PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

{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: (303) 223-4303 Fax: (303) 832-6700 #### 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 | anselmoc@reglera.com #### 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,<br>including the distal end, is free from extraneous<br>matter and surface defects (<0.2mm² TAPPI).<br>90% Confidence, 90% Reliability | PASS | | Visual inspection - distal tip | Distal tip is smooth, rounded, tapered, or<br>similarly finished.<br>90% Confidence, 90% Reliability | PASS | | Distal Bond Outer Diameter | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Distal Balloon Cone to Distal Tip | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Distal Tip to Proximal Outer Tube Tip<br>Length | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Soft Tip Length | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Wrapped Balloon Outer Diameter | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Guide Wire Lumen Inner Diameter | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Proximal Bond Outer Diameter | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Test | Accept/Reject Criteria | Results | | Marker Band Spacing | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Balloon Working Length | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Balloon Outer Diameter | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Catheter Overall Effective Length | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Catheter Overall Length | In Tolerance<br>90% Confidence, 90% Reliability | PASS | | Minimum Balloon Burst Pressure (RBP) | RBP $\ge$ 14atm<br>95% Confidence, 99.9% Reliability | PASS | | Balloon Fatigue (Repeated<br>Inflation/Deflations) | Inflation/Deflation Cycles $\ge$ 10 at 14atm (for<br>3x100)<br>No leakage, rupture, and/or herniation<br>Up to max 40 cycles<br>95% Confidence, 90% Reliability | PASS | | Tensile Strength- Distal Balloon to Inner<br>Tube (Peel) | $\ge$ 5N<br>90% Confidence, 95% Reliability | PASS | | Tensile Strength- Distal Balloon to Inner<br>Tube (Shear) | $\ge$ 5N<br>90% Confidence, 95% Reliability | PASS | | Tensile Strength- Proximal Balloon to<br>Outer Tube | $\ge$ 10N<br>90% Confidence, 95% Reliability | PASS | | Tensile Strength- Cylinder to T-Connector | $\ge$ 15N<br>90% Confidence, 90% Reliability | PASS | | Tensile Strength- Inflation Tube to T-<br>Connector | $\ge$ 15N<br>90% Confidence, 90% Reliability | PASS | | Tensile Strength- Outer Tube to T-<br>Connector | $\ge$ 15N<br>90% Confidence, 90% Reliability | PASS | | Tensile Strength- Inner Shaft to Pulling<br>Rod | $\ge$ 10N<br>90% Confidence, 95% Reliability | PASS | | Tensile Strength- Pulling Rod to Proximal<br>Luer | $\ge$ 15N<br>90% Confidence, 90% Reliability | PASS | | Tensile Strength- Pulling Rod to Knob<br>Base | $\ge$ 15N<br>90% Confidence, 90% Reliability | PASS | | Tensile Strength- Cylinder to O-ring Cap | $\ge$ 15N<br>90% Confidence, 90% Reliability | PASS | | Liquid Leakage | No leakage<br>90% Confidence, 90% Reliability | PASS | | Balloon Inflation/Deflation Testing | Inflation Time: $\le$ 14.0s<br>Deflation Time: $\le$ 30.6s<br>90% Confidence, 90% Reliability | PASS | | Balloon Compliance | Compliance: $\le$ 13%<br>Nominal Pressure: 8atm<br>RBP: 14atm<br>90% Confidence, 90% Reliability | PASS | | Flow Characteristics- Straight<br>Configuration | Distal flow observed in uninflated and deflated<br>state, occlusion of distal flow in inflated state<br>90% Confidence, 90% Reliability | PASS | | Flow Characteristics- Extreme Angle<br>Configuration | Distal flow observed in uninflated and deflated<br>state, occlusion of distal flow in inflated state<br>90% Confidence, 90% Reliability | PASS | | Test | Accept/Reject Criteria | Results | | Stroke Length | Minimum Stroke Length:<br>≥ 70% of the associated Balloon Working<br>Length<br><br>Maximum Stroke Length:<br>Balloon can be deflated after reaching stroke<br>limit. | PASS | | Simulated Use in Tortuous Anatomy<br>Model - guide wire compatibility | 90% Confidence / 90% Reliability<br>Catheter can be mounted over a 0.014" guide<br>wire<br>90% Confidence, 90% Reliability | PASS | | Simulated Use in Tortuous Anatomy<br>Model - Introducer Sheath Compatibility | 90% Confidence, 90% Reliability<br>Completely folded balloon passes through<br>identified Introducer Sheath at the end of<br>procedure.<br>90% Confidence, 90% Reliability | PASS | | Simulated Use in Tortuous Anatomy<br>Model - Kink Resistance | 90% Confidence, 90% Reliability<br>No permanent deformations (kinks) are present<br>once removed from the tortuous anatomy<br>model.