(172 days)
The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.
The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667. The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.
The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Niti-S Biliary Speed D Stent." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than performing a de novo clinical study to establish performance against acceptance criteria for a novel AI/software medical device.
Therefore, the information required to populate a table of acceptance criteria and a detailed study proving device performance (especially for an AI/software product, as implied by questions like sample size for training data, expert consensus, MRMC studies, etc.) is not present in this document.
Specifically, the document states:
- "Software Verification and Validation Testing: Not applicable. The subject device contains no software of any type." (Page 8)
- "Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device." (Page 9)
- "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." (Page 9)
The 510(k) pathway for this device relies primarily on:
- Identical Indications for Use
- Highly similar technological characteristics to a predicate device (Niti-S Biliary Stent, K073667).
- Non-clinical bench testing to confirm physical characteristics and performance (e.g., integrity, radial force, material properties) and biocompatibility testing for material changes in the delivery system.
- Sterilization and Shelf Life testing.
As such, I cannot provide the requested information about acceptance criteria and study details for an AI/software medical device based on this document. The document describes a physical medical device (stent and delivery system), not an AI or software product.
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May 26, 2023
Taewoong Medical Co., Ltd % Matthew Krueger Senior Consultant Biologics Consulting Group. Inc. 100 Daingerfield Road, Suite 400 Alexandria, VA 23314
Re: K223626
Trade/Device Name: Niti-S Biliary Speed D Stent Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 24, 2023 Received: April 25, 2023
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.
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:
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K223626 - Matthew Krueger
- 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 (OS) 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 -S
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) K223626
Device Name Niti-S Biliary Speed D Stent
Indications for Use (Describe)
The Niti-S Biliary Speed D 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 Speed D Stent is provided below.
SUBMITTER 1.
| Applicant: | Taewoong Medical Co., Ltd.14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea, 10022TEL: +82-31-996-0641FAX: +82-31-996-0645 |
|---|---|
| Contact: | Matthew KruegerSenior Consultant, Medical DevicesBiologics Consulting Group, Inc.Phone: (571) 777-9505Email: mkrueger@biologicsconsulting.com |
| Submission Correspondent: | Matthew KruegerSenior Consultant, Medical DevicesBiologics Consulting Group, Inc.Phone: (571) 777-9505Email: mkrueger@biologicsconsulting.com |
| Date Prepared: | May 22, 2023 |
2. DEVICE
Niti-S Biliary Speed D Stent Device Trade Name: 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
K073667 – Taewoong Medical Niti-S Biliary Stent Predicate Device:
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DEVICE DESCRIPTION 4.
The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent is a flexible and expandable tubular device made of Nitinol wire. Two Nitinol wires are woven in a hook-type design. The stent design is identical to the predicate device cleared in K073667.
The Stent Delivery System is a disposable system for the delivery and deployment of the stent at the target position.
5. INDICATIONS FOR USE
The Niti-S Biliary Speed D Stent is indicated for the palliation of malignant strictures in the biliary tree.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Predicate Device Indications for Use
Indicated for the palliation of malignant strictures in the biliary tree.
Subject Device Indications for Use
Indicated for the palliation of malignant strictures in the biliary tree.
Discussion of Similarities and Differences
The Indications for Use of the predicate and subject devices are identical.
Technological Comparisons
The table below compares the key technological feature of the subject devices to the predicate device (K073667 - Taewoong Medical Niti-S Biliary Stent).
