(121 days)
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No
The summary describes a mechanical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Peripheral Dilatation Catheter" intended for "Percutaneous Transluminal Angioplasty (PTA)" of arteries, which is a medical procedure used to treat blockages, indicating it has a therapeutic function.
No
The device is described as a "Peripheral Dilatation Catheter" intended for Percutaneous Transluminal Angioplasty, which is a therapeutic procedure to open narrowed arteries, not for diagnosis.
No
The device description clearly states it is a physical catheter with a balloon, which are hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The VANTAGE™ Peripheral Dilatation Catheter is a medical device used within the body (in vivo) to physically dilate arteries. It does not perform any diagnostic testing on samples.
- Intended Use: The intended use clearly states it's for "Percutaneous Transluminal Angioplasty (PTA)," which is a therapeutic procedure, not a diagnostic one.
Therefore, based on the provided information, the VANTAGE™ Peripheral Dilatation Catheter is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The VANTAGE™ Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Popliteal arteries. The VANTAGE™ Peripheral Dilatation Catheter is not intended for use in the coronary arteries or in neurovasculature.
Product codes
Not Found
Device Description
The 10 cm VANTAGE™ Peripheral Dilatation Catheter is a double-lumen catheter with a poly(ethylene)terephthalate (PET) balloon bonded to the shaft. The 10 cm VANTAGE™ Peripheral Dilatation Catheter has a range of balloon sizes from 3 mm to 7 mm in inflated diameter. The catheter is available in 75 cm to 125 cm shaft lengths.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Iliac, Femoral, and Popliteal arteries
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
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Summary of Performance Studies
The following tests were performed on the 10 cm VANTAGE™ Peripheral Dilatation Catheter:
- Catheter Preparation Test 1)
- Balloon Minimum Burst Strength Test (Balloon Rupture) 2)
- Balloon Compliance Test (Distensibility) 3)
- Balloon Inflation/Deflation Tests 4)
- Balloon Fatigue Test (Repeated Balloon Inflation) 5)
- Tip Pulling Test 6)
- Bonding Strength Test 7)
- Catheter Body Burst Pressure Test 8)
-
- Contrast Medium Flow Rate Test
- Dimensional Measurements (Tip Diameter and Profile Test) 10)
The results of each of the tests were found to be clinically acceptable.
The 10 cm VANTAGE™ Peripheral Dilatation Catheter has been tested per the Tripartite Biocompatibility Guidelines and has passed the USP Class IV for plastics. The following biocompatibility tests were conducted:
- Cytotoxicity Elution 1)
-
- Sensitization
-
- USP XXII Plastics Test (Class IV) - Intracutaneous Test
The 10 cm VANTAGE™ Peripheral Dilatation Catheter passed each of the biocompatibility tests conducted.
- USP XXII Plastics Test (Class IV) - Intracutaneous Test
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
K9665183
APR 2 4 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510 (k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990.
-
Submitted by 1.
Advanced Cardiovascular Systems 3200 Lakeside Drive Santa Clara, CA 95052 -
- General Information
Device Name: VANTAGE™ Peripheral Dilatation Catheter- Additional Sizes
- General Information
| Predicate Device: | VANTAGE™ Dilatation Catheter (ACS)
Ultra-thin™ Dilatation Catheter (Medi-Tech) |
| ------------------- | ----------------------------------------------------------------------------------- |
|---|
PTA Balloon Dilatation Catheter Common Name:
Device Classification: Class II
-
- Indications for Use
The VANTAGE™ Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Popliteal arteries. The VANTAGE™ Peripheral Dilatation Catheter is not intended for use in the coronary arteries or in neurovasculature.
- Indications for Use
-
- Product Description
The 10 cm VANTAGE™ Peripheral Dilatation Catheter is a double-lumen catheter with a poly(ethylene)terephthalate (PET) balloon bonded to the shaft. The 10 cm VANTAGE™ Peripheral Dilatation Catheter has a range of balloon sizes from 3 mm to 7 mm in inflated diameter. The catheter is available in 75 cm to 125 cm shaft lengths.
- Product Description
న. Rationale for Substantial Equivalence
The 10 cm VANTAGE" Peripheral Dilatation Catheter is substantially equivalent to the ACS VANTAGE™ Dilatation Catheter (510 (k) Notification K934433) and Medi-Tech's Ultra-thin" Balloon Dilatation Catheter (510 (k) Notification K920547). The 10 cm VANTAGE" Peripheral Dilatation Catheter is equivalent
1
to the VANTAGE™ and Ultra-thin" Balloon Dilatation Catheters in term of its indications for use, functionality, performance and safety. The VANTAGE™ Dilatation Catheter and Ultra-thin" Balloon Dilatation Catheter were found to be substantially equivalent to devices which were in commercial distribution prior to May 28, 1976.
播 |
6. Safety and Performance Studies
The following tests were performed on the 10 cm VANTAGE™ Peripheral Dilatation Catheter:
- Catheter Preparation Test 1)
- Balloon Minimum Burst Strength Test (Balloon Rupture) 2)
- Balloon Compliance Test (Distensibility) 3)
- Balloon Inflation/Deflation Tests 4)
- Balloon Fatigue Test (Repeated Balloon Inflation) ર)
- Tip Pulling Test ()
- Bonding Strength Test 7)
- Catheter Body Burst Pressure Test 8)
-
- Contrast Medium Flow Rate Test
- Dimensional Measurements (Tip Diameter and Profile Test) 10)
The results of each of the tests were found to be clinically acceptable.
The 10 cm VANTAGE™ Peripheral Dilatation Catheter has been tested per the Tripartite Biocompatibility Guidelines and has passed the USP Class IV for plastics. The following biocompatibility tests were conducted:
- Cytotoxicity Elution 1)
-
- Sensitization
-
- USP XXII Plastics Test (Class IV) - Intracutaneous Test
The 10 cm VANTAGE™ Peripheral Dilatation Catheter passed each of the biocompatibility tests conducted.
- Conclusions 7)
Based upon the indications for use, technological characteristics, and safety and performance studies, the 10 cm VANTAGE™ Peripheral Dilatation Catheter has been shown to be safe and effective for its intended use.