(396 days)
No
The description details a mechanical device for stone retrieval and contrast injection, with no mention of AI/ML components or functions.
Yes.
The device is used to remove stones from the biliary system, which is a therapeutic intervention. It also facilitates the injection of contrast medium while occluding the duct, aiding in diagnosis or treatment.
No
The device is indicated for therapeutic procedures (stone removal, contrast injection) and not for diagnosing conditions.
No
The device description clearly details a physical medical device, a balloon catheter, with specific materials (Pebax, natural latex), lumens, and physical components like radiopaque bands. It also describes physical performance testing.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon." This is a therapeutic and diagnostic procedure performed in vivo (within the body), not in vitro (outside the body).
- Device Description: The description details a physical catheter with a balloon designed for insertion into the biliary system. This is a medical device used for direct intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the Retrieval Balloon Catheter is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Product codes
FGE
Device Description
The proposed device Retrieval Balloon Catheter includes Sterile Biliary Stone Retrieval Balloon Catheter (hereafter referred as Category 1) and Retrieval Balloon / short-wire compatible (hereafter referred as Category 2). Category 1 is commonly used in traditional ERCP surgery with a long guidewire (4.5m) while Category 2 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 2, the main feature of the short wire design is the C-shaped groove on the sidewall of catheter which is used to separate guidewire from the proposed device. 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.
The proposed device Retrieval Balloon Catheter is sterile, single-use endoscopic device, and is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
The proposed Retrieval Balloon Catheter is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.
Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire and the guidewire is able to be loaded either from the front or the back. Another separate lumen is designed for contrast medium. There are for injection-distal or injection-proximal options offered to support physician preference and facilitate procedural needs.
The balloon can be inflated to 9 mm, 12 mm, 15 mm, 18 mm diameters using the pre-measured syringes and a single balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.
There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system, Biliary Tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Endoscopic Clinic
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)
Performance testing was conducted to demonstrate the performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device. The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
- Dimension;
- Endoscope Compatibility Test;
- Infusion Patency Testing;
- Guidewire Matching Test:
- Balloon Fatigue Test;
- Luer Connector Test;
- Connection Strength Test;
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. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
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 biocompatibility evaluation for the Retrieval Balloon Catheter 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:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Pyrogen
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device Extractor™ Pro Retrieval Balloon Catheter cleared under K102082.
No animal study is included in this submission.
No clinical study is included in this submission.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
May 6, 2022
Micro-Tech (Nanjing) Co., Ltd. Becky Li Senior Ouality and Regulatory Affairs Director No. 10 Goake Third Road, Nanjig National Hi-Tech Industrial Development Zone Narijing, Jiangsu Province 210032 CHINA
Re: K211021
Trade/Device Name: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: March 28, 2022 Received: April 4, 2022
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. 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
Je Hi An. Ph.D. Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211021
Device Name Retrieval Balloon Catheter
Indications for Use (Describe)
The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- |
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3
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 connected and appear to be made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo.
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: K211021
1. Date of Preparation: 2022-05-04
-
- 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: Becky Li
Position: Senior Quality and Regulatory Affairs Director
Tel: +86-25-58646378
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade/Product Name: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval
Balloon / short-wire compatible
Common Name: Retrieval Balloon Catheter
Regulatory Information
Classification Name: Biliary Catheter and Accessories
Classification: 2
Product Code: FGE
Regulation Number: 876.5010
Review Panel: Gastroenterology/Urology
4
K211021 Page 2 of 7
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 blocky and appear to be interconnected, with the "M" on the left and the "T" on the right. A registered trademark symbol is located in the upper right corner of the image, next to the top right corner of the "T". The logo has a clean and modern design.
4. Identification of Predicate Device
510(K) Number: K102082 Product Name: Extractor™ Pro Retrieval Balloon Catheter Manufacturer: Boston Scientific Corporation
5. Indications for Use
The device is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
6. Device Description
The proposed device Retrieval Balloon Catheter includes Sterile Biliary Stone Retrieval Balloon Catheter (hereafter referred as Category 1) and Retrieval Balloon / short-wire compatible (hereafter referred as Category 2). Category 1 is commonly used in traditional ERCP surgery with a long guidewire (4.5m) while Category 2 adopts short-wire design which is compatible with a short guidewire (2.6m). For specifications of Category 2, the main feature of the short wire design is the C-shaped groove on the sidewall of catheter which is used to separate guidewire from the proposed device. 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.
The proposed device Retrieval Balloon Catheter is sterile, single-use endoscopic device, and is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
The proposed Retrieval Balloon Catheter is comprised of a natural latex balloon mounted at the distal end of a Pebax catheter with three internal lumens for ballooning, guidewire and contrast medium. The internal lumen for ballooning is used to inflate/deflate the balloon. Multiple syringes are included with the packaging, allowing balloon inflation to a specific diameter.
