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.

AI/ML Overview

The provided document is a 510(k) Summary for the ValvuloPro Valvuloplasty Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies or AI/software performance. Therefore, many of the requested categories related to AI/software performance, clinical studies, and ground truth establishment are not applicable.

Here's the breakdown of the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests conducted and states that "All tests were passed" for each category. It does not provide specific numerical acceptance criteria or detailed performance metrics. Instead, it refers to compliance with established standards (e.g., ISO, internal technical requirements).

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, including specific tests like Hemolysis, Acute Systemic Toxicity, Cytotoxicity, Sensitization, etc.	All tests passed
Sterilization	Sterile with SAL of 10-6 via half-cycle overkill approach, in accordance with ISO 11135:2014.	Achieved required SAL
Packaging Test	Visual inspection, bacteriostasis performance, seal integrity (dye penetration, bubble emission), seal strength.	All tests passed
Balloon Catheter Testing	Guidewire compatibility, channel compatibility, dimensional inspection, compliance, balloon fatigue, RBP, simulated use, flexibility and kink, torque strength, peak tensile strength, leakage, hydratability, corrosion resistance.	All tests passed
Hub Testing	Gauging, stress cracking, liquid leakage, air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding.	All tests passed
Other	X-ray detectability, Chemical properties.	All tests passed

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated for each test. The document mentions "Relevant testing was conducted on samples before and after aging to establish device shelf life," indicating multiple samples were used for performance tests.
Data provenance: Not explicitly stated, but the tests are non-clinical, likely conducted in a controlled lab environment by the manufacturer (Dongguan TT Medical, Inc.) or their contracted labs. It is all prospective testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This section pertains to clinical studies or expert review of data for AI/software validation. The document describes non-clinical performance and biocompatibility testing against defined standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is relevant for clinical studies or expert consensus on clinical data. Non-clinical tests follow defined protocols and yield objective results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical medical device (balloon catheter), not an AI/software product that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For this type of device, "ground truth" refers to established engineering standards, material properties, and biological safety parameters defined in international standards (e.g., ISO 10993, ISO 11135, ISO 11607) and internal technical specifications. The device's performance is measured against these objective criteria rather than expert consensus on clinical cases.

8. The sample size for the training set:

Not applicable. This refers to machine learning models.

9. How the ground truth for the training set was established:

Not applicable. This refers to machine learning models.

Summary

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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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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

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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

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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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K231814 - 510(k) Summary

1. 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
EdwardsLifesciences, LLC	Edwards Balloon Catheter	K140241	OZT

5. Device Description

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,

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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® ValvuloplastyBalloon Catheter	Edwards TransfemoralBalloon Catheter	/
2	510 (K)Submitter	Dongguan TT Medical, Inc.	Edwards Lifesciences,LLC	/
3	510 (K)Number	/	K140241	/
3	ClassificationRegulation	21 CFR 870.1255	21 CFR 870.1255	Same
4	Classificationand Code	Class II, OZT	Class II, OZT	Same
5	Commonname	ValvuloPro® ValvuloplastyBalloon Catheter	Edwards Balloon Catheter	/
6	Intended Use	The ValvuloPro®Valvuloplasty BalloonCatheter is indicated forballoon aortic valvuloplasty.	The Edwards BalloonCatheter is indicated forballoon aorticvalvuloplasty.	Same
7	AnatomicalLocations	Aortic valve	Aortic valve	Same
8	Components	1. Tip2. Balloon3. Marker Band4. Inner Tube5. Outer Tube6. Strain Relief7. Hub8. Protective Sheath9. Mandrel	1. Tip2. Balloon3. Marker Band4. Inner Tube5. Outer Tube6. Strain Relief7. Hub8. Protective Sheath9. Mandrel	Same
9	DeviceDescription	The ValvuloPro®Valvuloplasty BalloonCatheters are indicated forballoon aortic valvuloplasty. Itconsists of an inflatableballoon on a catheter shaftwith multiple lumens forinflation. The effective lengthif the catheter is 130cm. They-connector consists of aballoon inflation port and aguidewire lumen. Tworadiopaque tantalum markerbands are positioned withinthe balloon shoulders toprovide visual referencepoints fluoroscopically forballoon positioning within thestricture. The balloon catheteris supplied sterilized byethylene oxide for single use.	The Edwards TransfemoralBalloon Catheter consistsof a shaft and balloon withtwo radiopaque markerbands that indicate theworking length of theballoon. The proximal endof the device has a

	Table 1 - General Comparison

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Premarket Notification – Traditional 510(k) 510(k) Summary

10	MarkerBand/Location	Two radiopaque tantalummarker bands are positionedwithin the balloon shoulders.	Two radiopaque markerbands indicate the workinglength of the balloon.	Same
11	HowSupplied	Sterile, Single use only	Sterile, Single use only	Same
12	Sterilizationmethod	EO	EO	Same
13	Workinglength(cm)	130	130	Same
14	Guiding wirechannel	0.89mm	0.89mm	Same
15	BalloonMinimumBurstStrength	6atm	6atm	Same
16	BalloonDilationlength	40mm	40mm	Same
17	Inflation ODand pressure	InflatedBalloonOD(mm) InflationPressure(ATM) 15 3 18 3 21 3 23 3 26 3 29 3			InflatedBalloon OD(mm) InflationPressure(ATM) 20 4 23 4 25 4	SimilarNominal Pressure(NP) of proposeddevices are similarto predicate devices,and satisfied withtechnicalrequirement incompliance.Differences do notraise new ordifferent questionsregarding safety oreffectiveness.
18	Applicabletunnel	15F(5.0mm)	20×40mm, 23×40mm:14Fr(4.7mm)25×40mm: 16F(5.3mm)	SimilarApplicable tunnel ofproposed device issatisfied withtechnicalrequirement incrossability.Differences do notraise new ordifferent questionsregarding safety oreffectiveness.

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	510(k) SummaryPage 4 / 6
19	Materials	1. Tip: Pebax2. Balloon: PA 123. Marker band: Tantalum4. Inner tube: Pebax5. Outer tube: PA126. Strain relief: PE7. Hub: Polycarbonate8. Protective Sheath: HDPE9. Mandrel:Polyformaldehyde	1. Tip: unknown2. Balloon: Nylon3. Marker band: Platinum / iridium4. Inner tube: Pebax5. Outer tube: Pebax6. Strain relief: unknown7. Hub: Polycarbonate8. Protective Sheath:unknown9. Mandrel: unknown	SimilarThe material used inmarker bands isdifferent from thepredicate device.The adhesives usedin the hubs differ.The marker bandsand the hub do nothave direct contactwith the humanbody. Theradiopacity of theTantalum markerbands is confirmedin testing.Therefore, thedifferences do notraise new questionsof safety or efficacy.
20	Storagecondition andShippingcondition	Store in a cool, dry, darkplace. Rotate inventory sothat catheters are used priorto the expiration date on thepackage 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 Length40 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

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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

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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.

Regulation Number and Section

§ 870.1255 Balloon aortic valvuloplasty catheter.

(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.