(127 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a catheter with a balloon for valvuloplasty, which is a medical procedure to repair or unblock a heart valve, indicating a therapeutic purpose to treat a medical condition.
No
The text describes a catheter used for balloon aortic valvuloplasty, which is a therapeutic procedure involving the treatment of a condition (aortic stenosis), not the diagnosis of a disease.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software-only.
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 surgical procedure performed on a patient to widen a narrowed aortic valve.
- Device Description: The description details a catheter with a balloon designed for mechanical intervention within the body. It's used to physically manipulate the aortic valve.
- Lack of Diagnostic Function: The device does not perform any tests on samples taken from the body (like blood, urine, or tissue) to diagnose a condition. Its function is purely therapeutic/interventional.
- Anatomical Site: The device is used directly on the aortic valve within the patient's body. IVDs typically analyze samples from the body, not operate within it.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
OZT
Device Description
The True™ Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. 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 luerlock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum quidewire 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
Not Found
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 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:
- Catheter Shaft Length
- Catheter Shaft Inner Diameter
- Catheter Shaft Outer Diameter
- Balloon Outer Diameter
- Balloon Length
- Marker Band Alignment
- Dye Penetration
- Visual Inspection of Product
- Visual Inspection of Sterile Barrier Packaging Heat Seals
- Tip Morphology
- Trackabilitv
- Sheath Compatibility
- Media Interaction
- Luer Interface
- Hub Stress
- Hub Stress (48 Hours)
- Inflation
- Deflation to Restore Valve Function
- Complete Deflation
- Fatigue
- Tip to Balloon Tensile
- Rated Burst Pressure
- Catheter Leak
- Failure Mode
- Shaft Burst
- Catheter Elongation
- Hub to Shaft Tensile
- Balloon to Shaft Tensile
- Radiopacity—Prior to Inflation
- Radiopacity—Inflated
- Balloon Distensibility
- Perfusion Test
- Radial Force Test
- MEM Elution Test
- Kligman Maximization Test
- Intracutaneous Injection Test
- Systemic Injection Test
- Rabbit Pyrogen Test
- Hemolysis - Rabbit Blood Contact
- Complement Activation Test
- In Vitro Thrombogenicity
- In Vivo Thrombogenicity
The following in vitro test was leveraged from previous testing:
- Pouch Tensile
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ Flow Valvuloplasty Perfusion 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 (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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
C. R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281
Re: K152613
Trade/Device Name: True Flow Valvuloplasty Perfusion Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II Product Code: OZT Dated: December 18, 2015 Received: December 21, 2015
Dear Aaron 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, 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 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,
M.A. Hillebrenner
for
for
for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
True™ Flow Valvuloplasty Perfusion Catheter
Indications for Use (Describe)
The True™ Flow Valvuloplasty Perfusion 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)
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3
True™ Flow Valvuloplasty Perfusion 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 Specialist |
| Date | September 11, 2015 |
Subject Device Name:
| Device Trade Name: | True™ Flow Valvuloplasty Perfusion
Catheter |
|-----------------------|---------------------------------------------------------------------|
| Common or Usual Name: | Balloon Aortic Valvuloplasty (21 CFR
870.1255, Product Code OZT) |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Predicate Device:
- . True™ Flow Valvuloplasty Perfusion Catheter (K142083; cleared April 17, 2015)
4
Device Description:
The True™ Flow Valvuloplasty Perfusion Catheter is an over-the-wire co-axial catheter with a balloon fixed at the tip. The balloon enables continuous hemodynamic flow through its central orifice. 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 luerlock hub (straight) connects to the guidewire lumen. The balloon is non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located on the guidewire lumen. These bands are positioned at the proximal and distal balloon shoulders. These markers are provided for fluoroscopic positioning of the device across the aortic valve. Balloon catheter dimensions, nominal pressure, maximum inflation pressure, recommended introducer size, and maximum quidewire size are indicated on the package label.
| Attribute | True™ Flow Valvuloplasty Perfusion
Catheter
Product Offering |
|-------------------------------------------------------------------|--------------------------------------------------------------------|
| Balloon Diameter
(mm) | 18, 20, 22, 24, 26 |
| Balloon Length
(cm) | 3.5 |
| Catheter Shaft
Length (cm) | 110 |
| Introducer Sheath
Compatibility by
Balloon Diameter
(mm) | 11F: 18 mm, 20 mm
12F: 22 mm
14F: 24 mm
16F: 26 mm |
Indications for Use of Device:
The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty.
