(170 days)
Not Found
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any AI/ML components or functionalities.
Yes
The device is used to dilate strictures, which is a therapeutic intervention aimed at treating a medical condition rather than just diagnosing or planning treatment.
No
The device is a dilatation balloon catheter used to treat strictures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical balloon catheter with a guidewire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Reliant™ Multistage Dilatation Balloon Catheter is a physical device used inside the body (in vivo) to mechanically dilate strictures in the gastrointestinal tract. It does not analyze or test any biological specimens.
- Intended Use: The intended use clearly states it is for "endoscopically dilate strictures of the gastrointestinal tract," which is a therapeutic procedure performed directly on the patient.
Therefore, the Reliant™ Multistage Dilatation Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
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™ 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.
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)
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
No clinical study is included in this submission.
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/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.
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 (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
2
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) | Comparison
on |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 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 Summary
Comparis
on |
| 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 ReliantTM
Multistage Dilitation
Balloon Catheter is
indicated for use in adult
and adolescent
populations to
endoscopically dilate
strictures of the
gastrointestinal tract. | The Disposable
Multistage Dilation
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 |
| Tensile Strength between
Balloon and Double
Lumen Tube(N) | $67.11\pm2.16$ | $78.11\pm9.59$ | Similar |
| Tensile Strength between
Double Lumen Tube and
Junction(N) | $109.99\pm2.12$ | $94.67\pm3.54$ | Similar |
| Biocompatibility-Cytotoxicity | The test article
extracts had not a
cytotoxic potential.
Neither SC extracts nor
CSO extracts of the
test article had | The test article
extracts had not a
cytotoxic potential.
Neither SC extracts nor
CSO extracts of the
test article had | Same |
| Biocompatibility-Sensitization | evidence of causing
sensitization in the
guinea pig. | evidence of causing
sensitization in the
guinea pig. | Same |
| Item | Proposed Device | Predicate Device
(K151671) | Comparison
on |
| 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. | 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
6
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).