(249 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a self-expanding metal stent, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is indicated for the "palliation of malignant strictures in the biliary tree" and is described as a "self-expanding uncoated tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors." These functions indicate it is used to treat or alleviate a medical condition.
No
The device is described as a self-expanding metal stent designed to maintain patency of bile duct strictures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a self-expanding metal stent made of Nickel Titanium alloy (Nitinol) wire and includes a delivery system, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The HANAROSTENT® BILIARY (NNN) is a physical implant (a stent) that is placed inside the body to treat a medical condition (malignant strictures in the biliary tree). It does not perform any testing on specimens.
The provided information clearly describes a medical device used for treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The HANAROSTENT® BILIARY (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
The HANAROSTENT® Biliary (NNN) is a self-expanding uncoated tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. It consists of a self-expanding metal stent and delivery system. The Biliary stent is made of Nickel Titanium alloy (Nitinol) wire, which expands at body temperature. The stent is deployed with supplied introducers for percutaneous and endoscopic use.
The Stent is available in two diameters (8 and 10mm) and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, and 120mm). User preference, individual patient condition and/or anatomy determine the appropriate type and size for use. The HANAROSTENT® Biliary (NNN) is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree / bile duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Appropriate bench testing including compression force, expansion force, deployment force and accuracy, withdrawal force and corrosion tests were performed to confirm the safety and effectiveness of the HANAROSTENT® Biliary (NNN) stent as compared to the identified predicate device. Biocompatibility safety was assessed in accordance with ISO10993-1:2003.
Based on the performance comparisons, the HANAROSTENT® Biliary (NNN) is substantially equivalent to the identified predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K111149
page 1 of 3
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 807.92.
1. Sponsor Information:
| Company Name & Address: | M.I.Tech Co., Ltd.
241-3 Habuk-ri, Jinwi-myeon,
Pyeongtaek-si, Gyeonggi-do
451-864 Republic of Korea |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Danny Lee |
| Contact Title: | Manager |
| Contact Phone Number: | +82 31 662-5645 |
| Contact Fax Number: | +82 31 662-5648 |
Date of Summary:
2. Device Name and Classification:
| Common and Usual Name: | Biliary Catheter |
|---|---|
| Proprietary Name: | HANAROSTENT® Biliary (NNN) |
| Classification Name: | Biliary Catheter |
| Classification Regulation: | 21 CFR 876.5010 |
| Regulatory Class: | Class 2 |
| Product Code: | FGE |
| Performance Standards: | No applicable performance standards have been |
| issued under section 514 or under section 513(b) of | |
| the Food, Drug and Cosmetic Act. |
October 21, 2011
3. Predicate Device(s):
Niti-S Biliary Stent & Introducer, K073667
4. Description of Device:
The HANAROSTENT® Biliary (NNN) is a self-expanding uncoated tubular prosthesis designed to maintain patency of bile duct strictures caused by malignant tumors. It consists of a self-expanding metal stent and delivery system. The Biliary stent is made of Nickel Titanium alloy (Nitinol) wire, which expands at body temperature. The stent is deployed with supplied introducers for percutaneous and endoscopic use.
The Stent is available in two diameters (8 and 10mm) and eight lengths (40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, and 120mm). User preference, individual patient condition and/or anatomy determine the appropriate type and size for use. The HANAROSTENT® Biliary (NNN) is intended for single use only.
క. Indications for Use:
The HANAROSTENT® Biliary (NNN) is indicated for the palliation of malignant structures in the biliary tree.
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K111149
page 2 of 3
| Proprietary Name | HANAROSTENT® Biliary (NNN) | Niti-S Biliary Stent & Introducer |
|---|---|---|
| Indications for use | The HANAROSTENT® Biliary (NNN) | |
| is indicated for the palliation of | ||
| malignant strictures in the biliary | ||
| tree. | The Niti-S Biliary Stent is indicated | |
| for the palliation of malignant | ||
| strictures in the biliary tree. | ||
| Design | ||
| (Stent) | Image: HANAROSTENT Biliary Stent | Image: Niti-S Biliary Stent |
| Nitinol wire | Nitinol wire | |
| Cylinder shape, Diamond pattern, | Cylinder shape, Diamond pattern | |
| Flare shape | Non Flare shape | |
| Length; 40, 50, 60, 70, 80, 90, 100, | ||
| 120mm | Length; 40, 50, 60, 70, 80, 90, 100, | |
| 120 mm | ||
| Diameter; 8, 10mm | Diameter; 8, 10mm | |
| Marker; 12 gold markers | Markers; 8 Pt/Ir | |
| 2 STS 316L | ||
| Design | ||
| (Introducer) | Image: HANAROSTENT Introducer | Image: Niti-S Introducer |
| Braided tube type | ||
| Length; 60, 180cm | ||
| Diameter; 2.36mm | Co-axial tube type | |
| Usable Length; 50,60,180,190cm | ||
| Diameter; 2.7, 2.8mm | ||
| Single Use | Yes | Yes |
| Sterile | EO Sterilization | EO Sterilization |
| Method of | ||
| Placement | Percutaneous, | |
| Endoscopic | Percutaneous, | |
| Endoscopic | ||
| Method of | ||
| Deployment | Release by pulling Outer sheath | Release by pulling Outer sheath |
| Materials | Stent - Nitinol | Stent - Nitinol |
| Marker - Gold | Marker - Pt/Ir, STS316L | |
| Introducer - Teflon, PEEK, ABS, SUS | ||
| 304, PC | Introducer - Teflon, PE, ABS |
6. Comparison with Predicate Device(s):
The HANAROSTENT® Biliary (NNN) has the same device characteristics, composition, function, and intended use as the predicate device, such as the Niti-S Biliary Stent & Introducer.
The minor differences between the devices are introducer type, marker materials, and dimensional differences. These minor differences do not raise new questions of safety or efficacy of the device.
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Image /page/2/Picture/0 description: The image shows the text "K111149 page 3 of 3". The text appears to be handwritten. The first line contains a series of numbers and letters, while the second line indicates that it is page 3 of 3.
Based on the comparison of intended use and technical features, the HANAROSTENT® Biliary (NNN) is substantially equivalent to the identified predicate device.
7. Performance Summary:
Appropriate bench testing including compression force, expansion force, deployment force and accuracy, withdrawal force and corrosion tests were performed to confirm the safety and effectiveness of the HANAROSTENT® Biliary (NNN) stent as compared to the identified predicate device. Biocompatibility safety was assessed in accordance with ISO10993-1:2003.
Based on the performance comparisons, the HANAROSTENT® Biliary (NNN) is substantially equivalent to the identified predicate device.
8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act. 21 CFR Part 807, and based on the information provided in this premarket notification M.I.Tech Co., Ltd. concludes that the HANAROSTENT® Biliary (NNN) stent and introducer system is safe and effective, performs at least as well, and is substantially equivalent to the predicate devices as described herein and similar devices legally commercially available.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
M.I.Tech Co., Ltd. % Mr. Paul Sumner Vice President Arkin Consulting Group 1733 Canton Lane MARIETTA GA 30062
DEC 30 2011
Re: K11149
Trade/Device Name: HANAROSTENT® Biliary (NNN) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 19, 2011 Received: December 22, 2011
Dear Mr. Sumner:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation 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.
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.
4
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 resure 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 may of cables to additions, 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 ievents) (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
fo
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111149
Device Name: HANAROSTENT® BILIARY (NNN)
Indications For Use: The HANAROSTENT® BILIARY (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Prescription Use __ > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:
Colin M. Pollard
Gastro-Rena
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