing, but it does not provide a table of acceptance criteria with corresponding device performance metrics in the way you've outlined. Instead, it states that "Testing found that all components and materials met or exceeded design specifications established by AMT" and "The AMT Suture Delivery System met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness."

The types of "performance" mentioned are largely for engineering and manufacturing validation, not clinical efficacy in the context of an AI device.

Performance Area	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility Testing	Compliance with ISO 10993 standards	Device is in compliance with ISO 10993-1, -5, -10, -11, -12, -17, and USP <151>
Sterilization	Sterility Assurance Level (SAL) 10⁻⁶, compliance with ANSI/AAMI/ISO 11135 and ISO 10993-7, USP chromogenic method for Bacterial Endotoxin	Validated to confirm SAL of 10⁻⁶, complies with standards.
Shelf Life	Compliance with ASTM F1980-16, ISO 11607, and ISTA 3A	Packaging complies with standards.
Bench Testing	Conformance to AMT specifications (deployment force, tensile testing), ISO 7864 (needle hub bond, needle penetration), USP <871> (suture bond), USP <881> (suture tear strength), ISO 9626 (resistance to breakage, needle stiffness)	Met or exceeded all acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device that uses a "test set" in the context of machine learning. The performance tests mentioned are physical and chemical property tests of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is not established in this manner for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

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: Not applicable. This device does not involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this device's performance is objective measurements against established engineering and material science standards (e.g., tensile strength, sterility assurance level, biocompatibility).

8. The sample size for the training set: Not applicable. This device does not involve a training set.

9. How the ground truth for the training set was established: Not applicable. This device does not involve a training set.

Summary of Device and Performance Information Provided:

The document describes the AMT Suture Delivery System, a sterile, single-use suturing device for anchoring a hollow viscus to the abdominal wall. The regulatory submission emphasizes its substantial equivalence to a predicate device (K182832, Enterostomy Suture Anchor Set from Cook, Inc.) in terms of intended use, indications for use, sterilization, prescription status, and principles of operation, despite minor differences in material of retention and method of deployment.

Key Performance Data (not related to AI):

Biocompatibility Testing: Demonstrated compliance with multiple ISO 10993 standards and USP <151> Pyrogen Test.
Sterilization: Validated for Ethylene Oxide sterilization to a Sterility Assurance Level (SAL) of 10⁻⁶, complying with ANSI/AAMI/ISO 11135 and ISO 10993-7, and Bacterial Endotoxin Testing (USP chromogenic method).
Shelf Life: Packaging tested in accordance with ASTM F1980-16, ISO 11607, and ISTA 3A, indicating compliance.
Bench Testing: Various tests performed according to AMT specifications (deployment force, tensile testing), ISO 7864 (needle hub bond, needle penetration), USP <871> (suture bond), USP <881> (suture tear strength), and ISO 9626 (resistance to breakage, needle stiffness). All stated to have met or exceeded acceptance criteria.
No Software, Electromagnetic Compatibility, Electrical Safety, Animal, or Clinical Studies were performed or deemed applicable for this submission.

In conclusion, this document is for a traditional physical medical device and does not contain any information relevant to AI/ML device performance or study design.

Summary

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March 12, 2020

Applied Medical Technology, Inc. Joy Tubero Regulatory Affairs Specialist 8006 Katherine Blvd. Brecksville, Ohio 44141

Re: K193612

Trade/Device Name: AMT Suture Delivery System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KGC Dated: December 20, 2019 Received: December 26, 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. 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

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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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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).

Sincerely,

Shanil P. Haugen, Ph.D. Acting 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) K193612

Device Name AMT Suture Delivery System

Indications for Use (Describe)

The AMT Suture Delivery System is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in child, adolescent, and adult populations.

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

X 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 Suture Delivery System

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 Specialist Email: joy.tubero@appliedmedical.net Date Prepared: February 19, 2020

II. DEVICE INFORMATION:

Trade/Device Name: AMT Suture Delivery System Common Name: Gastrointestinal tube and accessories Classification Name: Gastrointestinal tube and accessories (21 CFR 876.5980) Product Code: KGC Regulatory Class: Class II

III. PREDICATE INFORMATION:

Predicate Device: K182832, Enterostomy Suture Anchor Set (Cook, Inc.; cleared on June 26, 2019).

**This predicate devices has not been subject to design-related recalls.

IV. INDICATIONS FOR USE:

DEVICE DESCRIPTION: V.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE:

Applied Medical Technology, Inc. - 510(k) Submission AMT Suture Delivery System Section 5 - Page 5.1

