(54 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter for stone retrieval, with no mention of AI or ML.
No
The device is used for endoscopic removal of biliary stones, which is a procedure to remove an existing condition, not to prevent or treat a disease.
No
The device is described as being for "endoscopic removal of biliary stones," which is a therapeutic intervention, not a diagnostic one. While it allows for fluoroscopic visualization, this is for guidance during the therapeutic procedure rather than for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, balloon, lumens, stopcock, and radiopaque bands, 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:
- Intended Use: The intended use is "for endoscopic removal of biliary stones." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device (catheter with a balloon) used for a mechanical purpose (stone retrieval).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Performance Studies: The performance studies focus on the physical and biological properties of the device (biocompatibility, sterilization, seal strength, etc.), not on diagnostic accuracy or performance metrics like sensitivity or specificity.
The device is a therapeutic medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
Product codes
GCA
Device Description
The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Biliary
Indicated Patient Age Range
Not Found
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
A ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
A ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
A USP Bacterial Endotoxins Test
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.
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April 27, 2021
Anrei Medical (Hangzhou) Co., Ltd. Huibing Yang Director, Regulatory Affairs No.3 Ave.8. HEDA Hangzhou, Zhejiang 310018 CHINA
Re: K210660
Trade/Device Name: Stone Retrieval Balloon Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: GCA Dated: March 1, 2021 Received: March 4, 2021
Dear Huibing Yang:
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.
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
1
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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. Acting 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
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Indications for Use
510(k) Number (if known) K210660
Device Name Stone Retrieval Balloon Catheter
Indications for Use (Describe)
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
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)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
1. Date of Preparation: 04/27/2021
2. Sponsor Identification
Anrei Medical (Hangzhou) Co., Ltd. No. 3, Ave 8, Hangzhou Economic Development Area, 310018 Hangzhou, P.R.China
Establishment Registration Number: 3006621103 Contact Person: Huibing Yang Contact Title: Director, Regulatory Affairs Tel: +86-571-8691333 ext. 8658 Fax: +86-571-87603502 Email: huibing.yang@anrei.com.cn
3. Identification of Proposed Device
Trade Name: Stone Retrieval Balloon Catheter Common Name: Balloon Catheter
Regulatory Information Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulation Class: II Product Code: GCA Device Panel: Gastroenterology/Urology
Indications for Use Statement:
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
Device Description:
The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about
4
200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.
Identification of Predicate Device(s) 4.
510(k) Number: K200173
Product Name: Stone Retrieval Balloon
Manufacturer: Hangzhou AGS MedTech Co., Ltd.
Comparison of Technological Characteristics 5.
| Item | Proposed Device | Predicate Device K200173 | Remark |
|---|---|---|---|
| Device name | Stone Retrieval Balloon Catheter | Stone Retrieval Balloon | / |
| Classification name | Biliary catheter and accessories | Biliary catheter and accessories | Same |
| Classification | II | II | Same |
| Product code | GCA | GCA | Same |
| Regulation number | 21 CFR 876.5010 | 21 CFR 876.5010 | Same |
| Intended Use/ | |||
| Indications for Use | The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only. | The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only. | Same |
| Catheter O.D. | 2.3mm | 2.4mm | Analysis 1 |
| Catheter Length | 2000mm | 2000mm | Same |
| Balloon Inflated | |||
| O.D. | 8.5/12/15/18/8.5-12-15/12-15-18 | 8.5/12/15/18/8.5-12-15/13-15-18 | Analysis 2 |
| Recommended | |||
| Guidewire | 0.035/0.025in | 0.035/0.025in | Same |
| Single Use | Yes | Yes | Same |
| Supplied Sterile | Yes | Yes | Same |
| Sterilization | |||
| Method | Ethylene oxide (EO) | Ethylene oxide (EO) | Same |
| Shelf Life | Two years | Two years | Same |
| Labeling | Comply with 21 CFR Part 801 | Comply with 21 CFR Part 801 | Same |
| Packaging | Paper and film with one device per package | Paper and film with one device per package | Same |
| Patient contact | |||
| material | Three internal lumens: Pebax; | ||
| Radiopaque band: Ta; | |||
| Bind wire: PET; | |||
| Balloon: Natural latex; | |||
| Binder: UV-curing adhensive; | |||
| Marker: TPU ink. | Sheath: Pebax; | ||
| Radiopaque band: Tal; | |||
| Bind wire: PET; | |||
| Latex balloon: Natural latex; | |||
| Binder: UV-curing adhensive; | |||
| Marker: Polyurethane ink. | Analysis 3 | ||
| Biocompatibility | In Vitro Cytotoxicity Test : ISO | In Vitro Cytotoxicity Test : ISO | Same |
5
| 10993-5: 2009; | 10993-5: 2009; |
|---|---|
| Skin sensitization Test :ISO | Skin sensitization Test : ISO |
| 10993-10: 2010; | 10993-10: 2010; |
| Intracutaneous Reactivity Test: ISO | Intracutaneous Reactivity Test: ISO |
| 10993-10: 2010. | 10993-10: 2010. |
Analysis 1:
Slightly smaller. The slight difference does not affect the compatibility with the endoscope of the minimum working channel size of 2.8mm. Please refer to bench test.
Analysis 2:
There is a literature that retrieval balloon catheter is used to remove stones in the bile duct which the mean common bile duct (CBD) dilation was 19.2mm±3.9 and the mean size of stones 15.8±2.9. The tolerance of balloon inflation O.D. is (+2, -1) mm, and the slight difference does not affect the device performance. Please refer to bench test.
Analysis 3:
Biocompatibility test has been conducted on the proposed device and the test result can meet the requirements of ISO 10993 series standard. Therefore, this difference will not affect substantial equivalence between proposed device and predicate device.
6. Summary of Non-Clinical Performance Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards.
A ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
A ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
A USP Bacterial Endotoxins Test
7. Summary of Clinical Performance Testing
No clinical study is included in this submission.
8. Conclusion
6
Based on comparison and analysis above, the proposed Stone Retrieval Balloon Catheter is determined to be Substantially Equivalent (SE) to the predicate device.