(242 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a balloon catheter, with no mention of AI or ML technologies.
Yes
The device is used to "endoscopically dilate strictures of the gastrointestinal tract," which is a direct treatment for a medical condition.
No
Explanation: The device is a Multistage Dilatation Balloon Catheter designed to dilate strictures of the gastrointestinal tract. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon, guidewire, and locking device, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the gastrointestinal tract." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon for mechanical dilation. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body).
- Performance Studies: The performance studies listed are related to the physical properties and functionality of the device (tensile strength, balloon inflation, burst pressure, biocompatibility, etc.), not the analytical or diagnostic performance of testing biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
Product codes (comma separated list FDA assigned to the subject device)
FGE, KNQ
Device Description
The Reliant(TM) Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.
The Reliant(TM) Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 inch (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 inch (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.
The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
adult and adolescent populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on AAMI / ANSI / ISO 14971:2007/(R) 2010 (Corrected 4 October 2007), Medical Devices - Applications of Risk Management to Medical Devices. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
All necessary verification and validation tests have been performed on the proposed device to assure substantial equivalence to the predicate device. The tests include:
Balloon Appearance Test Retraction Test Tensile Strength Testing Test Balloon Inflation and Deflation Test Dimension Test EO Residual Test Sterility Test
Endoscopic Compatibility Test Balloon Burst Pressure Test Balloon Fatigue Testing Test Radiopacity Test Biocompatibility Evaluation ECH Residual Test Package Integrity Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. The logos are placed side-by-side.
October 15, 2018
Micro-Tech (Nanjing) CO., Ltd. Becky Li Quality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, 210032 China
Re: K180418
Trade/Device Name: Reliant(TM) Multistage Dilatation Balloon Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNQ Dated: August 9, 2018 Received: August 13, 2018
Dear Becky Li:
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 mav, 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 avare 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.
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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a faded, white logo of the Food and Drug Administration (FDA). The logo is stylized with the letters 'FDA' interlocked and surrounded by a circular emblem. The white color and faded appearance suggest the image may be a watermark or a low-contrast representation of the FDA logo.
Jeffrey W. Cooper -S 2018.10.15 18:30:40 -04'00'
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180418
Device Name
Reliant(TM) Multistage Dilatation Balloon Catheter
Indications for Use (Describe)
The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510K Summary
Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue stylized "MT" on the left, followed by the words "MICRO-TECH" in blue, with a curved line underneath. The "MT" is designed to look three-dimensional.
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.
1. Date of Preparation: 2018-10-10
Sponsor Identification 2.
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality and Regulatory Affairs Director Tel: +86-25-58646378 Fax: +86-25-58350006 Email: Beckyli mt@outlook.com
Identification of Proposed Device 3.
Product Name: Reliant™ Multistage Dilatation Balloon Catheter Common Name: Reliant™ Multistage Dilatation Balloon Catheter Regulatory Information Classification Name: Biliary catheter and accessories Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 876.5010 Review Panel: Gastroenterology/Urology
4. Identification of Predicate Device
510(k) Number: K162226 Product Name: Reliant™ Multistage Dilatation Balloon Catheter Common Name: Reliant™ Multistage Dilatation Balloon Catheter Regulatory Information Classification Name: Biliary catheter and accessories Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 876.5010 Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
4
Image /page/4/Picture/1 description: The image contains the logo for Micro-Tech. The logo consists of a stylized blue "MT" symbol on the left, followed by the words "MICRO-TECH" in blue, with a horizontal line underneath. The "MT" symbol is designed with a three-dimensional effect, giving it a modern and technological appearance.
Review Panel: Gastroenterology/Urology
This predicate device has not been subject to a design-related recall.
5. Indications for Use
The Reliant™ Multistage Dilatation Balloon Catheter is indicated for use in adult and
adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
6. Device Description
The Reliant™ Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.
The Reliant™ Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 inch (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 inch (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.
The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.
Comparison of Technological Characteristics 7.
The Reliant™ Multistage Dilatation Balloon Catheter incorporates substantially equivalent device design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices.
| Item | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Code | 1) FGE, 2) KNQ | 1) FGE, 2) KNQ | Same |
| Regulation No. | 1) 876.5010, 2) 876.5365 | 1) 876.5010, 2) 876.5365 | Same |
| Class | 2 | 2 | Same |
| Supplied | |||
| Sterile | Yes | Yes | Same |
| Balloon Diameter (mm) | 6-7-8, 8-9-10, 10-11-12, | ||
| 12-13.5-15, 15-16.5-18, | |||
| 18-19-20 | 6-7-8, 8-9-10, 10-11-12, | ||
| 12-13.5-15, 15-16.5-18, | |||
| 18-19-20 | Same | ||
| Balloon length (mm) | 30, 55, 80. | 30, 55, 80. | Same |
5
Image /page/5/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a stylized blue "MT" on the left, followed by the words "MICRO-TECH" in blue. A thin blue line underlines the words "MICRO-TECH".
510K Summarv
| 510K Summary | |||
|---|---|---|---|
| Item | Proposed Device | Predicate Device | Comparison |
| Rated | |||
| pressure(atm) | 3-6-10, 3-5.5-9, | ||
| 3-5-8,3-4.5-8,3-4.5-7,3-4.5-6 | 3-6-10, 3-5.5-9, | ||
| 3-5-8,3-4.5-8,3-4.5-7,3-4.5-6 | Same | ||
| Working | |||
| Length (mm) | 1800, 2300 | 1800, 2300 | Same |
| Indications for | |||
| Use | The Reliant™ Multistage | ||
| Dilitation Balloon Catheter is | |||
| indicated for use in adult and | |||
| adolescent populations to | |||
| endoscopically dilate | |||
| strictures of the | |||
| gastrointestinal tract. | The Reliant™ Multistage | ||
| Dilitation Balloon Catheter is | |||
| indicated for use in adult and | |||
| adolescent populations to | |||
| endoscopically dilate | |||
| strictures of the | |||
| gastrointestinal tract. | Same | ||
| Configuration | Tip, balloon, marker band, | ||
| handle junction, and | |||
| guidewire. | Tip, balloon, marker band, | ||
| handle junction, and | |||
| guidewire. | Same | ||
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized | ||
| pouch with one device per | |||
| pouch | Single-use EO sterilized | ||
| pouch with one device per | |||
| pouch | Same | ||
| Shelf Life | Three years (36 months) | Three years (36 months) | Same |
The modifications that were made are as follows:
-
Add silicone spray to the surface of balloon
-
Labelling change
-
Package material change
8. Performance Data
Risk analysis was carried out in accordance with established in-house acceptance criteria based on AAMI / ANSI / ISO 14971:2007/(R) 2010 (Corrected 4 October 2007), Medical Devices - Applications of Risk Management to Medical Devices. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Comparison to Predicate Device K162226, the modifications that were made are as follows:
- A Add silicone spray to the surface of balloon
- A Labelling change
-
Package material change
6
Image /page/6/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue stylized "MT" on the left, with the words "MICRO-TECH" in blue to the right of the letters. There is a thin blue line underneath the words "MICRO-TECH".
All necessary verification and validation tests have been performed on the proposed device to assure substantial equivalence to the predicate device. The tests include:
Balloon Appearance Test Retraction Test Tensile Strength Testing Test Balloon Inflation and Deflation Test Dimension Test EO Residual Test Sterility Test
Endoscopic Compatibility Test Balloon Burst Pressure Test Balloon Fatigue Testing Test Radiopacity Test Biocompatibility Evaluation ECH Residual Test Package Integrity Test
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Reliant™ Multistage Dilatation Balloon Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Predicate Devices.