HANAROSTENT Benefit Biliary (NNN)

K202973 · M.I.Tech Co., Ltd. · FGE · May 11, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202973
• Device Name: HANAROSTENT Benefit Biliary (NNN)
• Applicant: M.I.Tech Co., Ltd.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 11, 2021
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.

Device Story

Self-expanding metal stent (SEMS) system for biliary tract; consists of Nitinol wire stent and polymeric delivery device. Stent loaded into distal delivery device; deployed via outer sheath retraction. Imparts outward radial force to maintain luminal patency in malignant biliary strictures. Used in clinical settings by physicians. Stent-in-stent placement possible. Benefits include relief of biliary obstruction. Safety/effectiveness for vascular use not established.

Clinical Evidence

No clinical data submitted. Bench testing only, including design verification (foreshortening, crossing profile, trackability, deployment/withdrawal/expansion/compression forces, stent integrity, tensile strength), biocompatibility, MRI safety/compatibility, and corrosion testing (single and overlapping stents).

Technological Characteristics

Self-expanding tubular prosthesis. Materials: Nitinol (stent), polymeric (delivery system). Energy: Mechanical (self-expansion). Dimensions: 6mm/8mm diameters, 110mm length. Delivery system: 5.9Fr. Sterilization: Sterile, single-use. No software/electronics.

Indications for Use

Indicated for the palliation of malignant strictures in the biliary tree in patients requiring biliary stenting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HANAROSTENT® Biliary (NNN) (K111149)

Reference Devices

• Zilver 635 Biliary Stent (K163018)
• Wallflex Biliary RX Stent System (K140630)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

May 11, 2021

M.I.Tech Co., Ltd. % Kelly Kucharczyk Manager, Regulatory and Medical Writing Services NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426

Re: K202973 Trade/Device Name: HANAROSTENT Benefit Biliary (NNN) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: April 8, 2021 Received: April 12, 2021

Dear Kelly Kucharczyk:

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 and the limitations described below. 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.

The OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

{1}------------------------------------------------

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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. 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 provisions (Sections (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

{2}------------------------------------------------

(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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Courtney H. Lias, Ph.D. Acting Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K202973

Device Name HANAROSTENT® Benefit™ Biliary (NNN)

Indications for Use (Describe)

The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for M.I.Tech, a company with a red dot above the letters "MIT". Below the logo is the company's website address, www.mitech.co.kr. The logo and website address are in a blue font. The logo is simple and modern.

