The AMT Bridle™ – Nasal Tube Retention System is placed around the vomer bone of the nasal septum and attached to a nasogastric/nasointestinal (NG/NI) tube to prevent inadvertent displacement or removal of the tube. The AMT Bridle™ – Nasal Tube Retention System consists of a retrieval probe, catheter with stylet guide, a nasal tube clip, and removal pick. The AMT Bridle™ retrieval probe and catheter are the device components inserted through the patient's nares with the probe magnetically retrieving the catheter and creating a loop around the vomer bone. The nasal tube clip is the component directly attached to both the nasal tube and bridle catheter loop to hold the tube in place.

AI/ML Overview

Here's an analysis of the provided text regarding the AMT Bridle - Nasal Tube Retention System, focusing on acceptance criteria and supporting studies:

This document is a 510(k) Summary for a medical device seeking substantial equivalence to a predicate device, rather than a report on an AI algorithm's performance. As such, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size) are not applicable or directly addressed in this type of submission.

The "acceptance criteria" discussed are related to the safety and performance specifications of the physical medical device and its components, not an AI's accuracy or predictive power.

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

Acceptance Criteria Category	Specific Tests/Criteria	Reported Device Performance
Biocompatibility	ISO 10993-1, -5, -6, -10, -11, -12 for prolonged contact (≤ 30 days)	Met acceptance criteria for prolonged contact.
Performance Testing	Clip hinge and teeth integrity	Passed all performance testing.
	Retention force	Met or exceeded design specifications.
	Bond strength of material joints	Met or exceeded design specifications.
	Tape pullout force	Met or exceeded design specifications.
	Usability testing	(No specific outcome provided, but implied as satisfactory to meet equivalence)
	Shelf life testing	(No specific outcome provided, but implied as satisfactory to meet equivalence)
	New clip sizes (hinge integrity, clamp integrity, grip strength)	Passed all performance testing for hinge integrity, clamp integrity, and grip strength.
Substantial Equivalence	Equivalence to predicate device (K030784) in intended use, patient population, design, biocompatibility and testing criteria, and method of operation.	Concluded to be substantially equivalent.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: This document does not describe a "test set" in the context of an AI algorithm's performance evaluation. The performance testing was conducted on components of the physical device. The exact number of units or samples tested for each performance criterion (e.g., number of clips for hinge integrity) is not specified in this summary.
Data Provenance: Not applicable in the context of AI algorithm evaluation. The testing was physical device performance testing conducted by the manufacturer, Applied Medical Technology, Inc. (AMT).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI algorithm study requiring expert-established ground truth. The "ground truth" for the device's performance is derived from standardized physical and biological tests against established specifications.

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

Not applicable. This is not an AI algorithm study.

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 document pertains to a physical medical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's acceptance is based on:

Biocompatibility Standards: Adherence to international ISO 10993 standards (e.g., in vitro cytotoxicity, local effects, irritation, systemic toxicity).
Engineering Specifications: The device's components meeting established design specifications for physical properties such as retention force, bond strength, and integrity (hinge, clamp, grip strength). These specifications were likely derived from device design requirements and clinical needs for tube retention.

8. The sample size for the training set

Not applicable. This is not an AI algorithm and therefore does not involve a "training set."

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

Not applicable. This is not an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2015

Applied Medical Technology, Inc. Joshua D. Meinke OA/Regulatory Supervisor 8006 Katherine Blvd. Brecksville, OH 44141

Re: K142971

Trade/Device Name: AMT Bridle - Nasal Tube Retention System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 23, 2015 Received: April 24, 2015

Dear Joshua D. Meinke,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -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) K142971

Device Name AMT Bridle - Nasal Tube Retention System

Indications for Use (Describe)

The AMT Bridle - Nasal Tube Retention System is indicated to prevent inadvertent displacement or removal of Nasogastric/Nasointestinal (NG/NI) tubes.

