The Angioslide PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral transluminal angioplasty and for capture and removal of embolic material (e.g. debris, thrombus) 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 PROTEUSTM 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 shaft (4) comprises the outer shaft (6) and the inner shaft (7). The distal end of the balloon (A) is connected to the inner shaft and the proximal end of the balloon (B) is connected to the outer shaft. The inner shaft is connected to the proximal hub (10) which is connected to the pulling knob (1) and the outer shaft is connected to the handle grip (3). The pulling knob lock (11) locks the handle grip and the pulling knob together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by pressing on pulling knob lock (11) and pulling the pulling knob away from the handle (1). The inward-folding of the balloon forms a cavity and allows for collection and removal of embolic material.

AI/ML Overview

The provided document describes the Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature. It is a medical device designed for peripheral transluminal angioplasty and for capturing embolic material during angioplasty in various peripheral arteries. The document is a 510(k) summary, demonstrating substantial equivalence to a predicate device (K133043).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comprehensive table of non-clinical bench tests. All tests passed, indicating the device met its acceptance criteria. Below is a summarized version of the table provided in the document:

Test	Acceptance Criteria (Example)	Reported Device Performance
Visual inspection - external surface	Free from extraneous matter and surface defects (<0.2mm² TAPPI). 90% Confidence, 90% Reliability	PASS
Visual inspection - distal tip	Smooth, rounded, tapered, or similarly finished. 90% Confidence, 90% Reliability	PASS
Distal Bond Outer Diameter	In Tolerance. 90% Confidence, 90% Reliability	PASS
Wrapped Balloon Outer Diameter	In Tolerance. 90% Confidence, 90% Reliability	PASS
Guide Wire Lumen Inner Diameter	In Tolerance. 90% Confidence, 90% Reliability	PASS
Minimum Balloon Burst Pressure (RBP)	RBP 12atm. 95% Confidence, 99.9% Reliability	PASS
Balloon Fatigue (Repeated Inflation/Deflations)	Inflation/Deflation Cycles 10 at 12atm. No leakage, rupture, and/or herniation. 95% Confidence, 90% Reliability (Up to max 20 cycles)	PASS
Tensile Strength- Distal Balloon to Inner Tube (Peel/Shear)	10N. 90% Confidence, 95% Reliability	PASS
Liquid Leakage	No leakage. 90% Confidence, 90% Reliability	PASS
Balloon Inflation/Deflation Testing	Inflation Time: ≤ 14.0s; Deflation Time: ≤ 30.6s. No leakage on Inflation. 90% Confidence, 90% Reliability	PASS
Balloon Compliance	Compliance: ≤ 13%; Nominal Pressure: 8atm; RBP: 12atm. 90% Confidence, 90% Reliability	PASS
Stress & Strain	Passed (implied by overall performance for intended use)	PASS
Flow Characteristics (Straight & Extreme Angle Configuration)	Distal flow observed in uninflated/deflated state, occlusion of distal flow in inflated state. 90% Confidence, 90% Reliability	PASS
Stroke Length	Minimum 70% of Balloon Working Length; Max: Balloon deflatable after reaching stroke limit. 90% Confidence / 90% Reliability	PASS
Simulated Use in Tortuous Anatomy (Guidewire Compatibility)	Catheter can be mounted over a 0.035" guide wire. 90% Confidence, 90% Reliability	PASS
Simulated Use in Tortuous Anatomy (Sheath Compatibility)	Completely folded balloon passes through identified Introducer Sheath at the end of procedure. 90% Confidence, 90% Reliability	PASS
Simulated Use in Tortuous Anatomy (Kink Resistance)	No permanent deformations (kinks) once removed from the tortuous anatomy model. 90% Confidence, 90% Reliability	PASS

