(93 days)
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 or ML.
Yes
The device is used for "balloon aortic valvuloplasty," which is a medical procedure to treat a condition and improve patient health, indicating a therapeutic purpose.
No
The device description clearly states its purpose is for "balloon aortic valvuloplasty," which is a therapeutic procedure involving the use of a balloon to dilate a narrowed aortic valve. This is an interventional treatment, not a device used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines a physical catheter with a balloon, lumens, and marker bands, indicating it is a hardware device. The performance studies also focus on physical characteristics and in vitro testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "balloon aortic valvuloplasty." This is a procedure performed on a patient to treat a condition, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a catheter with a balloon designed to be inserted into the body and inflated at the aortic valve. This is a therapeutic device used for intervention, not a diagnostic device used for testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical (dilating the valve).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TrueTM Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Product codes
OZT
Device Description
The True™ Dilatation Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is noncompliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.
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
To demonstrate substantial equivalence of the subject device to the predicate device, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:
- Dimensional Testing (catheter shaft length, balloon OD, balloon length)
- Marker Band Alignment .
- Visual Inspection of Product •
- Visual Inspection of Sterile Barrier Packaging Heat Seals •
- . Trackability
- Sheath Compatibility •
- Inflation/Deflation .
- Fatigue
- Tip to Balloon Tensile .
- Balloon Burst
- Catheter Leak •
- Failure Mode •
- Shaft Burst
- Radiopacity (inflated) •
- Balloon Distensibility •
- Reinsertion .
The following in vitro tests were leveraged from the predicate True™ Dilatation device:
- . Dimensional testing (shaft ID, shaft OD)
- . Dye Penetration
- Pouch Tensile •
- . Tip Morphology
- Media Interaction .
- Catheter Elongation •
- Balloon to Shaft Tensile •
- . Radiopacity (prior to inflation)
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ Dilatation Balloon Valvuloplasty Catheter are substantially equivalent to the predicate device, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
C.R. Bard, Inc. Dr. Aaron Conovaloff Regulatory Affairs Associate 1625 W. Third St. Tempe, Arizona 85281
Re: K150667
Trade/Device Name: True Dilatation Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Regulatory Class: Class II Product Code: OZT Dated: March 13, 2015 Received: March 19, 2015
Dear Dr. Conovaloff:
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. Isting 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 (800) 638-2041 or (301) 796-7100 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" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
True™ Dilatation Balloon Valvuloplasty Catheter
Indications for Use (Describe)
The TrueTM Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (701) 443-574) EF
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True™ Dilatation Balloon Valvuloplasty Catheter 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 480-350-6012 |
| Fax: | 480-449-2546 |
| Contact: | Aaron Conovaloff, Regulatory Affairs Associate |
| Date | March 13, 2015 |
Subject Device Name:
| Device Trade Name: | True™ Dilatation Balloon Valvuloplasty Catheter |
|---|---|
| Common or Usual Name: | Balloon Aortic Valvuloplasty/Percutaneous Catheter (21 CFR 870.1255, Product Code OZT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Predicate Device:
- . True™ Dilatation Balloon Valvuloplasty Catheter (K133569; cleared December 20, 2013)
Summary of Change:
The modifications from the predicate device, the True™ Dilatation Balloon Valvuloplasty Catheter, to the subject device, the True™ Dilatation Balloon Valvuloplasty Catheter,
Image /page/3/Picture/14 description: The image shows the word "BARD" in a stylized, geometric font. Each letter is formed by thick, black lines, giving it a bold and modern appearance. The letters are interconnected, creating a sense of unity and visual interest. The overall design is clean and minimalist, emphasizing the word's shape and form.
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include additional size offerings, different balloon bonding materials, different hub and strain relief design and materials, different packaging hoop design, and improved readability and updated branding in the IFU.
Device Description:
The True™ Dilatation Balloon Valvuloplasty Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The catheter is 110 cm long and has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen. The balloon is noncompliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque marker bands are provided for fluoroscopic positioning of the device across the aortic valve. These bands are positioned at the proximal and distal balloon shoulders. Balloon catheter dimensions, balloon nominal pressure, maximum inflation pressure, recommended introducer size, and recommended guidewire size are indicated on the package label.
| Attribute | True™ Dilatation Balloon Valvuloplasty
Catheter
Product Offering |
|-----------------------------------------|------------------------------------------------------------------------|
| Balloon Diameter
(mm) | 18, 20, 21, 22, 23, 24, 25, 26, 28 |
| Balloon Length
(cm) | 4.5 |
| Catheter Shaft
Length (cm) | 110 |
| Introducer Sheath
Compatibility (Fr) | 11, 12, 13, 14 |
Indications for Use of Device:
The True™ Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Image /page/4/Picture/10 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and connected to the adjacent letters, creating a unified design. The font choice gives the word a modern and somewhat geometric appearance. The image is in black and white, with the letters being black outlines on a white background.
5
Comparison of Indications for Use to Predicate Device:
The indications for use statement for the subject True™ Dilatation Balloon Valvuloplasty Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices. Therefore, the subject device, the True™ Dilatation Balloon Valvuloplasty Catheter, is substantially equivalent to the predicate device.
Technological Comparison to Predicate Device:
The subject True™ Dilatation Balloon Valvuloplasty Catheter has the following similarities to the predicate device (clearance to market via K133569 on December 20, 2014):
- Same intended use
- Same indications for use .
- . Same target population
- Same operating principle .
- . Same fundamental scientific technology
- . Same sterility assurance level and method of sterilization
Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate device, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:
- Dimensional Testing (catheter shaft length, balloon OD, balloon length)
- Marker Band Alignment .
- Visual Inspection of Product ●
- Visual Inspection of Sterile Barrier Packaging Heat Seals ●
- . Trackability
- Sheath Compatibility ●
- Inflation/Deflation .
Image /page/5/Picture/23 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The overall design is simple and clean, with a focus on readability and visual impact.
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- Fatigue
- Tip to Balloon Tensile .
- Balloon Burst
- Catheter Leak ●
- Failure Mode ●
- Shaft Burst
- Radiopacity (inflated) ●
- Balloon Distensibility ●
- Reinsertion .
The following in vitro tests were leveraged from the predicate True™ Dilatation device:
- . Dimensional testing (shaft ID, shaft OD)
- . Dye Penetration
- Pouch Tensile ●
- . Tip Morphology
- Media Interaction .
- Catheter Elongation ●
- Balloon to Shaft Tensile ●
- . Radiopacity (prior to inflation)
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ Dilatation Balloon Valvuloplasty Catheter are substantially equivalent to the predicate device, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusions:
The subject device, the True™ Dilatation Balloon Valvuloplasty Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The True™ Dilatation Balloon Valvuloplasty Catheter is substantially equivalent to the legally marketed predicate device.