(66 days)
The HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
This self-expanding tubular prosthesis is designed to maintain patency of bile duct 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® FAST™ Biliary (NNN) is intended for single use only.
The provided document is a 510(k) Pre-Market Notification for a medical device called the HANAROSTENT® FAST™ Biliary (NNN). This notification primarily focuses on demonstrating substantial equivalence to a predicate device (HANAROSTENT® Biliary (NNN), K111149) rather than presenting a de novo study with explicit acceptance criteria and device performance for a new, unproven device.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for a clinical study to prove device performance in terms of patient outcomes. Instead, it describes bench testing to confirm the safety and effectiveness of the device compared to a predicate, focusing on technical characteristics and design changes.
The "reported device performance" is essentially that the device performed comparably to the predicate in these bench tests and that the modifications did not raise new safety or effectiveness issues.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Expansion force | Not explicitly stated as a numerical criterion from a clinical study for this 510(k). The implicit criterion is that it is comparable to the predicate and performs as intended. | Performed. Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Compression force | Not explicitly stated. Implicit criterion: comparable to predicate, performs as intended. | Performed. Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Deployment force | Not explicitly stated. Implicit criterion: comparable to predicate, performs as intended. | Performed. Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Tensile strength | Not explicitly stated. Implicit criterion: comparable to predicate, performs as intended. | Performed. Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Dimensional test | Not explicitly stated. Implicit criterion: comparable to predicate, performs as intended, and meets design specifications (e.g., new 110mm length). | Performed. Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Crossing profile | Not explicitly stated. Implicit criterion: comparable to predicate, performs as intended. | Performed. Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Tracking force | Not explicitly stated for a clinical study. Implicit criterion: comparable to predicate and allows for effective navigation in a simulated bile duct. | Performed "in a simulated bile duct." Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Deployment force (simulated) | Not explicitly stated for a clinical study. Implicit criterion: comparable to predicate and allows for proper deployment in a simulated bile duct. ) | Performed "in a simulated bile duct." Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Withdrawal force (simulated) | Not explicitly stated for a clinical study. Implicit criterion: comparable to predicate and allows for appropriate withdrawal of the delivery system without issues in a simulated bile duct. | Performed "in a simulated bile duct." Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Deployment accuracy (simulated) | Not explicitly stated for a clinical study. Implicit criterion: comparable to predicate and allows for accurate placement of the stent in a simulated bile duct. | Performed "in a simulated bile duct." Conclusion: "no new issues of safety or effectiveness as compared to the predicate device." |
| Biocompatibility safety | In accordance with ISO 10993-1:2003, 2012. (This standard specifies biological evaluation of medical devices within a risk management process.) | Assessed in accordance with ISO 10993-1:2003, 2012. Conclusion: "non-clinical data supports the safety of the proposed devices." |
| Overall Safety & Effectiveness | The device is "substantially equivalent" to the predicate device and "safe and effective and will perform as intended in the specified use conditions." (This is the overarching conclusion of the 510(k) process, based on the non-clinical data.) | "The non-clinical data supports the safety of the proposed devices and demonstrates that the HANAROSTENT® FAST™ Biliary (NNN) is safe and effective and will perform as intended in the specified use conditions." |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states that "Appropriate bench testing was performed" and refers to "non-clinical data." This indicates that no human test set (patients) was used for this 510(k) submission. The testing was performed on physical device samples. The number of samples for each specific bench test is not provided.
- Sample size for test set: Not specified numerically for individual tests, but refers to physical device samples for bench testing. No human test set was used.
- Data provenance: Bench testing results, likely conducted in-house or by a contracted lab. No country of origin for human data, as no human data was used. The study is not applicable for retrospective or prospective classification as it involves bench testing, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There was no human "test set" and therefore no ground truth established by medical experts in the context of this 510(k) submission. The ground truth for bench testing is determined by engineering specifications and physical measurements.
