The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

Device Description

The proposed device Retrieval Balloon Catheter includes Sterile Biliary Stone Retrieval Balloon Catheter (hereafter referred as Category 1) and Retrieval Balloon / short-wire compatible (hereafter referred as Category 2). Category 1 is commonly used in traditional ERCP surgery with a long guidewire (4.5m) while Category 2 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 2, the main feature of the short wire design is the C-shaped groove on the sidewall of catheter which is used to separate guidewire from the proposed device. The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.

The proposed device Retrieval Balloon Catheter is sterile, single-use endoscopic device, and is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

The proposed Retrieval Balloon Catheter is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.

Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire and the guidewire is able to be loaded either from the front or the back. Another separate lumen is designed for contrast medium. There are for injection-distal or injection-proximal options offered to support physician preference and facilitate procedural needs.

The balloon can be inflated to 9 mm, 12 mm, 15 mm, 18 mm diameters using the pre-measured syringes and a single balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.

There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

AI/ML Overview

This document describes the performance testing and acceptance criteria for the "Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible" (Device Name: Retrieval Balloon Catheter), submitted under 510(k) K211021.

It is important to note that this submission does not involve Artificial Intelligence (AI) or machine learning. Therefore, information concerning human reader improvement with AI, standalone algorithm performance, or training set details are not applicable to this medical device submission. The device is a physical medical instrument, not a diagnostic AI tool.

1. Acceptance Criteria and Reported Device Performance

The submission states that "Performance testing was conducted to demonstrate the performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device."

While specific numerical acceptance criteria and precise performance values are not detailed in this public summary, the document indicates that the following tests were conducted and the proposed device met the acceptance criteria and supported substantial equivalence to the predicate device.

Test Category	Acceptance Criteria (Implicit: Met requirements for substantial equivalence to predicate)	Reported Device Performance
Bench Tests	To confirm intended performance and substantial equivalence to predicate device (K102082)	All tests were conducted, and results supported substantial equivalence to predicate. Specific numerical values are not provided in this summary.
Dimension		Met acceptance criteria.
Endoscope Compatibility		Met acceptance criteria.
Infusion Patency		Met acceptance criteria.
Guidewire Matching		Met acceptance criteria.
Balloon Fatigue		Met acceptance criteria.
Luer Connector		Met acceptance criteria.
Connection Strength		Met acceptance criteria.
Shelf-Life & Packaging	Compliance with ASTM F1980-16, ISO 11607-1:2019, ISO 11607-2:2019. Initial shelf life of 12 months.	Conducted based on accelerated aging. Initial results support 12 months. Two-year aging test to be performed for longer stability.
Sterilization	Compliance with ISO 11135:2014+A1:2018 (EO Sterilization, SAL: 10^-6)	Validation carried out, results met requirements (SAL: 10^-6).
Biocompatibility	Compliance with ISO 10993-1:2009 and FDA guidance.	All listed tests conducted, results met requirements.
Testing Method	Test Results
Cytotoxicity	Met acceptance criteria.
Sensitization	Met acceptance criteria.
Irritation	Met acceptance criteria.
Acute Systemic Toxicity	Met acceptance criteria.
Pyrogen	Met acceptance criteria.

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

Sample Size: The document does not specify the exact sample sizes for each of the bench tests, shelf-life tests, or biocompatibility tests. It states that "Performance testing was conducted" and "results of the tests below were evaluated as substantially equivalent."
Data Provenance: The tests are described as bench tests and laboratory evaluations conducted by the manufacturer, Micro-Tech (Nanjing) Co., Ltd., which is located in Nanjing, Jiangsu Province, China. The data is retrospective in the sense that it was collected prior to the submission for regulatory review. It is not patient or clinical data.

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

This is not applicable as the described tests are laboratory-based performance and safety evaluations of a physical medical device, not a diagnostic AI tool requiring expert image interpretation or clinical consensus for ground truth. The "ground truth" for these tests relates to engineering specifications, material properties, and biological safety standards. These are established by validated test methods and established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This is not applicable for the same reason as above. Adjudication methods like "2+1" or "3+1" are relevant for establishing ground truth in clinical data (e.g., for diagnostic accuracy studies involving human readers or AI), not for bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance.

This is not applicable. This submission is for a physical medical device (Retrieval Balloon Catheter) and does not involve AI or machine learning. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

This is not applicable. As stated, this device is a physical medical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations of this device is based on:

Engineering Specifications: Meeting predefined dimensional tolerances, force requirements, fluid flow rates, and fatigue limits.
International Standards: Compliance with recognized standards such as ISO 11607 (packaging), ISO 11135 (sterilization), and ISO 10993 (biocompatibility).
Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is demonstrating substantial equivalence to a legally marketed predicate device (Extractor™ Pro Retrieval Balloon Catheter cleared under K102082) in terms of technology, safety, and performance.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" to establish ground truth for.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

May 6, 2022

Micro-Tech (Nanjing) Co., Ltd. Becky Li Senior Ouality and Regulatory Affairs Director No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial Development Zone Narijing, Jiangsu Province 210032 CHINA

Re: K211021

Trade/Device Name: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: March 28, 2022 Received: April 4, 2022

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 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.

