046 Zenith Flex

K190338 · Inneuroco, Inc. · NRY · Aug 2, 2019 · Cardiovascular

Device Facts

• Record ID: K190338
• Device Name: 046 Zenith Flex
• Applicant: Inneuroco, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Aug 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zenith Flex Aspiration System, including the 046 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.

Device Story

System for mechanical aspiration thrombectomy in acute ischemic stroke. Components: 046 Zenith Flex Catheter, Aspiration Tubing Set, VC-701 Cliq Aspirator Pump. Catheter: variable stiffness, Nitinol-reinforced shaft, PTFE-lined lumen, hydrophilic coating, radiopaque marker band. Used in neurointerventional procedures by physicians. Catheter tracks over guidewire to occlusion site; pump provides vacuum aspiration (22-28 in Hg) to remove thrombi. Output: revascularization of occluded intracranial vessels. Benefits: restores blood flow in stroke patients. Device is sterile, single-use (catheter/tubing), non-sterile, multi-use (pump).

Clinical Evidence

No clinical study conducted. Substantial equivalence supported by bench testing (biocompatibility, mechanical, performance, sterilization, shelf-life) and animal testing (swine model, 3-day/30-day follow-up, angiographic/histopathological assessment). Literature review of predicate and similar devices supported clinical outcomes.

Technological Characteristics

Variable stiffness catheter; shaft materials: PEBAX, Urethane, Nylon; reinforcement: Nitinol/stainless steel coil; liner: PTFE; coating: hydrophilic; marker: Platinum/Iridium; dimensions: 0.046" ID, 0.058"/0.056" OD; lengths: 153/160 cm; sterilization: Ethylene Oxide; connectivity: standalone aspiration pump 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

• 3 Max (K113163)

Reference Devices

• Zenith Flex System (071 Zenith Flex) (K172167)
• Intermediate Catheter (K152202)

Submission Summary (Full Text)

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August 2, 2019

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

Re: K190338

Trade/Device Name: Zenith Flex Aspiration System (046 Zenith Flex Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 3, 2019 Received: July 5, 2019

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190338

Device Name

Zenith Flex Aspiration System (046 Zenith Flex Catheter)

Indications for Use (Describe)

The Zenith Flex Aspiration System, including the 046 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.

| 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

#### 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 & Regulatory 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

February 12, 2019

## Device Trade or Proprietary Name Zenith Flex Aspiration System (046 Zenith Flex Catheter)

# Device Common or Classification Name:

Catheter, Percutaneous, 21 CFR 870.1250, Class II

Product Code: NRY (Catheter)

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### Identification of the Legally Marketed Devices to which Equivalence is Being Claimed

| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|--------------------------|----------------------|---------------|
| 3 Max | Penumbra | K113163 |

### Identification of the Legally Marketed Device used as the Reference Device

| Name of Reference Device | Name of Manufacturer | 510(k) Number |
|-----------------------------------------|----------------------|---------------|
| Zenith Flex System<br>(071 Zenith Flex) | InNeuroCo, Inc | K172167 |

## Device Description

The InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire sinqle coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. The 046 Zenith Flex Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The other system components are: the Aspiration Tubinq Set and the VC-701 Cliq Aspirator Pump. The Aspiration Tubing Set is provided sterile and is intended for single use only. The aspiration pump is provided non-sterile and is used in multiple procedures.