4. Adjudication Method for the Test Set
Not applicable. As no human test set was used, there was no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This 510(k) pertains to a physical medical device (stent), not a medical imaging AI algorithm. Therefore, an MRMC study or assessment of AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission was based on engineering specifications, physical measurements, and comparison to the predicate device's established performance. The core argument is substantial equivalence, meaning the new device performs similarly to a legally marketed device that has already been deemed safe and effective.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2021
M.I. Tech Co., Ltd. % Beryl St. Jeanne Medical Research Associate, Regulatory Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K183396 Trade/Device Name: HANAROSTENT FAST™ Biliary (NNN) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE
Dear Beryl St. Jeanne:
The Food and Drug Administration (FDA) is sending this letter to notify you of a change related to your previous substantial equivalence (SE) determination letter dated February 11, 2019.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Je Hi An, Ph.D. OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-0018, je.an@fda.hhs.gov.
Sincerely,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Acting Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters and "ADMINISTRATION" in smaller blue letters.
June 10, 2021
M.I. Tech Co., Ltd. % Beryl St. Jeanne Medical Research Associate, Regulatory Namsa 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K183396 Trade/Device Name: HANAROSTENT FAST™ Biliary (NNN) Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: December 5, 2018 Received: December 11, 2018
Dear Beryl St. Jeanne:
The Food and Drug Administration (FDA) is sending this letter to notify you of a change related to your previous substantial equivalence (SE) determination letter dated February 11, 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 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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The safety and effectiveness of this device for use in the vascular system have 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 reguirements 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.
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
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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. Acting 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)
Device Name HANAROSTENT® FAST™ Biliary (NNN)
Indications for Use (Describe)
The HANAROSTENT® FAST™ Biliary (NNN) 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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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 876.5010.
1. Submitter:
| Name: | M.I.Tech Co., Ltd.174 Habuk 2-gil, Jinwi-myeon,Pyeongtaek-si, Gyeonggi-do17706, Republic of Korea |
|---|---|
| Contact: | Ms. Inae Kim / ManagerPhone: +82 70-4304-7450Fax: +82 2-3463-4703 |
2. Device Name and Classification:
| Proprietary Name: | HANAROSTENT® FAST™ Biliary (NNN) |
|---|---|
| Device: | Stents, Drains and Dilators for the Biliary Ducts |
| Regulation Name: | Biliary catheter and accessories |
| Regulation No.: | 21 CFR 876.5010 |
| Product Code: | FGE |
| Third Party Reviewed: | No |
3. Predicate Device:
- HANAROSTENT® Biliary (NNN), K111149 ।
4. Description:
The same device description applies to both the predicate device HANAROSTENT® Biliary (NNN) (K111149) and the subject device HANAROSTENT® FAST™ Biliary (NNN).
This self-expanding tubular prosthesis is designed to maintain patency of bile duct 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
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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® FAST™ Biliary (NNN) is intended for single use only.
Indications for Use: 5.
HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Technological Characteristics: 6.
A new stent length (110mm) has been added to M.I. Tech's device since the predicate K111149 received clearance.
The proposed device has a similar design and the same technical characteristics as the predicate device. There have been no other changes to the technology since K111149 received clearance. The primary difference between the proposed and predicate devices is in the design of the delivery device. In the predicate device the guidewire runs through the entire length of the delivery device whereas in the proposed device the guidewire exits through a lumen near the tip of the delivery device. This modification allows for a single operator exchange technique.
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 modification to the delivery system has been validated and raised no new issues of safety or effectiveness as compared to the predicate device. Performance testing was performed as per the design control system and the following tests were conducted:
- Expansion force -
- Compression force
- Deployment force
- Tensile strength
- Dimensional test
- Crossing profile -
- । Tracking force in a simulated bile duct
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- Deployment force in a simulated bile duct -
- Withdrawal force in a simulated bile duct -
- Deployment accuracy in a simulated bile duct -
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® FAST™ Biliary (NNN) is 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 device, HANAROSTENT® Biliary (NNN); K111149.
§ 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.