Riptide Aspiration System

K172448 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · NRY · Dec 21, 2017 · Cardiovascular

Device Facts

• Record ID: K172448
• Device Name: Riptide Aspiration System
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Dec 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Device Story

Riptide™ Aspiration System restores blood flow in acute ischemic stroke patients. System components: Arc™ Catheter, aspiration tubing, vacuum pump, and collection canister. Physician navigates Arc™ Catheter through vasculature to occlusion site under fluoroscopy. Pump generates vacuum (20-25 inHg) transmitted via tubing to catheter tip to aspirate thrombus. Used in clinical settings by physicians. Output is physical removal of clot; healthcare provider monitors procedure via fluoroscopy and vacuum gauge. Benefits include rapid revascularization of occluded intracranial vessels.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing (mechanical, electrical, packaging, biocompatibility) and animal studies (porcine model, acute/chronic, with/without simulated clot).

Technological Characteristics

System includes Arc™ catheter (lubricous, tapered liner, radiopaque marker), aspiration tubing, vacuum pump, and collection canister. Materials are biocompatible. Vacuum source: 110-115 Vac, 60 Hz pump. Sterilization: Ethylene Oxide (EO). Connectivity: Standalone mechanical/vacuum system. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or failing IV t-PA therapy.

Regulatory Classification

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.

Predicate Devices

• Penumbra System® and Penumbra Pump MAX™ (K160449)

Reference Devices

• Arc™ Intracranial Support Catheter (K150107)
• Penumbra System®/Penumbra System MAX™ (K133317)
• Penumbra Pump MAX™ (K122756)
• Penumbra Reperfusion Catheter 054 (K090752)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 21, 2017

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K172448

Trade/Device Name: Riptide™ Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 20, 2017 Received: November 21, 2017

Dear Mr. Ryan Kenney:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172448

Device Name Riptide™ Aspiration System

#### Indications for Use (Describe)

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary: K172448

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | |
|-------------------------|--------------------------------------------------|--|
| | 9775 Toledo Way | |
| | Irvine, CA 92618 | |
| | Establishment Registration No.: 2029214 | |
| Contact Person: | Ryan Kenney | |
| | Senior Regulatory Affairs Specialist | |
| | Telephone: [phone] | |
| | Email: [e-mail] | |
| Date Summary Prepared: | December 18, 2017 | |
| Trade Name of Device: | Riptide™ Aspiration System | |
| Common Name of Device: | Catheter, Thrombus Retriever | |
| Regulation Description: | Percutaneous Catheter | |
| Review Panel: | Neurology | |
| Product Code: | NRY | |
| Regulation Number: | 21 CFR 870.1250 | |
| Device Classification: | Class II | |
| Predicate Device(s): | Penumbra System® and Penumbra Pump MAX™ | |
| | 510(k)#: K160449 | |
| Reference Device(s): | Arc™ Intracranial Support Catheter | |
| | 510(k)#: K150107 | |
| | Penumbra System®/Penumbra System MAX™ | |
| | 510(k)#: K133317 | |
| | Penumbra Pump MAX™ | |
| | 510(k)#: K122756 | |
| | Penumbra Reperfusion Catheter 054 | |
| | 510(k)#: K090752 | |

### Device Description:

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

- Arc™ Catheter .
- Riptide™ Aspiration Tubing .
- Riptide™ Aspiration Pump ●
- Riptide™ Collection Canister with Intermediate Tubing .

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The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

