(114 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its performance testing, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a Pheripheral Transluminal Angioplasty (PTA) balloon dilatation catheter, used to treat lesions in peripheral arteries as well as obstructive lesions of arteriovenous dialysis fistulae. This falls under the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is for percutaneous transluminal angioplasty (PTA), which is a therapeutic procedure to open narrowed or obstructed arteries, not to diagnose a condition. The device description also refers to it as a "Balloon Dilatation Catheter," which further indicates its therapeutic function.
No
The device description clearly states it is a physical catheter with a balloon, which is a hardware component. The performance studies also focus on physical properties and performance 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 describes a procedure performed on the patient (percutaneous transluminal angioplasty) to treat physical conditions (lesions in peripheral arteries and obstructive lesions of dialysis fistulae). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a balloon catheter, which is a tool used for mechanical dilation within the body. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to physically treat a condition within the body.
N/A
Intended Use / Indications for Use
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Advance 18LP Low Profile PTA Balloon Dilatation Catheter is an over-the-wire catheter. The 4 Fr balloon catheter will be compatible with a 0.018 inch wire guide. The balloon catheter will be supplied sterile, intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Advance® 18LP Low Profile PTA Balloon Dilatation 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 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 Profile - Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with a 4, 5, 6, or 7 Fr sheath (
§ 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
Special 510(k) Premarket Notification PTA Balloon Catheter: Advance® 18LP Low Profile PTA Balloon Dilatation Catheter Cook Incomorated May 22, 2013
510(k) Summary
Submitted By:
MAY 3 1 2013
David E. Chadwick, Ph.D., RAC, FRAPS Director, Regulatory Affairs/Regulatory Science Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812-339-2235 Fax: 812-332-0281
Device:
Trade Name: Common Name: Proposed Classification: Advance® 18LP Low Profile PTA Balloon Dilatation Catheter PTA Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal (LIT)
Indications for Use:
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Devices:
Advance® 18LP Low Profile PTA Balloon Dilatation Catheter, K073378, December 28, 2007
Device Description:
The Advance 18LP Low Profile PTA Balloon Dilatation Catheter is an over-the-wire catheter. The 4 Fr balloon catheter will be compatible with a 0.018 inch wire guide. The balloon catheter will be supplied sterile, intended for one-time use.
Substantial Equivalence:
Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance 18LP Low Profile PTA Balloon Dilatation Catheter. The identical indications for use and technological characteristics of the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter as compared to the predicate device support a determination of substantial equivalence.
Comparison to Predicate Device:
The Advance® 18LP Low Profile PTA Balloon Dilatation Catheter has been modified from the predicate Advance® 18LP Low Profile PTA Balloon Dilatation Catheter to include additional balloon diameters of 2, 9, and 10 mm, additional balloon lengths of 1.5, 2.5, 12, 15, 17, and 20 cm, a catheter length of 150 cm for the over-the-wire type, a peripheral exchange delivery system with single-to-dual lumen configuration and a stainless steel proximal catheter shaft, and usable catheter lengths of 110 and 170 cm for the peripheral exchange type. It has been demonstrated that the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter is comparable to the predicate device in terms of design, intended use, materials, fundamental technology, and principle of operation.
1
Test Data:
The Advance® 18LP Low Profile PTA Balloon Dilatation 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 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 Profile - Measurement of the diameter of catheter shaft, bonds, and folded balloon shows that the device is compatible with a 4, 5, 6, or 7 Fr sheath (