2. Sample size used for the test set and the data provenance

Sample Size: "Sample sizes used for the testing were based on required confidence/reliability levels as per FDA Guidance... and the results of the risk analysis (DFMEA). 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."
Data Provenance: The studies are described as "In vitro bench testing" and "Design Verification and Validation," performed in accordance with Angioslide's Risk Analysis and applicable FDA Guidance documents and ISO standards. This indicates the testing was conducted in a laboratory setting, likely at the manufacturer's facility in Israel. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is not an AI/imaging device requiring expert interpretation of medical images to establish ground truth. The acceptance criteria are based on objective, quantifiable physical and mechanical properties of the device, measured using standardized engineering and material science tests. Therefore, there are no "experts" in the traditional sense of medical image interpretation for a test set, nor are there qualifications of such experts relevant to the type of testing performed. The "ground truth" is established by the specifications defined in the design and validated through these bench tests against established industry standards (ISO, FDA guidance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests conducted are objective, measurable physical and mechanical tests of the device's components and functionality.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (a balloon catheter), not an artificial intelligence (AI) or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm. The testing described is for the physical and functional aspects of the catheter itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by engineering specifications, industry standards (ISO), and FDA guidance documents. For example, the definition of "In Tolerance" for dimensions or "No leakage" for liquid leakage comes from predetermined, objective criteria. For the purpose of substantial equivalence, the performance is compared against these predefined physical and functional benchmarks, rather than clinical outcomes or expert consensus on medical findings.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set. The device is a physical medical instrument.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

Summary

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December 15, 2017

Angioslide, Ltd. % Ilya Burovoy Principal Consultant Ilya Burovoy- Regulatory and Quality Consulting 21 Montefiore St. #17 Kiryat Ono, 5522635 Israel

Re: K172494

Trade/Device Name: PROTEUS PTA Balloon Catheter with Embolic Capture Feature Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 19, 2017 Received: November 22, 2017

Dear Ilya Burovoy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Ilya Burovoy

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172494

Device Name

PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

PROTEUS™ 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:	4 Ha'Omanut St,Poleg Industrial AreaNetanya 4250438Israel
	Tel: +972-4-790-4600Fax: +972-4-790-4620
Official Contact:	Ilya BurovoyPrincipal ConsultantIlya Burovoy – Regulatory and Quality Consulting
Address:	21 Montefiore St. #17Kiryat Ono 5522635Israel
	Phone: +972-54-479-7217Fax: +972-4-790-4620E-mail: ilyab700@gmail.com

Summary Preparation Date: August 2, 2017

Device Name and Classification:

Trade Name:	PROTEUS™ 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	LIT

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:

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2 Angioslide PROTEUS™ PTA Balloon Catheter with Embolic Capture Feature (K133043)
Performance Standards: There are no mandatory performance standards for this device.

Device Description: (see Figure 1)

Image /page/4/Figure/5 description: This image is a technical drawing of a medical device with several labeled parts. The main body of the device is labeled as '3', with a handle labeled as '1'. A tube is connected to the device, labeled as '2', and a thin, elongated section is labeled as '4'. Details A and B show magnified views of the device's tip, labeled with numbers 6, 7, 8, and 9.

Figure 1

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The balloon size and diameter are printed on the strain relief (12). Refer also to the package label for information about catheter length, balloon nominal and rated burst pressure, balloon size, balloon compliance, guidewire compatibility and sheath compatibility.

Indications for Use:

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

Comparison of Indications for Use:

The Indications for Use for the predicate PROTEUS™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature (K133043) are identical to the modified PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature.

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 PROTEUSTM PTA Balloon Catheter are substantially equivalent to those of the predicate PROTEUS™ PTA Balloon. In both devices lesion dilation is achieved by means of an inflatable balloon.

The modified PROTEUS™ PTA Balloon Catheter overall length, 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.

The modified PROTEUS™ PTA Balloon Catheter differs from the predicate device in that the introducer sheath sizing for 6x60mm, 6x80mm and 6x100mm balloons is 6Fr as compared to 7Fr for the predicate PROTEUS™ PTA Balloon Catheter. The change of the PROTEUS™ device 6x60, 6x80 and 6x100mm balloons compatibility from 7Fr to 6Fr introducer sheath includes minor changes to the balloons' distal end geometry to facilitate passage of the folded balloon through the introducer sheath of a smaller diameter.

