(170 days)
The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
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 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (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.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the performance tests in the typical sense of a target metric the device must achieve. Instead, it reports the measured values for the proposed device and compares them to the predicate device. The underlying acceptance criterion for these tests is that the new device should be substantially equivalent to the predicate device, meaning its performance characteristics are similar enough not to raise new questions of safety or effectiveness.
| Performance Test | Proposed Device Performance (Reliant™ Multistage Dilatation Balloon Catheter) | Predicate Device Performance (K151671) |
|---|---|---|
| Tensile Strength between Balloon and Double Lumen Tube (N) | $67.11 \pm 2.16$ | $78.11 \pm 9.59$ |
| Tensile Strength between Double Lumen Tube and Junction (N) | $109.99 \pm 2.12$ | $94.67 \pm 3.54$ |
| Biocompatibility - Cytotoxicity | The test article extracts had not a cytotoxic potential. Neither SC extracts nor CSO extracts had a cytotoxic potential. | The test article extracts had not a cytotoxic potential. Neither SC extracts nor CSO extracts had a cytotoxic potential. |
| Biocompatibility - Sensitization | No evidence of causing sensitization in the guinea pig. | No evidence of causing sensitization in the guinea pig. |
| Biocompatibility - Irritation | The test article extracts have no animal intracutaneous reactivity as compared to the control. | The test article extracts have no animal intracutaneous reactivity as compared to the control. |
Note: For tensile strength, the comparison indicates "similar," implying that the measured values, while not identical, are considered acceptable for demonstrating substantial equivalence given the context of the device's function and intended use. For biocompatibility, the results are identical, indicating the proposed device performs the same as the predicate in these aspects.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the tensile strength tests (e.g., how many balloons were tested). For biocompatibility, the tests are typically performed on a statistically relevant number of samples according to ISO standards, but the specific number is not disclosed.
- Data Provenance: The document does not explicitly state the country of origin for the test data for the tensile strength and biocompatibility tests. Given that Micro-Tech (Nanjing) Co., Ltd. is based in China, it is highly probable the testing was conducted in China or by a contracted lab. The data is retrospective in the sense that these tests were performed on the finished device before this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The "ground truth" for material property tests like tensile strength and biocompatibility is established by standardized laboratory methods and measurements, not by expert consensus or interpretation of images/clinical data. These are objective measures.
4. Adjudication method for the test set
This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and biological material characterization tests, which do not involve such human-based 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
This is not applicable. The device is a medical catheter (a physical instrument), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or is relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. As mentioned above, the device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed (tensile strength, biocompatibility) is based on:
- Standardized Laboratory Measurements: For tensile strength, the ground truth is the measured force required to break the material, determined by calibrated testing equipment and procedures.
- Standardized Biological Assay Results: For biocompatibility (cytotoxicity, sensitization, irritation), the ground truth is the observable biological response (or lack thereof) in laboratory assays, compared against established biological safety criteria (e.g., ISO 10993 series standards).
8. The sample size for the training set
This is not applicable. The concept of a "training set" (used for machine learning or AI algorithms) does not apply to the development or testing of this physical medical device. Device development involves engineering design, material selection, and physical testing, not algorithm training.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2017
Micro-Tech (Nanjing) CO., Ltd. Becky Li Quality Director NO. 10 Gaoke Third Road Nanjing, 210032 China
Re: K162226
Trade/Device Name: Reliant™ Multistage Dilatation Balloon Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE, KNO Dated: December 27, 2016 Received: December 27, 2016
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Image /page/1/Picture/8 description: The image shows the name "Charles Viviano -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible and well-spaced. There is a faint watermark in the background.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162226
Device Name
Reliant(TM) Multistage Dilatation Balloon Catheter
Type of Use (Select one or both, as applicable)
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.
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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Image /page/3/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font on the left, with the word "MICRO-TECH" in a simple sans-serif font on the right. Below the word "MICRO-TECH" are two Chinese characters.