#### Indications for Use

The Zenith Flex Aspiration System, including the 046 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 seqments, 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 3 Max | Subject Device<br>InNeuroCo, Inc.<br>046 Zenith Flex Catheter |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K113163 | K190338 |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Review Panel | Neurology | Same |
| Indications For<br>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 (in the<br>internal carotid, middle cerebral -<br>M1 and M2 segments, basilar, and<br>vertebral arteries) within 8 hours of<br>symptom onset. | The Zenith Flex Aspiration System,<br>including the 046 Zenith Flex<br>Catheter, Aspiration Tubing Set, and<br>VC-701 Cliq Aspirator Pump, is<br>indicated 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. Patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV t-<br>PA) or who failed IV t-PA therapy<br>are candidates for treatment. |
| Components<br>Supplied in the<br>catheter package | 3Max Reperfusion Catheter, | 046 Zenith Flex Catheter, Peel<br>Away Introducer, Hemostasis<br>Valve |
| System<br>components | Catheter, Pump, Aspiration Tubing | Same |
| Catheter Shaft<br>Material | Polyether Block Amide (PEBAX),<br>Urethane, Nylon | Same |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Stainless Steel | Polyolefin |
| Catheter Shaft<br>Reinforcement | Stainless Steel/Nitinol | Same |
| Reinforcement<br>pattern | Coil | Same |
| Lubricious<br>Coating | Hydrophilic Coating | Same |
| Radiopaque<br>Marker Band | Platinum/ Iridium | Same |
| Catheter<br>Packaging | Tyvek/Nylon Pouch, polyethylene<br>support tube, packaging card,<br>carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Working Lengths | 153 cm, 160 cm | Same |
| Inside Diameter<br>(ID) | 0.043 in distal<br>0.035 in proximal | 0.046 in |
| Proximal Outer<br>Diameter | 0.062 in | 0.058 in |
| Distal Outer<br>Diameter | 0.050 in nominal | 0.056 in |
| Introducer | Peelaway to aid in catheter tip<br>introduction into hemostasis valve | Peelaway to aid in catheter tip<br>introduction into hemostasis valve |
| Hemostasis Valve | Yes | Same |
| Luer Tapered Hub | Yes | Same |
| Aspiration Method | Pump | Same |
| Aspiration<br>Pressure | 20-29 in Hg | 22-28 in Hg |
| | Reference Device<br>InNeuroCo, Inc.<br>071 Zenith Flex | Subject Device<br>InNeuroCo, Inc.<br>046 Zenith Flex Catheter |
| 510(k) Number | K172167 | K190338 |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Review Panel | Neurology | Same |
| Indications For<br>Use | The Zenith Flex Aspiration System,<br>including the Zenith Flex Catheter,<br>Aspiration Tubing Set, and VC-701<br>Cliq Aspirator Pump, is indicated in<br>the revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle cerebral<br>- M1 and M2 segments, basilar,<br>and vertebral arteries) within 8<br>hours of symptom onset. Patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV t-<br>PA) or who failed IV t-PA therapy<br>are candidates for treatment. | Same |
| Components<br>Supplied in the<br>catheter package | Zenith Flex Catheter, Peel Away<br>Introducer, Hemostasis Valve,<br>Scout Introducer | 046 Zenith Flex Catheter, Peel<br>Away Introducer, Hemostasis<br>Valve |
| System<br>components | Catheter, Pump, Aspiration Tubing | Same |
| Catheter Shaft<br>Material | Polyether Block Amide (PEBAX),<br>Urethane, Nylon | Same |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Polyolefin | Same |
| Catheter Shaft<br>Reinforcement | Stainless Steel/Nitinol | Same |
| Reinforcement<br>pattern | Coil | Same |
| Lubricious<br>Coating | Hydrophilic Coating | Same |
| Radiopaque<br>Marker Band | Platinum/ Iridium | Same |
| Catheter<br>Packaging | Tyvek/Nylon Pouch, polyethylene<br>support tube, packaging card, SBS<br>carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Working Lengths | 115, 125, 132 cm | 153 cm, 160 cm |
| Inside Diameter<br>(ID) | 0.071 in | 0.046 in |
| Proximal Outer<br>Diameter | 0.085 in | 0.058 in |
| Distal Outer<br>Diameter | 0.082 in nominal | 0.056 in |
| Introducer | Peelaway to aid in catheter tip<br>introduction into hemostasis valve<br>Scout to help with the navigation | Peelaway to aid in catheter tip<br>introduction into hemostasis valve |
| Hemostasis Valve | Yes | Same |
| Luer Tapered Hub | Yes | Same |
| Aspiration Method | Pump | Same |
| Aspiration<br>Pressure | 22-28 in Hg | Same…