(156 days)
No
The summary focuses on the mechanical design and performance of the catheter and aspiration system, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used for revascularization and tissue plasminogen activator therapy, which are therapeutic medical interventions.
No
The device is indicated for revascularization in patients with acute intracranial large vessel occlusive disease, which is a treatment rather than a diagnostic purpose.
No
The device description clearly details physical hardware components including a catheter, tubing set, and pump, made of materials like Stainless-Steel and Nitinol.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the revascularization of patients with acute intracranial large vessel occlusive disease. This is a therapeutic intervention performed in vivo (within the body) to restore blood flow.
- Device Description: The device description details a catheter, aspiration tubing, and a pump. These are all components used for a medical procedure performed directly on the patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze samples (like blood or tissue), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on the device's ability to achieve revascularization (effectiveness) and its safety during the procedure, not on its diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY, DTL, DYB
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/Iridium 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries)
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)
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. 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 (Bench 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.
Key results from bench testing (all samples met acceptance criteria):
- Biocompatibility (Material Mediated Pyrogen, Cytotoxicity MEM Elution, Hemolysis (ASTM Method, extract human blood), Unactivated Partial Thromboplastin Time, Complement Activation, Dog Thromboresistance, Maximization Sensitization, Intracutaneous Toxicity/Reactivity, Acute Systemic Toxicity Test)
- Chemical Compatibility
- Working Length
- Hub compatibility
- Outside diameter
- Leak - Air
- Leak - Liquid
- Particulates
- Simulated Use - Bench
- Catheter Burst
- Tensile
- Corrosion
- PTFE Liner inspection
- Hydrophilic Coating Integrity
- Simulated Use Testing (Aspiration)
- Labeling Legibility
- Barcode
- Sterilization
- Shelf Life
- Torque Strength
- Kink Resistance
- Lumen Patency
- Tip Flexibility
- Friction Force
- Simulated Use Testing - Usability
- Visual Inspection (Aspiration Tubing Set)
- Tensile (Aspiration Tubing Set)
- Leak - Liquid (Aspiration Tubing Set)
- Leak - Air, Tubing and Control Switch (Aspiration Tubing Set)
- Luer Compatibility (Aspiration Tubing Set)
- Suction Connector Separation Force (Aspiration Tubing Set)
- Vacuum Drop / Suction Connector Secure Attachment (Aspiration Tubing Set)
- Lumen Patency (Aspiration Tubing Set)
- Dimensions (Aspiration Tubing Set)
- Packaging - Dye Leak
- Packaging - Peel
- Aspiration Tubing Set Biocompatibility (Cytotoxicity MEM Elution, Maximization Sensitization, Intracutaneous Toxicity/Reactivity)
Performance Data - Clinical:
No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by leveraging clinical outcomes from devices that are considered technologically similar.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) SUMMARY
K181354
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 & Requlatory 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
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
October 22, 2018
Device Trade or Proprietary Name
Zenith Flex System (074 Zenith Flex Catheter)
4
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.
5
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
InNeuroCo, Inc.
071 Zenith Flex | Reference Device
Penumbra Ace 68 | Subject Device
InNeuroCo, Inc.
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
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. | The Penumbra
System is intended
for use in the
revascularization of
patients with acute
ischemic stroke
secondary to
intracranial large
vessel occlusive
disease (within the
internal carotid,
middle cerebral
- M1 and M2
segments, basilar,
and vertebral
arteries) within 8
hours of symptom
onset. | Same as 071
Zenith Flex |
| | Predicate Device
InNeuroCo, Inc.
071 Zenith Flex | Reference Device
Penumbra Ace 68 | Subject Device
InNeuroCo, Inc.
