(169 days)
No
The summary describes a mechanical aspiration system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to revascularize patients with acute ischemic stroke, which directly treats a medical condition.
No
The device is an aspiration system used for revascularization in acute ischemic stroke, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components, including a catheter, tubing set, and aspirator pump. There is no mention of software as a standalone component or the primary function of the device.
Based on the provided information, the Zenith Flex Aspiration System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic intervention performed within the patient's body to treat a medical condition.
- Device Description: The device components (catheter, tubing, pump) are designed for mechanical aspiration and removal of blood clots from blood vessels. This is a physical procedure, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Zenith Flex Aspiration System is a therapeutic device used to treat a condition directly within the patient.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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 Tubing 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries (intracranial large vessel occlusive disease).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data:
- Biocompatibility tests (Material Mediated Pyrogen, Cytotoxicity MEM Elution, Hemolysis ASTM Method (extract human blood and non-extract), Unactivated Partial Thromboplastin Time, Complement Activation, Dog Thromboresistance, Maximization Sensitization, Intracutaneous Toxicity/Reactivity, Acute Systemic Toxicity Test) per ISO 10993 guidelines, 21CFR58 Good Laboratory Practices. All test articles met acceptance criteria.
- Chemical Compatibility (catheter exposed to chemicals readily available in a clinical setting)
- Working Length (per ISO 10555-1)
- Hub compatibility (per ISO 80369)
- Diameters (per ISO 10555-1)
- Leak - Air (per ISO 10555-1)
- Leak - Liquid (per ISO 10555-1)
- Particulates (conditioned in benchtop anatomical model, per USP 788 as a guide)
- Simulated Use – Bench (by a physician in a benchtop model)
- Catheter Burst (per ISO 10555-1)
- Tensile (per ISO 10555-1)
- Corrosion (leveraged from K152202 Intermediate Catheter)
- PTFE Liner inspection (challenged to demonstrate liner adherence)
- Hydrophilic Coating Integrity (conditioned samples repeatedly exposed to friction and introduced into an anatomical model)
- Simulated Use Testing (Zenith Flex System) (using a simulated model, samples retrieved thrombi with an aspiration pump)
- Labeling Legibility (product label and product peel-away label)
- Barcode (product label and product peel-away label)
- Sterilization (Zenith Flex Catheter & Aspiration Tubing Set) (per ISO 11135 and AAMI TIR 28)
- Shelf Life (Zenith Flex Catheter & Aspiration Tubing Set) (per ASTM F1980)
- Torque Strength (Zenith Flex Catheter) (samples placed in anatomical model and torqued until failure)
- Kink Resistance (Zenith Flex Catheter) (reduction in flow evaluated while samples exposed to appropriate tortuosity)
- Lumen Patency (Zenith Flex Catheter & Aspiration Tubing Set) (samples placed in benchtop anatomical model and evaluated for lumen collapse during aspiration)
- Tip Flexibility (Zenith Flex Catheter) (samples deflected, and associated forces measured)
- Friction Force (Zenith Flex Catheter) (samples tracked through benchtop anatomical model and frictional forces measured)
- Simulated Use Testing - Usability (Zenith Flex System) (by a physician in a benchtop model)
- Visual Inspection (Aspiration Tubing Set) (finished devices inspected for damage visually)
- Tensile (Aspiration Tubing Set) (finished devices elongated until failure)
- Leak - Liquid (Aspiration Tubing Set) (tubing pressurized with fluid and inspected for leak)
- Leak - Air, Tubing and Control Switch (Aspiration Tubing Set) (tubing samples evaluated for air leak during aspiration)
- Luer Compatibility (Aspiration Tubing Set) (per ISO 80369-7)
- Suction Connector Separation Force (Aspiration Tubing Set) (force to separate suction connector from canister evaluated using force gauge)
- Vacuum Drop / Suction Connector Secure Attachment (Aspiration Tubing Set) (vacuum pressure measured at source and tip)
- Dimensions (Aspiration Tubing Set) (critical dimensions measured)
- Packaging - Dye Leak (Zenith Flex Catheter & Aspiration Tubing Set) (per ASTM F1929-12)
- Packaging - Peel (Zenith Flex Catheter & Aspiration Tubing Set) (per ASTM F88-09)
- Peel Force (Peel-Away Introducer) (test samples pulled to failure)
- Unsplit length (Peel-Away Introducer) (unsplit length of test samples measured)
- Diameters (Peel-Away Introducer) (test samples inside and outside diameter measurement)
- Chemical Compatibility (Hemostasis valve) (Hemostasis valve exposed to chemicals readily available in a clinical setting)
- Dimensional (Hemostasis valve) (test samples inside diameter measurement)
Animal Testing:
- Clot used to create occlusions in swine arteries. One side treated with subject device, contralateral side with predicate device.
- Two follow-up evaluations: 3 days and 30 days.
- Endpoints: angiographic assessment of revascularization (effectiveness), angiographic assessment and histopathological assessment (safety).
- Results compared to predicate device to demonstrate substantial equivalence.
Clinical Data:
- No clinical study was conducted.
- A literature review of published clinical study articles featuring the predicate device and other devices with similar dimensions used for direct aspiration was used to support the proposed indications for use.
Key Results:
- All non-clinical tests passed acceptance criteria and supported substantial equivalence.
- Animal testing showed substantial equivalence in safety and effectiveness compared to the predicate device.
- The literature review supported the proposed indications for use by leveraging clinical outcomes from technologically similar devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) SUMMARY
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: 1-954-703-5271 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com
Secondary Contact:
Ming Cheng Chew Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave N, Suite 63 Brooklyn Park, MN 55428 Telephone: 763-232-3701 E-Mail: mcchew@libramed.com
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)
4
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 | ||
(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.
