(78 days)
Not Found
No
The device description and performance study summary focus on the mechanical aspects of a balloon catheter and its clinical performance in valvuloplasty, with no mention of AI or ML technology.
Yes.
The device is indicated for balloon aortic valvuloplasty, which is a therapeutic procedure to treat aortic stenosis by dilating the aortic valve.
No
The device description and intended use clearly state that the True® Flow Valvuloplasty Perfusion Catheter is used for balloon aortic valvuloplasty (a therapeutic procedure) and enables continuous hemodynamic flow during this intervention, rather than for diagnosing a condition. Its function is to expand the aortic valve, not to identify or characterize a disease.
No
The device description clearly outlines a physical catheter with a balloon, lumens, radiopaque markers, and connections for inflation and guidewire. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The True® Flow Valvuloplasty Perfusion Catheter is a medical device used within the body during a surgical procedure (balloon aortic valvuloplasty). It is used to physically dilate the aortic valve.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. Its function is mechanical and procedural.
The information provided clearly describes a device used for a therapeutic intervention within the body, not for analyzing samples outside the body.
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 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 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 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, aortic annulus
Indicated Patient Age Range
adult
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)
Subsequent to clearance of K152613, a post-market clinical study (the TRUE-FLOW study) was conducted on the predicate True® Flow Valvuloplasty Perfusion Catheter. Twenty- five subjects were enrolled, of which all were successfully treated with the study device. One subject withdrew consent following all study procedures and hospital discharge, and is thus not included in the Analysis Population (n =24). Subjects eligible to be enrolled in this study were adult male and non-pregnant females scheduled to undergo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis who had an annulus diameter that could be treated with the available sizes of the study device, in accordance with the IFU. The primary performance endpoint was successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter. The primary safety endpoint was freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure. In 21 (87.5%) cases the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. For one subject these data were not recorded. No device related serious adverse events were reported during the study. The results of the TRUE-FLOW prospective, observational study indicated that the design of the True® Flow Valvuloplasty Perfusion Catheter allowed adequate blood flow through the device's central orifice to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" above the words "U.S. FOOD & DRUG" and the word "ADMINISTRATION" below.
December 13, 2017
C. R. Bard, Inc. Aaron Conovaloff Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281
Re: K172932
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: September 25, 2017 Received: September 26, 2017
Dear Mr. 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
1
801); medical device 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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Indications for Use
510(k) Number (if known) K172932
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
True® Flow Valvuloplasty Perfusion Catheter
Submitter Information:
Bard Peripheral Vascular, Inc. 1625 West Third St. Tempe, AZ 85281
Phone: (480) 350-6012 Fax: (480) 449-2546
Contact Person: Aaron Conovaloff, Regulatory Affairs Specialist Date of Submission: September 25, 2017
Subject Device Name:
| Name of Device: | True® Flow Valvuloplasty Perfusion Catheter |
|---|---|
| Common or Usual Name: | Balloon Aortic Valvuloplasty |
| Classification Name: | Balloon Aortic Valvuloplasty |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 870.1255 |
Predicate Device:
| Name of Device: | True® Flow Valvuloplasty Perfusion Catheter (K152613 |
|---|---|
| Common or Usual Name: | Balloon Aortic Valvuloplasty |
| Classification Name: | Balloon Aortic Valvuloplasty |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 870.1255 |
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 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 non-compliant and is designed to reach a known diameter and length when inflated within the specified pressure range. Two radiopaque markers are located
4
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 guidewire 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.
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 K152613 on January 19, 2016):
- . 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 .
It should be noted that the subject True® Flow Valvuloplasty Perfusion Catheter is identical to the predicate device with respect to manufacturing and design. The only difference between the subject and predicate devices is an update to the Instructions for Use to provide results from clinical experience with the device.
5
Performance Data:
Subsequent to clearance of K152613, a post-market clinical study (the TRUE-FLOW study) was conducted on the predicate True® Flow Valvuloplasty Perfusion Catheter. Twenty- five subjects were enrolled, of which all were successfully treated with the study device. One subject withdrew consent following all study procedures and hospital discharge, and is thus not included in the Analysis Population (n =24). Subjects eligible to be enrolled in this study were adult male and non-pregnant females scheduled to undergo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis who had an annulus diameter that could be treated with the available sizes of the study device, in accordance with the IFU. The primary performance endpoint was successful dilatation of the aortic valve using the True® Flow Valvuloplasty Perfusion Catheter. The primary safety endpoint was freedom from device-related or procedure-related death, stroke, annulus rupture, coronary occlusion, ventricular perforation, during the pre-dilatation procedure. In 21 (87.5%) cases the True® Flow catheter successfully dilated the aortic annulus without clinically significant movement. For one subject these data were not recorded. No device related serious adverse events were reported during the study. The results of the TRUE-FLOW prospective, observational study indicated that the design of the True® Flow Valvuloplasty Perfusion Catheter allowed adequate blood flow through the device's central orifice to perform complete dilation of a stenotic aortic valve prior to TAVI without the need for rapid pacing.
Conclusions:
As the only difference between the subject and predicate devices is the addition of the above clinical experience to the IFU, there is no change to the intended use or indications for use, or any design specifications or manufacturing. Therefore the subject True® Flow Valvuloplasty Perfusion Catheter is substantially equivalent to the legally marketed predicate device, the True® Flow Valvuloplasty Perfusion Catheter.