Zenith Flex System
Device Facts
| Record ID | K172167 |
|---|---|
| Device Name | Zenith Flex System |
| Applicant | Inneuroco, Inc. |
| Product Code | NRY · Cardiovascular |
| Decision Date | Apr 19, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K172167 · Apr 19, 2018 | Zenith Flex System | Inneuroco, Inc. | Published clinical literature | A literature review of published clinical studies for devices with similar dimensions and technology was used to support the proposed indications for use by leveraging clinical outcomes. | literature review; clinical outcomes; supportive evidence |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Literature review of published clinical studies; Literature review | Patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease | Not applicable for this study | Clinical outcomes for direct aspiration devices |
Indications for 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
Zenith Flex System is an aspiration-based revascularization device for acute ischemic stroke. System components: Zenith Flex Catheter (variable stiffness, stainless-steel/nitinol reinforced, hydrophilic coating), Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump. Physician operates device in clinical setting to navigate intracranial vasculature; catheter introduced via peel-away/Scout introducers. Pump provides aspiration pressure to remove thrombi from occluded vessels. Output is visual confirmation of thrombus retrieval and restored blood flow. Device benefits patients by enabling mechanical revascularization when pharmacological therapy is contraindicated or ineffective.
Clinical Evidence
No clinical study was conducted. Evidence consists of bench testing (biocompatibility, mechanical integrity, simulated use) and animal testing (swine model with induced occlusions). Literature review of similar aspiration devices supported the indications for use.
Technological Characteristics
Catheter materials: PEBAX, Polycarbonate/Urethane, Nylon, Stainless-Steel, Nitinol, Platinum/Iridium. Reinforcement: Braid pattern. Sensing/Actuation: Aspiration pump (110-120 VAC, 60 Hz). Connectivity: Standalone. Sterilization: Ethylene Oxide. Standards: ISO 10993-1, ISO 10555-1, ISO 594-1/2, ASTM F1929-12, ASTM F88-09, ISO 11135, AAMI TIR 28.
Indications for Use
Indicated for 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 those 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
- Penumbra System ACE 68 Reperfusion Catheter (K161064)
Submission Summary (Full Text)
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April 19, 2018
InNeuroCo, Inc. Marianne Grunwaldt Director, Quality Assurance and Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351
# Re: K172167
Trade/Device Name: Zenith Flex System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY, DTL, DYB Dated: April 13, 2018 Received: April 16, 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. 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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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.
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) K172167
Device Name Zenith Flex System
#### 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) | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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#### 510(k) SUMMARY - K172167
#### Submitter's Name and Address
InNeuroCo, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989
# Contact Information
Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-305-495-3883 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com
#### Date Prepared
April 11, 2018
# Device Trade or Proprietary Name
Zenith Flex System
#### Device Common or Classification Name:
Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class II
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## Product Code:
NRY (Catheter) DTL (Hemostasis Valve) DYB (Catheter Introducer)
# ldentification of the Legally Marketed Devices to which Equivalence is Being Claimed
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|------------------------------------------------|----------------------|---------------|
| Penumbra System ACE 68<br>Reperfusion Catheter | Penumbra, Inc | K161064 |
#### Device Description
The Zenith Flex System consists of the Zenith Flex Catheter, the VC-701 Cliq Aspiration Pump and the Aspiration Tubing Set. The InNeuroCo Zenith Flex Catheter is a variable stiffness 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/Iridium marker band on the distal end. The distal 25 cm of the Zenith Flex Catheter has a hydrophilic coating. The Zenith Flex Catheter is available with an internal diameter of 0.0715 inch. The outer diameter is of 0.0850 inch in the proximal section, and tapers to a nominal of 0.082 inch in the distal section. The Zenith Flex Catheter is available in three working lengths: 115 cm, 125 cm, and 132 cm. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and two peel-away Introducers and a Scout introducer. The Scout may be used to introduce the Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy. The Zenith Flex Catheter is supplied sterile, nonpyrogenic, and intended for single use only. The off-the-shelf aspiration pump is provided non-sterile.
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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.
