(232 days)
Not Found
No
The device description focuses on the mechanical components and physical characteristics of the stent and introducer system. There is no mention of software, algorithms, data processing, or any features that would suggest the use of AI or ML. The performance studies listed are standard tests for medical devices (biocompatibility, mechanical testing, sterilization, shelf-life) and do not involve evaluation of AI/ML performance metrics.
Yes
The device is designed to drain obstructed biliary ducts, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a Biliary Plastic Stent Set, used for drainage of obstructed biliary ducts, an interventional/therapeutic procedure rather than a diagnostic one.
No
The device description clearly outlines physical components like stents and introducers, and the performance studies focus on material properties and mechanical performance, indicating a hardware-based device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The primary purpose of this device is to drain obstructed biliary ducts and facilitate endoscopic biliary stent placement. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a physical device (stent and introducer) used for a medical procedure. It does not describe a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical properties, functionality, and biocompatibility of the device for its intended procedural use, not on diagnostic accuracy or performance with biological samples.
In summary, this device is a medical device used for a therapeutic procedure (draining obstructed biliary ducts) and facilitating that procedure (stent placement). It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biliary Plastic Stent is used to drain obstructed biliary ducts.
The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The Biliary Plastic Stent Set short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
Product codes
FGE
Device Description
The proposed device Biliary Plastic Stent Set is a sterile, single-use endoscopic device, the device is used to drain obstructed biliary ducts. Biliary Plastic Stent Set includes Biliary Plastic Stent (hereafter referred as Category 1), Biliary Plastic Stent Introducer (hereafter referred as Category 2), Biliary Plastic Stent Set (hereafter referred as Category 3), Biliary Plastic Stent Introducer/ short-wire compatible (hereafter referred as Category 4) and Biliary Plastic Stent Set/ short-wire compatible (hereafter referred as Category 5). Category 3 is commonly used in traditional ERCP (short for endoscopic retrograde cholangiopancreatography) surgery with a long guidewire (4.5m) while Category 4 and Category 5 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 4 and Category 5, the main feature of the short wire design is the guide wire exit port on the inner tube of the introducer which is used to separate guidewire from the proposed device (For Biliary Plastic Stent Introducer (Normal), the guide wire exit on the inner tube; for Biliary Plastic Stent Introducer (Pusher), the guide wire exit on the outer tube). The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.
There are 66 specifications of Category 1 which mainly differ in plastic stent shape (side bend, center bend, double pigtails), plastic stent diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and plastic stent working length (3cm-18cm).
There are 4 specifications of Category 2 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and can be divided into two types including Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher) depending on whether with or without inner tube assembly. There are 66 specifications of Category 3, each specification contains both plastic stent and introducer. The plastic stent in Category 3 is the same as that in Category 1, which mainly differ in plastic stent shape, plastic stent diameter and plastic stent working length, the introducer in Category 3 is the same as that in Category 2, which includes Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 3 corresponds to Biliary Plastic Stent Introducer (Pusher), and the rest correspond to Biliary Plastic Stent Introducer (Normal).
There are 3 specifications of Category 4 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr) and can be divided into two types including Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher) depending on whether with or without inner tube assembly.
There are 54 specifications of Category 5, each specification contains both plastic stent and introducer/ short-wire compatible. The plastic stent included in Category 5 is the same as that (except 11.5Fr diameter) in Category 1, the introducer short-wire compatible in Category 5 is the same as that in Category 4, which includes Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 5 corresponds to Biliary Plastic Stent Introducer/ short-wire compatible (Normal), and the rest correspond to Biliary Plastic Stent Infroducer/ short-wire compatible (Pusher).
The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional. They have an indicated indwell of up to 3 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The plastic stent is visible under fluoroscopy, the radiopaque bands on the introducer are also visible under fluoroscopy. The plastic stent is placed within the body endoscopically using fluoroscopic monitoring.
Anatomical Site
Biliary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use of this device is restricted to a trained healthcare professional.
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 biocompatibility evaluation for the Biliary Plastic Stent Set was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
Biocompatibility Testing to the plastic stent:
- Cytotoxicity a)
- Sensitization b)
- Irritation c)
- Acute Systemic Toxicity d)
- e) Material Mediated Pyrogen
- f) Implantation
- g) Chemical Characterization and Biological Risk Assessment
Biocompatibility Testing to the introducer:
- Cytotoxicity a)
- b) Sensitization
- c) Irritation
- Acute Systemic Toxicity d)
- Material Mediated Pyrogenicity e)
The following tests were conducted and evaluated for the subject device:
- Dimension Testing a)
- Deformation Recovery Testing b)
- c) Flow Rate Testing
- Plastic Stent Strength Testing d)
- e) Retention Strength Testing
- f) Introducer System Patency Testing
- Introducer System Breaking Force Testing g)
- Corrosion Testing h)
- i) Visibility Under X-Ray Testing
- j) Plastic Stent Release Testing
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One-year accelerated aging test was performed to demonstrate the one-year stability in the shelf life.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device cleared under K172044.