074 Zenith Flex |
| Components
Supplied | Zenith Flex Catheter,
Peel Away Introducer,
Hemostasis Valve, Scout
Introducer | Penumbra
Reperfusion
Catheter, Aspiration
Pump,
Pump/Canister | Same as 071
Zenith Flex |
| Catheter Shaft
Material | Polyether Block Amide
(PEBAX),
Polycarbonate/Urethane,
Nylon | Pebax, Nylon,
Urethane | Same as 071
Zenith Flex |
| Inner Liner | PTFE | PTFE | Same |
| Hub Material | Polycarbonate | Grilamid | Same as 071
Zenith Flex |
| Strain Relief | Polyolefin | Polyolefin, PET
Yellow, Grilamid | Same as 071
Zenith Flex |
| Catheter Shaft
Reinforcement | Stainless Steel/Nitinol | Stainless Steel/Nitinol | Same |
| Reinforcement
pattern | Coil | Coil | Same |
| Lubricious
Coating | Hydrophilic Coating | Hydrophilic Coating | Same |
| Radiopaque
Marker Band | Platinum/ Iridium | Platinum/ Iridium | Same |
| Catheter
Packaging | Tyvek/Nylon Pouch,
polyethylene support
tube, packaging card,
SBS carton | Tyvek/Nylon Pouch,
polyethylene support
tube, packaging card,
SBS carton | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Same |
| Working Lengths | 115, 125, 132 cm | 115, 120, 125, 127,
132 cm | Same as 071
Zenith Flex |
| Inside Diameter
(ID) | 0.071 in | 0.068 in min. | 0.074 in |
| | Predicate Device
InNeuroCo, Inc.
071 Zenith Flex | Reference Device
Penumbra Ace 68 | Subject Device
InNeuroCo, Inc.
074 Zenith Flex |
| Proximal Outer
Diameter | 0.085 in max | 0.084 in max | 0.089 in max |
| Distal Outer
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
catheter tip introduction
into hemostasis valve
Scout to help with the
navigation | Included as part of
the Separator with a
torque device | Same as 071
Zenith Flex |
| Hemostasis Valve | Polycarbonate, Silicone
O-Ring, Side Port | Polycarbonate,
Silicone O-Ring, Side
Port | Same |
| Luer Tapered Hub | Yes | Yes | Same |
| Compatible
Guidewire | 0.038 inches | 0.038 inches | Same |
| Scout Introducer | Yes | No | Same as 071
Zenith Flex |
| Aspiration Method | Pump | Pump | Same |
| Aspiration
Pressure | 22-28 in Hg | 20-29 in Hg | Same as 071
Zenith Flex |
Comparison to Predicate Device
6
7
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.
8
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
Summary | Acceptance Criteria | Conclusions |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Zenith Flex Catheter
& its accessories
Biocompatibility-
Material Mediated
Pyrogen | Testing completed per
ISO 10993-11 | The test article extracts must
not cause a febrile reaction
greater than 0.5°C in any
individual subject. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject Zenith
Flex Catheter as the materials
and manufacturing processes
are equivalent. Test articles met
the acceptance criteria. |
| Zenith Flex Catheter
& its accessories
Biocompatibility-
Cytotoxicity MEM
Elution | Testing completed per
ISO 10993-5 | The cultures treated with the
test article must not have a
reactivity grade greater than
2. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject Zenith
Flex Catheter as the materials
and manufacturing processes
are equivalent. Test articles met
the acceptance criteria. |
| Zenith Flex Catheter & its
accessories
Biocompatibility- Hemolysis
ASTM Method, extract
human blood | Testing completed per
ISO 10993-4 | The hemolytic index
above the negative control
article must be less than
5%. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Zenith Flex Catheter &
its accessories
Biocompatibility-
Hemolysis, ASTM | Testing completed per
ISO 10993-4 | The hemolytic index
above the negative control
article must be less than
5%. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Zenith Flex Catheter &
its accessories
Biocompatibility-
Unactivated Partial
Thromboplastin Time | Testing completed per
ISO 10993-4 | There must be no
statistical decrease
between the UPTT of
plasma exposed to the
test article and to the
negative or untreated
control. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Zenith Flex Catheter &
its accessories
Biocompatibility-
Complement Activation | Testing completed per
ISO 10993-4 | There must be no
statistical increase
between either the C3a or
SC5b-9 concentrations in
plasma exposed to the
test article as compared to
the negative and
untreated controls | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Zenith Flex Catheter &
its accessories
Biocompatibility-Dog
Thromboresistance | Testing completed per
ISO 10993-4 | The test articles must
receive a thrombus
formation score less than
or equal to that of the
control. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Zenith Flex Catheter &
its accessories
Biocompatibility-
Maximization
Sensitization | Testing completed per
ISO 10993-10 | The test article must elicit
a positive response in less
than 10% of the test
animals. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Zenith Flex Catheter &