| Table 1: | Technological Comparison |
|---|---|
| ---------- | -------------------------- |
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| 510(k) number | TBD | K073667 |
| Trade/Device Name | Niti-S Biliary Speed D Stent | Niti-S Biliary Stent |
| Manufacturer | Taewoong Medical Co., Ltd. | Taewoong Medical Co., Ltd. |
| Regulation Number | 21 CFR 876.5010 | 21 CFR 876.5010 |
| Indication for use statement | The Niti-S Biliary Speed D 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. |
| Characteristic | Subject Device | Predicate Device |
| Expansion method | The stent is loaded into the distal partof the delivery device, and expandedin the body by pulling the outer sheathof the delivery device. | The stent is loaded into the distal partof the delivery device, and expandedin the body by pulling the outer sheathof the delivery device. |
| Method of introduction | Endoscopic | Endoscopic, Percutaneous |
| Sterility | EO Sterilization | EO Sterilization |
| Stent material | Nitinol, Pt/Ir, STS316L | Nitinol, Pt/Ir, STS316L |
| Stent lengths | 40 mm, 50 mm, 60 mm, 70 mm, 80mm, 90 mm, 100 mm, 120 mm | 40 mm, 50 mm, 60 mm, 70 mm, 80mm, 90 mm, 100 mm, 120 mm |
| Stent diameters | 8 mm, 10 mm | 8 mm, 10 mm |
| Stent geometry | - Hook shape- Straight ends- 10 radiopaque markers | - Hook shape- Straight ends- 10 radiopaque markers |
| Stent photo | Image: Stent photo of subject device | Image: Stent photo of predicate device |
| Hook Structure | Image: Hook structure of subject device | Image: Hook structure of predicate device |
| Cross Structure | Image: Cross structure of subject device | Image: Cross structure of predicate device |
| Cell width | App. 2.57 mm | App. 2.57 mm |
| Cell height | App. 2.02 mm | App. 2.02 mm |
| Overall Cell area | App. 2.60 mm² | App. 2.60 mm² |
| Delivery system photo | Image: Delivery system photo of subject device | Image: Delivery system photo of predicate device |
| Characteristic | Subject Device | Predicate Device |
| Delivery system material | PC/ABS, STS304, PTFE, PEBAX,Nylon, Tungsten, Pad printing ink, etc. | PC/ABS, STS304, PTFE, PEBAX,Nylon, Tungsten, etc. |
| Delivery system length | 180 cm (Endoscopic) | 180 cm (Endoscopic),50 cm (Percutaneous) |
| Delivery system profile | 8.5 Fr (2.8 mm) | 8 Fr (2.7 mm) |
| Guidewire (in inches) | 0.035 | 0.035 |
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PERFORMANCE DATA 7.
Sterilitv
The Niti-S Biliary Speed D Stent and stent delivery system (SDS) is provided as a sterile device sterilized using traditional ethylene oxide.
Table 2: Sterilization Cycle Parameters
| Parameter | Levels |
|---|---|
| Sterilization Method | Ethylene oxide |
| Sterility validation method | Half-cycle method using ISO 11135:2014 |
| Sterility Assurance Level | 10-6 |
Shelf Life and Shipping
Taewoong Medical performed the following shelf life and shipping testing to evaluate the Niti-S Biliary Speed D Stent.
The following tests were performed:
- ASTM 1980-21, Standard Guide For Accelerated Aging Of Sterile Barrier Systems . And Medical Devices
- ASTM D4169-16, Standard Practice For Performance Testing Of Shipping ● Containers And Systems
Biocompatibility Testing
The stent material of the subject device is identical to the 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).
The SDS material of the subject device is not identical to the Niti-S Biliary Stent cleared in K073667. Therefore, additional biocompatibility testing for the Stent Delivery System of the subject device was conducted in accordance with the ISO 10993 series to establish substantial equivalence.
The following testing was done:
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- ISO 10993-5:2009 Cytotoxicity .
- ISO 10993-10:2010 Irritation and skin sensitization ●
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The subject device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Not applicable. The subject device contains no software of any type.
Bench Testing
Taewoong Medical performed the following non-clinical bench testing to evaluate the Niti-S Biliary Speed D Stent. Test samples were obtained from different manufacturing lots for all tests.
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 (MR) Safety ●
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.
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Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
8. CONCLUSION
Based on the detailed comparison between the predicate device and the subject device, the performance testing, and conformance with applicable standards, the Niti-S Biliary Speed D Stent can be found substantially equivalent to the predicate device.
§ 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.