(58 days)
No
The summary describes a physical medical device (a stent) and its delivery system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on the physical properties and delivery of the stent.
Yes.
The device is indicated for the palliation of malignant strictures in the biliary tree, which is a therapeutic purpose.
No
The device is a stent used for palliation of malignant strictures, which is a treatment, not a diagnostic function.
No
The device description explicitly states it consists of an implantable metallic stent and an introducer system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Niti-S Biliary Slim M Stent is an implantable metallic stent. It is a physical device inserted into the body to open up a blocked or narrowed passage (in this case, in the biliary tree).
- Intended Use: The intended use is the "palliation of malignant strictures in the biliary tree." This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The device is a medical device used for treatment, not for diagnosing a condition based on analyzing a biological sample.
N/A
Intended Use / Indications for Use
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
The Niti-S Biliary Slim M Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 7 radiopaque markers; 3 in each end 1 in the center. It has a diameter of 6 or 8 mm and the length ranges from 40 to 120mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
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
Biocompatibility Testing
The material of the subject device in its final finished form, including the stent and delivery system, is identical to the Taewoong Medical Co. Ltd. Niti-S Biliary Stent cleared in K073667 including the formulation, processing and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Not applicable. It contains no software of any type.
Bench Testing
The following tests were performed on the stent:
- Pitting Corrosion Potential,
- Galvanic Corrosion,
- Dimensional Verification,
- Foreshortening,
- Stent Integrity,
- Radial Compression Force,
- Radial Outward Force,
- Radiopacity,
- Magnetic resonance environment.
The following tests were performed on the Stent Delivery System (SDS): - Delivery,
- Deployment,
- Withdrawal,
- SDS Bond Strength,
- Crossing Profile.
The following test was performed on the packaged components: - Shipping test
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
Key Metrics
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
June 9, 2022
Taewoong Medical Co., Ltd % Matthew Krueger Senior Consultant Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314
Re: K221071
Trade/Device Name: Niti-S Biliary Slim M Stent Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: April 7, 2022 Received: April 12, 2022
Dear Matthew Krueger:
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 and the limitations described below. 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.
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K221071 - Matthew Krueger
The OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices 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 has 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.
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 letter 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 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. 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.
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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,
Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221071
Device Name Niti-S Biliary Slim M Stent
Indications for Use (Describe)
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.
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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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Niti-S Biliary Slim M Stent is provided below.
1. SUBMITTER
| Applicant: | Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-
do, Korea, 10022
TEL: +82-31-996-0641
FAX: +82-31-996-0645 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Matthew Krueger
Senior Consultant, Medical Devices
Biologics Consulting Group, Inc.
Phone: (571) 777-9505
Email: mkrueger@biologicsconsulting.com |
| Submission Correspondent: | Matthew Krueger
Senior Consultant, Medical Devices
Biologics Consulting Group, Inc.
Phone: (571) 777-9505
Email: mkrueger@biologicsconsulting.com |
| Date Prepared: | 05/26/2022 |
2. DEVICE
Device Trade Name: Niti-S Biliary Slim M Stent Device Common Name: Biliary catheter and accessories Classification Name 21 CFR 876.5010, Biliary Catheter & Accessories Regulatory Class: Class II Product Code: FGE
3. PREDICATE DEVICE
Primary Predicate Device: Taewoong Medical Niti-S Biliary Stent (K073667) M.I.Tech Co., Ltd., HANAROSTENT Benefit™ Biliary (NNN) Secondary Predicate Device: (K202973)
DEVICE DESCRIPTION 4.
The Niti-S Biliary Slim M Stent consists of the implantable metallic stent and introducer system.
5
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 7 radiopaque markers; 3 in each end 1 in the center. It has a diameter of 6 or 8 mm and the length ranges from 40 to 120mm.
INTENDED USE/INDICATIONS FOR USE 5.
