074 Zenith Flex System

K181354 · Inneuroco, Inc. · NRY · Oct 25, 2018 · Cardiovascular

Device Facts

• Record ID: K181354
• Device Name: 074 Zenith Flex System
• Applicant: Inneuroco, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Oct 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute 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 failed IV t-PA therapy are candidates for treatment.

Device Story

The Zenith Flex System is a percutaneous catheter-based aspiration system used for revascularization in acute ischemic stroke. The device consists of the 074 Zenith Flex Catheter, aspiration tubing, and the VC-701 Cliq Aspirator Pump. The catheter features a variable stiffness shaft reinforced with stainless steel (proximal) and nitinol (distal) coils, a PTFE-lined lumen, and a hydrophilic coating. It is navigated through the vasculature to the site of occlusion, where the pump provides aspiration to remove thrombi. The system is operated by a physician in a clinical setting (e.g., neuro-interventional suite). The device provides mechanical aspiration to restore blood flow, potentially improving patient outcomes by resolving large vessel occlusions.

Clinical Evidence

No clinical study was conducted. Substantial equivalence is supported by bench testing (biocompatibility, mechanical performance, sterilization, shelf-life) and animal testing (swine model for revascularization effectiveness and safety). A literature review of devices with similar dimensions used for direct aspiration was provided to support the indications for use.

Technological Characteristics

Variable stiffness catheter; stainless steel/nitinol coil reinforcement; PTFE-lined lumen; hydrophilic coating; Platinum/Iridium marker band. Dimensions: 0.074" ID, 0.089"/0.083" OD. Accessories: Tuohy-Borst Hemostasis Valve, peel-away introducers, Scout introducer. Sterilization: Ethylene Oxide. Connectivity: None (mechanical aspiration system).

Indications for Use

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

• Zenith Flex Catheter (K172167)

Reference Devices

• Penumbra Ace 68 (K161064)

Submission Summary (Full Text)

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October 25, 2018

InNeuroCo. Inc. Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351

Re: K181354

Trade/Device Name: Zenith Flex System (074 Zenith Flex Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY. DTL. DYB Dated: September 21, 2018 Received: September 25, 2018

Dear Marianne Grunwaldt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Xiaolin Zheng -S

for 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)

#### K181354

Device Name

Zenith Flex System (074 Zenith Flex Catheter)

#### Indications for Use (Describe)

The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute 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 failed IV t-PA therapy are candidates for treatment.

| 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

#### K181354

#### Submitter's Name and Address

InNeuroCo, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989

## Contact Information

Marianne Grunwaldt Director, Quality Assurance & Requlatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: [phone] Facsimile: 1-954-742-5989 E-Mail: [e-mail]

# Secondary Contact

Ming Cheng Chew Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave N, Suite 63 Brooklyn Park, MN 55428 Telephone: [phone] E-Mail: [e-mail]

## Date Prepared

October 22, 2018

## Device Trade or Proprietary Name

Zenith Flex System (074 Zenith Flex Catheter)

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## Device Common or Classification Name:

Percutaneous Catheter, 21 CFR 870.1250, Class II Hemostasis Valve, 21 CFR 870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class II

## Product Code:

NRY (Catheter, Thrombus Retriever) DTL (Hemostasis Valve) DYB (Catheter Introducer)

| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|--------------------------|----------------------|---------------|
| Zenith Flex Catheter | InNeuroCo, Inc | K172167 |
| Name of Reference Device | Name of Manufacturer | 510(k) Number |

ldentification of the Legally Marketed Devices to which Equivalence is Being Claimed

## Device Description

The InNeuroCo 074 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/lridium marker band on the distal 25 cm of the 074 Zenith Flex Catheter has a hydrophilic coating. The 074 Zenith Flex Catheter is available with an internal diameter of 0.074 inches. The outer diameter is of 0.089 inches along its proximal shaft, and 0.083 inches along its distal shaft. The 074 Zenith Flex Catheter is available in three workinq lengths: 115 cm, 125 cm, and 132 cm. The 074 Zenith Flex Catheter has a PTFE lined lumen. Accessories included with the device are a Tuohy-Borst Hemostasis Valve, two peel-away Introducers, and a Scout introducer. The Scout may be used to introduce the 074 Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy.