### Indications for Use:

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

| | Predicate Penumbra System® and<br>Penumbra Pump MAX™<br>(K160449) | Subject Riptide™ Aspiration System |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use<br>(IFU) Statement | Reperfusion Catheters and<br>Separators:<br>As part of the Penumbra System®,<br>the Reperfusion Catheters and<br>Separators are indicated for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral – M1 and M2 | The Riptide™ Aspiration System is<br>intended for use in the<br>revascularization of patients with acute<br>ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral – M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. Patients who are ineligible for |
| | Predicate Penumbra System® and<br>Penumbra Pump MAX™<br>(K160449) | Subject Riptide™ Aspiration System |
| | segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. | intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA<br>therapy are candidates for treatment. |
| | Penumbra Aspiration Tubing:<br>As part of the Penumbra System®,<br>the Penumbra Sterile Aspiration<br>Tubing is indicated to connect the<br>Penumbra Reperfusion Catheters to<br>the Penumbra Pump MAX™.<br><br>Penumbra Pump MAX™:<br>The Penumbra Pump MAX™ is<br>indicated as a vacuum source for<br>Penumbra Aspiration Systems. | |
| | 5MAX™ ACE Reperfusion Catheter | Arc™ Catheter |
| Materials | Biocompatible, commonly utilized<br>for interventional devices. | Same |
| Coating | Hydrophilic | Same |
| Markerband | Radiopaque | Same |
| Guidewire | Yes | Same |
| Compatible | | |
| Dimensions | | |
| Usable Length | 132cm | 132-135cm |
| Proximal Inner<br>Diameter | 0.068" | 0.069" |
| Proximal Outer<br>Diameter | 0.083" | 0.0825" |
| Distal Inner<br>Diameter | 0.060" | 0.061" |
| Distal Outer<br>Diameter | 0.074" | 0.071" |
| Sterilization | | |
| Method | Ethylene Oxide (EO) | Same |
| Packaging | | |
| Pouch | Polyethylene | Nylon-Tyvek® |
| Packaging Hoop | Polyethylene | Same |
| Packaging Card | Polyethylene | Same |
| Carton | Solid Bleached Sulfate (SBS)<br>Paperboard | Same |
| Shelf Life | 36 Months | Same |
| | Penumbra MAX™ Aspiration Tubing | Riptide™ Aspiration Tubing |
| Materials | Biocompatible, commonly utilized | Same |
| | Predicate Penumbra System® and<br>Penumbra Pump MAX™<br>(K160449) | Subject Riptide™ Aspiration System |
| | for interventional devices. | |
| Dimensions | | |
| Usable Length | 112.0" | Same |
| Distal Length | 7.0" | Same |
| Inner Diameter | 0.088" | Same |
| Outer Diameter | 0.188" | Same |
| Sterilization | | |
| Method | Ethylene Oxide (EO) | Same |
| Packaging | | |
| Shelf Life | 36 Months | 3 Months |
| | Penumbra Pump MAX™ | Riptide™ Aspiration Pump |
| Performance Characteristics | | |
| Vacuum Range | 0-29 inHg (0-98.2 kPa) | Same |
| Flow Rate | 0-0.8 SCFM (0-23 LPM) | Same |
| Dimensions | | |
| Length | 15.5" | 16.1" |
| Depth | 11.2" | 13.2" |
| Height | 13.2" | 12.3" |
| Weight | 22.3lbs | 23.6lbs |
| Electrical Requirements | | |
| Voltage | 100-115 Vac | 110-115 Vac |
| Frequency | 50 Hz/60 Hz | 60 Hz |
| Duty Cycle | Non-continuous<br>97.8% (45 minutes on, 1 minute off) | Non-continuous<br>97% (58.2 minutes on, 1.8 minutes off) |
| IEC 60601-1<br>Compliance | Yes | Same |
| IEC 60601-1-2<br>Compliance | Yes | Same |
| | Penumbra MAX™ Canister | Riptide™ Collection Canister with<br>Intermediate Tubing |
| Dimensions | | |
| Volume | 1000ml | 1200ml |

### Device Comparison:

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# Biocompatibility:

Biocompatibility was performed for the Arc™ Catheter and the Riptide™ Aspiration Tubing. The Arc™ Catheter is categorized as a limited exposure (< 24 hours), external communicating device contacting circulating blood. The Riptide™ Aspiration Tubing is categorized, for worst-case, as a limited exposure (< 24 hours), external communicating device with indirect blood path contact.

