HANAROSTENT FASTTM Biliary (NNN)
Device Facts
| Record ID | K183396 |
|---|---|
| Device Name | HANAROSTENT FASTTM Biliary (NNN) |
| Applicant | M.I.Tech Co., Ltd. |
| Product Code | FGE · Gastroenterology, Urology |
| Decision Date | Feb 11, 2019 |
| Decision | SESU |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Device Story
Self-expanding tubular prosthesis designed to maintain patency of bile duct obstructions caused by malignant tumors. Consists of Nitinol wire stent and polymeric delivery system. Stent loaded into distal delivery system; expanded by pulling outer sheath. Used in clinical settings for biliary procedures. Modification from predicate allows single operator exchange technique via guidewire exit through lumen near delivery tip. Physician operates device to place stent; stent provides mechanical support to keep strictures open, facilitating bile flow and palliating symptoms. Benefits patient by relieving biliary obstruction.
Clinical Evidence
Bench testing only. Tests included expansion force, compression force, deployment force, tensile strength, dimensional tests, crossing profile, and simulated bile duct performance (tracking, deployment, withdrawal, and accuracy). Biocompatibility assessed per ISO 10993-1:2003, 2012.
Technological Characteristics
Self-expanding metal stent made of Nitinol wire; delivery system made of polymeric materials. Single-use. Features single operator exchange delivery system design. Sterilization method not specified.
Indications for Use
Indicated for the palliation of malignant strictures in the biliary tree.
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)
Submission Summary (Full Text)
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June 10, 2021
M.I. Tech Co., Ltd. % Beryl St. Jeanne Medical Research Associate, Regulatory Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K183396 Trade/Device Name: HANAROSTENT FAST™ Biliary (NNN) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE
Dear Beryl St. Jeanne:
The Food and Drug Administration (FDA) is sending this letter to notify you of a change related to your previous substantial equivalence (SE) determination letter dated February 11, 2019.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Je Hi An, Ph.D. OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-0018, je.an@fda.hhs.gov.
Sincerely,
# Courtney H. Lias -S
Courtney H. Lias, Ph.D. Acting Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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June 10, 2021
M.I. Tech Co., Ltd. % Beryl St. Jeanne Medical Research Associate, Regulatory Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K183396 Trade/Device Name: HANAROSTENT FAST™ Biliary (NNN) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: December 5, 2018 Received: December 11, 2018
Dear Beryl St. Jeanne:
The Food and Drug Administration (FDA) is sending this letter to notify you of a change related to your previous substantial equivalence (SE) determination letter dated February 11, 2019.
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:
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The safety and effectiveness of this device for use in the vascular system have not been established.
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 reguirements 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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
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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,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Acting Director 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)
K183396
### Device Name HANAROSTENT® FAST™ Biliary (NNN)
Indications for Use (Describe)
The HANAROSTENT® FAST™ 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)
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# Pre-Market Notification 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 876.5010.
#### 1. Submitter:
| Name: | M.I.Tech Co., Ltd.<br>174 Habuk 2-gil, Jinwi-myeon,<br>Pyeongtaek-si, Gyeonggi-do<br>17706, Republic of Korea |
|----------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Inae Kim / Manager<br>Phone: +82 70-4304-7450<br>Fax: +82 2-3463-4703 |
#### 2. Device Name and Classification:
| Proprietary Name: | HANAROSTENT® FAST™ Biliary (NNN) |
|-----------------------|---------------------------------------------------|
| Device: | Stents, Drains and Dilators for the Biliary Ducts |
| Regulation Name: | Biliary catheter and accessories |
| Regulation No.: | 21 CFR 876.5010 |
| Product Code: | FGE |
| Third Party Reviewed: | No |
#### 3. Predicate Device:
- HANAROSTENT® Biliary (NNN), K111149 ।
#### 4. Description:
The same device description applies to both the predicate device HANAROSTENT® Biliary (NNN) (K111149) and the subject device HANAROSTENT® FAST™ Biliary (NNN).
This self-expanding tubular prosthesis is designed to maintain patency of bile duct obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, and the
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delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® FAST™ Biliary (NNN) is intended for single use only.
#### Indications for Use: 5.
HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
#### Technological Characteristics: 6.
A new stent length (110mm) has been added to M.I. Tech's device since the predicate K111149 received clearance.
The proposed device has a similar design and the same technical characteristics as the predicate device. There have been no other changes to the technology since K111149 received clearance. The primary difference between the proposed and predicate devices is in the design of the delivery device. In the predicate device the guidewire runs through the entire length of the delivery device whereas in the proposed device the guidewire exits through a lumen near the tip of the delivery device. This modification allows for a single operator exchange technique.
#### Performance Summary: 7.
Appropriate bench testing was performed to confirm the safety and effectiveness of the proposed devices as compared to the identified predicate device. The modification to the delivery system has been validated and raised no new issues of safety or effectiveness as compared to the predicate device. Performance testing was performed as per the design control system and the following tests were conducted:
- Expansion force -
- Compression force
- Deployment force
- Tensile strength
- Dimensional test
- Crossing profile -
- । Tracking force in a simulated bile duct
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- Deployment force in a simulated bile duct -
- Withdrawal force in a simulated bile duct -
- Deployment accuracy in a simulated bile duct -
Biocompatibility safety was assessed in accordance with ISO 10993-1:2003, 2012.
#### Conclusions: 8.
The non-clinical data supports the safety of the proposed devices and demonstrates that the HANAROSTENT® FAST™ Biliary (NNN) is safe and effective and will perform as intended in the specified use conditions.
The non-clinical data also demonstrates that the proposed device is substantially equivalent to the predicate device, HANAROSTENT® Biliary (NNN); K111149.
