(176 days)
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No
The document describes a physical medical device (a balloon catheter) and its performance characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties and simulated use, not data analysis or prediction.
Yes
The device is a percutaneous transluminal angioplasty (PTA) balloon catheter, which is used to treat blockages in arteries, directly performing a therapeutic action.
No
Explanation: The device is a PTA balloon catheter, which is used for treatment (percutaneous transluminal angioplasty) to dilate narrowed arteries, not for diagnosis.
No
The device description clearly describes a physical catheter with a balloon, intended for insertion into the body. The performance studies also focus on physical properties and performance of the hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries and arteriovenous dialysis fistulae. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a balloon catheter, which is a physical tool used to dilate blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DOY, LIT
Device Description
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is an over-the-wire catheter available with an inflated balloon diameter of 1.5 mm with balloon lengths of 2 and 4 cm and balloon diameters of 2, 2.5, and 3 mm with balloon lengths of 2, 3, 4, 6, 8, 10, and 12 cm. The catheter is 2.5 French in outer diameter with a length of 50, 90, or 150 cm. The catheter is compatible with a 0.014 inch (0.36 mm) diameter wire guide. It will be supplied sterile, intended for one-time use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Balloon Minimum Burst Strength Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
- Balloon Preparation and Simulated Use All materials withstand contact with saline/heparin and contrast medium (1:1 ratio) during simulated use. Simulated use testing shows the devices are compatible with the recommended introducer and wire guide and perform according to the instructions for use. The predetermined acceptance criteria were met.
- Catheter Diameter and Balloon Profile Measurement of the diameter of catheter shaft. bonds, and folded balloon shows that the device profile is less than 1.016 mm (0.040 inch). The predetermined acceptance criteria were met.
- Balloon Compliance Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met.
- Balloon Fatigue Testing shows that balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation. The predetermined acceptance criteria were met.
- Bond Strength Testing shows the tensile force during proper clinical use should not fracture or rupture the balloon catheter bonds. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Inflation / Deflation Time Testing shows that the balloon will inflate to rated burst pressure within 60 seconds and fully deflate within 60 seconds. The predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Traditional 510(k)
5. 510(k) Summary
MAR 1 9 2013