The modified PROTEUS™ PTA Balloon Catheter differs from the predicate device in cancelling the handle pulling knob end position lock feature for the 5x60, 5x80, 5x100, 6x60, 6x80 and 6x100mm balloon sizes. This modification is aimed to improve user comfort by improving usability of the pulling knob feature.

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The modified PROTEUS™ PTA Balloon Catheter differs from the predicate device in the handle internal sealing design for the 5x60, 5x80, 5x100, 6x60, 6x80 and 6x100mm balloon sizes.

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 capture 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 vitro 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

FDA Guidance - Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, April 18, 2010

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

FDA Guidance - Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010

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 PROTEUSTM 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 PROTEUS™ 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 and simulated use. No additional capture efficiency testing was required for the modified PROTEUS™ PTA Balloon Catheter as previous testing continues to support the capture efficiency performance.

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Test	Accept/Reject Criteria	Results
Visual inspection - external surface	External surface of catheter effective length,including the distal end, is free from extraneousmatter and surface defects (<0.2mm² TAPPI).90% Confidence, 90% Reliability	PASS
Visual inspection - distal tip	Distal tip is smooth, rounded, tapered, orsimilarly finished.90% Confidence, 90% Reliability	PASS
Distal Bond Outer Diameter	In Tolerance90% Confidence, 90% Reliability	PASS
Distal Balloon Cone to Distal Tip	In Tolerance90% Confidence, 90% Reliability	PASS
Wrapped Balloon Outer Diameter	In Tolerance90% Confidence, 90% Reliability	PASS
Guide Wire Lumen Inner Diameter	In Tolerance90% Confidence, 90% Reliability	PASS
Proximal Bond Outer Diameter	In Tolerance90% Confidence, 90% Reliability	PASS
Marker Band Spacing	In Tolerance90% Confidence, 90% Reliability	PASS
Balloon Working Length	In Tolerance90% Confidence, 90% Reliability	PASS
Catheter Overall Effective Length	In Tolerance90% Confidence, 90% Reliability	PASS
Catheter Overall Length	In Tolerance90% Confidence, 90% Reliability	PASS
Distal Tip Inner Diameter	In Tolerance90% Confidence, 90% Reliability	PASS
Minimum Balloon Burst Pressure (RBP)	RBP 12atm95% Confidence, 99.9% Reliability	PASS
Balloon Fatigue (RepeatedInflation/Deflations)	Inflation/Deflation Cycles 10 at 12atmNo leakage, rupture, and/or herniation95% Confidence, 90% ReliabilityUp to max 20 cycles	PASS
Tensile Strength- Distal Balloon to InnerTube (Peel)	10N90% Confidence, 95% Reliability	PASS
Tensile Strength- Distal Balloon to InnerTube (Shear)	10N90% Confidence, 95% Reliability	PASS
Tensile Strength- Proximal Balloon toOuter Tube	10N90% Confidence, 90% Reliability	PASS
Tensile Strength- Cylinder to T-Connector	15N90% Confidence, 90% Reliability	PASS
Tensile Strength- Inflation Tube to T-Connector	15N90% Confidence, 90% Reliability	PASS
Tensile Strength- Outer Tube to T-Connector	10N90% Confidence, 90% Reliability	PASS
Tensile Strength- Inner Shaft to PullingRod	10N90% Confidence, 95% Reliability	PASS
Tensile Strength- Pulling Rod to ProximalLuer	15N90% Confidence, 90% Reliability	PASS
Tensile Strength- Pulling Rod to KnobBase	15N90% Confidence, 90% Reliability	PASS
Tensile Strength- Cylinder to O-ring Cap	15N90% Confidence, 90% Reliability	PASS
Test	Accept/Reject Criteria	Results
Liquid Leakage	No leakage90% Confidence, 90% Reliability	PASS
Balloon Inflation/Deflation Testing	Inflation Time: 14.0sDeflation Time: 30.6sNo leakage on Inflation90% Confidence, 90% Reliability	PASS
Balloon Compliance	Compliance: 13%Nominal Pressure: 8atmRBP: 12atm90% Confidence, 90% Reliability	PASS
Balloon OD at Nominal Pressure	Balloon Outer Diameter within Tolerance @Nominal Pressure 8atm 90% Confidence, 90% Reliability	PASS
Flow Characteristics- Straight Configuration	Distal flow observed in uninflated and deflated state, occlusion of distal flow in inflated state 90% Confidence, 90% Reliability	PASS
Flow Characteristics- Extreme Angle Configuration	Distal flow observed in uninflated and deflated state, occlusion of distal flow in inflated state 90% Confidence, 90% Reliability	PASS
Stroke Length	Minimum Stroke Length:70% of the associated Balloon Working LengthMaximum Stroke Length:Balloon can be deflated after reaching stroke limit.90% Confidence / 90% Reliability	PASS
Simulated Use in Tortuous AnatomyModel - guide wire compatibility	Catheter can be mounted over a 0.035" guide wire90% Confidence, 90% Reliability	PASS
Simulated Use in Tortuous AnatomyModel - Introducer Sheath Compatibility	Completely folded balloon passes through identified Introducer Sheath at the end of procedure.90% Confidence, 90% Reliability	PASS
Simulated Use in Tortuous AnatomyModel - Kink Resistance	No permanent deformations (kinks) are present once removed from the tortuous anatomy model.90% Confidence, 90% Reliability	PASS
Simulated Use in Tortuous AnatomyModel - Max Advancement Force	N/A - Characterization only	N/A
Simulated Use in Tortuous AnatomyModel - Max Collapse Force	N/A - Characterization only	N/A
Simulated Use in Tortuous AnatomyModel - Max Anatomy Retraction Force	N/A - Characterization only	N/A
Simulated Use in Tortuous AnatomyModel - Max Removal Retraction Force	N/A - Characterization only	N/A