Image /page/4/Picture/7 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are bold and outlined in black, giving them a three-dimensional appearance. The "A" in "BARD" is designed with a unique, angular shape, setting it apart from the other letters.
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Comparison of Indications for Use to Predicate Device:
The indications for use statement for the True™ Flow Valvuloplasty Perfusion Catheter does not raise any new issues of safety and effectiveness based on the proposed indications for use statement as compared to the predicate device. Therefore, the subject device, the True™ Flow Valvuloplasty Perfusion Catheter, is substantially equivalent to the predicate device.
Technological Comparison to Predicate Devices:
The True™ Flow Valvuloplasty Perfusion Catheter has the following similarities to the predicate device, the True™ Flow Valvuloplasty Perfusion Catheter (clearance to market via K142083 on April 17, 2015):
- . 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 subject True™ Flow Valvuloplasty Perfusion Catheter incorporates the following changes as compared to the predicate device:
- . Offering of additional balloon diameters
- . Change in balloon design and materials
- Change in marker band materials and positions .
- . Change in guidewire lumen material
- Change in catheter tip material .
- . Change in packaging components
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:
Image /page/5/Picture/22 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is formed by thick, black lines, creating a bold and modern look. The letters are interconnected, with the lines flowing smoothly from one letter to the next, giving the word a sense of unity and continuity. The overall design is clean and geometric, making it visually appealing and easy to read.
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- Catheter Shaft Length
- Catheter Shaft Inner Diameter .
- Catheter Shaft Outer Diameter
- Balloon Outer Diameter ●
- Balloon Length ●
- Marker Band Alignment ●
- Dye Penetration ●
- Visual Inspection of Product ●
- Visual Inspection of Sterile . Barrier Packaging Heat Seals
- Tip Morphology ●
- . Trackabilitv
- Sheath Compatibility ●
- Media Interaction ●
- Luer Interface ●
- Hub Stress .
- Hub Stress (48 Hours) ●
- Inflation ●
- Deflation to Restore Valve . Function
- Complete Deflation .
- . Fatigue
- Tip to Balloon Tensile .
- . Rated Burst Pressure
- Catheter Leak .
- . Failure Mode
- Shaft Burst ●
- Catheter Elongation ●
- Hub to Shaft Tensile ●
- . Balloon to Shaft Tensile
- Radiopacity—Prior to Inflation .
- Radiopacity—Inflated ●
- Balloon Distensibility .
- Perfusion Test ●
- Radial Force Test .
- MEM Elution Test ●
- Kligman Maximization Test .
- . Intracutaneous Injection Test
- Systemic Injection Test ●
- Rabbit Pyrogen Test .
- . Hemolysis - Rabbit Blood Contact
- Complement Activation Test ●
- In Vitro Thrombogenicity .
- In Vivo Thrombogenicity ●
The following in vitro test was leveraged from previous testing:
- Pouch Tensile
The results from these tests demonstrate that the technological characteristics and performance criteria of the True™ Flow Valvuloplasty Perfusion 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.
Image /page/6/Picture/48 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are bold and outlined in black, giving them a three-dimensional appearance. The "A" in "BARD" is represented by a triangle, adding a unique visual element to the design. The overall design is simple, clean, and modern.
7
Conclusions:
The subject device, the True™ Flow Valvuloplasty Perfusion 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™ Flow Valvuloplasty Perfusion Catheter is substantially equivalent to the legally marketed predicate device, the True™ Flow Valvuloplasty Perfusion Catheter.
Image /page/7/Picture/6 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. The letters are interconnected, with the "A" having a unique design where the crossbar is angled upwards. The overall design is clean and modern, with a focus on geometric shapes.