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# Comparison to Predicate Device
| | Predicate Device<br>Penumbra Ace 68 | InNeuroCo, Inc.<br>Zenith Flex System |
|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K161064 | K172167 |
| Classification | Class II | Class II |
| Product Code | NRY | NRY |
| Review Panel | Neurology | Neurology |
| Indications For Use | The Penumbra System is intended<br>for use in the revascularization of<br>patients with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within the<br>internal carotid, middle cerebral<br>- M1 and M2 segments, basilar,<br>and vertebral arteries) within 8<br>hours of symptom onset. | The Zenith Flex System, including<br>the Zenith Flex Catheter, Aspiration<br>Tubing Set, and VC-701 Cliq<br>Aspirator Pump, is indicated 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<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who failed IV t-<br>PA therapy are candidates<br>for treatment. |
| Components Supplied | Penumbra Reperfusion Catheter,<br>Aspiration Pump, Pump/Canister<br>Tubing, Aspiration Tubing,<br>Separator | Zenith Flex Catheter, Peel Away<br>Introducer, Hemostasis Valve,<br>Scout Introducer, VC-701 Cliq<br>Aspirator Pump, Aspiration<br>Tubing Set |
| | Predicate Device Penumbra Ace 68 | InNeuroCo, Inc.<br>Zenith Flex System<br>(Zenith Flex Catheter) |
| Catheter Shaft Material | Pebax, Nylon, Urethane | Polyether Block Amide<br>(PEBAX),<br>Polycarbonate/Urethane, Nylon |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Polyolefin | Same |
| Catheter Shaft Reinforcement | Stainless Steel/Nitinol | Same |
| Reinforcement pattern | Coil | Braid |
| Lubricious Coating | Hydrophilic Coating | Same |
| Radiopaque Marker Band | Platinum/Iridium | Same |
| Packaging | Tyvek/Nylon Pouch, polyethylene<br>support tube, packaging card, SBS<br>carton | Tyvek/Nylon Pouch,<br>polyethylene support tube,<br>packaging card, SBS carton |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic |
| Working Lengths | 115, 120, 125, 127, 132 cm | 115, 125, 132 cm |
| Inside Diameter (ID) | 0.068 inch min. | 0.071 inch |
| Proximal Outer Diameter | 0.084 inch max | 0.085 inch |
| Distal Outer Diameter | 0.084 inch max | 0.082 inch nominal |
| Shelf Life | 3 years | 3 years |
| Introducer | Included as part of the<br>Separator with a torque device | Peelaway to aid in catheter tip<br>introduction into hemostasis<br>valve Scout to help with the<br>navigation |
| Hemostasis Valve | Polycarbonate, Silicone O-Ring, Side<br>Port | Same |
| Luer Tapered Hub | Yes | Yes |
| Compatible Guidewire | 0.038 inch | 0.038 inch |
| Scout Introducer | No | Yes |
| Aspiration Method | Pump | Same |
| Aspiration Pressure | 20-29 in Hg | 26.6 in Hg |
| | Predicate Device<br>Penumbra Aspiration Tubing | InNeuroCo, Inc.<br>Zenith Flex System<br>(Aspiration Tubing Set) |
| Components Supplied | Tubing, Flow Control Switch, Luer<br>Fittings, Vacuum connector | SAME |
| Control Switch identifies<br>ON/OFF | Yes | SAME |
| Materials | Biocompatible, commonly utilized<br>for interventional devices | SAME |
| Tubing OD | 0.188 inch | 0.142 inch |
| Tubing ID | 0.071 inch to 0.110 inch | 0.071 inch |
| Overall Length | 112.0 inch | 84.0 inch |
| Display Carton | SBS Paperboard | SAME |
| Packaging Configuration | Individual | SAME |
| Sterilization | EO | SAME |
| Shelf Life | 36 Months | SAME |
| | Predicate Device<br>Penumbra Ace 68 | InNeuroCo, Inc.<br>Zenith Flex System<br>(VC-701 Cliq Aspirator Pump) |
| IEC 60601-1 Compliance | Yes | SAME |
| IEC 60601-2 Compliance | Yes | SAME |
| Voltage | 110 VAC to 115 VAC | 110 VAC to 120 VAC |
| Frequency | 50/60 Hz | 60 Hz |
| Sterilization | Non-Sterile | SAME |
| Shelf Life | N/A | SAME |
| Ability to function as a<br>system | Yes | SAME |
| Specified Pressure Ranges | 29 in Hg max | 27 in Hg max |
| Measured Pressure Ranges | 26 in Hg max | 27 in Hg max |
| Maximum duration of time the<br>pump can operate while<br>producing pressures that are<br>clinically significant | After 4 hours of continuous use,<br>measured pressures ranges are<br>retained | SAME |
| Insulated handle | Yes | SAME |
| Pressure gage range | 0-760 mm Hg | SAME |
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#### Summary of Non-Clinical Data
Biocompatibility tests conducted with the Zenith Flex Catheter and its accessories were selected in accordance with ISO 10993-1 quidelines (Biological Evaluation of Medical Devices) for limited duration (< 24 hours), external communicating devices, contacting circulating blood. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Zenith Flex Catheter to be biocompatible and non-pyrogenic.
