ValvuloPro Valvuloplasty Balloon Catheter

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October 12, 2023 Dongguan TT Medical, Inc Yuying Bi R&D Director Bld #1, Rm 501, 502, Taoyuan Rd Songshan Lake, Dongguan, Guangdong Dongguan, GD 523808 China Re: K231814 Trade/Device Name: ValvuloPro Valvuloplasty Balloon Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: August 31, 2023 Received: August 31, 2023 Dear Yuying Bi: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jennifer Bastijanic -S for Jaime Raben, PhD Assistant Director {2}------------------------------------------------ DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231814 Device Name ValvuloPro Valvuloplasty Balloon Catheter Indications for Use (Describe) The ValvuloPro Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty. Type of Use (Select one or both, as applicable) | <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |------------------------------------------------------------------------------------| | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submission Sponsor Dongguan TT Medical, Inc. Address: BLD#1, 1 Taoyuan Road, Songshan Lake, Dongguan, Guangdong, 523808 China Phone: +86 15553341910 Contact: Yuying Bi, Regulatory Affairs Specialist Email: ybi@ttmedicalinc.com #### 2. Date Prepared October 12, 2023 #### 3. Device Identification Trade Name: ValvuloPro® Valvuloplasty Balloon Catheter Common Name/Classification Name: Balloon aortic valvuloplasty catheter Regulation Number: 21 CFR 870.1255 Regulation Class: Class II Review Panel: Cardiovascular # 4. Predicate Devices The proposed devices are substantially equivalent to the following predicate devices: | Applicant | Device name | 510(k) Number | Product code | |------------------------------|--------------------------|---------------|--------------| | Edwards<br>Lifesciences, LLC | Edwards Balloon Catheter | K140241 | OZT | # 5. Device Description The ValvuloPro® Valvuloplasty Balloon Catheters are indicated for balvoon aortic valvuloplasty. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation. The effective length of the catheter is 130cm. The y-connector consists of a balloon inflation port and a guidewire lumen. Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. The balloon catheter is supplied sterilized by ethylene oxide (EO) for single use. # 6. Indication for Use Statement The ValvuloPro® Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty. #### 7. Comparison of Technological Characteristics The following table compares the proposed device with the predicate device in terms of intended use, {5}------------------------------------------------ technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalence. | # | Items | Subject Device | Predicate Device | Comments | |---|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | 1 | Trade Name | ValvuloPro® Valvuloplasty<br>Balloon Catheter | Edwards Transfemoral<br>Balloon Catheter | / | | 2 | 510 (K)<br>Submitter | Dongguan TT Medical, Inc. | Edwards Lifesciences,<br>LLC | / | | 3 | 510 (K)<br>Number | / | K140241 | / | | 3 | Classification<br>Regulation | 21 CFR 870.1255 | 21 CFR 870.1255 | Same | | 4 | Classification<br>and Code | Class II, OZT | Class II, OZT | Same | | 5 | Common<br>name | ValvuloPro® Valvuloplasty<br>Balloon Catheter | Edwards Balloon Catheter | / | | 6 | Intended Use | The ValvuloPro®<br>Valvuloplasty Balloon<br>Catheter is indicated for<br>balloon aortic valvuloplasty. | The Edwards Balloon<br>Catheter is indicated for<br>balloon aortic<br>valvuloplasty. | Same | | 7 | Anatomical<br>Locations | Aortic valve | Aortic valve | Same | | 8 | Components | 1. Tip<br>2. Balloon<br>3. Marker Band<br>4. Inner Tube<br>5. Outer Tube<br>6. Strain Relief<br>7. Hub<br>8. Protective Sheath<br>9. Mandrel | 1. Tip<br>2. Balloon<br>3. Marker Band<br>4. Inner Tube<br>5. Outer Tube<br>6. Strain Relief<br>7. Hub<br>8. Protective Sheath<br>9. Mandrel | Same | | 9 | Device<br>Description | The ValvuloPro®<br>Valvuloplasty Balloon<br>Catheters are indicated for<br>balloon aortic valvuloplasty. It<br>consists of an inflatable<br>balloon on a catheter shaft<br>with multiple lumens for<br>inflation. The effective length<br>if the catheter is 130cm. The<br>y-connector consists of a<br>balloon inflation port and a<br>guidewire lumen. Two<br>radiopaque tantalum marker<br>bands are positioned within<br>the balloon shoulders to<br>provide visual reference<br>points fluoroscopically for<br>balloon positioning within the<br>stricture. The balloon catheter<br>is supplied sterilized by<br>ethylene oxide for single use. | The Edwards Transfemoral<br>Balloon Catheter consists<br>of a shaft and balloon with<br>two radiopaque marker<br>bands that indicate the<br>working length of the<br>balloon. The proximal end<br>of the device has a | | | | Table 1 - General Comparison | | |--|------------------------------|--| | | | | {6}------------------------------------------------ # Premarket Notification – Traditional 510(k) 510(k) Summary | 10 | Marker<br>Band/Location | Two radiopaque tantalum<br>marker bands are positioned<br>within the balloon shoulders. | Two radiopaque marker<br>bands indicate the working<br>length of the balloon. | Same | | | | | | | | | | | | | | | | | | | | | | | |----|-----------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 11 | How<br>Supplied | Sterile, Single use only | Sterile, Single use only | Same | | | | | | | | | | | | | | | | | | | | | | | | 12 | Sterilization<br>method | EO | EO | Same | | | | | | | | | | | | | | | | | | | | | | | | 13 | Working<br>length(cm) | 130 | 130 | Same | | | | | | | | | | | | | | | | | | | | | | | | 14 | Guiding wire<br>channel | 0.89mm | 0.89mm | Same | | | | | | | | | | | | | | | | | | | | | | | | 15 | Balloon<br>Minimum<br>Burst<br>Strength | 6atm | 6atm | Same | | | | | | | | | | | | | | | | | | | | | | | | 16 | Balloon<br>Dilation<br>length | 40mm | 40mm | Same | | | | | | | | | | | | | | | | | | | | | | | | 17 | Inflation OD<br>and pressure | Inflated<br>Balloon<br>OD(mm) Inflation<br>Pressure<br>(ATM) 15 3 18 3 21 3 23 3 26 3 29 3 | | | | | | | | | | | | | | | Inflated<br>Balloon OD<br>(mm) Inflation<br>Pressure<br>(ATM) 20 4 23 4 25 4 | | | | | | | | | Similar<br>Nominal Pressure<br>(NP) of proposed<br>devices are similar<br>to predicate devices,<br>and satisfied with<br>technical<br>requirement in<br>compliance.<br>Differences do not<br>raise new or<br>different questions<br>regarding safety or<br>effectiveness. | | 18 | Applicable<br>tunnel | 15F(5.0mm) | 20×40mm, 23×40mm:<br>14Fr(4.7mm)<br>25×40mm: 16F(5.3mm) | Similar<br>Applicable tunnel of<br>proposed device is<br>satisfied with<br>technical<br>requirement in<br>crossability.<br>Differences do not<br>raise new or<br>different questions<br>regarding safety or<br>effectiveness. | | | | | | | | | | | | | | | | | | | | | | | {7}------------------------------------------------ | | 510(k) Summary<br>Page 4 / 6 | | | | |----|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 19 | Materials | 1. Tip: Pebax<br>2. Balloon: PA 12<br>3. Marker band: Tantalum<br>4. Inner tube: Pebax<br>5. Outer tube: PA12<br>6. Strain relief: PE<br>7. Hub: Polycarbonate<br>8. Protective Sheath: HDPE<br>9. Mandrel:<br>Polyformaldehyde | 1. Tip: unknown<br>2. Balloon: Nylon<br>3. Marker band: Platinum / iridium<br>4. Inner tube: Pebax<br>5. Outer tube: Pebax<br>6. Strain relief: unknown<br>7. Hub: Polycarbonate<br>8. Protective Sheath:<br>unknown<br>9. Mandrel: unknown | Similar<br>The material used in<br>marker bands is<br>different from the<br>predicate device.<br>The adhesives used<br>in the hubs differ.<br>The marker bands<br>and the hub do not<br>have direct contact<br>with the human<br>body. The<br>radiopacity of the<br>Tantalum marker<br>bands is confirmed<br>in testing.