PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

• K Number: K120805
• Device Name: PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE
• Manufacturer: ANGIOSLIDE, LTD
• Date Cleared: 2012-04-13 ( 28 days)
• Product Code: LIT DQY
• Regulation Number: 870.1250

Intended Use

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angroplasty and for capture and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries. The Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

Device Description

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9). One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) 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.

Predicate Devices

K111750, K093720

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (balloon catheter) and its performance testing. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.

Therapeutic

Yes
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter used for angioplasty and embolic capture, which are therapeutic interventions.

Diagnostic

No

Explanation: The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter used for therapeutic purposes like dilating arteries and capturing embolic material, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with a balloon and lumens, indicating it is a hardware medical device. The performance studies also focus on physical characteristics and performance of the catheter.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used for "peripheral transluminal angioplasty and for capture and containment of embolic material during angioplasty" in specific arteries within the body. This is an in vivo procedure, meaning it is performed within a living organism.
• Device Description: The description details a catheter with a balloon designed for mechanical dilation and embolic capture within blood vessels. This is consistent with an in vivo medical device.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, 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 to treat a condition within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Angioslide PROTEUS™ 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 PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

Product codes (comma separated list FDA assigned to the subject device)

DQY, LIT

Device Description

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) 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 Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9),

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion. The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement.

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. (Not intended for use in the renal, cerebral, coronary or carotid vasculature.)

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)

Study Type: Non-Clinical Testing (in vitro bench testing), Design Verification and Validation, Comparative Capture Efficiency Testing, Biocompatibility Testing, Sterilization, Packaging, Shelf Life.

Sample size: Varies from test to test depending on whether data collected was variable data or attribute data, meeting required number of units based on risk analysis and confidence/reliability levels. Specific confidence/reliability levels are provided for each test.

Key results: All tests passed their respective accept/reject criteria, demonstrating that the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature design met all specifications and is adequate for its intended use. The test results also demonstrated substantial equivalence to its predicate devices.

Specific test results:

