(283 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility 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.
Yes
The device is indicated for palliative treatment of colorectal and duodenal obstructions, which involves relieving symptoms and improving quality of life, aligning with the definition of a therapeutic device.
No
This device is a self-expanding metal stent designed for palliative treatment of colorectal or duodenal obstructions caused by malignant tumors, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "self-expanding tubular prosthesis" consisting of a "self-expandable metal stent and a delivery system," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction" and "palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms." This describes a therapeutic intervention performed directly on the patient's body to treat a condition.
- Device Description: The device is described as a "self-expanding tubular prosthesis" and a "delivery system" made of metal and polymeric materials. This is consistent with a medical device used for implantation or placement within the body.
- Mechanism of Action: The device works by physically expanding to maintain patency of obstructions. This is a mechanical action within the body, not an in vitro test performed on a sample outside the body.
- Input Imaging Modality: The input imaging modalities (Fluoroscopic, Endoscopic) are used to guide the placement of the device within the body, not to analyze a sample.
- Anatomical Site: The anatomical sites (Colorectal, Duodenum/Pylorus) are locations within the patient's body where the device is placed.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform any such analysis on a sample.
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 patients with malignant structures.
The HANAROSTENT LowAxTM DuodenumPylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
MQR, MUM
Device Description
This self-expanding tubular prosthesis is 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, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colorectum, Duodenum/Pylorus
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 was performed to confirm the safety and effectiveness of the proposed devices as compared to the identified predicate device.
The device specific FDA guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998. Performance testing was performed as per the design control system and the following tests were conducted:
- Axial force
- Compression force
- Corrosion
- Deployment force
- Deployment accuracy
- Dimensions
- Expansion force
- Repositioning force
- Stent separation
- Tensile strength
- Trackability
Biocompatibility safety was assessed in accordance with ISO 10993-1:2003, 2012.
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.
Boston Scientific Corporation's WallflexTM Enteral Colonic Stent with Anchor Lock Delivery System, K042065
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.”
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
November 2, 2018
M.I. Tech Co., Ltd. % Carol Buchert Principal Medical Research Scientist NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K180180
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: September 20, 2018 Received: September 24, 2018
Dear Carol Buchert:
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 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.
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,
Jeffrey W. Cooper -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) K180180
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 patients with malignant structures.
The HANAROSTENT LowAxTM DuodenumPylorus (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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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. Submitter:
| Name: | M.I.Tech Co., Ltd.
174 Habuk 2-gil, Jinwi-myeon,
Pyeongtaek-si, Gyeonggi-do
17706, Republic of Korea |
|----------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Inae Kim / Manager
Phone: +82 70-4304-7450
Fax: +82 2-3473-4702 |
2. Device Name and Classification:
| Proprietary Name: | HANAROSTENT® LowAx™ Colon/Rectum (NNN) |
|---|---|
| Common Name: | Colon/Rectum Stent |
| Classification Name: | Stent, Colonic, Metallic, Expandable |
| Classification: | 21 CFR 878.3610 |
| Product Code: | MQR |
| Third Party Reviewed: | No |
| Proprietary Name: | HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) |
|---|---|
| Common Name: | Duodenum/Pylorus Stent |
| Classification Name: | Stent, Duodenal, Metallic, Expandable |
| Classification: | 21 CFR 878.3610 |
| Product Code: | MUM |
| Third Party Reviewed: | No |
3. Predicate Device:
Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System, K061877 Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System, K062750
4
4. Description:
The same device description applies to both the HANAROSTENT® LowAx™ Colon/Rectum (NNN) and the HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN).
This self-expanding tubular prosthesis is 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, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® LowAx™ Colon/Rectum (NNN) and HANAROSTENT® LowAxTM Duodenum/Pylorus (NNN) are intended for single use only.
Indications for use: 5.
The HANAROSTENT® LowAx™ 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 structures.
The HANAROSTENT® LowAx™ Duodenum/Pylorus (NNN) is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
Technological Characteristics: 6.
The proposed devices are substantially equivalent to the predicate devices, the Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System, K061877 and Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System, K062750.
Both predicate devices share identical technological characteristics to each other. This is evidenced in 510(k)s K061877 and K02750. Both predicate devices cite the same predicate device within their submission: Boston Scientific Corporation's WallflexTM Enteral Colonic Stent with Anchor Lock Delivery System, K042065
Per K061877's Technological Characteristics section:
"The proposed Wallflex Enteral Colonic Stent with Anchor Lock Delivery System has the identical technological characteristics as the currently marketed Wallflex Enteral Colonic Stent with Anchor Lock Delivery System (K042065)."