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Comparative Capture Efficiency Testing:

The modified PROTEUS™ PTA Balloon Catheter includes modification of the 6x60, 6x80mm and 6x100mm balloon sizes which do not represent the worst case from the Capture Efficiency prospective therefore the Capture Efficiency test data submitted with the predicate PROTEUS™M PTA Balloon Catheter K133043 remains representative to provide sufficient supporting evidence

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for substantial equivalence of the entire modified device family and no additional Capture Efficiency testing was required for this modification.

Biocompatibility Testing:

Based on Risk Analysis, no additional biocompatibility testing was required for this modification.

Sterilization:

There have been no changes to the sterilization method or parameters of the EtO sterilization process and packaging materials or methods of the device since the clearance of the predicate device K133043; therefore, no sterilization validation was performed.

Packaging:

There have been no changes to the packaging materials or assembly for the modified PROTEUSTM PTA Balloon Catheter from its predicate device, K133043; therefore, no packaging validation was performed.

Shelf Life:

Apart from the 6x60, 6x80 and 6x100mm balloon sizes the shelf-life of the modified PROTEUSTM PTA Balloon Catheter is identical to the currently validated three (3) year shelf life for its predicate device, PROTEUSTM PTA Balloon Catheter.

The modified Angioslide PROTEUS™ 6x60, 6x80 and 6x100mm balloon sizes have been validated for one (1) year shelf life to support the modification in geometry of the balloons.

The shelf life testing included:

Σ visual inspection.
Σ dimensional inspection.
2 burst pressure testing,
E fatigue testing,
∑ inflation/deflation testing,
人 balloon compliance testing,
∑ bond tensile strength testing,
Σ simulated use testing,
Σ flow characterization.

Substantial Equivalence Conclusion:

The modified Angioslide PROTEUS™ PTA Balloon Catheter is substantially equivalent with respect to the indications for use, technological characteristics and performance characteristics to the following legally marketed predicate devices:

Σ PROTEUS™ PTA Balloon Catheter, Angioslide Ltd. K133043

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).