The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

Device Description

The Reliant™ Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The Reliant™ Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 inch (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 inch (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.

The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.

AI/ML Overview

This document is a 510(k) summary for the Reliant™ Multistage Dilatation Balloon Catheter, indicating that it is a medical device for endoscopically dilating strictures of the gastrointestinal tract.

Here's an analysis of the provided information regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several design verification tests conducted on the proposed device. For each test, it implicitly states that the device was found to be "substantially equivalent" to the predicate device, meaning it met the acceptance criteria derived from the predicate device's performance or established industry standards. The specific quantitative acceptance criteria values are not provided in this summary, but the successful completion of these tests indicates compliance.

Acceptance Criteria (Test)	Reported Device Performance
Balloon Appearance Test	Test performed, results indicate substantial equivalence to predicate.
Retraction Test	Test performed, results indicate substantial equivalence to predicate.
Tensile Strength Testing Test	Test performed, results indicate substantial equivalence to predicate.
Balloon Inflation and Deflation Test	Test performed, results indicate substantial equivalence to predicate.
Dimension Test	Test performed, results indicate substantial equivalence to predicate.
EO Residual Test	Test performed, results indicate substantial equivalence to predicate.
Sterility Test	Test performed, results indicate substantial equivalence to predicate.
Endoscopic Compatibility Test	Test performed, results indicate substantial equivalence to predicate.
Balloon Burst Pressure Test	Test performed, results indicate substantial equivalence to predicate.
Balloon Fatigue Testing Test	Test performed, results indicate substantial equivalence to predicate.
Radiopacity Test	Test performed, results indicate substantial equivalence to predicate.
Biocompatibility Evaluation	Test performed, results indicate substantial equivalence to predicate.
ECH Residual Test	Test performed, results indicate substantial equivalence to predicate.
Package Integrity Test	Test performed, results indicate substantial equivalence to predicate.
Risk analysis (referencing ISO 14971)	Carried out in accordance with established in-house acceptance criteria.

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

The document does not specify the sample sizes used for each of the design verification tests. It also does not explicitly state the data provenance (e.g., country of origin or whether data was retrospective or prospective). However, as a 510(k) submission, the tests are typically conducted in a controlled laboratory environment by the manufacturer for regulatory purposes, implying an internal, prospective testing approach.

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

This document describes device performance testing, not clinical studies involving human or expert interpretation of data. Therefore, the concept of "ground truth" established by experts for a test set, as would be relevant in an AI/diagnostic imaging context, does not directly apply here. The "ground truth" for these engineering tests would be the established specifications and performance limits for the device components.

4. Adjudication Method

Not applicable, as this is device performance testing, not a clinical study requiring adjudication of expert interpretations.

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

No. This is a 510(k) submission for a physical medical device (a balloon catheter), not an AI/software device that would typically involve MRMC studies to assess human reader improvement with AI assistance. The document explicitly states "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device performance tests would be based on engineering specifications, industry standards, and regulatory requirements. For example:

Balloon Burst Pressure: The ground truth is the specified burst pressure beyond which the balloon should not fail.
Dimensions: The ground truth is the specified dimensional tolerances of the device components.
Sterility: The ground truth is the standard for sterility, often validated through methods like bacterial endotoxin testing and direct inoculation.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device performance evaluation and not an AI/machine learning submission, there is no "training set."

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

Not applicable, as there is no training set.

Summary

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October 15, 2018

Micro-Tech (Nanjing) CO., Ltd. Becky Li Quality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, 210032 China

Re: K180418

Trade/Device Name: Reliant(TM) Multistage Dilatation Balloon Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNQ Dated: August 9, 2018 Received: August 13, 2018

Dear Becky Li:

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 medical devices and radiation-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,

Image /page/1/Picture/7 description: The image shows a faded, white logo of the Food and Drug Administration (FDA). The logo is stylized with the letters 'FDA' interlocked and surrounded by a circular emblem. The white color and faded appearance suggest the image may be a watermark or a low-contrast representation of the FDA logo.

Jeffrey W. Cooper -S 2018.10.15 18:30:40 -04'00'

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) K180418

Device Name

Reliant(TM) Multistage Dilatation Balloon Catheter

Indications for Use (Describe)

The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

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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510K Summary

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510K Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 2018-10-10

Sponsor Identification 2.