Biocompatibility tests conducted with the Aspiration Tubing Set were selected in accordance with ISO 10993-1 quidelines (Biological Evaluation of Medical Devices) for a surface device in contact with intact skin for limited (< 24 hours) duration. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Aspiration Tubing Set to be biocompatible.
The conclusions drawn from the physical, mechanical, and performance testing of the subject Zenith Flex System demonstrates that the product is Substantially Equivalent to the legally marketed predicate device.
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# Animal Testing
Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the Zenith Flex Catheter and the contralateral side was treated with predicate device. The study included two follow up evaluations: 3 days and 30 days. 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 predicate device, results were compared to demonstrate substantial equivalence.
## Zenith Flex Performance Testing
| 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<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met the<br>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<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met the<br>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<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| 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<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
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| Test | Test Method<br>Summary | Acceptance Criteria | Conclusions |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Zenith Flex Catheter & its<br>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 test<br>article and to the negative<br>or untreated control. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| Zenith Flex<br>Catheter & its<br>accessories<br>Biocompatibility-<br>Complement<br>Activation | Testing completed per<br>ISO 10993-4 | There must be no statistical<br>increase between either the<br>C3a or SC5b-9<br>concentrations in plasma<br>exposed to the test article as<br>compared to the negative and<br>untreated controls. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| Zenith Flex Catheter &<br>its accessories<br>Biocompatibility-Dog<br>Thromboresistance | Testing completed per<br>ISO 10993-4 | The test articles must receive<br>a thrombus formation score<br>less than or equal to that of<br>the control. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| Zenith Flex Catheter & its<br>accessories<br>Biocompatibility-<br>Maximization Sensitization | Testing completed per<br>ISO 10993-10 | The test article must elicit a<br>positive response in less than<br>10% of the test animals. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheteras the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance 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 the<br>control. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| Zenith Flex Catheter & its<br>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 the<br>control. | Test results for the Zenith<br>Catheter (K171672) were<br>leveraged for the Zenith Flex<br>Catheter as the materials and<br>manufacturing processes are<br>equivalent. Test articles met<br>the acceptance criteria. |
| Chemical Compatibility<br>(Zenith Flex Catheter) | Catheter exposed to<br>chemicals readily<br>available in a clinical<br>setting. | Product<br>shall<br>withstand<br>exposure<br>to<br>chemicals<br>without degradation. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Chemical<br>Compatibility to demonstrate<br>that the Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device. |
| Radiographic<br>Detectability<br>(Zenith Flex<br>Catheter) | Testing completed per<br>ISO 10555-1 | Product shall be visible<br>under fluoro imaging. | Zenith Flex Catheter test<br>samples met the acceptance<br>criteria for Radiographic<br>Detectability to demonstrate<br>that the Zenith Flex Catheter is<br>substantially equivalent to the<br>predicate device. |
| Visual Inspection<br>(Zenith Flex<br>Catheter) | Testing completed per<br>ISO 10555-1 | Test samples should meet<br>visual inspection<br>specifications. | Zenith Fl…