| ArcTM Catheter | | |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Test Description | Results | Conclusions |
| USP Physiochemical | Meets USP Physicochemical | Pass. |
| Arc™ Catheter | | |
| Test Description | Results | Conclusions |
| ISO MEM Elution Using L-929<br>Mouse Fibroblast Cells | extraction parameters<br>The test article scored '0' at 24, 48 and 72 ± 4 hours and is<br>considered non-cytotoxic under<br>the conditions of this test. | Non-cytotoxic. |
| ISO Guinea Pig Maximization<br>Sensitization Test | Under the conditions of this<br>protocol, the test article did not<br>elicit a sensitization response. | Non-sensitizer. |
| ISO Intracutaneous Irritation<br>Test | The differences in the mean test<br>and control scores of the extract<br>dermal observations were < 1.0,<br>indicating that the requirements<br>of the ISO Intracutaneous<br>Reactivity Test have been met<br>by the test article. | Non-irritant. |
| ISO Acute Systemic Injection<br>Test | None of the test article extract<br>treated animals were observed<br>with clinical signs consistent<br>with toxicity at any of the<br>observation periods. | Non-cytotoxic. |
| ISO Materials Mediated Rabbit<br>Pyrogen | This response did not exceed<br>the USP limit and meets the<br>requirements for this test.<br>Therefore, these results indicate<br>that the test article was<br>determined to be non-<br>pyrogenic. | Non-pyrogenic. |
| ASTM Hemolysis Assay –<br>Direct Contact and Extract<br>Method | There were no significant<br>differences between the test<br>article extract and negative<br>control article results. The test<br>article is considered non-<br>hemolytic. | Non-hemolytic. |
| Complement activation C3a<br>and SC5b-9 Assay | The levels of C3a and SC5b-9<br>of the test article are<br>comparable to the comparison<br>article and less than that of the<br>positive control. | The compliment activation of<br>the C3a and SC5b assays were<br>similar for test and comparison<br>articles. |
| Thromboresistance Evaluation | The thromboresistance<br>properties of the Arc™<br>Catheter are acceptable in<br>clinical use. | The test and control articles<br>exhibited similar<br>thromboresistant<br>characteristics. |
| ISO Bacterial Mutagenicity<br>Test - Ames Assay | Based on the criteria and<br>conditions of the study | Non-mutagenic. |
| Arc™ Catheter | | |
| Test Description | Results | Conclusions |
| ISO in vitro Mouse Lymphoma<br>with Extended Treatment | protocol, the test article is<br>considered non-mutagenic.<br>The test article is considered to<br>be non-mutagenic (non-<br>genotoxic and non-clastogenic)<br>in this test system. | Non-mutagenic. |
| ISO in vivo Mouse<br>Micronucleus Assay | Based on the criteria of the<br>assay, the test article is<br>considered non-mutagenic<br>in this test system. | Non-mutagenic. |
| Partial Thromboplastin Time | Clotting times for Arc™<br>Catheter were similar to the<br>negative control and the<br>reference material (HDPE),<br>indicating that the device<br>materials are not an activator of<br>the intrinsic coagulation<br>pathway. | Non-activator. |
| <i>in vitro</i> Hemocompatibility<br>Assay | The Arc™ Catheter did not<br>result in a decrease in any<br>blood component as compared<br>to the reference material. These<br>results indicate that the cause of<br>thrombi is not related to the<br>materials exposed to human<br>blood during use | No adverse effect on leukocyte<br>or platelet counts. |

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| Riptide™ Aspiration Tubing | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Test Description | Results | Conclusions |
| ISO MEM Elution Using L-929<br>Mouse Fibroblast Cells | The test article scored '0' at 24,<br>48 and 72 ± 4 hours and is<br>considered non-cytotoxic under<br>the conditions of this test. | Non-cytotoxic. |
| ISO Guinea Pig Maximization<br>Sensitization Test | Under the conditions of this<br>protocol, the test article did not<br>elicit a sensitization response. | Non-sensitizer. |
| ISO Intracutaneous Irritation<br>Test | The differences in the mean test<br>and control scores of the extract<br>dermal observations were < 1.0,<br>indicating that the requirements<br>of the ISO Intracutaneous<br>Reactivity Test have been met<br>by the test article. | Non-irritant. |
| ISO Acute Systemic Injection | None of the test article extract | Non-cytotoxic. |

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| Riptide™ Aspiration Tubing | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Test Description | Results | Conclusions |
| Test | treated animals were observed<br>with clinical signs consistent<br>with toxicity at any of the<br>observation periods. | |
| ASTM Hemolysis Assay -<br>Extract Method | Based on the criteria set forth in<br>the protocol, the assay was<br>valid. Therefore, it was capable<br>of correctly assessing the<br>hemolytic potential for test<br>articles. In this case, the test<br>article is considered non-<br>hemolytic under the test<br>conditions employed. | Non-hemolytic. |
| ISO Materials Mediated Rabbit<br>Pyrogen | This response did not exceed<br>the USP limit and meets the<br>requirements for this test.<br>Therefore, these results indicate<br>that the test article was<br>determined to be non-<br>pyrogenic. | Non-pyrogenic. |

The Arc™ Catheter and the Riptide™ Aspiration Tubing have been evaluated to meet requirements specified in ISO 10993-1.

# Performance Data - Bench:

Non-clinical bench testing was performed for each component of the Riptide™ Aspiration System. Non-clinical bench testing was performed to evaluate the performance of the design modifications incorporated into the Riptide™ Aspiration System.

