(403 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of the balloon catheter and its embolic capture feature. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for peripheral transluminal angioplasty and containment of embolic material, which are therapeutic interventions to restore blood flow and prevent complications.
No
The device is indicated for therapeutic purposes, specifically for peripheral transluminal angioplasty and containment of embolic material, rather than for diagnosing a medical condition.
No
The device description clearly details a physical catheter with a balloon, shaft, and handle, indicating it is a hardware device. The performance studies also focus on bench testing of physical properties and animal/clinical testing of the physical device's performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Angioslide eXtra™ PTA Balloon Catheter is a medical device used within the body (in vivo) for a therapeutic procedure (angioplasty) and to capture embolic material. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's arteries.
- Device Description: The description details a catheter with a balloon and a mechanism for capturing material within the blood vessel.
- Performance Studies: The studies described involve bench testing, animal testing, and clinical testing performed on living subjects, not laboratory analysis of specimens.
Therefore, the Angioslide eXtra™ PTA Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide eXtra™ PTA Balloon Catheter is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is a single-use disposable over-the-wire co-axial dual lumen catheter with a foldable balloon near the distal tip. The balloon catheter consists of the balloon located near the distal atraumatic soft tip, the telescopic shaft and the handle.
One lumen is used for inflation of the balloon and is accessed via the inflation port. The other lumen, starting at the quidewire port. allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopague markers for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.
The shaft comprises the outer shaft and the inner shaft. The distal end of the balloon is connected to the inner shaft and the proximal end of the balloon is connected to the outer shaft. The inner shaft is connected to the pulling rod and the outer shaft is connected to the handle body. The pulling rod lock locks the handle body and the pulling rod together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by unlocking the pulling rod lock counter-clockwise and retracting the pulling rod. The inward-folding of the balloon forms a cavity and allows for collection of embolic material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Study Type: In vitro bench testing
Key Results: All tests passed. Tests included: Catheter Dimensional Verification, Balloon Burst, Balloon Compliance, Catheter Inflation / Deflation Time, Balloon Fatigue, Corrosion, Leakage, Bond Tensile Strength (all bonds), Distal Bond Peel Strength, Marker Radiopacity, Simulated Use (Guidewire Compatibility, Deployment and Retraction, Kink Resistance, Advancement Force, Retraction Force, Tortuous Anatomy Compatibility), Introducer Sheath Compatibility, Catheter Flow Characteristics, Comparative Capture Efficiency.
Biocompatibility Testing:
Study Type: Biocompatibility
Key Results: All tests passed. Tests included: Cytotoxicity, Sensitization, Irritation Test, Acute Systemic Toxicity, USP Pyrogen study, Hemocompatibility (ASTM Hemolysis, C3a Complement Activation Assay, SC5b-9 Complement Activation Assay), In Vivo Thromboresistance Study in the Dog Femoral Artery.
Animal Testing:
Study Type: Chronic GLP study (porcine model)
Sample Size: Not specified
Key Results: The safety and performance of the Angioslide eXtra™ PTA Balloon Catheter was substantially equivalent to that of the control article when used in an in vivo model.
Clinical Testing:
Study Type: Multi-Center Studies for Lower Extremity Angioplasty with DEbris Removal (MC-LEADER and MC-LEADER Supplemental) – prospective, multi-center (three and two centers respectively, outside of the US), non-randomized, single arm studies.
Sample Size: Not specified
Key Results: The studies met performance goals derived from historical literature describing PTA performance. Endpoints included: acute device success, acute procedural success (
§ 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
510(k) Summary: Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature (K090364)
510(k) Summary: Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature
This summary of substantial equivalence information is being submitted in accordance with the requirements set forth in 21 CFR 807.92.
Submitter: Angioslide Ltd.
Establishment Registration Number: Not Yet Assigned
MAR 2 8 2010
Contact Information:
Ilya Burovoy
Vice President of Regulatory Affairs and Quality Assurance
Angioslide Ltd.