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: 2016-12-15
2. Sponsor Identification 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 Director Tel: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Product Name: Reliant™ Multistage Dilatation Balloon Catheter Common Name: Reliant™ Multistage Dilatation Balloon Catheter Regulatory Information Classification Name: 1) Catheter, Biliary, diagnostic, 2) Dilator, esophageal Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 1) 876.5010, 2) 876.3565 Review Panel: Gastroenterology/Urology
4. Identification of Predicate Device
510(k) Number: K151671 Product Name: Disposable Multistage Dilation Balloon Catheter Common Name: Disposable Multistage Dilation Balloon Catheter Regulatory Information Classification Name: 1) Catheter, Biliary, diagnostic, 2) Dilator, esophageal Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 1) 876.5010, 2) 876.5365
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Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of a blue, stylized "MT" symbol on the left, followed by the text "MICRO-TECH" in blue. Below the text, there are two Chinese characters, also in blue.
Manufacture: Micro-Tech (Nanjing) Co., Ltd 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 qastrointestinal 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 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (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.
7. Comparison of Technological Characteristics
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 device.
| Item | Proposed Device | Predicate Device(K151671) | Comparisonon |
|---|---|---|---|
| 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 |
| Item | Proposed Device | Predicate Device(K151671) | 510K SummaryComparison |
| Balloon length (mm) | 30, 55, 80. | 30, 55, 80. | Same |
| 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 ReliantTMMultistage DilitationBalloon Catheter isindicated for use in adultand adolescentpopulations toendoscopically dilatestrictures of thegastrointestinal tract. | The DisposableMultistage DilationBalloon Catheter isindicated for use in adultand adolescentpopulations toendoscopically dilatestrictures of thegastrointestinal tract. | Same |
| Configuration | Tip, balloon, markerband, handle junction,and guidewire. | Tip, balloon, markerband, handle junction,and guidewire. | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilizedpouch with one deviceper pouch | Single-use EO sterilizedpouch with one deviceper pouch | Same |
| Shelf Life | Three years (36 months) | Three years (36 months) | Same |
| Tensile Strength betweenBalloon and DoubleLumen Tube(N) | $67.11\pm2.16$ | $78.11\pm9.59$ | Similar |
| Tensile Strength betweenDouble Lumen Tube andJunction(N) | $109.99\pm2.12$ | $94.67\pm3.54$ | Similar |
| Biocompatibility-Cytotoxicity | The test articleextracts had not acytotoxic potential.Neither SC extracts norCSO extracts of thetest article had | The test articleextracts had not acytotoxic potential.Neither SC extracts norCSO extracts of thetest article had | Same |
| Biocompatibility-Sensitization | evidence of causingsensitization in theguinea pig. | evidence of causingsensitization in theguinea pig. | Same |
| Item | Proposed Device | Predicate Device(K151671) | Comparisonon |
| Biocompatibility-Irritation | The test articleextracts have noanimal intracutaneousreactivity as comparedto the control. | The test articleextracts have noanimal intracutaneousreactivity as comparedto the control. | Same |
Comparison to Predicate Devices:
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Image /page/5/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of a blue, stylized "MT" on the left, followed by the text "MICRO-TECH" in blue. Below the text "MICRO-TECH" are two Chinese characters, also in blue.
510K Summary
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Image /page/6/Picture/0 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional blue font on the left. To the right of the letters, the words "MICRO-TECH" are written in a simple, sans-serif font, also in blue. Below the words "MICRO-TECH", there are two Chinese characters.
510K Summary
8. Performance Data
The modifications that were made include:
- Double lumen tube is modified due to change the tubing material.
- The product name is changed slightly.
Comparison to Predicate Devices K151671, the material of double lumen tube is changed, according by FMEA, all necessary verification and validation tests have been performed for the Reliant™ Multistage Dilatation Balloon Catheter to assure substantial equivalence to the predicate device.
- Tensile Strength between Balloon and Double Lumen Tube
- Tensile Strength between Double Lumen Tube and Junction
- Biocompatibility Test
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use and technological characteristics, substantially equivalent to the predicate device, the Reliant™ Multistage Dilatation Balloon Catheter is considered to be substantially equivalent to the Predicate Device (K151671 Disposable Multistage Dilation Balloon Catheter).
§ 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.