TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

K133569 · Bard Peripheral Vascular, Inc. · OZT · Dec 20, 2013 · Cardiovascular

Device Facts

• Record ID: K133569
• Device Name: TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: OZT · Cardiovascular
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1255
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The True Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Device Story

True Dilatation Balloon Valvuloplasty Catheter is a coaxial catheter with a fixed distal balloon used for balloon aortic valvuloplasty (BAV). The device features two lumens: one for balloon inflation/deflation using radiopaque contrast media via a syringe inflation device, and one for guidewire positioning. The clinician operates the device under fluoroscopic guidance to position the balloon across the aortic valve. Inflation expands the balloon to dilate the valve; subsequent deflation allows for catheter withdrawal into an introducer. The device is used in a clinical setting (e.g., cath lab) by a physician. It benefits patients by providing a mechanical means to dilate stenotic aortic valves.

Clinical Evidence

No clinical data. Bench testing only. Testing included dimensional verification, simulated use (access, inflation, re-sheathing, withdrawal), inflation/deflation time, and assessment of rupture, herniation, and leaking in accordance with ISO 10993-1, ISO 11135-1, ASTM D4169, and ISO 10555-1.

Technological Characteristics

Coaxial catheter; Pebax shaft; polymer composite balloon; platinum image bands. Inflation pressure 3-6 ATM. Diameter variation <2% across operating range. Sterilization: Ethylene Oxide. Standards: ISO 10993-1, ISO 11135-1, ASTM D4169, ISO 10555-1.

Indications for Use

Indicated for balloon aortic valvuloplasty in patients requiring aortic valve dilation.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the NuMED NuCLEUS and NuCLEUS-X BAV Catheters are subject to the following special controls:

Predicate Devices

• True Dilatation Balloon Valvuloplasty Catheter (K121083)

Submission Summary (Full Text)

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| 510(k) Summary | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Loma Vista Medical |
| | 863A Mitten Road, Suite 100A |
| | Burlingame, CA 94010 |
| | Phone: [phone] |
| | Fax: [phone]<br>Email: [e-mail] |
| Contact Person: | Tiffini Diage |
| | 1307 South Mary Avenue, Suite 280<br>Sunnyvale, CA 94087 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date Prepared: | 12/20/2013 |
| Trade Name: | True Dilatation Balloon Valvuloplasty Catheter |
| Classification: | Class II<br>Balloon Aortic Valvuloplasty<br>21 CFR 870.1250 |
| Product Code: | OZT |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>True Dilatation Balloon Valvuloplasty Catheter, 510(k) number<br>K121083 |
| Device Description: | The True Dilatation Catheter is a coaxial catheter with a balloon<br>fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of<br>the aortic valve. The effective length of the catheter is 110 cm<br>and it has two lumens: one lumen is used to inflate and deflate<br>the balloon and the other permits the use of a guidewire to<br>position the catheter. The balloon inflation luer-lock hub<br>(angled) connects to a syringe inflation device to deliver<br>radiopaque contrast media for inflation. The guidewire luer-lock<br>hub (straight) connects to the guidewire lumen. The balloon<br>functions by connecting an inflation device to the angled luer<br>lock and injecting contrast/sailine into the inflation lumen;<br>which inflates the balloon on the distal end of the catheter. The<br>inflation device plunger is pulled back to deflate the balloon and<br>it can then be withdrawn into the introducer for removal. |
| Indication for Use: | The True Dilatation Catheter is indicated for balloon aortic<br>valvuloplasty. |
| Technological<br>Characteristics: | The True Dilatation Balloon Valvuloplasty Catheter in this<br>submission is identical to the previously cleared device. The<br>technical characteristics are the identical. The only change<br>being made in this submission is the addition of the 26mm |
| Balloon Length | 4.5cm |
| Materials | Shaft: Pebax |
| | Balloon: Polymer composite |
| | Image Band: Platinum |
| Recommended Inflation Pressure | 3-6 ATM |
| Diameter Variation over Operating Pressure Range | 20mm: <2%<br>22mm: <2%<br>24mm: <2%<br>26mm: <2% |
| Marker Band Locations | 1 at proximal balloon shoulder<br>1 at distal balloon shoulder |
| Sterilization Method | Ethylene Oxide |
| Functional and Safety Testing: | To verify that the device design met its functional and<br>performance requirements, representative samples of the device<br>underwent biocompatibility, sterility, packaging integrity, and<br>mechanical testing in accordance with ISO 10993-1 2009, ISO<br>11135-1 2007, ASTM D4169:2009, ISO 10555-1 2009. The<br>following mechanical tests were performed:<br>● Dimensional verification of inflated balloon<br>● Simulated use for access to annulus, inflation, re-<br>sheathing, and withdrawal<br>● Inflation and deflation time<br>● Rupture, herniation, and leaking<br>● Compatibility with introducer |
| Conclusion: | Loma Vista Medical considers the True Dilatation Catheter to be<br>substantially equivalent to the predicate device listed above.<br>This conclusion is based upon the devices' similarities in<br>principles of operation, performance requirements, and |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine, with a staff and two snakes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2015

Bard Peripheral Vascular Inc. Ms. Tiffini Diage Medical Research Manager NAMSA 863A Mitten Road, Suite 100A Burlingame, CA 94010

Re: K133569

Trade/Device Name: True Dilation Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Regulatory Class: Class II Product Code: OZT Dated: November 18, 2013 Received: November 25, 2013

Dear Ms. Diage:

This letter corrects our substantially equivalent letter of December 20, 2013.

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. 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Tiffini Diage

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix S: Indications for Use

## Indications for Use Statement

510(k) Number: K133569

Device Name: True Dilatation Balloon Valvuloplasty Catheter

Indications for Use:

The True Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

い

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A.Silliman

Loma Vista Medical

Page 58 of 61 Special 510(k) for the True Dilatation Balloon Valvuloplasty Catheter