K Number
K231814
Device Name
ValvuloPro Valvuloplasty Balloon Catheter
Date Cleared
2023-10-12

(113 days)

Product Code
Regulation Number
870.1255
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ValvuloPro® Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty.
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.
More Information

Not Found

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI/ML components or data processing beyond fluoroscopic visualization.

Yes
The device is used for balloon aortic valvuloplasty, which is a medical procedure to treat a condition (aortic valve stricture), making it a therapeutic device.

No

The device description clearly states its purpose is for "balloon aortic valvuloplasty," which is a therapeutic procedure involving the physical widening of a valve. It is not described as being used to identify or analyze a medical condition.

No

The device description clearly details a physical catheter with an inflatable balloon, lumens, a y-connector, and radiopaque markers. This indicates a hardware-based medical device, not a software-only one.

No, 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. These tests are performed outside of the body.
  • Device Function: The ValvuloPro® Valvuloplasty Balloon Catheter is a device used inside the body to physically treat a condition (aortic valvuloplasty). It is a therapeutic device, not a diagnostic one.
  • Intended Use: The intended use clearly states "balloon aortic valvuloplasty," which is a procedure to open a narrowed aortic valve. This is a treatment, not a diagnostic test.
  • Device Description: The description details a catheter with an inflatable balloon designed for insertion into the body and manipulation within the aortic valve. This is consistent with an interventional/therapeutic device.
  • Input Imaging Modality: Fluoroscopy is used for guidance during the procedure within the body, not for analyzing samples outside the body.

The device is an interventional medical device used for a therapeutic procedure.

N/A

Intended Use / Indications for Use

The ValvuloPro® Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty.

Product codes (comma separated list FDA assigned to the subject device)

OZT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Aortic valve

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)

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, including: Hemolysis, Partial Thromboplastin Time, Prothrombin time, Thromboresistance, Acute Systemic Toxicity, Cvtotoxicitv, Sensitization, Intracutaneous reactivity test, Pyrogenicity, Complement activation (SC5b-9), Complement activation (C3a). 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

Hub Testing:

  • 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.

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.

K140241

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

§ 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.

0

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.

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)

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

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4

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:

ApplicantDevice name510(k) NumberProduct code
Edwards
Lifesciences, LLCEdwards Balloon CatheterK140241OZT

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.

#ItemsSubject DevicePredicate DeviceComments
1Trade NameValvuloPro® Valvuloplasty
Balloon CatheterEdwards Transfemoral
Balloon Catheter/
2510 (K)
SubmitterDongguan TT Medical, Inc.Edwards Lifesciences,
LLC/
3510 (K)
Number/K140241/
3Classification
Regulation21 CFR 870.125521 CFR 870.1255Same
4Classification
and CodeClass II, OZTClass II, OZTSame
5Common
nameValvuloPro® Valvuloplasty
Balloon CatheterEdwards Balloon Catheter/
6Intended UseThe ValvuloPro®
Valvuloplasty Balloon
Catheter is indicated for
balloon aortic valvuloplasty.The Edwards Balloon
Catheter is indicated for
balloon aortic
valvuloplasty.Same
7Anatomical
LocationsAortic valveAortic valveSame
8Components1. Tip
  1. Balloon
  2. Marker Band
  3. Inner Tube
  4. Outer Tube
  5. Strain Relief
  6. Hub
  7. Protective Sheath
  8. Mandrel | 1. Tip
  9. Balloon
  10. Marker Band
  11. Inner Tube
  12. Outer Tube
  13. Strain Relief
  14. Hub
  15. Protective Sheath
  16. Mandrel | Same |
    | 9 | Device
    Description | The ValvuloPro®
    Valvuloplasty Balloon
    Catheters are indicated for
    balloon aortic valvuloplasty. It
    consists of an inflatable
    balloon on a catheter shaft
    with multiple lumens for
    inflation. The effective length
    if 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 for single use. | The Edwards Transfemoral
    Balloon Catheter consists
    of a shaft and balloon with
    two radiopaque marker
    bands that indicate the
    working length of the
    balloon. The proximal end
    of the device has a | |
Table 1 - General Comparison

6

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

| 10 | Marker
Band/Location | Two radiopaque tantalum
marker bands are positioned
within the balloon shoulders. | Two radiopaque marker
bands indicate the working
length of the balloon. | Same | | | | | | | | | | | | | | | | | | | | | | |
|----|-----------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11 | How
Supplied | Sterile, Single use only | Sterile, Single use only | Same | | | | | | | | | | | | | | | | | | | | | | |
| 12 | Sterilization
method | EO | EO | Same | | | | | | | | | | | | | | | | | | | | | | |
| 13 | Working
length(cm) | 130 | 130 | Same | | | | | | | | | | | | | | | | | | | | | | |
| 14 | Guiding wire
channel | 0.89mm | 0.89mm | Same | | | | | | | | | | | | | | | | | | | | | | |
| 15 | Balloon
Minimum
Burst
Strength | 6atm | 6atm | Same | | | | | | | | | | | | | | | | | | | | | | |
| 16 | Balloon
Dilation
length | 40mm | 40mm | Same | | | | | | | | | | | | | | | | | | | | | | |
| 17 | Inflation OD
and pressure | Inflated
Balloon
OD(mm) Inflation
Pressure
(ATM) 15 3 18 3 21 3 23 3 26 3 29 3 | | | | | | | | | | | | | | | Inflated
Balloon OD
(mm) Inflation
Pressure
(ATM) 20 4 23 4 25 4 | | | | | | | | | Similar
Nominal Pressure
(NP) of proposed
devices are similar
to predicate devices,
and satisfied with
technical
requirement in
compliance.
Differences do not
raise new or
different questions
regarding safety or
effectiveness. |
| 18 | Applicable
tunnel | 15F(5.0mm) | 20×40mm, 23×40mm:
14Fr(4.7mm)
25×40mm: 16F(5.3mm) | Similar
Applicable tunnel of
proposed device is
satisfied with
technical
requirement in
crossability.
Differences do not
raise new or
different questions
regarding safety or
effectiveness. | | | | | | | | | | | | | | | | | | | | | | |

7

| | 510(k) Summary
Page 4 / 6 | | | |
|----|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19 | Materials | 1. Tip: Pebax
2. Balloon: PA 12
3. Marker band: Tantalum
4. Inner tube: Pebax
5. Outer tube: PA12
6. Strain relief: PE
7. Hub: Polycarbonate
8. Protective Sheath: HDPE
9. Mandrel:
Polyformaldehyde | 1. Tip: unknown
2. Balloon: Nylon
3. Marker band: Platinum / iridium
4. Inner tube: Pebax
5. Outer tube: Pebax
6. Strain relief: unknown
7. Hub: Polycarbonate
8. Protective Sheath:
unknown
9. Mandrel: unknown | Similar
The material used in
marker bands is
different from the
predicate device.
The adhesives used
in the hubs differ.
The marker bands
and the hub do not
have direct contact
with the human
body. The
radiopacity of the
Tantalum marker
bands is confirmed
in testing.
Therefore, the
differences do not
raise new questions
of safety or efficacy. |
| 20 | Storage
condition and
Shipping
condition | Store in a cool, dry, dark
place. Rotate inventory so
that catheters are used prior
to the expiration date on the
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
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.