(264 days)
Not Found
No
The 510(k) summary describes a mechanical stent and its delivery system. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The performance studies are bench tests focused on mechanical properties.
Yes
The device is indicated for palliative treatment of obstructions caused by malignant neoplasms and to relieve large bowel obstruction, which directly addresses a medical condition to improve health.
No
Explanation: The device is a stent used for the palliative treatment of obstructions caused by malignant neoplasms. Its purpose is therapeutic (to relieve obstruction) rather than diagnostic (to identify or determine the nature of a disease).
No
The device description explicitly states that the device consists of an implantable metallic stent and an introducer system, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are implantable medical devices designed to physically open up blockages in the duodenum, pylorus, colon, or rectum caused by malignant tumors. They are placed inside the body.
- Intended Use: Their intended use is for the palliative treatment of obstructions, meaning they are used to relieve symptoms and improve quality of life, not to diagnose the underlying condition by analyzing samples.
- Device Description: The description clearly states they are "implantable metallic stents" and part of an "introducer system" for placement within the body.
- Input: The input is the physical placement of the device within the body, guided by fluoroscopy, not the analysis of biological samples.
The device is a therapeutic medical device, specifically an implantable stent, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The Niti-S Colonic Comfort Stent 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 strictures.
Product codes
MUM, MQR
Device Description
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of the implantable metallic stent and introducer system.
The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm.
The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pyloric or duodenal; colorectal
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)
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent and introducer are provided as sterile devices. The sterilization method, validation method, and sterility assurance level are in accordance with ISO 11135:2014. "Sterilization of health-care products - Ethylene oxide - Requirement for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1(2018)]".
Packaging was designed, tested, and validated in accordance with AAMI/ANSI/ISO 11607-1:2019, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging" and AAMI/ANSI/ISO 11607-2:2019, "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes".
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent were evaluated according to the FDA's guidance "Use of InternationalStandard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluating and testing within a risk management process". The stent and introducer were evaluated for cytotoxicity, sensitization, and irritation/ intracutaneous reactivity effects. The stent was also evaluated for acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, chronic toxicity, and implantation effects. The evaluation determined that the devices have an acceptable biocompatibility profile.
Bench testing was conducted to validate the performance of both devices. The following tests were conducted:
- Deployment Accuracy
- Deployment Force
- Expansion Force
- Compression Force
- Dimensional
- Tensile Strength
- Shipping
- Shelf-life
- Corrosion
- MR Compatibility
- Axial Force
- Trackability and Visualization
- Repositioning Force
- Radiopacity
The results of the bench testing show that the subject devices meet their specifications and are substantially equivalent to the predicate devices.
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
§ 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
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June 14, 2023
Taewoong Medical Co., Ltd. % Daniel Dillon Senior Regulatory Specialist MED Institute 1330 Win Hentschel Boulevard Suite 100 West Lafayette, Indiana 47906
Re: K223067
Trade/Device Name: Niti-S Duodenal Comfort Stent Niti-S Colonic Comfort Stent Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: MUM (Niti-S Duodenal Comfort Stent) MQR (Niti-S Colonic Comfort Stent) Dated: May 9, 2023 Received: May 10, 2023
Dear Daniel Dillon:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 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.
Nicholas Clay -S
for Glenn Bell, Ph.D. Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223067
Device Name
Niti-S Duodenal Comfort Stent; Niti-S Colonic Comfort Stent
Indications for Use (Describe)
The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The Niti-S Colonic Comfort Stent is indicative treatment of colorectal strictures produced 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SUBMITTER 1.
| Applicant: | Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do,
Korea, 10022
Phone: +82-31-996-0641
Fax: +82-31-996-0645 |
|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Yonjin Jeff Kim
Regulatory Affairs Manager / R&D and RA Department
Phone: +82-31-993-0641-4 (Ext.# 222)
Fax: 82-31-996-0645-6
E-mail: jinjeff@stent.net |
| Date Prepared: | May 9, 2023 |
| 2.
DEVICE | |
| Device Trade Names:
Device Common Names:
Regulation Number:
Classification Name:
Regulatory Class:
Product Codes: | Niti-S Duodenal Comfort Stent;
Niti-S Colonic Comfort Stent
Duodenal stent; colonic stent
21 CFR 878.3610
Esophageal Prosthesis
Class II
MUM (Niti-S Duodenal Comfort Stent)
MQR (Niti-S Colonic Comfort Stent) |
PREDICATE DEVICES 3.