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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SECTION - 5

510(K) Summary

AMT Bridle™ – Nasal Tube Retention System

Date Prepared:	May 26, 2015
Submitter:	Joshua D. MeinkeQA/Regulatory SupervisorApplied Medical Technology, Inc.8006 Katherine BoulevardBrecksville, OH 44141Phone: 440-717-4252Fax: 440-717-4200Email: Joshua.Meinke@appliedmedical.netContact Person: Joshua Meinke
DeviceInformation:	Trade Name: AMT Bridle™ - Nasal Tube Retention SystemCommon Name: Nasal Tube Fixation DeviceClassification Name: Gastroenterology and Urology (21 CFR 876.5980)Regulatory Class: IIProduct Code: KNT
PredicateDevice:	AMT Nasogastric Bridle™ System with Magnet Retrieval(cleared under K030784)
Intended Use:	The AMT Bridle™ – Nasal Tube Retention System is a device placed around thevomer bone of the nasal septum and attached to a Nasogastric/Nasointestinal(NG/NI) tube to prevent inadvertent displacement or removal of the nasal tube.
DeviceDescription:	The AMT Bridle™ – Nasal Tube Retention System is placed around the vomer boneof the nasal septum and attached to a nasogastric/nasointestinal (NG/NI) tube toprevent inadvertent displacement or removal of the tube. The AMT Bridle™ – NasalTube Retention System consists of a retrieval probe, catheter with stylet guide, anasal tube clip, and removal pick. The AMT Bridle™ retrieval probe and catheterare the device components inserted through the patient's nares with the probemagnetically retrieving the catheter and creating a loop around the vomer bone. Thenasal tube clip is the component directly attached to both the nasal tube and bridlecatheter loop to hold the tube in place.
TechnologicalCharacteristics:	The AMT Bridle™ – Nasal Tube Retention System is provided non-sterile for singleuse only in a healthcare facility or unit. The AMT Bridle™ is provided in twodifferent configurations, a standard size and a smaller Micro sized design.Description of each device type is described below:AMT Bridle™:Probe size: Larger diameter and longer length compared to AMT Micro Bridle™Catheter Size: Same diameter as AMT Micro Bridle™, longer lengthClip Sizes(FR): 08 - 18 FRClip Thickness: Double thickness of AMT Micro Bridle™Part Number Scheme: 4-41XX (where XX = French size of clip)AMT Micro Bridle™:Probe size: Smaller diameter and shorter length compared to AMT Bridle™Catheter Size: Same diameter as AMT Bridle™, shorter lengthClip Sizes: 05 - 08 FRClip Thickness: Half thickness of AMT Bridle™Part Number Scheme: 4-41XXM (where XX = French size of clip)The standard and Micro designs maintain the same materials, manufacturingmethods, and instructions for use. Both devices are made from DEHP and Latex freematerials. Both designs incorporate the same components inside of a kit, includingthe retrieval probe, catheter with stylet guide, nasal tube clip, and removal pick.Placement of both devices is identical with the nasal clip attaching the Bridle loop tothe Nasal tube, securing the tube in place by connection to the vomer bone.
BiocompatibilityTesting:	The AMT Bridle – Nasal Tube Retention System has been tested for prolongedcontact (less than or equal to 30 days) to the applicable sections of the followingstandards:ISO 10993-1: 2009 Biological Evaluation of Medical Devices – Part 1:Evaluation and testing within a risk management process ISO 10993-5: 2009 Biological Evaluation of Medical Devices – Part 5: Testsfor in vitro cytotoxicity ISO 10993-6: 2007 Biological Evaluation of Medical Devices – Part 6: Testsfor local effects after implantation 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 10993-12:2007 Biological Evaluation of Medical Devices – Part 12:Sample preparation and reference materials An independent risk assessment was completed for the above biocompatibility testingand it was determined that the biocompatibility results for the AMT Bridle – NasalTube Retention System met the acceptance criteria for prolonged contact (less than orequal to 30 days).
PerformanceTesting:	AMT conducted various performance tests on all components contained within theAMT Bridle® - Nasal Tube Retention System. Testing found that all componentsand materials met or exceeded design specifications established and cleared underK030784. The following tests were used to show substantial equivalence:• Clip hinge and teeth integrity• Retention force• Bond strength of material joints• Tape pullout force• Usability testing• Shelf life testingBridle catheter, stylet guide, and probe designs remain very similar or the same as thepredicate device cleared under K030784, so performance testing remains ultimatelyunchanged. Several performance tests were conducted for the new clip sizes toensure that molded parts maintained the required performance specifications. Bridleclips passed all performance testing for hinge integrity, clamp integrity, and gripstrength. Based on the test results, design and assembly integrity remainsubstantially equivalent to the predicate device.
Conclusions:	The AMT Bridle™ - Nasal Tube Retention System is substantially equivalent to thepredicate device cleared under K030784 in intended use, patient population, design,biocompatibility and testing criteria, and method of operation.

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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.