• Visual inspection - external surface: PASS (90% Confidence, 90% Reliability)
• Visual inspection - distal tip: PASS (90% Confidence, 90% Reliability)
• Distal Bond Outer Diameter: PASS (90% Confidence, 90% Reliability)
• Distal Balloon Cone to Distal Tip: PASS (90% Confidence, 90% Reliability)
• Distal Tip to Proximal Outer Tube Tip Length: PASS (90% Confidence, 90% Reliability)
• Soft Tip Length: PASS (90% Confidence, 90% Reliability)
• Wrapped Balloon Outer Diameter: PASS (90% Confidence, 90% Reliability)
• Guide Wire Lumen Inner Diameter: PASS (90% Confidence, 90% Reliability)
• Proximal Bond Outer Diameter: PASS (90% Confidence, 90% Reliability)
• Marker Band Spacing: PASS (90% Confidence, 90% Reliability)
• Balloon Working Length: PASS (90% Confidence, 90% Reliability)
• Balloon Outer Diameter: PASS (90% Confidence, 90% Reliability)
• Catheter Overall Effective Length: PASS (90% Confidence, 90% Reliability)
• Catheter Overall Length: PASS (90% Confidence, 90% Reliability)
• Minimum Balloon Burst Pressure (RBP): PASS (RBP $\ge$ 14atm; 95% Confidence, 99.9% Reliability)
• Balloon Fatigue (Repeated Inflation/Deflations): PASS (Inflation/Deflation Cycles $\ge$ 10 at 14atm (for 3x100); No leakage, rupture, and/or herniation; Up to max 40 cycles; 95% Confidence, 90% Reliability)
• Tensile Strength- Distal Balloon to Inner Tube (Peel): PASS ($\ge$ 5N; 90% Confidence, 95% Reliability)
• Tensile Strength- Distal Balloon to Inner Tube (Shear): PASS ($\ge$ 5N; 90% Confidence, 95% Reliability)
• Tensile Strength- Proximal Balloon to Outer Tube: PASS ($\ge$ 10N; 90% Confidence, 95% Reliability)
• Tensile Strength- Cylinder to T-Connector: PASS ($\ge$ 15N; 90% Confidence, 90% Reliability)
• Tensile Strength- Inflation Tube to T-Connector: PASS ($\ge$ 15N; 90% Confidence, 90% Reliability)
• Tensile Strength- Outer Tube to T-Connector: PASS ($\ge$ 15N; 90% Confidence, 90% Reliability)
• Tensile Strength- Inner Shaft to Pulling Rod: PASS ($\ge$ 10N; 90% Confidence, 95% Reliability)
• Tensile Strength- Pulling Rod to Proximal Luer: PASS ($\ge$ 15N; 90% Confidence, 90% Reliability)
• Tensile Strength- Pulling Rod to Knob Base: PASS ($\ge$ 15N; 90% Confidence, 90% Reliability)
• Tensile Strength- Cylinder to O-ring Cap: PASS ($\ge$ 15N; 90% Confidence, 90% Reliability)
• Liquid Leakage: PASS (No leakage; 90% Confidence, 90% Reliability)
• Balloon Inflation/Deflation Testing: PASS (Inflation Time: $\le$ 14.0s; Deflation Time: $\le$ 30.6s; 90% Confidence, 90% Reliability)
• Balloon Compliance: PASS (Compliance: $\le$ 13%; Nominal Pressure: 8atm; RBP: 14atm; 90% Confidence, 90% Reliability)
• Flow Characteristics- Straight Configuration: PASS (Distal flow observed in uninflated and deflated state, occlusion of distal flow in inflated state; 90% Confidence, 90% Reliability)
• Flow Characteristics- Extreme Angle Configuration: PASS (Distal flow observed in uninflated and deflated state, occlusion of distal flow in inflated state; 90% Confidence, 90% Reliability)
• Stroke Length: PASS (Minimum Stroke Length: $\ge$ 70% of the associated Balloon Working Length; Maximum Stroke Length: Balloon can be deflated after reaching stroke limit.)
• Simulated Use in Tortuous Anatomy Model - guide wire compatibility: PASS (Catheter can be mounted over a 0.014" guide wire; 90% Confidence, 90% Reliability)
• Simulated Use in Tortuous Anatomy Model - Introducer Sheath Compatibility: PASS (Completely folded balloon passes through identified Introducer Sheath at the end of procedure; 90% Confidence, 90% Reliability)
• Simulated Use in Tortuous Anatomy Model - Kink Resistance: PASS (No permanent deformations (kinks) are present once removed from the tortuous anatomy model; 90% Confidence, 90% Reliability)
• Simulated Use in Tortuous Anatomy Model - Max Advancement Force: N/A - Characterization only
• Simulated Use in Tortuous Anatomy Model - Max Collapse Force: N/A - Characterization only
• Simulated Use in Tortuous Anatomy Model - Max Anatomy Retraction Force: N/A - Characterization only
• Simulated Use in Tortuous Anatomy Model - Max Removal Retraction Force: N/A - Characterization only
• Capture Efficiency Comparison: N/A - Characterization only. Testing approach was identical to that used for baseline data submitted in K090364. No significant anomalies found and performance trends were as expected.
• Biocompatibility Testing: No additional testing required.
• Sterilization: Results meet all acceptance criteria, confirmed a SAL of 1x10 °, and EtO/ECh residuals were found to be within the ISO 10993-7 standard specification.
• Packaging: No changes from predicate, so no validation performed.
• Shelf Life: Identical to predicate (3 years), so no validation performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K111750, K093720

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 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).

Summary

0

20805

Angioslide Ltd. - Special 510(k) PROTEUS™ PTA Catheter with Embolic Capture Feature Section 7: 510(k) Summary

APR 1 3 2012

510(k) Summary

PROTEUSTM PTA Catheter with Embolic Capture Feature

Introduction:

.

This document contains the 510(k) summary for the modified PROTEUS™ PTA Catheter with Embolic Capture Feature. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

Applicant Name and Address:

Name: Angioslide, Ltd. Address: 7 Halamish St. Business and Industry Park - North Caesarea 30889 Israel Tel: +(972)4-6187200 Fax: +(972)4-6187222 Official Contact: Clay Anselmo CEO Reglera LLC 11925 W. I-70 Frontage Road North Address: Suite 900 Wheat Ridge, CO 80033 Phone: [phone] Fax: [phone]

Summary Preparation Date: March 14, 2012

Device Name and Classification:

Trade Name:	PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature
Common Name:	Percutaneous Transluminal Angioplasty Balloon Catheter
Classification Name:	Catheter, Percutaneous
Classification:	Class II, 21 CFR 870.1250
Product Code:	DQY/LIT

[e-mail]

Predicate Devices:

The modified PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is claimed to be substantially equivalent to the following legally marketed predicate devices:

1

• Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature . (K111750)
• Boston Scientific Sterling® SL Monorail PTA Balloon,Dilation Catheter (K093720) .

