(15 days)
Not Found
No
The device description focuses on the physical components (stent and delivery system) and materials (Nitinol, polymeric materials). There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The input imaging modality is fluoroscopy, which is a standard imaging technique, and there is no indication that the device itself processes or analyzes these images using AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for palliative treatment of strictures and obstructions caused by malignant neoplasms, which is a therapeutic purpose.
No
The device is a self-expanding tubular prosthesis used for the palliative treatment of colorectal or duodenal obstructions caused by malignant neoplasms, which is a therapeutic function rather than diagnostic.
No
The device description explicitly states it consists of a self-expandable metal stent and a delivery system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly describes a self-expanding metal stent and its delivery system. This device is intended to be implanted inside the body to treat obstructions in the colon, rectum, duodenum, or pylorus.
- Mechanism of Action: The device works by physically expanding to maintain the patency of a stricture or obstruction within the digestive tract. This is a mechanical action performed in vivo.
The device described is an implantable medical device used for therapeutic purposes within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in palignant structures.
The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The HANAROSTENT® LowAx™ Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant structures.
The HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Product codes
MQR, MUM
Device Description
This self-expanding tubular prosthesis designed to maintain patency of colorectal or duodenal 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 delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic procedures
Anatomical Site
colorectal, pyloric or duodenal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopic or fluoroscopic delivery, department of internal treatment
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)
The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the performance testing provided with K180180: - Axial force - Compression force - Corrosion - Deployment force - Deployment accuracy - Dimensions - Expansion force - Repositioning force - Stent separation - Tensile strength - Trackability M.I. Tech is providing new bench testing with this Traditional 510(k) in support of its subject device: - MR compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”
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January 10, 2019
M.I. Tech Co., Ltd. % Beryl St. Jeanne Associate Regulatory Specialist NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K183616
Trade/Device Name: HANAROSTENT LowAxTM Colon/Rectum (NNN) HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: MQR, MUM Dated: December 21, 2018 Received: December 26, 2018
Dear Beryl St. Jeanne:
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.
1
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 mediation-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,
Daniel G. Walter Jr -S
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
2
Indications for Use
510(k) Number (if known)
K183616
Device Name
HANAROSTENT LowAxTM Colon/Rectum (NNN) HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
Indications for Use (Describe)
The HANAROSTENT LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in palignant structures.
The HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
| 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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Image /page/3/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the letters "MIT" in a stylized font, with a red dot above the "I". To the right of the letters is the text "M.I.Tech" in a bold, sans-serif font. Below the logo is the website address "www.mitech.co.kr".
HEAD OFFICE
174, HABUK2-GIL, JilNWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
5 510(k) Summary
| 510(k) Number | K183616 | Intended Use /
Indications for Use: | The HANAROSTENT® LowAx™ Colon/Rectum (NNN) is indicated
for the palliative treatment of colorectal strictures produced by
malignant neoplasms and to relieve large bowel obstruction prior to
colectomy in patients with malignant structures. | |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date: | December 21, 2018 | | The HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) is
indicated for the palliative treatment of pyloric or duodenal obstructions
caused by malignant neoplasms. | |
| Submitter: | M.I. Tech Co., Ltd.
174 Habuk 2-gil, Jinwi-myeon,
Pyeongtaek-si, Gyeonggi-do
17706, Republic of Korea
Phone: 82-31-662-5645
Fax: 82-31-662-5648 | Device Description: | This self-expanding tubular prosthesis designed to maintain patency of
colorectal or duodenal 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 delivery system is made of polymeric materials. The stent
is loaded into the distal part of the delivery system. The
HANAROSTENT® LowAx™ Colon/Rectum (NNN) and
HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) are intended
for single use only. | |
| Primary Contact: | Inae Kim
Medical Affairs Team Manager
M.I. Tech Co., Ltd.