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
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 6, 2023
Micro-Tech (Nanjing) Co., Ltd. Sally He, Regional RA Manager No.10 Gaoke Third Road. Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu Province 210032 China
Re: K230127
Trade/Device Name: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: August 2, 2023 Received: August 7, 2023
Dear Sally He:
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.
Glenn B. Bell -S
Glenn Bell 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K230127
Device Name
Biliary Plastic Stent, Biliary Plastic Stent Set, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer short-wire compatible and Biliary Plastic Stent Set/ short-wire compatible
Indications for Use (Describe)
The Biliary Plastic Stent is used to drain obstructed biliary ducts.
The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The Biliary Plastic Stent Set short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Y Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are large and bold, with the "M" slightly overlapping the "T". The logo has a registered trademark symbol (®) in the upper right corner. The logo appears to be for a company or organization with the initials "MT".
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _ K230127
1. Date of Preparation: 2023-07-28
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing,
Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Region Manager
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: ra.micro-tech@outlook.com
3. Identification of Proposed Device
| Trade Device Name: | Biliary Plastic Stent |
|---|---|
| Biliary Plastic Stent Introducer | |
| Biliary Plastic Stent Set | |
| Biliary Plastic Stent Introducer/ short-wire compatible Biliary | |
| Plastic Stent Set/ short-wire compatible |
| Product Code: | FGE |
|---|---|
| Classification Name: | Biliary Catheter And Accessories |
| Regulation Number: | 21 CFR 876.5010 |
| Regulatory Class: | Class II |
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Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the left. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern design.
4. Identification of Predicate Device
510(k) Number: K172044
Trade/Device Name:
Cotton-Huibregtse® Biliary Stent, Cotton-Leung® Biliary Stent, CottonLeung® Sof-Flex® Biliary
Stent, ST-2 Soehendra Tannenbaum® Biliary Stent,
Zimmon® Biliary Stent, Cotton-Huibregtse® Biliary Stent Set, CottonLeung® Biliary Stent Set,
Zimmon® Biliary Stent Set, Solus® Double Pigtail Stent with Introducer,
Guiding Catheter, Pushing Catheter, Fusion® Pushing Catheter, Stent Introducer Set,
Oasis® One Action Stent Introduction System,
Fusion® Oasis® One Action Stent Introduction System,
Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary Stent,
Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.
Manufacturer: Cook Ireland Ltd
ട. Indications for Use
The Biliary Plastic Stent is used to drain obstructed biliary ducts.
The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The Biliary Plastic Stent Set/ short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
6. Device Description
The proposed device Biliary Plastic Stent Set is a sterile, single-use endoscopic device, the device is used to drain obstructed biliary ducts. Biliary Plastic Stent Set includes Biliary Plastic Stent (hereafter referred as Category 1), Biliary Plastic Stent Introducer (hereafter referred as Category 2), Biliary Plastic Stent Set (hereafter referred as Category 3), Biliary Plastic Stent Introducer/
5
short-wire compatible (hereafter referred as Category 4) and Biliary Plastic Stent Set/ short-wire compatible (hereafter referred as Category 5). Category 3 is commonly used in traditional ERCP (short for endoscopic retrograde cholangiopancreatography) surgery with a long guidewire (4.5m) while Category 4 and Category 5 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 4 and Category 5, the main feature of the short wire design is the guide wire exit port on the inner tube of the introducer which is used to separate guidewire from the proposed device (For Biliary Plastic Stent Introducer (Normal), the guide wire exit on the inner tube; for Biliary Plastic Stent Introducer (Pusher), the guide wire exit on the outer tube). The guidewire can be locked in place using Guidewire Locking Device to maintain guidewire access. Then the exchange of various devices can be performed without concern over wire displacement.
There are 66 specifications of Category 1 which mainly differ in plastic stent shape (side bend, center bend, double pigtails), plastic stent diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and plastic stent working length (3cm-18cm).
There are 4 specifications of Category 2 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr, 11.5Fr) and can be divided into two types including Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher) depending on whether with or without inner tube assembly. There are 66 specifications of Category 3, each specification contains both plastic stent and introducer. The plastic stent in Category 3 is the same as that in Category 1, which mainly differ in plastic stent shape, plastic stent diameter and plastic stent working length, the introducer in Category 3 is the same as that in Category 2, which includes Biliary Plastic Stent Introducer (Normal) and Biliary Plastic Stent Introducer (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 3 corresponds to Biliary Plastic Stent Introducer (Pusher), and the rest correspond to Biliary Plastic Stent Introducer (Normal).