its accessories
Biocompatibility-
Intracutaneous
Toxicity/Reactivity | Testing completed per
ISO 10993-10 | The test article extracts
must not induce a
significantly greater
biological reaction than
the control. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Zenith Flex Catheter &
its accessories
Biocompatibility-Acute
Systemic Toxicity Test | Testing completed per
ISO 10993-11 | The test article extracts
must not induce a
significantly greater
biological reaction than
the control. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Chemical Compatibility
(Zenith Flex Catheter) | Catheter exposed to
chemicals readily
available in a clinical
setting. | Product shall withstand
exposure to chemicals
without degradation. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Working Length
(Zenith Flex Catheter) | Testing completed per
ISO 10555-1 | Test samples should be
within existing working
length specification. | Zenith Flex Catheter test
samples met the acceptance
criteria for Working Length to
demonstrate that the Zenith
Flex Catheter is substantially
equivalent to the predicate
device. |
| Hub compatibility
(Zenith Flex Catheter) | Testing completed per
ISO 594-1 and ISO
594-2 | Hub shall meet existing
Luer specifications. | Test results for the Zenith
Catheter (K171672) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance
criteria. |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Outside diameter
(Zenith Flex
Catheter) | Testing completed per
ISO 10555-1 | Test samples should be
within existing outside
diameter specification. | Zenith Flex Catheter test
samples met the acceptance
criteria for Outside diameter to
demonstrate that the Zenith
Flex Catheter is substantially
equivalent to the predicate
device. |
| Leak - Air
(Zenith Flex Catheter) | Testing completed per
ISO 10555-1 | Test samples should be
within existing Air - Leak
specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for Leak - Air to
demonstrate that the Zenith
Flex Catheteris substantially
equivalent to the predicate
device. |
| Leak - Liquid
(Zenith Flex Catheter) | Testing completed per
ISO 10555-1 | Test samples should be
within existing Leak -
Liquid specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for Leak – Liquid to
demonstrate that the Zenith
Flex Catheter is substantially
equivalent to the predicate
device. |
| Particulates
(Zenith Flex Catheter) | Samples conditioned in
benchtop anatomical
model.
Testing completed per
USP 788 | Test samples should be
within existing Particulate
specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent. Test
articles met the acceptance |
| Simulated Use - Bench
(Zenith Flex Catheter) | Zenith Flex underwent
simulated use testing by
a physician in a
benchtop model | Test samples must meet
predetermined user needs | Zenith Flex Catheter test
samples met the acceptance
criteria for Simulated Use
- Bench to demonstrate that
the Zenith Flex Catheter is
substantially equivalent to the
predicate device. |
| Catheter Burst
(Zenith Flex Catheter) | Testing completed per
ISO 10555-1 | Test sample burst
pressures must meet or
exceed existing minimum
burst pressure
specification. | Zenith Flex Catheter test
samples met the acceptance
criteria for Catheter Burst to
demonstrate that the Zenith
Flex Catheter is substantially
equivalent to the predicate
device. |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Tensile
(Zenith Flex Catheter) | Testing completed per
ISO 10555-1 | Test sample ultimate
tensile strength must meet
or exceed existing tensile
strength specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for Tensile to
demonstrate that the Zenith
Flex Catheter is substantially
equivalent to the predicate
device. |
| Corrosion
(Zenith Flex Catheter) | Testing completed per
ISO 10555-1 | Test samples shall exhibit
no evidence of corrosion. | Test results for the
Intermediate Catheter
(K152202) were leveraged for
the subject Zenith Flex
Catheter as the materials and
manufacturing processes are
equivalent. Test articles met
the acceptance criteria. |
| PTFE Liner inspection
(Zenith Flex Catheter) | Zenith Flex was
challenged to
demonstrate liner
adherence. | Test sample liner
adhesion must meet or
exceed existing PTFE
Liner inspection
specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for PTFE Liner
inspection to demonstrate that
the Zenith Flex Catheter is
substantially equivalent to the
predicate device. |
| Hydrophilic Coating
Integrity
(Zenith Flex Catheter) | Conditioned samples
were repeatedly exposed
to friction and introduced
into an anatomical model
to demonstrate that the
hydrophilic coating is not
affected. | Test sample results must
meet or exceed existing
Hydrophilic Coating
Integrity specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent.