## 510(k) Summary

| 510(k) Number | K202973 | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Preparation Date | May 11, 2021 | |
| Submitter | M.I.Tech Co., Ltd.<br>174 Habuk 2-gil, Jinwi-myeon,<br>Pyeongtaek-si, Gyeonggi-do<br>17706, Republic of Korea<br>Phone: [phone]<br>Fax: [phone] | |
| Primary Contact | Inae Kim, PhD<br>Medical Affairs Team Manager<br>M.I.Tech Co., Ltd.<br>174 Habuk 2-gil, Jinwi-myeon,<br>Pyeongtaek-si, Gyeonggi-do<br>17706, Republic of Korea<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] | |
| Subject Device | Device Trade Name: | HANAROSTENT® Benefit™ Biliary (NNN) |
| | Device Classification Name: | Stents, Drains And Dilators For The Biliary Ducts |
| | Regulation Number: | 21 CFR 876.5010 |
| | Regulation Description: | Biliary catheter and accessories |
| | Device Class: | Class II |
| | Classification Product Code: | FGE |
| | Regulation Medical Specialty: | Gastroenterology/Urology |
| | 510(k) Review Panel: | Gastroenterology/Urology |
| Device Description | The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designed<br>to maintain patency of biliary obstructions caused by malignant tumors. It consists of a self-<br>expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel<br>titanium alloy (Nitinol) wire. The delivery device is made of polymeric materials. The stent is<br>loaded into the distal part of the delivery device, and expanded in the body by pulling the outer<br>sheath of the delivery device. The stent and delivery device are provided sterile and are intended<br>for single use only. | |
| Intended Use /<br>Indications for Use | The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant<br>strictures in the biliary tree. | |
| Mechanism of Action | The stent is loaded by the delivery device. Upon deployment of the stent, it imparts an outward<br>radial force on the luminal surface of the biliary tract to establish patency. | |
| Predicate Device | 510(k) Number: | K111149 |
| | Applicant: | M.I.Tech Co., Ltd. |
| | Trade Name: | HANAROSTENT® Biliary (NNN) |
| | Device Classification Name: | Stents, Drains And Dilators For The Biliary Ducts |
| | Regulation Number: | 21 CFR 876.5010 |
| | Regulation Description: | Biliary catheter and accessories |
| | Device Class: | Class II |
| | Classification Product Code: | FGE |
| | Regulation Medical Specialty: | Gastroenterology/Urology |
| | 510(k) Review Panel: | Gastroenterology/Urology |
| Reference Devices | Reference Device 1: | |
| | 510(k) Number: | K163018 |
| | Applicant: | Cook Ireland Ltd. |
| | Trade Name: | Zilver 635 Biliary Stent |
| | Device Classification Name: | Stents, Drains And Dilators For The Biliary Ducts |
| | Regulation Number: | 21 CFR 876.5010 |
| | Regulation Description: | Biliary catheter and accessories |
| | Device Class: | Class II |
| | Classification Product Code: | FGE |
| | Regulation Medical Specialty: | Gastroenterology/Urology |
| | 510(k) Review Panel: | Gastroenterology/Urology |
| | | |
| | Reference Device 2: | |
| | 510(k) Number: | K140630 |
| | Applicant: | Boston Scientific |
| | Trade Name: | Wallflex Biliary RX Stent System |
| | Device Classification Name: | Stents, Drains And Dilators For The Biliary Ducts |
| | Regulation Number: | 21 CFR 876.5010 |
| | Regulation Description: | Biliary catheter and accessories |
| | Device Class: | Class II |
| | Classification Product Code: | FGE |
| | Regulation Medical Specialty: | Gastroenterology/Urology |
| | 510(k) Review Panel: | Gastroenterology/Urology |
| Technological | The subject device and predicate device have substantially equivalent technological characteristics | |
| Characteristics | with only minor differences regarding: | |
| | • Stent shape: the subject device has straight ends; the predicate has flared ends. | |
| | • Stent radiopaque marker quantity: the subject device has 9; the predicate device has 12. | |
| | • Stent diameters: the subject device offers 6mm and 8mm diameter stents; the predicate device offers 8mm and 10mm diameter stents. | |
| | • Stent lengths: the subject device offers a 110mm length stent; the predicate device does not offer a 110mm length stent. | |
| | • Delivery device diameter: the subject delivery device diameter is 5.9Fr; the predicate delivery device diameter is 7.08Fr. | |
| | • Stenting procedure: two subject devices can be implanted; only one predicate device is typically implanted. | |
| | • Performance testing: The subject and predicate devices have equivalent deployment, expansion, and compression forces. | |
| | • Corrosion testing: The subject and predicate devices have equivalent simulated single stent implant corrosion susceptibility. The subject and reference devices have equivalent simulated stent-in-stent implant corrosion susceptibility | |
| FDA Guidance<br>Documents | The following FDA guidance documents were consulted in preparing this premarket submission:<br>• Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions, issued July 2019<br>• Shelf Life of Medical Devices, issued April 1991<br>• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 2016<br>• Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June 2012<br>• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 2016<br>• Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol, issued October 2020<br>• Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 2014<br>• Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, issued August 2019 | |
| Performance - Bench | Bench testing was performed to confirm the safety and effectiveness of the subject device as compared to the predicate device. Testing was performed as per the design control system. The following tests were conducted:<br>• Design Verification Testing<br>○ Foreshortening<br>○ Crossing Profile<br>○ Trackability<br>○ Deployment Force<br>○ Withdrawal (Repositioning) Force<br>○ Expansion Force<br>○ Stent Separation<br>○ Deployment Accuracy<br>○ Compression Force<br>○ Stent Integrity<br>○ Stent Dimensional Verification<br>○ Delivery System Tensile Strength<br>• Biocompatibility Testing<br>• MRI Safety and Compatibility Testing<br>• Corrosion Testing:<br>○ Single stent<br>○ Overlapping stents | |
| Performance - Animal | No animal performance data is submitted in this 510(k). | |
| Performance - Clinical | No clinical performance data is submitted in this 510(k). | |
| Substantial<br>Equivalence | The subject device is substantially equivalent to the predicate device when evaluating intended use and technological characteristics.…