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TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THEPREDICATE DEVICES
	Subject Device:	Predicate:
Device Classand ProductCode:	Class II; KGC	Class II; KGC
	Substantial Equivalence:	Same
Sterilization:	Sterile (Ethylene Oxide), single use only.	Sterile (Ethylene Oxide), single use only.
	Sterility Assurance Level (SAL) 10-6	Sterility Assurance Level (SAL) 10-6
	Substantial Equivalence:	Same
Prescription	Single use: Prescription Only.	Single use: Prescription Only.
	Substantial Equivalence:	Same
Indications forUse:	The AMT Suture Delivery System isintended for anchoring the wall of a hollowviscus to the abdominal wall prior to theintroduction of interventional cathetersand stay in place for up to 14 days inchild, adolescent, and adult populations.	The Enterostomy Suture Anchor Set isintended for anchoring the wall of a hollowviscus to the abdominal wall prior to theintroduction of interventional cathetersand stay in place for up to 14 days inchild, adolescent, and adult populations.
	Substantial Equivalence:	Similar
Intended Use:	Approximation of the wall of a hollowviscus to the anterior abdominal wall priorto the introduction of interventionalcatheters.	Approximation of the wall of a hollowviscus to the anterior abdominal wall priorto the introduction of interventionalcatheters.
	Substantial Equivalence:	Same
Principles ofOperation	• Needles inserted percutaneously throughthe abdominal wall and into a hollowviscus.• Securement achieved by manual (non-powered) activation of application device.• Needles are removed, leaving behindsuture.• Anchoring achieved by tension applied tothe suture.	• Needle inserted percutaneously throughthe abdominal wall and into a hollowviscus.• Securement achieved by manual (non-powered) activation of application device.• Needle is removed, leaving behindsutures and metal anchors.• Anchoring achieved by tension applied tothe sutures.
	Substantial Equivalence:	Similar
TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THEPREDICATE DEVICES
	Subject Device:	Predicate:
Major DesignCharacteristics	• Device is preloaded with non-absorbable suture.• Insert needles to percutaneouslydeliver suture.• All suture securement.• Stainless steel and plasticconstruction.	• Device is preloaded with non-absorbable sutures and anchors.• Insert needle to percutaneouslydeliver suture and anchor.• Suture and metal anchor securement.• Stainless steel and plasticconstruction.
	Substantial Equivalence:	Similar

Applied Medical Technology, Inc. – 510(k) Submission AMT Suture Delivery System Section 5 – Page 5.2

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As outlined above, minor differences exist among the AMT Suture Delivery System and the predicate devices. These differences include:

Material of Retention: The subject device applies tension to approximate tissues using only suture material. The predicate device approximates tissues using suture attached to internal metal anchors.
Method of deployment: The subject device features a delivery system featuring two needles ● that when deployed, pass suture from one needle to ther in order to form a percutaneous u-stitch; the predicate uses a single needle that when deployed percutaneously delivers suture and metal anchors.

These design differences between the Suture Delivery System (subject device), and the predicate (K182832) do not raise different questions of safety and/or effectiveness from the predicate device. The intended use and indications for use remain the identical between the AMT Suture Delivery System and the predicate device.

VII. PERFORMANCE DATA:

A. Biocompatibility Testing:

Following a well-documented biological evaluation plan, biocompatibility testing results demonstrate that the device is in compliance with ISO 10993-1- Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.

ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5 Biological Evaluation of Medical Devices . - Part 5: Tests for in vitro cytotoxicity.
. ISO 10993-10 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11 Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity
ISO 10993-12 Biological Evaluation of Medical Devices .

Applied Medical Technology, Inc. - 510(k) Submission AMT Suture Delivery System Section 5 - Page 5.3

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Part 12: Sample preparation and reference materials
ISO 10993-17 Biological Evaluation of Medical Device ●
- Part 17: Toxicological risk assessment of medical device constituents
USP <151> Pyrogen Test (USP Rabbit Test)

B. Software:

There are no software components related in any way to this device. Therefore, this section for Software Validation is not applicable to this device.

C. Electromagnetic Compatibility & Electrical Safety:

The metal suture delivery component is discarded after placing suture in the patient's tissues. Use of the manually operated suture delivery device leaves only a suture in the patient. Therefore, Electromagnetic Compatibility and Electrical Safety Validation is not applicable to this device.

D. Performance Testing:

AMT conducted various performance tests on the components contained within the AMT Suture Delivery System. Testing found that all components and materials met or exceeded design specifications established by AMT.

1. Sterilization

The Micro Transgastric Feeding Device is provided sterile (ethylene oxide) and testing has been completed to evaluate the sterilization process. The tests carried out are outlined below:

Testing per ANSI/AAMI/ISO 11135:
- Sterilization process validation O
Testing per ISO 10993-7:
- o Part 7: Ethylene Oxide Sterilization Residuals.
Bacterial Endotoxin Testing:
- O USP chromogenic method

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

The sterilized packaging for the subject device was tested in accordance with the following:

Testing in accordance with ASTM F1980-16:
- Accelerated aging of sterile barrier systems O
· Testing per ISO 11607:

Packaging system performance testing O Applied Medical Technology, Inc. - 510(k) Submission AMT Suture Delivery System Section 5 - Page 5.4

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· Testing per ISTA 3A:
- Packaged products for parcel delivery system shipments O

Testing of the sterile barrier system has indicated that the packaging for the subject device complies with the standards.

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. The tests carried out are outlined below:

Testing per AMT specifications: ●
- Deployment force o
  - o Tensile testing
. Testing per ISO 7864:
- Needle hub bond o
- o Needle Penetration
Testing per USP <871>: ●
- o Suture Bond
Testing per USP <881>: ● O Suture Tear Strength
Testing per ISO 9626: ●
- Resistance to Breakage (Needle) o
- o Needle Stiffness

The AMT Suture Delivery System met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness.

E. Animal Study: Animal testing was NOT performed.
F. Clinical Study: Clinical testing was NOT performed.

VIII. CONCLUSION:

The AMT Suture Delivery System can be found substantially equivalent to the predicate device cleared under K182832 in intended use, performance, and principles of operation. The minor design differences between the subject and the legally marketed predicate 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 current legally marketed device.

Applied Medical Technology, Inc. - 510(k) Submission AMT Suture Delivery System Section 5 - Page 5.5

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.