(115 days)
Not Found
No
The 510(k) summary describes a mechanical balloon catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for angioplasty, which is a therapeutic procedure to open narrowed or obstructed blood vessels.
No
Explanation: The device is a balloon dilatation catheter used for angioplasty, which is a therapeutic procedure to open narrowed or obstructed blood vessels, not to diagnose a condition.
No
The device description clearly indicates it is a physical balloon catheter, a hardware device, not software.
Based on the provided information, the Bipore Balloon Dilatation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae." This describes a procedure performed on the patient's body to treat a condition, not a test performed on a sample taken from the patient's body to diagnose a condition.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into blood vessels. This is consistent with an interventional medical device, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the Bipore Balloon Dilatation Catheter is an interventional medical device used for therapeutic purposes within the patient's body, not an in vitro diagnostic device used to perform tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
Product codes
Not Found
Device Description
The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessels. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guidewire to locate the balloon at the site of stenosis.
The Bipore Balloon Dilatation Catheter will be offered in three balloon sizes and one shaft length, as follows:
Inflated Balloon Diameter (mm): 6, 8, 4
Balloon Length (cm): 4, 5
Catheter Size (Fr): 5, 100
Usable Length (cm): 100
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, and renal arteries, autologous or synthetic arteriovenous dialysis fistulae
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
The following in vitro functional tests were performed on the Bipore Balloon Dilatation Catheter: Balloon Burst, Balloon Multiple Inflation, Balloon Compliance, Balloon Inflation/Deflation Time.
The following biocompatibility tests were performed: Systemic Toxicity, Intracutaneous Toxicity, Implantation, Hemolysis, Cytotoxicity.
Key Metrics
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
SEP 1 2 1996
K961980
SUMMARY OF SAFETY AND EFFECTIVENESS BIPORE BALLOON DILATATION CATHETER May 15, 1996
| Trade Name: | Bipore Balloon Dilatation Catheter | |||
|---|---|---|---|---|
| Manufacturer: | Bipore, Inc. | |||
| 31 Industrial Parkway | ||||
| Northvale, NJ 07647 | ||||
| Tel: (201) 767-1993 Fax: (201) 767-0435 | ||||
| Device Generic Name: | Balloon Dilatation Catheter | |||
| Classification: | Class II, Performance Standards | |||
| Predicate Devices: | Medi-tech Ultra-Thin Balloon Dilatation Catheter | |||
| 510(k): K897106 and K920547 | ||||
| Description of Device: | The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessels. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guidewire to locate the balloon at the site of stenosis. |
The Bipore Balloon Dilatation Catheter will be offered in three balloon sizes and one shaft length, as follows: | | | |
| | Inflated
Balloon
Diameter
(mm) | Balloon
Length
(cm) | Catheter
Size
(Fr) | Usable
Length
(cm) |
| | 6 | 4 | 5 | 100 |
| | 8 | 4 | 5 | 100 |
10
Indications for Use:
The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
4
5
100
1
| Safety and Performance: | The following in vitro functional tests were performed on the
Bipore Balloon Dilatation Catheter: Balloon BurstBalloon Multiple InflationBalloon ComplianceBalloon Inflation/Deflation Time |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following biocompatibility tests were performed: Systemic ToxicityIntracutaneous ToxicityImplantationHemolysisCytotoxicity |
| Conclusion: | Based on the indications for use, technological characteristics, and
safety and performance tests, it has been demonstrated that the
Bipore Balloon Dilatation Catheter is safe and effective for its
intended use. |
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