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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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,

Je Hi An. 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) K211021

Device Name Retrieval Balloon Catheter

Indications for Use (Describe)

The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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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.

The assigned 510(K) Number: K211021

1. Date of Preparation: 2022-05-04

1. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing,

Jiangsu Province, PRC

Establishment Registration Number: 3004837686

Contact Person: Becky Li

Position: Senior Quality and Regulatory Affairs Director

Tel: +86-25-58646378

Fax: +86-25-58350006

Email: RA.Micro-Tech@outlook.com

3. Identification of Proposed Device

Trade/Product Name: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval

Balloon / short-wire compatible

Common Name: Retrieval Balloon Catheter

Regulatory Information

Classification Name: Biliary Catheter and Accessories

Classification: 2

Product Code: FGE

Regulation Number: 876.5010

Review Panel: Gastroenterology/Urology

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K211021 Page 2 of 7

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4. Identification of Predicate Device

510(K) Number: K102082 Product Name: Extractor™ Pro Retrieval Balloon Catheter Manufacturer: Boston Scientific Corporation

5. Indications for Use

The device is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

6. Device Description

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BalloonInflatedDiameter	9/12	12/15	9/12/15	15/18	12/15/18	18/21	15/18/21
---------------------------------	------	-------	---------	-------	----------	-------	----------

There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.

7. Comparison of Technological Characteristics

The Retrieval Balloon Catheter incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Extractor™ Pro Retrieval Balloon Catheter.

Table 7.1 Technological comparison between the proposed device and predicate device

Item	Proposed DeviceRetrieval Balloon Catheter	Predicate DeviceExtractor™ Pro RetrievalBalloon Catheter(K102082)	Remark
Product Code	FGE	FGE	Same
Regulation No.	876.5010	876.5010	Same
Class	II	II	Same
Supplied in Sterile	YES	YES	Same
Configuration	Catheter, Balloon, RadiopaqueMarker, Handle	Catheter, Balloon, RadiopaqueMarker, Handle	Same
Item	Proposed DeviceRetrieval Balloon Catheter	Predicate DeviceExtractor™ Pro RetrievalBalloon Catheter(K102082)	Remark
Main Material	Natural Latex, Platinum IridiumAlloy, Polyether Block Amide	Natural Latex, PolymerMaterials, Alloy Materials	Similar
Injection	Contrast Medium	Contrast Medium	Same
UsingEnvironment	Endoscopic Clinic	Endoscopic Clinic	Same
Working Length	2000 mm	2000 mm	Same
CompatibleEndoscopyWorking Channel	≥3.2mm	≥3.2mm	Same
Balloon Size	The Balloon Inflatable Diameter:9mm/12mm/15mm/18mm/21mm	The Balloon InflatableDiameter:9mm/12mm/15mm/18mm	Similar
Indications for Use	The proposed devices are indicatedfor use endoscopically to removestones from biliary system, or tofacilitate injection of contrastmedium while occluding the ductwith the balloon.	The predicate devices areindicated for use endoscopicallyto remove stones from thebiliary system, or to facilitateinjection of contrast mediumwhile occluding the duct withthe balloon.	Same
Applicable BodyParts	Biliary Tract	Biliary Tract	Same
Single Use	Yes	Yes	Same
Packaging	Single-use EO sterilized pouchwith one device per pouch	Single-use EO sterilized pouchwith one device per pouch	Same
Shelf Life	12 Months	24 Months	Different
Biocompatibility	Comply with ISO10993-1	Comply with ISO10993-1	Same
Sterilization	EO Sterilized, SAL: 10-6	EO Sterilized, SAL: 10-6	Same
Labeling	Conforms to 21 CFR part 801	Conforms to 21 CFR part 801	Same

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Image /page/7/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a sense of unity and strength. To the upper right of the letters, there is a small circle with the "R" symbol inside, indicating that the logo is a registered trademark.

8. Performance Data

Performance testing was conducted to demonstrate the performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device. The bench tests below were tested and evaluated as substantially equivalent to the predicate device.

Dimension;
Endoscope Compatibility Test;
Infusion Patency Testing;
Guidewire Matching Test:
Balloon Fatigue Test;
Luer Connector Test;
Connection Strength Test;

Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.

Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".

The biocompatibility evaluation for the Retrieval Balloon Catheter was conducted in

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are blocky and appear to be angled slightly, giving them a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:

The biocompatibility evaluation for the was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:

Cytotoxicity
Sensitization
Irritation
Acute systemic toxicity
Pyrogen

The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device Extractor™ Pro Retrieval Balloon Catheter cleared under K102082.

9. Animal Study

No animal study is included in this submission.

10. Clinical Study

No clinical study is included in this submission.

11. Substantially Equivalent (SE) Conclusion

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Based on the indications for use, technological characteristics, and safety and performance testing, the Retrieval Balloon Catheter (including Sterile Biliary Stone Retrieval Balloon Catheter and Retrieval Balloon / short-wire compatible) has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Predicate Device Extractor™ Pro Retrieval Balloon Catheter (K102082).

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.