(116 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 dilate strictures of the gastrointestinal tract, which is a therapeutic intervention.
No
The device is a therapeutic device used for dilating strictures, not for diagnosing conditions.
No
The device description clearly details a physical catheter with a balloon, guidewire, and locking device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Disposable Multistage Dilation Balloon Catheter is a device used within the body (endoscopically) to physically dilate strictures in the gastrointestinal tract. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states it's for dilating strictures, which is a treatment, not a diagnostic test.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable Multistage Dilation 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 Disposable Multistage Dilation 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 Disposable Multistage Dilation 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)
Bench testing was performed to support a determination of substantial equivalence. The Disposable Multistage Dilation Balloon Catheter performs as well as the predicate and is substantially equivalent to the predicate devices. The following in-vitro performance tests were completed on the Disposable Multistage Dilation Balloon Catheter:
Balloon Diameter
Balloon length
Rated pressure
Working Length
Retraction testing
Tensile Strength
Tip Pull Testing
Endoscopic Compatibility Testing
Balloon Burst Pressure
Balloon Fatigue Testing
Radiopacity
Balloon Inflation/Deflation Testing
Package integrity
Shelf Life Testing
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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2015
Micro-Tech (Nanjing) CO., Ltd. Becky Li Quality Manager No.10 Gaoke Third Rd., Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu 210032 China
Re: K151671
Trade/Device Name: Disposable Multistage Dilation Balloon Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, KNQ Dated: September 6, 2015 Received: September 10, 2015
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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) K151671
Device Name
Disposable Multistage Dilation Balloon Catheter
Indications for Use (Describe)
The Disposable Multistage Dilation 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)
| X 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
3
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, with the word "MICRO-TECH" to the right of the letters. Below the word "MICRO-TECH" are two Chinese characters. The logo is blue and white.
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: K151671
1. Date of Preparation: 10/14/2015
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: Manager of Quality Department Tel: +86-25-58646378 Fax: +86-25-58744269
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Product Name: Disposable Multistage Dilation Balloon Catheter Common Name: Disposable Multistage Dilation Balloon Catheter Requlatory 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: K112994 Trade Name: CRE Dilatation Balloon Common Name: CRE Wireguided Dilatation Balloon
5. Indications for Use
The Disposable Multistage Dilation Balloon Catheter is indicated for use in
4
Image /page/4/Picture/1 description: The image shows a logo for Micro-Tech. The logo consists of a blue, stylized "MT" symbol on the left, followed by the text "MICRO-TECH" in a sans-serif font. Below the text, there are two Chinese characters. The overall design is clean and modern.
adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.
6. Device Description
The Disposable Multistage Dilation 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 Disposable Multistage Dilation 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 Disposable Multistage Dilation Balloon Catheter incorporates substantially equivalent device materials, design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific predicate devices.
| ltem | Proposed Device | Comparison to |
|---|---|---|
| Disposable Multistage Dilation Balloon Catheter | Predicate Devices | |
| Product Code | 1) FGE, 2) KNQ | Similar |
| Regulation No. | 1) 876.5010, 2) 876.3565 | Similar |
| Class | 2 | Same |
| Supplied Sterile | Yes | Same |
| Balloon Diameter | 6-7-8, 8-9-10, 10-11-12, 12-13.5-15, 15-16.5-18, | Same |
| (mm) | 18-19-20 | |
| Balloon length (mm) | 30, 55, 80. | Similar |
| 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 | Same |
| Working Length | 1800, 2300 | Similar |
| (mm ) |
Comparison to predicate Devices:
5
Image /page/5/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the word "MICRO-TECH" in a similar blue font, with a line underneath it. Below the line are two Chinese characters.
510K Summary
| Item | Proposed Device
Disposable Multistage Dilation Balloon Catheter | Comparison to
Predicate Devices |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Indications for Use | The Disposable Multistage Dilation Balloon
Catheter is indicated for use in adult and
adolescent populations to endoscopically dilate
strictures of the gastrointestinal tract. | Similar |
| Configuration | Tip, balloon, marker band, handle junction, and
guidewire. | Similar |
| Single Use | Yes | Same |
| Packaging | Single-use EO sterilized pouch with one device
per pouch | Similar |
| Shelf Life | Three years (36 months) | Similar |
8. Performance Data
Bench testing was performed to support a determination of substantial equivalence. The Disposable Multistage Dilation Balloon Catheter performs as well as the predicate and is substantially equivalent to the predicate devices. The following in-vitro performance tests were completed on the Disposable
Multistage Dilation Balloon Catheter:
| Balloon Diameter | Endoscopic Compatibility Testing |
|---|---|
| Balloon length | Balloon Burst Pressure |
| Rated pressure | Balloon Fatigue Testing |
| Working Length | Radiopacity |
| Retraction testing | Balloon Inflation/Deflation Testing |
| Tensile Strength | Package integrity |
| Tip Pull Testing | Shelf Life Testing |
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 Disposable Multistage Dilation Balloon Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific CRE Wireguided Dilatation Balloon 。