5
Per K062750's Technological Characteristics section:
"The proposed WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System has the identical technological (materials, construction, processing) characteristics as the predicate WallFlex Enteral Colonic Stent with Anchor Lock Delivery System and has the identical indication statement as the predicate Wallstent Enteral Endoprosthesis."
The proposed devices have the same characteristics as the predicate devices as listed below:
- -Stent design
- Single use -
- Sterilization method -
- Method of placement -
- Method of deployment -
- -Stent materials
The following technological differences exist between the proposed devices and the currently marketed predicate devices, the Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System and the Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System.
- Stent diameter -
- -Stent length
- Delivery diameter -
- Radiopaque markers -
Please see the table below summarizing the technological characteristics of the subject devices and predicate devices.
6
| Device Name | Subject Device #1
HANAROSTENT®
LowAxTM
Colon/Rectum (NNN) | Subject Device #2
HANAROSTENT®
LowAxTM
Duodenum/Pylorus (NNN) | Predicate Device #1
WallflexTM Enteral
Colonic Stent | Predicate Device #2
WallflexTM Enteral
Duodenal Stent | Comment | | Yes | Yes | Yes | Yes | Identical |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Applicant | M.I. Tech Co., Ltd. | M.I. Tech Co., Ltd. | Boston Scientific Corp. | Boston Scientific Corp. | N/A | Single Use | | | | | |
| 510(k) Number | TBD | TBD | K061877 | K062750 | N/A | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical |
| Decision Date | TBD | TBD | 09/15/2006 | 12/04/2006 | N/A | Method of Placement | Fluoroscopic,
Endoscopic | Fluoroscopic,
Endoscopic | Fluoroscopic,
Endoscopic | Fluoroscopic,
Endoscopic | Identical |
| Common Name | Colon/Rectum Stent | Duodenum/Pylorus
Stent | Colon/Rectum Stent | Duodenum/Pylorus
Stent | Identical | Method of Deployment | Release by pulling
outer sheath | Release by pulling
outer sheath | Release by pulling
outer sheath | Release by pulling
outer sheath | Identical |
| Indications for Use | The palliative treatment
of colorectal strictures
caused by malignant
neoplasms and to
relieve large bowel
obstruction prior to
colectomy in patients
with malignant
structures. | The palliative treatment
of gastroduodenal
obstructions caused by
malignant neoplasms. | The palliative treatment
of colonic strictures
caused by malignant
neoplasms and to
relieve large bowel
obstruction prior to
colectomy in patients
with malignant
structures. | The palliative treatment
of gastroduodenal
obstructions caused by
malignant neoplasms. | Identical | Stent Materials | Nitinol | Nitinol | Nitinol | Nitinol | Identical |
| Stent Diameter | 20mm body with 25mm
dumbbell
22mm body with 27mm
dumbbell | 20mm body with 25mm
dumbbell
22mm body with 27mm
dumbbell | 22mm body with 27mm
flare
25mm body with a
30mm flare | 22mm body with 27mm
flare | Equivalent. Subject
device offers a model
that is 2mm smaller in
stent diameter for the
body and dumbbell. | Radiopaque Marker
Materials | Gold | Gold | N/A | N/A | Equivalent. Subject device has 12 gold radiopaque markers. The predicate device does not have radiopaque markers. |
| Stent Length | 60mm
70mm
80mm
90mm
100mm
110mm
120mm | 60mm
70mm
80mm
90mm
100mm
110mm
120mm | 60mm
90mm
120mm | 60mm
90mm
120mm | Equivalent. The length
of subject device is
subdivided within the
smallest and largest
lengths of predicate
devices. | Shelf life | 3 years | 3 years | 3 years | 3 years | Identical |
| Delivery Diameter | 3.40mm (10.2Fr) | 3.40mm (10.2Fr) | 3.33mm (10Fr) | 3.33mm (10Fr) | Equivalent. The
diameter of our delivery
system is 0.06mm
larger than the predicate
device. This level is
within a 5% tolerance
of the dimension | | | | | | |
7
K180180
Page 5 of 6
8
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 device specific FDA guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th, 1998. Performance testing was performed as per the design control system and the following tests were conducted:
- Axial force i
- । Compression force
- Corrosion i
- Deployment force i
- । Deployment accuracy
- Dimensions ।
- Expansion force i
- Repositioning force ।
- Stent separation ।
- । Tensile strength
- Trackability -
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 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.
The non-clinical data also demonstrates that the proposed device is substantially equivalent to the predicate devices, Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System (K061877) and Wallflex™ Enteral Duodenal Stent with Anchor Lock Delivery System (K062750).