There are 3 specifications of Category 4 which mainly differ in introducer diameter (7Fr, 8.5Fr, 10Fr) and can be divided into two types including Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher) depending on whether with or without inner tube assembly.
There are 54 specifications of Category 5, each specification contains both plastic stent and
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Image /page/6/Picture/1 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional font. The letters are a solid blue color, and the "M" is positioned to the left of the "T". The logo has a registered trademark symbol (®) in the upper right corner.
introducer/ short-wire compatible. The plastic stent included in Category 5 is the same as that (except 11.5Fr diameter) in Category 1, the introducer short-wire compatible in Category 5 is the same as that in Category 4, which includes Biliary Plastic Stent Introducer/ short-wire compatible (Normal) and Biliary Plastic Stent Introducer/ short-wire compatible (Pusher). Among them, the plastic stent with a diameter of 7Fr in Category 5 corresponds to Biliary Plastic Stent Introducer/ short-wire compatible (Normal), and the rest correspond to Biliary Plastic Stent Infroducer/ short-wire compatible (Pusher).
The device is supplied sterile, intended for single use only, and is available for prescription use only. Use of this device is restricted to a trained healthcare professional. They have an indicated indwell of up to 3 months
7. Comparison of Technological Characteristics
The proposed device incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device cleared under K172044.
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Biliary Plastic Stent Set | (K172044) | ||
| Product Code | FGE | FGE | SE |
| Regulation No. | 21 CFR 876.5010 | 21 CFR 876.5010 | SE |
| Class | II | II | SE |
| Indication for Use | The Biliary Plastic Stent is used to drain | ||
| obstructed biliary ducts. | |||
| The Biliary Plastic Stent Introducer is | |||
| used for endoscopic biliary stent | |||
| placement. | |||
| The Biliary Plastic Stent Introducer/ | |||
| short-wire compatible is used for | |||
| endoscopic biliary stent placement. | |||
| The Biliary Plastic Stent Set is intended | |||
| for endoscopic biliary stent placement to | The stents are used to drain obstructed | ||
| biliary ducts. | |||
| The introducers are used for endoscopic | |||
| biliary stent placement. | |||
| The systems are intended for endoscopic | |||
| biliary stent placement to drain obstructed | |||
| bile ducts. | SE | ||
| Item | Proposed Device | Predicate Device (K172044) | Remark |
| Biliary Plastic Stent Set | |||
| drain obstructed bile ducts. | |||
| The Biliary Plastic Stent Set/ short-wire | |||
| compatible is intended for endoscopic | |||
| biliary stent placement to drain obstructed | |||
| bile ducts. | |||
| Single Use | YES | YES | SE |
| Supplied in Sterile | YES | YES | SE |
| Configuration | Biliary Plastic Stent only, Biliary Plastic | ||
| Stent Introducer only, Biliary Plastic Stent | |||
| Introducer/ short-wire compatible only, | |||
| Biliary Plastic Stent Set, Biliary Plastic | |||
| Stent Set/ short-wire compatible | Stents only, Introducers | ||
| only/Introduction systems, Stent sets | SE | ||
| Main Material | The Biliary Plastic Stent Set is comprised | ||
| of two main parts: Biliary Plastic Stent | |||
| and Biliary Plastic Stent Introducer, the | |||
| Biliary Plastic Stent Set/ short-wire | |||
| compatible is comprised of two main | |||
| parts: Biliary Plastic Stent and Biliary | |||
| Plastic Stent Introducer/ short-wire | |||
| compatible. The main material of plastic | |||
| stent is TPU. The main material of | |||
| introducer is PTFE, ABS, PC, SUS304 | |||
| and Ta | The main material of plastic stent is | ||
| plastic. The main material of introducer is | |||
| plastic and metal. | Similar | ||
| Plastic Stent | |||
| Shape | Side bend/ Center bend/ Double pigtails | Side bend/ Center bend/ Center bend with | |
| four side flaps/ Double pigtails | Similar | ||
| Plastic Stent | |||
| Diameter | 7Fr/8.5Fr/10Fr/11.5Fr | 5Fr/7Fr/8.5Fr/10Fr/11.5Fr | Similar |
| Plastic Stent | |||
| Working Length | 30mm/50mm/70mm/90mm/100mm/ | ||
| 120mm/150mm/180mm | 30mm/40mm/50mm/60mm/70mm/80mm/ | ||
| 90mm/100mm/110mm/ | |||
| 120mm/130mm/140mm/150mm/160mm/ | |||
| 170mm/180mm | Similar | ||
| Introducer | |||
| Diameter | 7Fr/8.5Fr/10Fr/11.5Fr | 5Fr/7Fr/8.5Fr/10Fr/11.5Fr | Similar |
| Item | Proposed Device | Predicate Device | |
| (K172044) | Remark | ||
| Biliary Plastic Stent Set | |||
| Introducer | |||
| Working Length | 1700mm/ 2200mm | 1950mm/2050mm/3180mm/3200mm | Similar |
| Working Channel | |||
| of Endoscope | 7Fr: ≥2.8mm, 8.5Fr: ≥3.2mm, | ||
| 10Fr: ≥3.7mm, 11.5Fr ≥4.2mm | 5Fr: ≥2mm, 7Fr: ≥2.8mm, | ||
| 8.5Fr: ≥3.2mm, 10Fr: ≥3.7mm, | |||
| 11.5Fr ≥4.2mm | Similar | ||
| Guidewire | 0.035" | 0.035" | SE |