The following non-clinical bench testing was performed for the Arc™ Catheter:

| Arc™ Catheter | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Test | Test Method Summary | Results |
| <i>Microbial</i> | | |
| Ethylene Oxide (EO) Residual | EO Residual for the Arc™ Catheter is performed per ISO 10993-7. | The Arc™ Catheter met the acceptance criteria for EO Residual. |
| Ethylene Chlorohydrin (ECH) | ECH for the Arc™ Catheter is performed per ISO 10993-7. | The Arc™ Catheter met the acceptance criteria for ECH. |
| Bioburden | Bacterial Endotoxin for the Arc™ Catheter is performed per ANSI/AAMI ST72 and USP 161. | The Arc™ Catheter met the acceptance criteria for Bacterial Endotoxin. |
| <i>Packaging</i> | | |
| Arc™ Catheter | | |
| Test | Test Method Summary | Results |
| Visual Inspection | Visual Inspection for the Arc™ Catheter is performed per ASTM F1886. | The Arc™ Catheter met the acceptance criteria for Visual Inspection. |
| Bubble Leak | Bubble Leak for the Arc™ Catheter is performed per ASTM F2096. | The Arc™ Catheter met the acceptance criteria for Bubble Leak. |
| Seal Strength | Seal Strength for the Arc™ Catheter is performed per ASTM F88. | The Arc™ Catheter met the acceptance criteria for Seal Strength. |
| Performance | | |
| Lumen Patency | The proximal hub to the distal tip of the Arc™ Catheter must pass through a stainless-steel mandrel of required size. | The Arc™ Catheter met the acceptance criteria for Lumen Patency. |
| Dimensional Inspection | The usable length, proximal and distal inner and outer diameter of the Arc™ Catheter is recorded. | The Arc™ Catheter met the acceptance criteria for Dimensional Inspection. |
| Tip Buckling | The repeated distal tip buckling force under compressive load is evaluated for stiffness. | The Arc™ Catheter met the acceptance criteria for Tip Buckling. |
| Injection Flow Rate | Injection Flow Rate for the Arc™ Catheter is performed per ISO 10555-1, Annex E with injection through the proximal hub. | The Arc™ Catheter met the acceptance criteria for Injection Flow Rate. |
| Suction Flow Rate | Suction Flow Rate for the Arc™ Catheter is performed per ISO 10555-1, Annex E with injection through the distal tip. | The Arc™ Catheter met the acceptance criteria for Suction Flow Rate. |
| Vacuum Resistance | Vacuum Resistance for the Arc™ Catheter is performed under static conditions using a 60cc syringe. | The Arc™ Catheter met the acceptance criteria for Vacuum Resistance. |
| Air Aspiration Leak | Air Aspiration Leak for the Arc™ Catheter is performed per ISO 10555-1, Annex D. | The Arc™ Catheter met the acceptance criteria for Air Aspiration Leak. |
| Hub/Shaft Peak Tensile Force | Hub/Shaft Peak Tensile Force for the Arc™ Catheter is performed per ISO 10555-1, Annex B. | The Arc™ Catheter met the acceptance criteria for Hub/Shaft Peak Tensile Force. |
| Coating Integrity | Coating Integrity for the Arc™ Catheter was assessed using a staining method pre and post. | Characterization only. |
| ArcTM Catheter | | |
| Test | Test Method Summary | Results |
| Coating Lubricity/Durability | simulation to estimated coating<br>coverage. | The ArcTM Catheter met the<br>acceptance criteria for Coating<br>Lubricity/Durability. |
| Particulate | Particulate for the ArcTM<br>Catheter was performed in a<br>tortuous model per USP <788>. | ArcTM Catheter met the<br>acceptance criteria for<br>Particulate. |
| Kink Resistance | Kink Resistance for the ArcTM<br>Catheter is performed with the<br>device wrapped around a rod or<br>known radius at which point<br>the ArcTM Catheter is inspected<br>for kinking. | The ArcTM Catheter met the<br>acceptance criteria for Kink<br>Resistance. |
| Liquid Leak | Liquid Leak for the ArcTM<br>Catheter is performed per ISO<br>10555-1, Annex C. | The ArcTM Catheter met the<br>acceptance criteria for Liquid<br>Leak. |
| Static/Dynamic Burst | Static/Dynamic Burst for the<br>ArcTM Catheter is performed<br>per ISO 10555-1, Annex F. | The ArcTM Catheter met the<br>acceptance criteria for<br>Static/Dynamic Burst. |
| Corrosion Resistance | Corrosion Resistance for the<br>ArcTM Catheter is performed<br>per ISO 10555-1, Annex A. | The ArcTM Catheter met the<br>acceptance criteria for<br>Corrosion Resistance. |
| Torque to Failure | The ArcTM Catheter is<br>navigated through a tortuous<br>model where the distal tip is<br>secured, and the proximal end<br>of the catheter is rotated 360°.<br>The total number of 360°<br>rotations prior to failure is<br>recorded | Characterization only. |

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