(58 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of the balloon catheter, with no mention of AI or ML.
Yes.
The device is used for "balloon aortic valvuloplasty," which is a procedure to treat a medical condition (aortic valve issues) and restore proper function, aligning with the definition of a therapeutic device.
No
The device is a treatment device, not a diagnostic one. It is a balloon catheter indicated for balloon aortic valvuloplasty, which is a therapeutic procedure to enlarge a narrowed heart valve. None of the documentation suggests it is used to diagnose a condition.
No
The device description clearly details a physical catheter with a balloon, guidewire lumen, and other hardware components. The performance studies also focus on physical characteristics and mechanical 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," which is a surgical procedure performed in vivo (within the body) to treat a heart valve condition.
- Device Description: The description details a physical catheter with a balloon designed for mechanical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly designed for a therapeutic procedure performed inside the body.
N/A
Intended Use / Indications for Use
The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
OZT
Device Description
The True™ BAV Balloon Valvuloplasty Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
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)
To demonstrate substantial equivalence of the subject device to the predicate devices, 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:
- Visual Inspection
- Balloon Distensibility
The following in vitro tests were leveraged from the predicate Vida™ PTV Dilatation Catheter:
- Tip Length
- Balloon Outer Diameter (i.e. Diameter and Profile Test)
- Balloon Working Length
- Catheter Shaft Outer Diameter
- Catheter Shaft Inner Diameter
- Tip Visibility
- Catheter Shaft Visibility
- Marker Band Visibility
- Tip Morphology
- Tip Tensile (i.e. Tip Pull and Torque Test, and Bond Strength Test)
- Balloon to Shaft Tensile
- Hub to Shaft Tensile
- Catheter Shaft Elongation
- Balloon Nominal (Operating) Pressure
- Rated Burst Pressure (i.e. Balloon Minimum Burst Strength)
- Balloon Burst Mode
- Fatigue (i.e. Repeated Balloon Inflation)
- Catheter Shaft Leaks (i.e. Catheter Body Maximum Pressure Test)
- Catheter Shaft Burst (i.e. Catheter Body Maximum Pressure Test)
- Media Interaction (i.e. Balloon Preparation Test)
- Catheter Shaft Length
- Trackability
- Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon Inflatability Test)
- Marker Band Alignment
- Sheath Compatibility
- Equipment Interface
- Visual Inspection of Packaging
- Dye Penetration
- Pouch Tensile Strength
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ BAV Balloon Valvuloplasty Catheter are substantially equivalent to the predicate devices, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
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.
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
True™ BAV 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: | July 21, 2014 |
Subject Device Name:
| Device Trade Name: | True™ BAV Balloon Valvuloplasty Catheter |
|---|---|
| Common or Usual Name: | Balloon Aortic Valvuloplasty (21 CFR |
| 870.1250, Product Code OZT) | |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Predicate Devices:
- True Dilatation™ Balloon Valvuloplasty Catheter (K133569; cleared . December 20, 2013)
- Vida™ PTV Dilatation Catheter (K131002, cleared July 2, 2013) ●
Image /page/0/Picture/13 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 yet impactful, making the word easily recognizable.
1
Device Description:
The True™ BAV Balloon Valvuloplasty Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
| Attribute | True™ BAV Balloon Valvuloplasty Catheter
Product Offering |
|-------------------------------------------------------------------|--------------------------------------------------------------|
| Balloon Diameter
(mm) | 18, 20, 22, 24, 26 |
| Balloon Length
(cm) | 4 |
| Catheter Shaft
Length (cm) | 100 |
| Introducer Sheath
Compatibility by
Balloon Diameter
(mm) | 8F: 18 mm
9F: 20 mm
10F: 22 mm, 24 mm
12F: 26 mm |
Indications for Use of Device:
The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
2
Comparison of Indications for Use to Predicate Devices:
The indications for use statement for the True™ BAV 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™ BAV Balloon Valvuloplasty Catheter, is substantially equivalent to the predicate devices.
Technological Comparison to Predicate Devices:
The True™ BAV Balloon Valvuloplasty Catheter has the following similarities to the predicate device, the True Dilatation™ Balloon Valvuloplasty Catheter (clearance to market via K133569 on December 20, 2013):
- . 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 .
The True™ BAV Balloon Valvuloplasty Catheter has the following similarities to the predicate device, the Vida™ PTV Dilatation Catheter (clearance to market via K131002, on July 2, 2013):
- Same operating principle .
- . Same fundamental scientific technology
- Same packaging materials and configurations .
- . Same sterility assurance level and method of sterilization
Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate devices, 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:
- . Visual Inspection
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3
-
o Balloon Distensibility
The following in vitro tests were leveraged from the predicate Vida™ PTV Dilatation Catheter: -
0 Tip Length
-
Balloon Outer Diameter (i.e. Diameter and Profile Test) o
-
Balloon Working Length .
-
Catheter Shaft Outer Diameter o
-
0 Catheter Shaft Inner Diameter
-
0 Tip Visibility
-
0 Catheter Shaft Visibility
-
Marker Band Visibility 0
-
Tip Morphology o
-
Tip Tensile (i.e. Tip Pull and Torque Test, and Bond Strength Test) 0
-
Balloon to Shaft Tensile 0
-
0 Hub to Shaft Tensile
-
Catheter Shaft Elongation 0
-
o Balloon Nominal (Operating) Pressure
-
Rated Burst Pressure (i.e. Balloon Minimum Burst Strength) 0
-
o Balloon Burst Mode
-
Fatigue (i.e. Repeated Balloon Inflation) 0
-
Catheter Shaft Leaks (i.e. Catheter Body Maximum Pressure Test) 0
-
Catheter Shaft Burst (i.e. Catheter Body Maximum Pressure Test) 0
-
0 Media Interaction (i.e. Balloon Preparation Test)
-
Catheter Shaft Length .
-
Trackability
-
Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon . Inflatability Test)
-
Marker Band Alignment .
-
Sheath Compatibility 0
-
Equipment Interface o
-
0 Visual Inspection of Packaging
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4
- 0 Dye Penetration
- Pouch Tensile Strength .
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ BAV Balloon Valvuloplasty Catheter are substantially equivalent to the predicate devices, 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™ BAV 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™ BAV Balloon Valvuloplasty Catheter is substantially equivalent to the legally marketed predicate devices, the True Dilatation™ Balloon Valvuloplasty Catheter and the Vida™ PTV Dilatation Catheter.
Image /page/4/Picture/9 description: The image shows the word "BARD" in a stylized, blocky font. Each letter is outlined in black, giving it a bold and distinct appearance. The "A" in "BARD" is designed with a unique triangular shape, setting it apart from the other letters.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
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. Dr. Aaron Conovaloff Regulatory Affairs Associate 1625 West 3rd Street Tempe, Arizona 85281
Re: K141985
Trade/Device Name: True BAV Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OZT Dated: July 21, 2014 Received: July 22, 2014
Dear Dr. Conovaloff:
This letter corrects our substantially equivalent letter of September 18, 2014.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Dr. Aaron Conovaloff
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
7
Indications for Use
510(k) Number (if known): K141985
Device Name: True™ BAV Balloon Valvuloplasty Catheter
Indications for Use: The True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Prescription Use X (Part21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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