Performance Standards: There are no mandatory performance standards for this device. Device Description: (see Figure 1)

Image /page/1/Figure/4 description: This image shows a technical drawing of a medical device with labeled parts. The drawing includes two detailed views labeled "Detail A" and "Detail B", providing a closer look at specific components. The main view shows the device's overall structure, including a handle, a needle, and a connector. The parts are labeled with numbers 1 through 12 to identify different components of the device.

Figure 1

The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9).

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopaque markers (8) 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 Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is an over the wire dual lumen catheter with a foldable balloon (5) located near the distal atraumatic soft tip (9),

One lumen is used for inflation of the balloon and is accessed via the inflation port (2). The other lumen, starting at the guidewire port (10), allows access to the distal tip for guidewire insertion. The balloon has two radiopaque markers (8) for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement.

2

The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

Indications for Use:

The PROTEUS™ 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, illo-femoral, popliteal, tibial, peroneal, and profunda arteries.

The PROTEUS™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

Comparison of Modified Indications for Use:

The Indications for Use for the predicate PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature (K11750) are identical to the modified PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature, but includes the addition of the 3x100mm balloon size.

Comparison of Technological Characteristics:

The PROTEUS™ 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 a 0.014" guidewire in the 3x100mm size only, and a 0.035" guidewire for all other sizes, which are currently cleared.

The balloon technological characteristics of the modified PROTEUS™ PTA Balloon Catheter are substantially equivalent to those of the PROTEUS™ PTA Balloon Catheter and the Sterling® SL Monorail PTA Balloon Dilation Catheter. In both devices lession dilation is achieved by means of an inflatable balloon.

The modified PROTEUS™ PTA Balloon Catheter overall length, catheter sheath sizing, balloon diameter, balloon length, balloon nominal pressure, balloon rated burst pressure and end hole diameter are the same or similar to the PROTEUS™ PTA Balloon Catheter and the Sterling® SL Monorail PTA Balloon Dilation Catheter.

The embolic capture technological characteristics of the modified PROTEUS™ PTA Balloon Catheter are identical to those of the PROTEUS™ PTA Balloon Catheter. In both devices the containment and removal of embolic material is achieved by proximal vessel occlusion, by means of an inflatable balloon, and subsequent aspiration of embolic material.

Summary of Non-Clinical Testing:

In viro bench testing of the Angioslide PROTEUS™ 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

3

FDA Guidance - Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, January 13, 2005

FDA Guidance - Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions, February 15, 2008

All bench testing, unless otherwise specified, was conducted using finished devices which were sterilized by the final validated sterilization process. .

Design Verification and Validation:

Sample sizes used for the testing were based on required confidence/reliability levels as per FDA Guidance "Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems " and the results of the risk analysis (DFMEA) performed for the PROTEUS™ PTA catheter. The number of units utilized for each test depends on whether the data to be collected was variable data or attribute data, therefore the number of units tested varies from test to test. However, in all cases, the number utilized for testing met the required number of units based on the risk analysis, and the required confidence/reliability levels.

The results of verification and validation testing demonstrated that the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature design met all specifications, and is adequate for its intended use. Additionally, the test results demonstrated substantial equivalence of the modified PROTEUSTM PTA Balloon Catheter with Embolic Capture Feature to its predicate devices.

Verification and validation testing of the modified PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature included catheter and balloon dimensional evaluation, minimum balloon burst strength (RBP), balloon compliance, balloon inflation and deflation time, balloon fatigue, tensile strength, simulated use, and capture efficiency testing.

Test	Accept/Reject Criteria	Results
Visual inspection - external surface	External surface of catheter effective length,
including the distal end, is free from extraneous
matter and surface defects (