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality and Regulatory Affairs Director Tel: +86-25-58646378 Fax: +86-25-58350006 Email: Beckyli mt@outlook.com

Identification of Proposed Device 3.

Product Name: Reliant™ Multistage Dilatation Balloon Catheter Common Name: Reliant™ Multistage Dilatation Balloon Catheter Regulatory Information Classification Name: Biliary catheter and accessories Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 876.5010 Review Panel: Gastroenterology/Urology

4. Identification of Predicate Device

510(k) Number: K162226 Product Name: Reliant™ Multistage Dilatation Balloon Catheter Common Name: Reliant™ Multistage Dilatation Balloon Catheter Regulatory Information Classification Name: Biliary catheter and accessories Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 876.5010 Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

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Image /page/4/Picture/1 description: The image contains the logo for Micro-Tech. The logo consists of a stylized blue "MT" symbol on the left, followed by the words "MICRO-TECH" in blue, with a horizontal line underneath. The "MT" symbol is designed with a three-dimensional effect, giving it a modern and technological appearance.

Review Panel: Gastroenterology/Urology

This predicate device has not been subject to a design-related recall.

5. Indications for Use

The Reliant™ Multistage Dilatation Balloon Catheter is indicated for use in adult and

adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

6. Device Description

The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.

Comparison of Technological Characteristics 7.

The Reliant™ Multistage Dilatation Balloon Catheter incorporates substantially equivalent device design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices.

Item	Proposed Device	Predicate Device	Comparison
Product Code	1) FGE, 2) KNQ	1) FGE, 2) KNQ	Same
Regulation No.	1) 876.5010, 2) 876.5365	1) 876.5010, 2) 876.5365	Same
Class	2	2	Same
SuppliedSterile	Yes	Yes	Same
Balloon Diameter (mm)	6-7-8, 8-9-10, 10-11-12,12-13.5-15, 15-16.5-18,18-19-20	6-7-8, 8-9-10, 10-11-12,12-13.5-15, 15-16.5-18,18-19-20	Same
Balloon length (mm)	30, 55, 80.	30, 55, 80.	Same

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510K Summarv

510K Summary
Item	Proposed Device	Predicate Device	Comparison
Ratedpressure(atm)	3-6-10, 3-5.5-9,3-5-8,3-4.5-8,3-4.5-7,3-4.5-6	3-6-10, 3-5.5-9,3-5-8,3-4.5-8,3-4.5-7,3-4.5-6	Same
WorkingLength (mm)	1800, 2300	1800, 2300	Same
Indications forUse	The Reliant™ MultistageDilitation Balloon Catheter isindicated for use in adult andadolescent populations toendoscopically dilatestrictures of thegastrointestinal tract.	The Reliant™ MultistageDilitation Balloon Catheter isindicated for use in adult andadolescent populations toendoscopically dilatestrictures of thegastrointestinal tract.	Same
Configuration	Tip, balloon, marker band,handle junction, andguidewire.	Tip, balloon, marker band,handle junction, andguidewire.	Same
Single Use	Yes	Yes	Same
Packaging	Single-use EO sterilizedpouch with one device perpouch	Single-use EO sterilizedpouch with one device perpouch	Same
Shelf Life	Three years (36 months)	Three years (36 months)	Same

The modifications that were made are as follows:

Add silicone spray to the surface of balloon
Labelling change
Package material change

8. Performance Data

Risk analysis was carried out in accordance with established in-house acceptance criteria based on AAMI / ANSI / ISO 14971:2007/(R) 2010 (Corrected 4 October 2007), Medical Devices - Applications of Risk Management to Medical Devices. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

Comparison to Predicate Device K162226, the modifications that were made are as follows:

A Add silicone spray to the surface of balloon
A Labelling change
Package material change

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Image /page/6/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue stylized "MT" on the left, with the words "MICRO-TECH" in blue to the right of the letters. There is a thin blue line underneath the words "MICRO-TECH".

All necessary verification and validation tests have been performed on the proposed device to assure substantial equivalence to the predicate device. The tests include:

Balloon Appearance Test Retraction Test Tensile Strength Testing Test Balloon Inflation and Deflation Test Dimension Test EO Residual Test Sterility Test

Endoscopic Compatibility Test Balloon Burst Pressure Test Balloon Fatigue Testing Test Radiopacity Test Biocompatibility Evaluation ECH Residual Test Package Integrity Test

9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Reliant™ Multistage Dilatation Balloon Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Predicate Devices.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.