<br>90% Confidence, 90% Reliability | PASS | | Simulated Use in Tortuous Anatomy<br>Model - Max Advancement Force | N/A - Characterization only | N/A | | Simulated Use in Tortuous Anatomy<br>Model - Max Collapse Force | N/A - Characterization only | N/A | | Simulated Use in Tortuous Anatomy<br>Model - Max Anatomy Retraction Force | N/A - Characterization only | N/A | | Simulated Use in Tortuous Anatomy .<br>Model - Max Removal Retraction Force | N/A - Characterization only | N/A | | Capture Efficiency Comparison | N/A - Characterization only | N/A | {4}------------------------------------------------ : : . · · : : : : : : {5}------------------------------------------------ ## Comparative Capture Efficiency Testing: To ensure comparability of results, the testing approach was identical to that used to gather baseline data submitted in the original 510(K) for the eXtra™ device family (K090364). The CE testing for the modified PROTEUS™ PTA Balloon Catheter was identical to that of its predicate and is comparable to events that could happen in vivo. A review of the data in detail revealed no significant anomalies in the raw or analyzed data; and trends in performance based on differences in device size were as expected. #### Biocompatibility Testing: Based on Risk Analysis, no additional biocompatibility testing was required for this modification. #### Sterilization: The PROTEUS™ PTA Balloon Catheter is packaged and sterilized using substantially equivalent materials, methods, and sterilization parameters used for most commercially available PTA balloon catheter products. The PROTEUS™ PTA Balloon Catheter is sterilized by ethylene oxide (EtO) sterilization providing a Sterility Assurance Level (SAL) of 1x10 °. EtO sterilization validation was completed in accordance with ISO 11135-1:2007 "Medical devices - Validation and routine control of ethylene oxide sterilization". Testing of EtO residuals was performed in {6}------------------------------------------------ accordance with ISO 10993-7:2008 "Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals." Results of the sterilization were found to 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: There have been no changes to the packaging materials or assembly for the modified PROTEUS™ PTA Balloon Catheter from its predicate device, K111750; therefore, no packaging validation was performed. #### Shelf Life: The shelf-life of the modified PROTEUS™ PTA Balloon Catheter is identical to the currently validated three (3) year shelf life for its predicate device, PROTEUS™ PTA Balloon Catheter. Therefore, no shelf-life validation or accelerated aging tested were performed. ### 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: - PROTEUSTM PTA Balloon Catheter, Angioslide K111750 . - Sterling® SL Monorail PTA Balloon Catheter, Boston Scientific K093720 {7}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 APR 1 3 2012 Angioslide, LTD. c/o Clay Anselmo Chief Executive Officer Reglera, LLC 11925 West I-70 Frontage Road North, Suite 900 Wheat Ridge, CO 80033 Re: K120805 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, DQY Dated: March 14, 2012 Received: March 16, 2012 Dear Mr. Anselmo: 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. {8}------------------------------------------------ # Page 2 - Mr. Clay Anselmo Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that I Dri 3 150aan.co or device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally Federal statutes and regaranents and limited to: registration and listing (21 Comply will an the Her 5 requirements (0); medical device reporting (reporting of medical CI K I at 607), labeling (21 OFR 803); good manufacturing practice requirements as set device in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 form in the quality of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for go to intep.//www.laagonomical Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radiological g by reference to premarket notification" (21CFR Part) flore the regulations 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. You may obtain other general information on your responsibilities under the Act from the You may obtain only general miormaneneas and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, M. A. Hillham Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use 510(k) Number (if known): #### PROTEUSTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Device Name: Embolic Capture Feature Indications for 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) .A. Hillian Page 1 of | (Division Sign-Off) | | |------------------------------------|--| | Division of Cardiovascular Devices | | K120805 510(k) Number Page 22 of 117