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# Indications for Use

The Zenith Flex System, including the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated 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 failed IV t-PA therapy are candidates for treatment.

| | Predicate Device<br>InNeuroCo, Inc.<br>071 Zenith Flex | Reference Device<br>Penumbra Ace 68 | Subject Device<br>InNeuroCo, Inc.<br>074 Zenith Flex |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 510(k) Number | K172167 | K161064 | K181354 |
| Classification | Class II | Class II | Same |
| Product Code | NRY | NRY | Same |
| Review Panel | Neurology | Neurology | Same |
| Indications For<br>Use | The Zenith Flex System,<br>including the Zenith Flex<br>Catheter, Aspiration<br>Tubing Set, and VC-701<br>Cliq Aspirator Pump, is<br>indicated in the<br>revascularization of<br>patients with acute<br>ischemic stroke<br>secondary to intracranial<br>large vessel occlusive<br>disease (within the<br>internal carotid, middle<br>cerebral - M1 and M2<br>segments, basilar, and<br>vertebral arteries) within<br>8 hours of symptom<br>onset. Patients who are<br>ineligible for intravenous<br>tissue plasminogen<br>activator (IV t-PA) or who<br>failed IV t-PA therapy are<br>candidates for treatment. | The Penumbra<br>System is intended<br>for use in the<br>revascularization of<br>patients with acute<br>ischemic stroke<br>secondary to<br>intracranial large<br>vessel occlusive<br>disease (within the<br>internal carotid,<br>middle cerebral<br>- M1 and M2<br>segments, basilar,<br>and vertebral<br>arteries) within 8<br>hours of symptom<br>onset. | Same as 071<br>Zenith Flex |
| | Predicate Device<br>InNeuroCo, Inc.<br>071 Zenith Flex | Reference Device<br>Penumbra Ace 68 | Subject Device<br>InNeuroCo, Inc.<br>074 Zenith Flex |
| Components<br>Supplied | Zenith Flex Catheter,<br>Peel Away Introducer,<br>Hemostasis Valve, Scout<br>Introducer | Penumbra<br>Reperfusion<br>Catheter, Aspiration<br>Pump,<br>Pump/Canister | Same as 071<br>Zenith Flex |
| Catheter Shaft<br>Material | Polyether Block Amide<br>(PEBAX),<br>Polycarbonate/Urethane,<br>Nylon | Pebax, Nylon,<br>Urethane | Same as 071<br>Zenith Flex |
| Inner Liner | PTFE | PTFE | Same |
| Hub Material | Polycarbonate | Grilamid | Same as 071<br>Zenith Flex |
| Strain Relief | Polyolefin | Polyolefin, PET<br>Yellow, Grilamid | Same as 071<br>Zenith Flex |
| Catheter Shaft<br>Reinforcement | Stainless Steel/Nitinol | Stainless Steel/Nitinol | Same |
| Reinforcement<br>pattern | Coil | Coil | Same |
| Lubricious<br>Coating | Hydrophilic Coating | Hydrophilic Coating | Same |
| Radiopaque<br>Marker Band | Platinum/ Iridium | Platinum/ Iridium | Same |
| Catheter<br>Packaging | Tyvek/Nylon Pouch,<br>polyethylene support<br>tube, packaging card,<br>SBS carton | Tyvek/Nylon Pouch,<br>polyethylene support<br>tube, packaging card,<br>SBS carton | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Same |
| Working Lengths | 115, 125, 132 cm | 115, 120, 125, 127,<br>132 cm | Same as 071<br>Zenith Flex |
| Inside Diameter<br>(ID) | 0.071 in | 0.068 in min. | 0.074 in |
| | Predicate Device<br>InNeuroCo, Inc.<br>071 Zenith Flex | Reference Device<br>Penumbra Ace 68 | Subject Device<br>InNeuroCo, Inc.<br>074 Zenith Flex |
| Proximal Outer<br>Diameter | 0.085 in max | 0.084 in max | 0.089 in max |
| Distal Outer<br>Diameter | 0.082 in nominal | 0.084 in max | 0.083 in nominal |
| Shelf Life | 3 years | 3 years | Same |
| Introducer | Peel away to aid in<br>catheter tip introduction<br>into hemostasis valve<br>Scout to help with the<br>navigation | Included as part of<br>the Separator with a<br>torque device | Same as 071<br>Zenith Flex |
| Hemostasis Valve | Polycarbonate, Silicone<br>O-Ring, Side Port | Polycarbonate,<br>Silicone O-Ring, Side<br>Port | Same |
| Luer Tapered Hub | Yes | Yes | Same |
| Compatible<br>Guidewire | 0.038 inches | 0.038 inches | Same |
| Scout Introducer | Yes | No | Same as 071<br>Zenith Flex |
| Aspiration Method | Pump | Pump | Same |
| Aspiration<br>Pressure | 22-28 in Hg | 20-29 in Hg | Same as 071<br>Zenith Flex |