<br>Therefore, the<br>differences do not<br>raise new questions<br>of safety or efficacy. | | 20 | Storage<br>condition and<br>Shipping<br>condition | Store in a cool, dry, dark<br>place. Rotate inventory so<br>that catheters are used prior<br>to the expiration date on the<br>package label | Store in a cool, dry place. | Same | | 21 | Shelf-life | 3 years | 3 years | Same | ValvuloPro® Valvuloplasty Balloon Catheter has 6 models: | Balloon Diameter (mm) | Balloon Length<br>40 mm | |-----------------------|-------------------------| | 15 | VBC1540 | | 18 | VBC1840 | | 21 | VBC2140 | | 23 | VBC2340 | | 26 | VBC2640 | | 29 | VBC2940 | The proposed device shares the same indications for use, similar materials, same device operation, and same overall technical and functional capabilities as the predicate device. It also has the same standards and requirements as the predicate device. # 8. Description of Non-clinical Testing The non-clinical tests of the subject device and predicate device are in compliance with the following standards and guidance. The biocompatibility evaluation for ValvuloPro® Valvuloplasty Balloon Catheter was conducted in accordance with ISO 10993-1. K231814 {8}------------------------------------------------ Premarket Notification – Traditional 510(k) 510(k) Summary - · Hemolysis (ISO10993-4) - Partial Thromboplastin Time (ISO10993-4) - Prothrombin time (ISO10993-4) - · Thromboresistance (ISO10993-4) - · Acute Systemic Toxicity (ISO 10993-11) - Cvtotoxicitv (ISO 10993-5) - · Sensitization (ISO 10993-10) - · Intracutaneous reactivity test (ISO 10993-10) - · Pyrogenicity (ISO10993-11) - · Complement activation (SC5b-9) (ISO10993-4) - · Complement activation (C3a) (ISO10993-4) Result: All tests were passed. Sterile barrier systems for ValvuloPro® Valvuloplasty Balloon Catheter were evaluated in accordance with ISO 11607-1:2019. The ethylene oxide sterilization process has been validated in accordance with ISO 11135:2014. Result: The ValvuloPro® Valvuloplasty Balloon Catheter is sterile with a determination of lethal rate of the sterilization process to demonstrate achievement of the required SAL of 10-6 via half cycle overkill approach. Technological characteristics for ValvuloPro® Valvuloplasty Balloon Catheter have been tested including verification of performance characteristics relevant to the intended device function. Relevant testing was conducted on samples before and after aging to establish device shelf life. # Packaging Test: - . Visual inspection - Bacteriostasis performance of pouch ● - . Seal integrity: Dye penetration test - Seal integrity: Bubble emission test ● - Seal strength: Pouch tension test ● # Balloon Catheter Testing: - . Guidewire compatibility test - Channel compatibility ● - Product Dimensional Inspection ● - Compliance ● - Balloon fatigue; No leakage and damage when inflated - Balloon rated burst pressure (RBP) ● - Simulated use - Flexibility and kink ● - Torque strength ● - Peak tensile strength ● - . Leakage Test - Hydratability ● - . Corrosion resistance {9}------------------------------------------------ # Premarket Notification – Traditional 510(k) 510(k) Summary - . Hub - Gauging - Stress cracking - ~ Liquid leakage - Air leakage - ~ Separation force - ~ Unscrewing torque - ~ Easy of assembly - ~ Resistance to overriding - X-ray detectability ● - Chemical properties ● Result: All tests were passed. The results of Non-Clinical Performance testing demonstrate that the ValvuloPro® Valvuloplasty Balloon Catheter is substantially equivalent to the predicate. # 9. Performance Data-Clinical No clinical study is included in this submission. # 10. Conclusion The evidence presented in this 510(k) submission demonstrates that the differences between the proposed device and the predicate device do not raise any new questions regarding safety or effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use. Therefore, the proposed device is determined to be substantially equivalent to the referenced predicate device.