Test articles met the
acceptance criteria. |
| Simulated Use Testing
(Zenith Flex System) | Using a simulated model,
the samples retrieved
thrombi with an
aspiration pump | Successfully removed the
thrombi | Zenith Flex System test
samples met the acceptance
criteria for Aspiration to
demonstrate that the Zenith
Flex System is substantially
equivalent to the predicate
device |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Labeling Legibility | Label is legible after
printing. | Test samples shall
demonstrate text legibility. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
materials and manufacturing
processes are equivalent.
Test articles met the
acceptance criteria. |
| Barcode | Barcode is readable with
a standard barcode
reader. | Test samples shall
demonstrate readily
readable barcodes | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex as the materials
and manufacturing processes
are equivalent. Test articles
met the acceptance criteria. |
| Sterilization
(Zenith Flex Catheter &
Aspiration Tubing Set) | ISO 11135 and
AAMI TIR 28 | Sterilization load shall
pose an equal or lesser
challenge to sterilize than
existing sterile product
loads. | Sterilization loads met the
acceptance criteria for
sterilization to demonstrate
that the Zenith Flex and the
Aspiration Tubing Set is
substantially equivalent to the
predicate device. |
| Shelf Life
(Zenith Flex Catheter &
Aspiration Tubing Set) | ASTM F1980 | Aged test samples must
meet or exceed existing
specifications | Zenith Flex Catheter &
Aspiration Tubing Set test
samples met the acceptance
criteria for shelf life to
demonstrate that the Zenith
Flex Catheter & Aspiration
Tubing Set are substantially
equivalent to the predicate
device. |
| Toque Strength
(Zenith Flex Catheter) | Samples were placed in
anatomical model and
torqued until failure | Test sample results must
meet or exceed existing
torque specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for torque to
demonstrate that the subject
Zenith Flex Catheter is
substantially equivalent to the
predicate device |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Kink Resistance
(Zenith Flex Catheter) | Reduction in flow was
evaluated while samples
were exposed to
appropriate tortuosity | Test sample results must
meet or exceed existing
kink resistance
specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for kink resistance to
demonstrate that the subject
Zenith Flex Catheter is
substantially equivalent to the
predicate device |
| Lumen Patency
(Zenith Flex Catheter) | Samples were placed in
benchtop anatomical
model and evaluated for
lumen collapse during
aspiration | Test sample results must
meet or exceed existing
lumen patency
specifications. | Zenith Flex Catheter test
samples met the acceptance
criteria for lumen patency to
demonstrate that the subject
Zenith Flex Catheter is
substantially equivalent to the
predicate device |
| Tip Flexibility
(Zenith Flex Catheter) | Samples were deflected,
and associated forces
were measured | Zenith Flex tip flexibility
results were compared to
predicate device results. | Zenith Flex Catheter test
samples performed
comparatively against the
predicate device
demonstrating that the subject
Zenith Flex Catheter is
substantially equivalent to the
predicate device |
| Friction Force
(Zenith Flex Catheter) | Samples were tracked
through benchtop
anatomical model and
frictional forces were
measured | Zenith Flex friction force
results were compared to
predicate device results. | Zenith Flex Catheter test
samples performed
comparatively against the
predicate device
demonstrating that the subject
Zenith Flex Catheter is
substantially equivalent to the
predicate device |
| Simulated Use Testing - Usability
(Zenith Flex System) | Zenith Flex underwent
simulated use testing by a
physician in a benchtop
model | Test samples must meet
predetermined user needs | Zenith Flex System test
samples met the acceptance
criteria for Simulated Use - Usability to demonstrate that
the Zenith Flex System is
substantially equivalent to the
predicate device. |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Visual Inspection (Aspiration
Tubing Set) | Finished Devices were
inspected for damage
visually | Test samples should meet
visual inspection
specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Tensile
(Aspiration Tubing Set) | Finished devices were