5
Comparison to Predicate Device
| | Predicate Device
Penumbra 3 Max | Subject Device
InNeuroCo, Inc.
046 Zenith Flex Catheter |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K113163 | K190338 |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Review Panel | Neurology | Same |
| Indications For
Use | The Penumbra System is intended
for use in the revascularization of
patients with acute ischemic stroke
secondary to intracranial large
vessel occlusive disease (in the
internal carotid, middle cerebral -
M1 and M2 segments, basilar, and
vertebral arteries) within 8 hours of
symptom onset. | 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. |
| Components
Supplied in the
catheter package | 3Max Reperfusion Catheter, | 046 Zenith Flex Catheter, Peel
Away Introducer, Hemostasis
Valve |
| System
components | Catheter, Pump, Aspiration Tubing | Same |
| Catheter Shaft
Material | Polyether Block Amide (PEBAX),
Urethane, Nylon | Same |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Stainless Steel | Polyolefin |
| Catheter Shaft
Reinforcement | Stainless Steel/Nitinol | Same |
| Reinforcement
pattern | Coil | Same |
| Lubricious
Coating | Hydrophilic Coating | Same |
| Radiopaque
Marker Band | Platinum/ Iridium | Same |
| Catheter
Packaging | Tyvek/Nylon Pouch, polyethylene
support tube, packaging card,
carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Working Lengths | 153 cm, 160 cm | Same |
| Inside Diameter
(ID) | 0.043 in distal
0.035 in proximal | 0.046 in |
| Proximal Outer
Diameter | 0.062 in | 0.058 in |
| Distal Outer
Diameter | 0.050 in nominal | 0.056 in |
| Introducer | Peelaway to aid in catheter tip
introduction into hemostasis valve | Peelaway to aid in catheter tip
introduction into hemostasis valve |
| Hemostasis Valve | Yes | Same |
| Luer Tapered Hub | Yes | Same |
| Aspiration Method | Pump | Same |
| Aspiration
Pressure | 20-29 in Hg | 22-28 in Hg |
| | Reference Device
InNeuroCo, Inc.
071 Zenith Flex | Subject Device
InNeuroCo, Inc.
046 Zenith Flex Catheter |
| 510(k) Number | K172167 | K190338 |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Review Panel | Neurology | Same |
| Indications For
Use | The Zenith Flex Aspiration 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. | Same |
| Components
Supplied in the
catheter package | Zenith Flex Catheter, Peel Away
Introducer, Hemostasis Valve,
Scout Introducer | 046 Zenith Flex Catheter, Peel
Away Introducer, Hemostasis
Valve |
| System
components | Catheter, Pump, Aspiration Tubing | Same |
| Catheter Shaft
Material | Polyether Block Amide (PEBAX),
Urethane, Nylon | Same |
| Inner Liner | PTFE | Same |
| Hub Material | Polycarbonate | Same |
| Strain Relief | Polyolefin | Same |
| Catheter Shaft
Reinforcement | Stainless Steel/Nitinol | Same |
| Reinforcement
pattern | Coil | Same |
| Lubricious
Coating | Hydrophilic Coating | Same |
| Radiopaque
Marker Band | Platinum/ Iridium | Same |
| Catheter
Packaging | Tyvek/Nylon Pouch, polyethylene
support tube, packaging card, SBS
carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Same |
| Working Lengths | 115, 125, 132 cm | 153 cm, 160 cm |
| Inside Diameter
(ID) | 0.071 in | 0.046 in |
| Proximal Outer
Diameter | 0.085 in | 0.058 in |
| Distal Outer
Diameter | 0.082 in nominal | 0.056 in |
| Introducer | Peelaway to aid in catheter tip
introduction into hemostasis valve
Scout to help with the navigation | Peelaway to aid in catheter tip
introduction into hemostasis valve |
| Hemostasis Valve | Yes | Same |
| Luer Tapered Hub | Yes | Same |
| Aspiration Method | Pump | Same |
| Aspiration
Pressure | 22-28 in Hg | Same |
6
The 046 Zenith Flex catheter is very similar to the predicate Penumbra 3Max device. The catheter are built using similar materials – Pebax, Urethane, and Nylon for the shaft with a PTFE liner. Both devices have a stainless steel coil reinforcement for the shaft and have a polycarbonate hub. Each device has a hydrophilic coating with platinum/iridium marker bands for visualization. The 046 Zenith Flex catheter has a polyolefin strain relief compared to a stainless steel for the predicate
7
device; however, this difference is not significant as the polyolefin strain relief provides the same function, passed all performance testing, and passed the relevant biocompatibility testing.
The sizing of the catheters is also similar. The working lengths are the same for both devices. The proximal and distal OD of 046 Zenith Flex Catheter is 0.058 inches and 0.056 inches, respectively, compared to 0.062 inches proximal OD and 0.050 inches distal OD of the predicate device. The difference in OD is small and the 046 Zenith Flex Catheter has an overall smaller profile when entering the body than the predicate. The inner diameter of the 046 Zenith Flex Catheter is larger than the predicate due to a thinner wall.
Both devices go through EO sterilization and use a pump for aspiration. The 046 Zenith Flex Catheter has a narrower aspiration pressure operation range, but this range is within the predicate's operating pressure range.
Comparison to Reference Device
8
9
Summary of Non-Clinical Data
Biocompatibility tests conducted with the 046 Zenith Flex catheter and its accessories were selected in accordance with ISO 10993-1 quidelines (Biological Evaluation of Medical Devices) for limited duration (