(30 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven analysis.
Yes
The device is indicated for "balloon aortic valvuloplasty," which is a medical procedure to treat a condition and restore normal function, thereby classifying it as a therapeutic device.
No
The device description clearly states its purpose is for "Balloon Aortic Valvuloplasty (BAV)," which is a therapeutic intervention, not a diagnostic one. It's used to dilate the aortic valve.
No
The device description clearly details a physical catheter with a balloon, lumens, and hubs, indicating it is a hardware medical 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 therapeutic procedure performed directly on a patient's aortic valve to widen it.
- Device Description: The description details a catheter with a balloon used for mechanical intervention within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not interact with or analyze such specimens.
The device is a medical device used for a therapeutic intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The True Dilatation Catheter is indicated for balloon aortic valvuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
OZT
Device Description
The True Dilatation Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of the aortic valve. The effective length of the catheter is 110 cm and it 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 functions by connecting an inflation device to the angled luer lock and injecting contrast/sailine into the inflation lumen; which inflates the balloon on the distal end of the catheter. The inflation device plunger is pulled back to deflate the balloon and it can then be withdrawn into the introducer for removal.
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 verify that the device design met its functional and performance requirements, representative samples of the device underwent biocompatibility, sterility, packaging integrity, and mechanical testing in accordance with ISO 10993-1 2009, ISO 11135-1 2007, ASTM D4169:2009, ISO 10555-1 2009. The following mechanical tests were performed:
● Dimensional verification of inflated balloon
● Simulated use for access to annulus, inflation, re-sheathing, and withdrawal
● Inflation and deflation time
● Rupture, herniation, and leaking
● Compatibility with introducer
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
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:
| 510(k) Summary | |
|---|---|
| Submitter: | Loma Vista Medical |
| 863A Mitten Road, Suite 100A | |
| Burlingame, CA 94010 | |
| Phone: (650) 490-4747 | |
| Fax: (480) 449-2546 | |
| Email: chris.timmons@crbard.com | |
| Contact Person: | Tiffini Diage |
| 1307 South Mary Avenue, Suite 280 | |
| Sunnyvale, CA 94087 | |
| Phone: (707) 799-6732 | |
| Fax: (408) 462-9132 | |
| Email: tdiage@namsa.com | |
| Date Prepared: | 12/20/2013 |
| Trade Name: | True Dilatation Balloon Valvuloplasty Catheter |
| Classification: | Class II |
| Balloon Aortic Valvuloplasty | |
| 21 CFR 870.1250 | |
| Product Code: | OZT |
| Predicate Device(s): | The subject device is equivalent to the following devices: |
| True Dilatation Balloon Valvuloplasty Catheter, 510(k) number | |
| K121083 | |
| Device Description: | The True Dilatation Catheter is a coaxial catheter with a balloon |
| fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of | |
| the aortic valve. The effective length of the catheter is 110 cm | |
| and it 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 | |
| functions by connecting an inflation device to the angled luer | |
| lock and injecting contrast/sailine into the inflation lumen; | |
| which inflates the balloon on the distal end of the catheter. The | |
| inflation device plunger is pulled back to deflate the balloon and | |
| it can then be withdrawn into the introducer for removal. | |
| Indication for Use: | The True Dilatation Catheter is indicated for balloon aortic |
| valvuloplasty. | |
| Technological | |
| Characteristics: | The True Dilatation Balloon Valvuloplasty Catheter in this |
| submission is identical to the previously cleared device. The | |
| technical characteristics are the identical. The only change | |
| 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: |