# Comparison to Predicate Device

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## Summary of Non-Clinical Data

The subject device has the same materials, packaging, manufacturing process, and sterilization process as the predicate device. Therefore, testing was only conducted for specifications that were affected by the catheter size change.

## Animal Testing

Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the subject Zenith Flex system and the contralateral side was treated with the reference device. The study included two follow up evaluations: 3 days and 30 days.

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There were 3 endpoints of the study: angiographic assessment of revascularization to establish effectiveness, angiographic assessment and histopathological assessment to demonstrate safety. As testing included the reference device, results were compared to demonstrate substantial equivalence.

#### Zenith Flex Performance Testing

To demonstrate substantial equivalence between the subject 074 Zenith Flex Catheter and the predicate 071 Zenith Flex Catheter and the reference Penumbra ACE 68 Catheter, performance testing was conducted. The testing covered verification and validation testing, including biocompatibility, bench testing, sterilization and shelf life. Additionally, some tests were leveraged from previous testing conducted by InNeuroCo. The tests were performed using standard test methods and pre-determined acceptance criteria and all samples passed. Therefore, this test data supports the argument that the 074 Zenith Flex Catheter has similar performance characteristics as the predicate device and the reference device. All of the testing conducted to demonstrate substantial equivalence are presented in the following table.

| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Zenith Flex Catheter<br>& its accessories<br>Biocompatibility-<br>Material Mediated<br>Pyrogen | Testing completed per<br>ISO 10993-11 | The test article extracts must<br>not cause a febrile reaction<br>greater than 0.5°C in any<br>individual subject. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject Zenith<br>Flex Catheter as the materials<br>and manufacturing processes<br>are equivalent. Test articles met<br>the acceptance criteria. |
| Zenith Flex Catheter<br>& its accessories<br>Biocompatibility-<br>Cytotoxicity MEM<br>Elution | Testing completed per<br>ISO 10993-5 | The cultures treated with the<br>test article must not have a<br>reactivity grade greater than<br>2. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject Zenith<br>Flex Catheter as the materials<br>and manufacturing processes<br>are equivalent. Test articles met<br>the acceptance criteria. |
| Zenith Flex Catheter & its<br>accessories<br>Biocompatibility- Hemolysis<br>ASTM Method, extract<br>human blood | Testing completed per<br>ISO 10993-4 | The hemolytic index<br>above the negative control<br>article must be less than<br>5%. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-<br>Hemolysis, ASTM | Testing completed per<br>ISO 10993-4 | The hemolytic index<br>above the negative control<br>article must be less than<br>5%. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-<br>Unactivated Partial<br>Thromboplastin Time | Testing completed per<br>ISO 10993-4 | There must be no<br>statistical decrease<br>between the UPTT of<br>plasma exposed to the<br>test article and to the<br>negative or untreated<br>control. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-<br>Complement Activation | Testing completed per<br>ISO 10993-4 | There must be no<br>statistical increase<br>between either the C3a or<br>SC5b-9 concentrations in<br>plasma exposed to the<br>test article as compared to<br>the negative and<br>untreated controls | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-Dog<br>Thromboresistance | Testing completed per<br>ISO 10993-4 | The test articles must<br>receive a thrombus<br>formation score less than<br>or equal to that of the<br>control. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-<br>Maximization<br>Sensitization | Testing completed per<br>ISO 10993-10 | The test article must elicit<br>a positive response in less<br>than 10% of the test<br>animals. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-<br>Intracutaneous<br>Toxicity/Reactivity | Testing completed per<br>ISO 10993-10 | The test article extracts<br>must not induce a<br>significantly greater<br>biological reaction than<br>the control. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-Acute<br>Systemic Toxicity Test | Testing completed per<br>ISO 10993-11 | The test article extracts<br>must not induce a<br>significantly greater<br>biological reaction than<br>the control. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Chemical Compatibility<br>(Zenith Flex Catheter) | Catheter exposed to<br>chemicals readily<br>available in a clinical<br>setting. | Product shall withstand<br>exposure to chemicals<br>without degradation. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Working Length<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 10555-1 | Test samples should be<br>within existing working<br>length specification. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Working Length to<br>demonstrate that the Zenith<br>Flex Catheter is substantially<br>equivalent to the predicate<br>device. |