The Niti-S Biliary Slim M Stent is indicated for the palliation of malignant strictures in the biliary tree.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
| Subject Device | Primary Predicate (K073667) | Secondary Predicate (K202973) |
|---|---|---|
| Indicated for the palliation of | Indicated for the palliation of | Indicated for the palliation of |
| malignant strictures in the biliary | malignant strictures in the biliary | malignant strictures in the biliary |
| tree. | tree. | tree. |
Technological Comparisons
The table below compares the key technological feature of the subject devices to the primary predicate device (Niti-S Biliary Stent, K073667) and the secondary predicate (HANAROSTENT Benefit™ Biliary (NNN), K202973).
Table 1: Technological Comparison
| Characteristic | Subject Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|---|
| 510(k) number | TBD | K073667 | K202973 |
| Trade/Device Name | Niti-S Biliary Slim M Stent | Niti-S Biliary Stent | HANAROSTENT Benefit™ Biliary (NNN) |
| Manufacturer | Taewoong Medical Co., Ltd. | Taewoong Medical Co., Ltd. | M.I. Tech Co., Ltd. |
| Regulation Number | 21 CFR 876.5010 | 21 CFR 876.5010 | 21 CFR 876.5010 |
| Indication for use statement | The Niti-S Biliary Slim M Stent 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. | The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree. |
| Expansion method | The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. | The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. | The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. |
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| Characteristic | Subject Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|---|
| Method of | |||
| introduction | Endoscopic | Endoscopic, Percutaneous | Endoscopic, Percutaneous |
| Sterility | EO Sterilization | EO Sterilization | EO Sterilization |
| Stent photo | Image: Stent photo | Image: Stent photo | Image: Stent photo |
| Stent material | Nitinol, Pt/Ir, STS316L | Nitinol, Pt/Ir, STS316L | Nitinol, Gold |
| Stent lengths | 40 mm, 50 mm, 60 mm, | ||
| 70 mm, 80 mm, 90 mm, | |||
| 100 mm, 120 mm | 40 mm, 50 mm, 60 mm, 70 | ||
| mm, 80 mm, 90 mm, 100 mm, | |||
| 120 mm | 40 mm, 120 mm | ||
| Stent diameters | 6 mm, 8 mm | 8 mm, 10 mm | 6 mm, 8 mm |
| Stent geometry | - Cross & hook shape |
- Straight ends
- 9 radiopaque markers | - Hook shape
- Straight ends
- 10 radiopaque markers | - Cross & hook shape
- Straight ends
- 9 radiopaque markers |
| Delivery system photo | Image: Delivery system photo | Image: Delivery system photo | Image: Delivery system photo |
| Delivery system
material | Teflon, PE, ABS | Teflon, PE, ABS | Polymeric materials |
| Delivery system
length | 180 cm (Endoscopic) | 180 cm (Endoscopic),
50 cm (Percutaneous) | 180 cm (Endoscopic),
60 cm (Percutaneous) |
| Delivery system
profile | 6 Fr | 8 Fr | 5.9 Fr |
| Guidewire (in inches) | 0.025 | 0.035 | 0.025 |
7. PERFORAMNCE DATA
Biocompatibility Testing
The material of the subject device in its final finished form, including the stent and delivery system, is identical to the Taewoong Medical Co. Ltd. Niti-S Biliary Stent cleared in K073667 including the formulation, processing and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
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Electrical safety and electromagnetic compatibility (EMC)
Not applicable. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Not applicable. It contains no software of any type.
Bench Testing
The following tests were performed on the stent:
- Pitting Corrosion Potential,
- Galvanic Corrosion, ●
- Dimensional Verification, ●
- Foreshortening, ●
- Stent Integrity, ●
- Radial Compression Force, ●
- Radial Outward Force, ●
- Radiopacity, ●
- Magnetic resonance environment. ●
The following tests were performed on the Stent Delivery System (SDS):
- . Delivery,
- Deployment,
- Withdrawal, ●
- SDS Bond Strength, ●
- Crossing Profile.
The following test was performed on the packaged components:
- Shipping test
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
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CONCLUSION 8.
Based on the detailed comparison between the primary predicate device, secondary predicate device and the subject device, the performance testing and conformance with applicable standards, the Niti-S Biliary Slim M Stent can be found substantially equivalent to the predicate device.