(193 days)
Not Found
No
The description focuses on the mechanical function of a balloon catheter and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is described as a "balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature." This process directly treats a medical condition (narrowed vessels) to restore function, which is a therapeutic purpose.
No
The device is a balloon dilatation catheter used to dilate narrow vessel segments, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical catheter with a balloon, which is a hardware component, not software. The performance studies also focus on physical properties and 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 "percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The description details a physical catheter with a balloon used to exert force within a blood vessel. This is a medical device used for intervention, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic tool used for physical intervention within the body.
N/A
Intended Use / Indications for Use
The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.
Product codes
Not Found
Device Description
The FOCUSTM PV Balloon Dilatation Catheter, styled after the Grüntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.
Modifications include larger balloon sizes and reduced balloon compliance. The balloon changes from a double layer polyethylene with polyethylene terephalate to a single layer polyethylene terephalate balloon. The balloon is bonded with an adhesive to a nylon shaft instead of heat sealed to a polyethylene shaft. The catheter shaft tubing changes from a side by side tubing configuration to a coaxial tubing configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large vessels of the peripheral vasculature.
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)
Testing of the FOCUS™-PV Balloon Dilatation Catheter included balloon burst, balloon cycle, radiopacity, tensile strength of connector to catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the balloons meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip as well as torsion strength of the catheter tip met design specifications. There were no failures during these tests.
Overall, all testing demonstrated that the FOCUS™-PV Balloon Dilatation Catheter is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
CardioVascular Dynamics, Inc. 510(k) Notification
SECTION 2 - 510(k) SUMMARY
K963688
march 28, 1997
Submitted By:
CardioVascular Dynamics Incorporated (CVD) 13900 Alton Parkway, Suite 122 Irvine, CA 92618 714-457-9546 Contact: Michael Crocker
Summary Preparation:
Device:
September 13, 1996
FOCUS™-PV Balloon Dilatation Catheter
Classification Name:
Predicate Device: PTA Catheters: Match 35™ PTA Balloon Catheters Schneider
Catheter, Peripheral, Balloon Type
Total Cross™ Balloon Dilatation Catheter Schneider
MS Classique™ Balloon Dilatation Catheter Medi-tech
Ultra-Thin™ Balloon Dilatation Catheter Medi-tech
FOCUSTM Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K944016 SE Date: December 20, 1994
FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K952064 SE Date: June 21, 1995
FOCUS™ Balloon Dilatation Catheter CardioVascular Dynamics, Inc. 510(k) K954313 SE Date: December 1, 1995
367
1
The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.
The FOCUSTM PV Balloon Dilatation Catheter, styled after the Grüntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.
There are many commercially available catheters indicated for peripheral transluminal balloon angioplasty which were marketed prior to promulgation of the Act (May 28, 1976) or have been found substantially equivalent to pre-enactment devices. The FOCUSTM PV device is intended for use in exactly the same manner. In particular, the FOCUSTM-PV Balloon Dilatation Catheter is equivalent in indications and intended use to the listed predicate devices in the table below.
All catheters are manufactured from similar biocompatible materials. They are all preformed plastic tubes with luer fittings.
The FOCUSTM-PV Balloon Dilatation Catheter is a peripheral balloon dilatation catheter. The FOCUS™-PV Balloon Dilatation Catheter is substantially equivalent to existing balloon dilation catheters.
The FOCUS™-PV Balloon Dilatation Catheter is designed for use during peripheral vascular balloon dilatation. Numerous catheters are available in a large range of sizes for use in this manner. The comparison table lists several commercially available devices. Comparisons are made based on the size, construction, materials and use.
This 510(k) is for modifications to existing devices, 510(k) number K944016, substantial equivalence December 20, 1994, 510(k) number K952064, substantial equivalence June 21, 1995, 510(k) number K954313, substantial equivalence December 1, 1995. Modifications include larger balloon sizes and reduced balloon compliance. The balloon changes from a double layer polyethylene with polyethylene terephalate to a single layer polyethylene terephalate balloon. The balloon is bonded with an adhesive to a nylon shaft instead of heat sealed to a polyethylene shaft. The catheter shaft tubing changes from a side by side tubing configuration to a coaxial tubing configuration.
368
Page 7
2
COMPARISON OF FOCUS™-PV WITH CURRENTLY MARKETED PTA CATHETERS
| MANUFACTURER
Product Name | Cardio Vascular
Dynamics
FOCUS Balloon
Dilatation
Catheter | CardioVascular
Dynamics
FOCUSTM-PV
Balloon
Dilatation
Catheter | Schneider
Match 35 PTA
Balloon
Dilatation
Catheter | Schneider
Total Cross
PTA Balloon
Dilatation
Catheter | Medi-tech
MS Classique
Balloon
Dilatation
Catheter | Medi-tech
MS Ultra-Thin
Balloon
Dilatation
Catheter |
|------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------|
| | Balloon Size | 2.5 - 4.0 mm
(0.5 incr.) | 4.0/5.0-7.0/8.0
mm (1.0 incr) | 3.0 - 10.0 mm | 2.0 - 8.0 mm | 4.0 - 10.0 mm |
| | Balloon Length | 20, 25 mm | 25, 30, 40 mm | 20, 40, 80, 100
mm | 20, 40, 80
mm | 25, 40, 80,
100 mm |
| | Shaft Size | 3.5 F proximal
3.0 F distal | 4.3F/5.0F | 4.3F/5.0 F | 4.3F | 4.8F and 5.2F |
| | Shaft Length | 135 cm | 75 - 150 cm | 75 - 150 cm | 95 - 150 cm | 75 - 120 cm |
| | Materials
Balloon | Polyethylene/
PET | Polyethylene
Terephalate
(PET) | Polyethylene
Terephalate
(PET) | Polyethylene/
PET | Polyethylene
Terephalate
(PET) |
| | Shaft | Polyethylene | Nylon | Polyester | Polyester | Polyester |
| | Guidewire Size
(Max) | 0.014 in. | 0.018/0.035 in. | 0.035 in. | 0.021 in. | 0.035 in. |
Testing of the FOCUS™-PV Balloon Dilatation Catheter included balloon burst, balloon cycle, radiopacity, tensile strength of connector to catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the balloons meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip as well as torsion strength of the catheter tip met design specifications. There were no failures during these tests.
Overall, all testing demonstrated that the FOCUS™-PV Balloon Dilatation Catheter is safe and effective.
369