| Hub compatibility<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 594-1 and ISO<br>594-2 | Hub shall meet existing<br>Luer specifications. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance<br>criteria. |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Outside diameter<br>(Zenith Flex<br>Catheter) | Testing completed per<br>ISO 10555-1 | Test samples should be<br>within existing outside<br>diameter specification. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Outside diameter to<br>demonstrate that the Zenith<br>Flex Catheter is substantially<br>equivalent to the predicate<br>device. |
| Leak - Air<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 10555-1 | Test samples should be<br>within existing Air - Leak<br>specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Leak - Air to<br>demonstrate that the Zenith<br>Flex Catheteris substantially<br>equivalent to the predicate<br>device. |
| Leak - Liquid<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 10555-1 | Test samples should be<br>within existing Leak -<br>Liquid specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Leak – Liquid to<br>demonstrate that the Zenith<br>Flex Catheter is substantially<br>equivalent to the predicate<br>device. |
| Particulates<br>(Zenith Flex Catheter) | Samples conditioned in<br>benchtop anatomical<br>model.<br>Testing completed per<br>USP 788 | Test samples should be<br>within existing Particulate<br>specifications. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent. Test<br>articles met the acceptance |
| Simulated Use - Bench<br>(Zenith Flex Catheter) | Zenith Flex underwent<br>simulated use testing by<br>a physician in a<br>benchtop model | Test samples must meet<br>predetermined user needs | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Simulated Use<br>- Bench to demonstrate that<br>the Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device. |
| Catheter Burst<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 10555-1 | Test sample burst<br>pressures must meet or<br>exceed existing minimum<br>burst pressure<br>specification. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Catheter Burst to<br>demonstrate that the Zenith<br>Flex Catheter is substantially<br>equivalent to the predicate<br>device. |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Tensile<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 10555-1 | Test sample ultimate<br>tensile strength must meet<br>or exceed existing tensile<br>strength specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Tensile to<br>demonstrate that the Zenith<br>Flex Catheter is substantially<br>equivalent to the predicate<br>device. |
| Corrosion<br>(Zenith Flex Catheter) | Testing completed per<br>ISO 10555-1 | Test samples shall exhibit<br>no evidence of corrosion. | Test results for the<br>Intermediate Catheter<br>(K152202) were leveraged for<br>the subject Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| PTFE Liner inspection<br>(Zenith Flex Catheter) | Zenith Flex was<br>challenged to<br>demonstrate liner<br>adherence. | Test sample liner<br>adhesion must meet or<br>exceed existing PTFE<br>Liner inspection<br>specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for PTFE Liner<br>inspection to demonstrate that<br>the Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device. |
| Hydrophilic Coating<br>Integrity<br>(Zenith Flex Catheter) | Conditioned samples<br>were repeatedly exposed<br>to friction and introduced<br>into an anatomical model<br>to demonstrate that the<br>hydrophilic coating is not<br>affected. | Test sample results must<br>meet or exceed existing<br>Hydrophilic Coating<br>Integrity specifications. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent.<br>Test articles met the<br>acceptance criteria. |
| Simulated Use Testing<br>(Zenith Flex System) | Using a simulated model,<br>the samples retrieved<br>thrombi with an<br>aspiration pump | Successfully removed the<br>thrombi | Zenith Flex System test<br>samples met the acceptance<br>criteria for Aspiration to<br>demonstrate that the Zenith<br>Flex System is substantially<br>equivalent to the predicate<br>device |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Labeling Legibility | Label is legible after<br>printing. | Test samples shall<br>demonstrate text legibility. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>materials and manufacturing<br>processes are equivalent.<br>Test articles met the<br>acceptance criteria. |