5
Image /page/5/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 registered trademark symbol (®) is located in the upper right corner of the logo. The logo has a clean and modern design.
Following insufflation, the balloon surface lies flat against the bile duct wall, enabling efficient and complete cleaning of the bile duct. A separate lumen is designed for a 0.035 inch guidewire and the guidewire is able to be loaded either from the front or the back. Another separate lumen is designed for contrast medium. There are for injection-distal or injection-proximal options offered to support physician preference and facilitate procedural needs.
The balloon can be inflated to 9 mm, 12 mm, 15 mm, 18 mm diameters using the pre-measured syringes and a single balloon can be inflated to two or three distinct sizes if a different diameter is needed without having to exchange devices. During stone removal process, the balloon can be filled to removal multiple stones in the biliary tract.
| Balloon
Inflated
| Diameter | 9/12 | 12/15 | 9/12/15 | 15/18 | 12/15/18 | 18/21 | 15/18/21 |
|---|---|---|---|---|---|---|---|
| --------------------------------- | ------ | ------- | --------- | ------- | ---------- | ------- | ---------- |
There are two radiopaque bands placed at the distal and proximal ends of the balloon providing high fluoroscopic visualization of the balloon location.
7. Comparison of Technological Characteristics
The Retrieval Balloon Catheter incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Extractor™ Pro Retrieval Balloon Catheter.
Table 7.1 Technological comparison between the proposed device and predicate device
| Item | Proposed Device
Retrieval Balloon Catheter | Predicate Device
Extractor™ Pro Retrieval
Balloon Catheter
(K102082) | Remark |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FGE | FGE | Same |
| Regulation No. | 876.5010 | 876.5010 | Same |
| Class | II | II | Same |
| Supplied in Sterile | YES | YES | Same |
| Configuration | Catheter, Balloon, Radiopaque
Marker, Handle | Catheter, Balloon, Radiopaque
Marker, Handle | Same |
| Item | Proposed Device
Retrieval Balloon Catheter | Predicate Device
Extractor™ Pro Retrieval
Balloon Catheter
(K102082) | Remark |
| Main Material | Natural Latex, Platinum Iridium
Alloy, Polyether Block Amide | Natural Latex, Polymer
Materials, Alloy Materials | Similar |
| Injection | Contrast Medium | Contrast Medium | Same |
| Using
Environment | Endoscopic Clinic | Endoscopic Clinic | Same |
| Working Length | 2000 mm | 2000 mm | Same |
| Compatible
Endoscopy
Working Channel | ≥3.2mm | ≥3.2mm | Same |
| Balloon Size | The Balloon Inflatable Diameter:
9mm/12mm/15mm/18mm/21mm | The Balloon Inflatable
Diameter:
9mm/12mm/15mm/18mm | Similar |
| Indications for Use | The proposed devices are indicated
for use endoscopically to remove
stones from biliary system, or to
facilitate injection of contrast
medium while occluding the duct
with the balloon. | The predicate devices are
indicated for use endoscopically
to remove stones from the
biliary system, or to facilitate
injection of contrast medium
while occluding the duct with
the balloon. | Same |
| Applicable Body
Parts | Biliary Tract | Biliary Tract | 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 | 12 Months | 24 Months | Different |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 | Same |
| Sterilization | EO Sterilized, SAL: 10-6 | EO Sterilized, SAL: 10-6 | Same |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Same |
6
Image /page/6/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 made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo.
7
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 bold and appear to be interconnected, creating a sense of unity and strength. To the upper right of the letters, there is a small circle with the "R" symbol inside, indicating that the logo is a registered trademark.
8. Performance Data
Performance testing was conducted to demonstrate the performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the predicate device. The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
-
Dimension;
-
Endoscope Compatibility Test;
-
Infusion Patency Testing;
-
Guidewire Matching Test:
-
Balloon Fatigue Test;
-
Luer Connector Test;
-
Connection Strength Test;
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. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
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 biocompatibility evaluation for the Retrieval Balloon Catheter was conducted in
8
Image /page/8/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are blocky and appear to be angled slightly, giving them a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
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:
The biocompatibility evaluation for the 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:
-
Cytotoxicity
-
Sensitization
-
Irritation
-
Acute systemic toxicity
-
Pyrogen
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device Extractor™ Pro Retrieval Balloon Catheter cleared under K102082.
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
9
Image /page/9/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be constructed from multiple layers, giving them a sense of depth. A registered trademark symbol is located in the upper right corner of the logo.
Based on the indications for use, technological characteristics, and safety and performance testing, the Retrieval Balloon Catheter (including Sterile Biliary Stone Retrieval Balloon Catheter and Retrieval Balloon / short-wire compatible) has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Predicate Device Extractor™ Pro Retrieval Balloon Catheter (K102082).