174 Habuk 2-gil, Jinwi-myeon,
Pyeongtaek-si, Gyeonggi-do
17706, Republic of Korea
Email: inae116@mitech.co.kr
Phone: 82-70-4304-7450
Fax: 82-2-3473-4702 | Predicate Device: | HANAROSTENT® LowAx™ Colon/Rectum (NNN);
HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN)
510(k) Number: K180180
Decision Date: 11/02/2018 | |
| Subject Device: | Trade Name:
Common Name:
Classification Regulation:
Classification Name:
Regulatory Class:
Product Code:
Classification Panel:
Trade Name:
Common Name:
Classification Regulation:
Classification Name:
Regulatory Class:
Product Code:
Classification Panel: | HANAROSTENT® LowAx™
Colon/Rectum (NNN)
Colon/Rectum Stent
21 CFR 878.3610
Esophageal Prosthesis
Class II
MQR
Gastroenterology/Urology
HANAROSTENT® LowAx™
Duodenum/Pylorus (NNN)
Duodenum/Pylorus Stent
21 CFR 878.3610
Esophageal Prosthesis
Class II
MUM
Gastroenterology/Urology | Mechanism of
Action: | The delivery system is supplied for either endoscopic or fluoroscopic
delivery. The delivery system for use with endoscopes is mostly used
at the department of internal treatment. The stent and delivery system
are inserted through the channel of endoscopes and the stent is
expanded and deployed at the target region. The fluoroscopic delivery
device is used for inserting the device at the target position during
fluoroscopic procedures. |
| | The stent is loaded by the delivery system and upon deployment of the
stent it imparts an outward radial force on the luminal surface of the
colon to establish patency. The stent is constrained and loaded between
the two sheaths. Through the use of a 0.035 inch guidewire, the delivery
system and stent are introduced to the intended target location.
Radiopaque markers allow visualizing and measuring placement
accuracy. After deployment of the stent the delivery system is removed
and discarded | | | |
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| Technological
| Characteristics: | The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the identical technological characteristics provided with K180180. There have been no changes to the fundamental technological characteristics since K180180 received clearance. Therefore, the subject and predicate device have identical technological characteristics: - Biocompatible materials - Stent design - Delivery device design - Radiopaque markers - Single use - Method of placement - Method of deployment - Sterilization method - Packaging configuration and materials - Shelf life The only difference in technological characteristics between the subject and predicate device is that M.I. Tech is providing MR compatibility testing with this submission to support MR conditional labeling for the subject device. |
|---|---|
| Performance Testing: | The subject device in this Traditional 510(k) submission is the exact same, identical device as predicate device K180180. M.I. Tech intends to leverage the performance testing provided with K180180: - Axial force - Compression force - Corrosion - Deployment force - Deployment accuracy - Dimensions - Expansion force - Repositioning force - Stent separation - Tensile strength - Trackability M.I. Tech is providing new bench testing with this Traditional 510(k) in support of its subject device: - MR compatibility |
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Image /page/6/Picture/1 description: The image shows the logo for M.I.Tech. The logo is blue and features the company name in a stylized font. Below the logo is the company's website address, www.mitech.co.kr.
HEAD OFFICE
174, HABUK2-GIL, JilNWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
| Substantial | The subject device in this Traditional 510(k) submission is the exact |
|---|---|
| Equivalence: | same, identical device as predicate device K180180. There are no |
| differences between the subject device and the predicate device with | |
| respect to indications and intended use. The only difference in | |
| technological characteristics between the subject and predicate device | |
| is that M.I. Tech is providing MR Compatibility testing with this | |
| submission to support MR Conditional labeling for the subject device. | |
| Therefore, the subject device and the predicate device are identical | |
| devices, and support M.I. Tech's claim of substantial equivalence. | |
| Conclusion: | The subject and predicate devices have the identical intended |
| use/indications for use, device description, mechanism of action, | |
| technological characteristics, and performance testing. |
The only difference in technological characteristics between the subject
and predicate device is that M.I. Tech is providing MR Compatibility
testing with this submission to support MR Conditional labeling for the
subject device.
Performance data supports the safety of the subject device and
demonstrates that the HANAROSTENT® LowAx™ Colon/Rectum
(NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus
(NNN) are safe and effective and will perform as intended in the
specified use conditions. |