32 Maskit St., P.O. Box 12489
Herzliya 46733
Israel
Tel: 972-09-9556500
Fax: 972-09-9556700
Email: ilyab@angioslide.com
Date Summary Prepared: March 1, 2010
Name of Device: Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature
Classification Name: Percutaneous Catheter
Device Classification:
Classification: Il
Classification Panel: Cardiovascular
Regulation Number: 21 CFR 870.1250
Product Code: LIT, DQY
Predicate Devices:
-
- AgilTrac . 035 Peripheral Dilatation Catheter (K023320)
-
- ATB Advance PTA Balloon Catheter (K052036)
- Spider FX Embolic Protection Device (K063785) 3.
1
510(k) Summary: Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature (K090364)
Device Description:
The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is a single-use disposable over-the-wire co-axial dual lumen catheter with a foldable balloon near the distal tip. The balloon catheter consists of the balloon located near the distal atraumatic soft tip, the telescopic shaft and the handle.
One lumen is used for inflation of the balloon and is accessed via the inflation port. The other lumen, starting at the quidewire port. allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopague markers for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.
The shaft comprises the outer shaft and the inner shaft. The distal end of the balloon is connected to the inner shaft and the proximal end of the balloon is connected to the outer shaft. The inner shaft is connected to the pulling rod and the outer shaft is connected to the handle body. The pulling rod lock locks the handle body and the pulling rod together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by unlocking the pulling rod lock counter-clockwise and retracting the pulling rod. The inward-folding of the balloon forms a cavity and allows for collection of embolic material.
Indications for Use:
The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.
The Angioslide eXtra™ PTA Balloon Catheter is not intended for use in the renal, cerebral, coronary or carotid vasculature.
Technological Characteristics:
The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over the wire co-axial dual lumen catheter with a foldable balloon located near the distal atraumatic soft tip. The catheter is compatible with 0.035" guidewire.
The technological characteristics of the eXtra"™ PTA Balloon Catheter are substantially equivalent to those of the AgilTrac .035 Peripheral Dilatation Catheter (K023320), the ATB Advance PTA Dilatation Catheter (K052036), and the Spider FX Embolic Protection Device (K063785).
Summary of Bench Testing:
In vitro bench testing of the Angioslide eXtra™ PTA Balloon Catheter was conducted in accordance with Angioslide's Risk Analysis and all applicable FDA Guidance documents and ISO standards, including:
ISO 10555-1 - Sterile, Single Use Intravascular Catheters- Part 1: General Requirements
ISO 10555-4 - Sterile, Single Use Intravascular Catheters- Part 4: Balloon Dilatation Catheters
FDA Guidance - Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems , January 13, 2005 (http://www.fda.gov/cdrh/ode/guidance/1545.html)
FDA Guidance - Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions, February 15, 2008 (http://www.fda.gov/cdrh/ode/guidance/1658.html)
2
510(k) Summary: Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature (K090364)
The following bench tests were conducted. All bench testing, unless otherwise specified, was conducted using finished devices which were double-sterilized by the final validated sterilization process.
- Catheter Dimensional Verification .
- . Balloon Burst
- Balloon Compliance .
- Catheter Inflation / Deflation Time .
- . Balloon Fatigue
- . Corrosion
- . Leakage
- Bond Tensile Strength (all bonds) .
- Distal Bond Peel Strength ●
- Marker Radiopacity .
- Simulated Use including; Guidewire Compatibility, Deployment and Retraction, Kink . Resistance, Advancement Force, Retraction Force, Tortuous Anatomy Compatibility
- . Introducer Sheath Compatibility
- . Catheter Flow Characteristics
- . Comparative Capture Efficiency
Biocompatibility Testing:
The Angioslide eXtra™ Percutaneous Transluminal Angioplasty catheter is an Externally Communicating Device, which contacts circulating blood for the Limited Contact Duration (