(37 days)
No
The description focuses on the mechanical properties and materials of a self-expanding metal stent and its delivery system. There is no mention of AI, ML, image processing for analysis, or any data-driven algorithms. The performance studies are bench testing and packaging validation, not studies related to AI/ML performance metrics.
Yes
The device is indicated for palliative treatment of colorectal strictures and to relieve large bowel obstruction, which are therapeutic interventions.
No
Explanation: The device is a self-expanding metal stent designed to maintain patency of colorectal obstructions and relieve bowel obstruction. Its intended use is palliative treatment and obstruction relief, not diagnosis.
No
The device description explicitly states it consists of a self-expandable metal stent and a delivery system, which are hardware components. The performance studies also focus on physical properties and packaging validation, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the palliative treatment of colorectal strictures and relief of large bowel obstruction. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a self-expanding metal stent and a delivery system, designed to be implanted within the body.
- Mechanism of Action: The device works by physically expanding to maintain the patency of the colorectal lumen.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used to treat a physical obstruction within the body.
N/A
Intended Use / Indications for Use
The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Product codes
MQR
Device Description
This self-expanding tubular prosthesis designed to maintain patency of colorectal 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® LowAxTM Colon/Rectum (NNN) is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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.
Anatomical Site
Colon/Rectum
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
The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616 with the exception of the 25mm stent diameter proposed with the subject device. M.I. Tech intends to leverage the testing provided with K183616:
- Corrosion
- MR compatibility
M.I. Tech performed new bench testing to support the subject device: - Axial force
- Compression force
- Deployment force
- Deployment accuracy
- Dimensions
- Expansion force
- Repositioning force
- Stent separation
- Tensile strength
- Trackability
M.I. Tech performed new packaging validation testing to support the subject device: - Dye penetration
- Seal strength
- Sterility
The new testing reports are not provided in this submission. The proposed 25mm diameter stent is supported with design control activities.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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March 15, 2019
M.I.Tech Co., Ltd. % Beryl St. Jeanne Medical Research Associate, Regulatory NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K190141
Trade/Device Name: HANAROSTENT® LowAxTM Colon/Rectum (NNN) Regulation Number: 21 CFR& 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR Dated: January 28, 2019 Received: January 29, 2019
Dear Beryl St. Jeanne:
This letter corrects our substantially equivalent letter of March 7, 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. 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.
1
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/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)
Device Name
HANAROSTENT® LowAxTM Colon/Rectum (NNN)
Indications for Use (Describe)
The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
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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Image /page/3/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 HEAD OF CONCLOSE
174, HABUK2-GL, JINWHMYEON, 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: | TBD |
|---|---|
| Preparation Date: | January 28, 2019 |
| 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 | |
| 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 | |
| Subject Device: | Trade Name: HANAROSTENT® LowAxTM Colon/Rectum (NNN) |
| Common Name: Colon/Rectum Stent | |
| Classification Name: Esophageal Prosthesis | |
| Classification Regulation: 21 CFR 878.3610 | |
| Regulatory Class: Class II | |
| Product Code: MQR | |
| Classification Panel: Gastroenterology/Urology | |
| Intended Use / | |
| Indications for Use: | The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated |
| for the palliative treatment of colorectal strictures caused by malignant | |
| neoplasms and to relieve large bowel obstruction prior to colectomy in | |
| patients with malignant strictures. | |
| Device Description: | This self-expanding tubular prosthesis designed to maintain patency of |
| colorectal 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® | |
| LowAxTM Colon/Rectum (NNN) is intended for single use only. | |
| Predicate Device: | M.I. Tech Co., Ltd. |
| HANAROSTENT® LowAxTM Colon/Rectum (NNN); | |
| HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) | |
| 510(k) Number: K183616 | |
| Decision Date: 01/10/2019 |
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Image /page/4/Picture/1 description: The image shows the logo for M.I.Tech, with the company name in blue and the website address "www.mitech.co.kr" below it. The logo features a stylized "MIT" with a red dot above the "I", followed by the full name "M.I.Tech" in a larger, bolder font. The overall design is clean and corporate, suggesting a technology-oriented company.
HEAD OFFICE
174, HABUK2-GIL, JINWHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
| Reference Devices: | Cook Ireland Ltd.
Evolution Duodenal Stent System - Uncovered;
Evolution Colonic Stent System - Uncovered
510(k) Number: K163468
Decision Date: 05/04/2017
Boston Scientific Corp.
Wallflex™™™ Enteral Colonic Stent with Anchor Lock Delivery System
510(k) Number: K061877
Decision Date: 09/15/2006
M.I. Tech Co., Ltd.
HANAROSTENT® Biliary (NNN)
510(k) Number: K111149
Decision Date: 12/30/2011 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Technological
Characteristics: | The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616. M.I. Tech intends to leverage the identical technological characteristics provided with K183616. There have been no changes to the fundamental technological characteristics since K183616 received clearance. Therefore, the subject and predicate devices have identical technological characteristics:
- Biocompatible materials
- Stent design (except stent diameter size range)
- Delivery device design
- Radiopaque markers
- Single use
- Method of placement |
| | - Method of deployment |
| | - Sterilization method and processes |
| | - Packaging configuration and materials |
| | - Shelf life |
| | The only difference between the subject and predicate devices is that |
| | M.I. Tech is proposing an expanded stent diameter range to include a |
| | 25mm diameter stent with the subject device. |
| Performance Testing: | The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616 with the exception of the 25mm stent diameter proposed with the subject device. M.I. Tech intends to leverage the testing provided with K183616: - Corrosion
- MR compatibility |
| | M.I. Tech performed new bench testing to support the subject device: - Axial force
- Compression force
- Deployment force
- Deployment accuracy
- Dimensions
- Expansion force
- Repositioning force
- Stent separation
- Tensile strength
- Trackability |
| | M.I. Tech performed new packaging validation testing to support the subject device: - Dye penetration
- Seal strength
- Sterility |
| | The new testing reports are not provided in this submission. The proposed 25mm diameter stent is supported with design control activities. |
| Substantial
Equivalence: | The subject device in this Special 510(k) submission is the exact same, identical device as predicate device K183616. There are no differences between the subject device and the predicate device with respect to indications and intended use. The only difference between the subject and predicate devices is that the subject device proposes a 25mm diameter stent. Therefore, the subject device and the predicate device are identical devices, with the exception of stent diameter size range |
| | 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, and
technological characteristics. |
| | The only difference between the subject and predicate devices is that
M.I. Tech is proposing an expanded stent diameter range to include a
25mm diameter stent. Bench testing is being provided with this
submission. |
| | Performance data supports the safety of the subject device and
demonstrates that the HANAROSTENT® LowAx™ Colon/Rectum
(NNN) is safe and effective and will perform as intended in the
specified use conditions. |
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Image /page/5/Picture/1 description: The image shows the logo for M.I.Tech. The logo consists of the text "MIT" in a stylized font with a red dot above the "I", followed by the text "M.I.Tech" in a larger, bolder font. Below the logo is the website address "www.mitech.co.kr".
HEAD OFFICE
174, HABUK2-GIL, JihwHMYEON, PYEONGTAEK-SI, GYEONGGI-DO,
17706, REPUBLIC OF KOREA
TEL +82 31 662 5645 FAX +82 31 662 5648
6
Image /page/6/Picture/1 description: The image shows the logo for M.I.Tech, a company with a website at www.mitech.co.kr. The logo features the company name in a stylized blue font. The letters "MIT" are connected with a curved line, and there is a red dot above the "I" in "MIT".