elongated until failure | Test sample ultimate
tensile strength must meet
or exceed existing tensile
strength specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Leak - Liquid
(Aspiration Tubing
Set) | Tubing pressurized with
fluid and inspected for leak | Test samples should be
within existing Leak -
Liquid specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Leak - Air, Tubing and
Control Switch
(Aspiration Tubing Set) | Tubing samples evaluated
for air leak during
aspiration | Test samples should be
within existing Air - Leak
specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Luer Compatibility
(Aspiration Tubing Set) | Testing completed per ISO
80369-7 | Hub shall meet existing
Luer specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Suction Connector
Separation Force (Aspiration
Tubing Set) | Force to separate suction
connector from cannister
was evaluated using force
gauge | Test sample results must
meet or exceed existing
force specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Vacuum Drop / Suction
Connector Secure
Attachment
Aspiration Tubing Set) | Vacuum pressure
measured at source and
tip to evaluate pressure
difference | Test sample results must
meet or exceed existing
pressure specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Lumen Patency
(Aspiration Tubing Set) | Samples were evaluated
for lumen collapse during
aspiration | Test sample results must
meet or exceed existing
lumen patency
specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Dimensions
(Aspiration Tubing Set) | Critical dimensions were
measured. | Test samples should be
within existing dimensional
specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Packaging - Dye Leak
(Zenith Flex Catheter and
Aspiration Tubing Set) | Testing completed per
ASTM F1929-12 | Test sample shall not
exhibit any visual leaks or
channels | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
packaging is the same. Test
articles met the acceptance
criteria. |
| Test | Test Method
Summary | Acceptance Criteria | Conclusions |
| Packaging - Peel
(Zenith Flex Catheter and
Aspiration Tubing Set) | Testing completed per
ASTM F88-09 | Test sample tensile
strength must meet or
exceed existing tensile
strength specifications. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
packaging is the same. Test
articles met the acceptance
criteria. |
| Aspiration Tubing Set
Biocompatibility-
Cytotoxicity MEM Elution | Testing completed per ISO
10993-5 | The cultures treated with
the test article must not
have a reactivity grade
greater than 2. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Aspiration Tubing Set
Biocompatibility-
Maximization Sensitization | Testing completed per ISO
10993-10 | The test article must elicit
a positive response in less
than 10% of the test
animals. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
| Aspiration Tubing Set
Biocompatibility-
Intracutaneous
Toxicity/Reactivity | Testing completed per ISO
10993-10 | The test article extracts
must not induce a
significantly greater
biological reaction than
the control. | Test results for the Zenith Flex
Catheter (K172167) were
leveraged for the subject
Zenith Flex Catheter as the
aspiration tubing is the same.
Test articles met the
acceptance criteria. |
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Performance Data - Clinical
No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the Reference Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use under the NRY product code by leveraging clinical outcomes from devices that are considered technologically similar.
Summary of Substantial Equivalence
The performance characteristics and the test results demonstrate that the 074 Zenith Flex Catheter meets the acceptance criteria to determine that the 074 Zenith Flex Catheter is substantially equivalent to the predicate device. Furthermore, the intended use, the operating principles, the design, materials and the results of biocompatibility testing, shelf-life, packaging and sterilization processes are all equivalent and support the all devices are
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technologically similar. Lastly, the review of published clinical data also supports the use of the 074 Zenith Flex Catheter under the NRY product code based on the similar technological characteristics to devices currently available.