M.I. Tech Co., Ltd, HANAROSTENT LowAx™ Duodenum/Pylorus K183616 M.I. Tech Co., Ltd, HANAROSTENT LowAx™ Colon/Rectum K190141
DEVICE DESCRIPTION 4.
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of the implantable metallic stent and introducer system.
The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm.
The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.
4
INDICATIONS FOR USE 5.
The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.
The Niti-S Colonic Comfort Stent 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 strictures.
SUBSTANTIAL EQUIVALENCE 6.
The table below compares the key technological features of the subject devices to the predicate devices (M. I. Tech Co., Ltd, HANAROSTENT LowAx™ Colon/Rectum and HANAROSTENT LowAx™ Duodenum/Pylorus).
| | Niti-S Duodenal
Comfort Stent
(Subject Device) | HANAROSTENT
LowAX™
Duodenum/Pylorus
Stent (K183616) | Niti-S Colonic
Comfort Stent
(Subject Device) | HANAROSTENT
LowAx™
Colon/Rectum Stent
(K190141) |
|------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| Stent | | | | |
| Main material | Nitinol wire | Nitinol wire | Nitinol wire | Nitinol wire |
| Design | Cross-and-hook weave
using two wires;
one head/flare | Cross-and-hook weave
using two wires;
one head/flare | Cross-and-hook weave
using two wires;
one head/flare | Cross-and-hook weave
using two wires;
one head/flare |
| Body
Diameters/Head
Diameters | 22 mm/27 mm | 22 mm/27 mm | • 22 mm/27 mm
• 24 mm/29 mm | • 22 mm/27 mm
• 25mm /30 mm |
| Lengths | 60, 80, 100, 120 mm | 60, 90, 120 mm | 60, 80, 100, 120 mm | 60, 90, 120 mm |
| Polymer cover? | No | No | No | No |
| Radiopaque
Markers | 11 Pt/Ir, 2 STS 316L | 12 Gold | 11 Pt/Ir, 2 STS 316L | 12 Gold |
| Introducer | | | | |
| Design | Co-axial tube | Co-axial tube | Co-axial tube | Co-axial tube |
| Method of
placement and
deployment | Endoscopic; release
by pulling outer sheath | Endoscopic; release
by pulling outer sheath | Endoscopic; release
by pulling outer sheath | Endoscopic; release
by pulling outer sheath |
| Diameter | 10 Fr (3.3 mm) | 10.2 Fr (3.4 mm) | 10 Fr (3.3 mm) | 10.2 Fr (3.4 mm) |
| Usable Length | 220 cm | 230 cm | 220 cm | 230 cm |
| Compatible
guidewire | 0.035" | 0.035" | 0.035" | 0.035" |
7. PERFORMANCE DATA
Sterility and Packaging Testing
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent and introducer are provided as sterile devices. The sterilization method, validation method, and sterility assurance level are in accordance with ISO 11135:2014. "Sterilization of health-care products - Ethylene oxide - Requirement for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1(2018)]".
Packaging was designed, tested, and validated in accordance with AAMI/ANSI/ISO 11607-1:2019, "Packaging for terminally sterilized medical devices - Part 1: Requirements for
5
materials, sterile barrier systems and packaging" and AAMI/ANSI/ISO 11607-2:2019, "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes".
Biocompatibility Testing
The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent were evaluated according to the FDA's guidance "Use of InternationalStandard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluating and testing within a risk management process". The stent and introducer were evaluated for cytotoxicity, sensitization, and irritation/ intracutaneous reactivity effects. The stent was also evaluated for acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, chronic toxicity, and implantation effects. The evaluation determined that the devices have an acceptable biocompatibility profile.
Bench Testing
To establish the substantial equivalence of both Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent, bench testing was conducted to validate the performance of both devices. The following tests were conducted:
- Deployment Accuracy .
- . Deployment Force
- Expansion Force .
- Compression Force .
- Dimensional .
- . Tensile Strength
- . Shipping
- . Shelf-life
- Corrosion .
- . MR Compatibility
- . Axial Force
- . Trackability and Visualization
- . Repositioning Force
- . Radiopacity
The results of the bench testing show that the subject devices meet their specifications and are substantially equivalent to the predicate devices.
CONCLUSION 8.
The subject devices have indications for use that are the same as the predicate devices and technological characteristics that are similar to the predicate devices. The performance data demonstrate that the subject devices meet their specification and do not raise new questions of
6
| K223067 | |
|---|---|
| 510(k) Summary | Page 4 of 4 |
safety or effectiveness. These results support a determination of substantial equivalence of the subject devices to the predicate devices.