| Applicable Body | |||
| Parts | Biliary tract | Biliary tract | SE |
| Packaging | Single-use EO sterilized pouch with one | ||
| device per pouch | Single-use EO sterilized pouch with one | ||
| device per pouch | SE | ||
| Operation | |||
| Principle | The plastic stent is loaded on the | ||
| introducer, and then advance the | |||
| introducer and the plastic stent to the | |||
| desired position in the human body | |||
| through the preposition guide wire. After | |||
| plastic stent reaching the desired position, | |||
| release the plastic stent, and then | |||
| withdraw the introducer. | The plastic stent is loaded on the | ||
| introducer, and then advance the | |||
| introducer and the plastic stent to the | |||
| desired position in the human body | |||
| through the preposition guide wire. After | |||
| plastic stent reaching the desired position, | |||
| release the plastic stent, and then withdraw | |||
| the introducer. | SE | ||
| Surgical | |||
| Technique | The plastic stent is visible under | ||
| fluoroscopy, the radiopaque bands on the | |||
| introducer are also visible under | |||
| fluoroscopy. The plastic stent is placed | |||
| within the body endoscopically using | |||
| fluoroscopic monitoring. | The stent material is visible under | ||
| fluoroscopy, the radiopaque bands on the | |||
| introducer are also visible under | |||
| fluoroscopy. The plastic stent is placed | |||
| within the body endoscopically using | |||
| fluoroscopic monitoring. | SE | ||
| Shelf Life | Conform to ASTM 1980 | Conform to ASTM 1980 | SE |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | SE |
| Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | SE |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | SE |
Comparison to predicate Devices:
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Image /page/7/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A registered trademark symbol is located in the upper right corner of the logo.
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Image /page/8/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and appear to be three-dimensional. A circled "R" trademark symbol is located in the upper right corner of the image.
The proposed device is similar in design to predicate device cleared under K172044, which consists of plastic stent, introducer and system combines a plastic stent and an introducer.
The shapes and dimensions of proposed device are covered within the range of that of the predicate
9
device. All comparative non-clinical performance testing have been tested and have met the requirements of substantial equivalence to the predicate device.
Therefore, the difference between proposed device and predicated device is considered not to affect substantial equivalence between the proposed and predicate devices concerning safety and effectiveness.
8. Performance Data
The biocompatibility evaluation for the Biliary Plastic Stent Set was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
Biocompatibility Testing to the plastic stent:
- Cytotoxicity a)
- Sensitization b)
- Irritation c)
- Acute Systemic Toxicity d)
- e) Material Mediated Pyrogen
- f) Implantation
- g) Chemical Characterization and Biological Risk Assessment
Biocompatibility Testing to the introducer:
- Cytotoxicity a)
- b) Sensitization
- c) Irritation
- Acute Systemic Toxicity d)
- Material Mediated Pyrogenicity e)
The following tests were conducted and evaluated for the subject device:
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Image /page/10/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are blocky and connected, with the "M" appearing in front of the "T". A registered trademark symbol is visible in the upper right corner of the image.
- Dimension Testing a)
- Deformation Recovery Testing b)
- c) Flow Rate Testing
- Plastic Stent Strength Testing d)
- e) Retention Strength Testing
- f) Introducer System Patency Testing
- Introducer System Breaking Force Testing g)
- Corrosion Testing h)
- i) Visibility Under X-Ray Testing
- j) Plastic Stent Release Testing
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. One-year accelerated aging test was performed to demonstrate the one-year stability in the shelf life.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device cleared under K172044.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
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Image /page/11/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The "M" is on the left and the "T" is on the right, and they appear to be connected or overlapping. There is a small registered trademark symbol in the upper right corner of the logo.
Based on the indications for use, technological characteristics, and safety and performance testing, the proposed device has been shown to be appropriate for its intended use and is substantially equivalent to the currently cleared predicate device under K172044.