| Barcode | Barcode is readable with<br>a standard barcode<br>reader. | Test samples shall<br>demonstrate readily<br>readable barcodes | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex as the materials<br>and manufacturing processes<br>are equivalent. Test articles<br>met the acceptance criteria. |
| Sterilization<br>(Zenith Flex Catheter &<br>Aspiration Tubing Set) | ISO 11135 and<br>AAMI TIR 28 | Sterilization load shall<br>pose an equal or lesser<br>challenge to sterilize than<br>existing sterile product<br>loads. | Sterilization loads met the<br>acceptance criteria for<br>sterilization to demonstrate<br>that the Zenith Flex and the<br>Aspiration Tubing Set is<br>substantially equivalent to the<br>predicate device. |
| Shelf Life<br>(Zenith Flex Catheter &<br>Aspiration Tubing Set) | ASTM F1980 | Aged test samples must<br>meet or exceed existing<br>specifications | Zenith Flex Catheter &<br>Aspiration Tubing Set test<br>samples met the acceptance<br>criteria for shelf life to<br>demonstrate that the Zenith<br>Flex Catheter & Aspiration<br>Tubing Set are substantially<br>equivalent to the predicate<br>device. |
| Toque Strength<br>(Zenith Flex Catheter) | Samples were placed in<br>anatomical model and<br>torqued until failure | Test sample results must<br>meet or exceed existing<br>torque specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for torque to<br>demonstrate that the subject<br>Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Kink Resistance<br>(Zenith Flex Catheter) | Reduction in flow was<br>evaluated while samples<br>were exposed to<br>appropriate tortuosity | Test sample results must<br>meet or exceed existing<br>kink resistance<br>specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for kink resistance to<br>demonstrate that the subject<br>Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device |
| Lumen Patency<br>(Zenith Flex Catheter) | Samples were placed in<br>benchtop anatomical<br>model and evaluated for<br>lumen collapse during<br>aspiration | Test sample results must<br>meet or exceed existing<br>lumen patency<br>specifications. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for lumen patency to<br>demonstrate that the subject<br>Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device |
| Tip Flexibility<br>(Zenith Flex Catheter) | Samples were deflected,<br>and associated forces<br>were measured | Zenith Flex tip flexibility<br>results were compared to<br>predicate device results. | Zenith Flex Catheter test<br>samples performed<br>comparatively against the<br>predicate device<br>demonstrating that the subject<br>Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device |
| Friction Force<br>(Zenith Flex Catheter) | Samples were tracked<br>through benchtop<br>anatomical model and<br>frictional forces were<br>measured | Zenith Flex friction force<br>results were compared to<br>predicate device results. | Zenith Flex Catheter test<br>samples performed<br>comparatively against the<br>predicate device<br>demonstrating that the subject<br>Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device |
| Simulated Use Testing<br>- Usability<br>(Zenith Flex System) | Zenith Flex underwent<br>simulated use testing by a<br>physician in a benchtop<br>model | Test samples must meet<br>predetermined user needs | Zenith Flex System test<br>samples met the acceptance<br>criteria for Simulated Use<br>- Usability to demonstrate that<br>the Zenith Flex System is<br>substantially equivalent to the<br>predicate device. |
| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
| Visual Inspection (Aspiration<br>Tubing Set) | Finished Devices were<br>inspected for damage<br>visually | Test samples should meet<br>visual inspection<br>specifications. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>aspiration tubing is the same.<br>Test articles met the<br>acceptance criteria. |
| Tensile<br>(Aspiration Tubing Set) | Finished devices were<br>elongated until failure | Test sample ultimate<br>tensile strength must meet<br>or exceed existing tensile<br>strength specifications. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>aspiration tubing is the same.<br>Test articles met the<br>acceptance criteria. |
| Leak - Liquid<br>(Aspiration Tubing<br>Set) | Tubing pressurized with<br>fluid and inspected for leak | Test samples should be<br>within existing Leak -<br>Liquid specifications. | Test results for the Zenith Flex<br>Catheter (K172167) were<br>leveraged for the subject<br>Zenith Flex Catheter as the<br>aspiration tubing is the same.<br>Test articles met the<br>acceptance criteria. |
| Leak - Air, Tubing and<br>Control Switch<br>(Aspiration Tubing Set) | Tubing samples evaluated<br>for air l…