(275 days)
Penumbra System ACE 68 Reperfusion Catheter K161064
No
The summary describes a mechanical aspiration system for treating stroke and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "revascularization of patients with acute secondary to intracranial large vessel occlusive disease," which is a treatment for a medical condition.
No
The device is described as a system for revascularization, which is a treatment (therapeutic) procedure, not a diagnostic one. It is used to remove occlusions, not to detect or analyze disease states.
No
The device description clearly outlines physical components like catheters, pumps, and tubing, indicating it is a hardware-based system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Zenith Flex System is used for the "revascularization of patients with acute secondary to intracranial large vessel occlusive disease". This is a therapeutic procedure performed directly on the patient to treat a medical condition.
- Device Description: The device description details a catheter, aspiration pump, and tubing set designed for physically removing blood clots from blood vessels. This is a medical device used for intervention, not for testing samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests.
The Zenith Flex System is a therapeutic medical device used for a procedure to treat a specific condition within the body.
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
NRY, DTL, DYB
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.
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 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.
Non-Clinical Data Summary:
Biocompatibility tests were conducted for the Zenith Flex Catheter and its accessories (ISO 10993-1 guidelines) and the Aspiration Tubing Set (ISO 10993-1 guidelines).
Physical, mechanical, and performance testing demonstrated that the Zenith Flex System is Substantially Equivalent to the legally marketed predicate device.
Various performance tests were conducted on the Zenith Flex Catheter and Aspiration Tubing Set, including Biocompatibility (Material Mediated Pyrogen, Cytotoxicity MEM Elution, Hemolysis ASTM Method (extract human blood), Hemolysis ASTM, Unactivated Partial Thromboplastin Time, Complement Activation, Dog Thromboresistance, Maximization Sensitization, Intracutaneous Toxicity/Reactivity, Acute Systemic Toxicity Test), Chemical Compatibility, Radiographic Detectability, Visual Inspection, Working Length, Hub compatibility, Outside diameter, Leak - Air, Leak - Liquid, Particulates, Simulated Use - Bench, Catheter Burst, Tensile, Corrosion, Packaging - Dye Leak, Packaging - Peel, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Aspiration, Labeling Legibility, Barcode, Sterilization, Shelf Life, Toque Strength, Lumen Patency, Tip Flexibility, Friction Force, Simulated Use Testing - Usability, Suction Connector Separation Force, Vacuum Drop / Suction Connector Secure Attachment, Dimensions.
All tests met their respective acceptance criteria, demonstrating substantial equivalence to the predicate device.
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 article Device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the proposed indications for use by leveraging clinical outcomes from devices that are considered technologically similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Penumbra System ACE 68 Reperfusion Catheter K161064
Reference Device(s)
Intermediate Catheter (K152202)
Zenith (K171672)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | ||
| 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
Penumbra Ace 68 | InNeuroCo, Inc.
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
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. | 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. |
| Components Supplied | Penumbra Reperfusion Catheter,
Aspiration Pump, Pump/Canister
Tubing, Aspiration Tubing,
Separator | Zenith Flex Catheter, Peel Away
Introducer, Hemostasis Valve,
Scout Introducer, VC-701 Cliq
Aspirator Pump, Aspiration
Tubing Set |
| | Predicate Device Penumbra Ace 68 | InNeuroCo, Inc.
Zenith Flex System
(Zenith Flex Catheter) |
| Catheter Shaft Material | Pebax, Nylon, Urethane | Polyether Block Amide
(PEBAX),
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
support tube, packaging card, SBS
carton | Tyvek/Nylon Pouch,
polyethylene support tube,
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
Separator with a torque device | Peelaway to aid in catheter tip
introduction into hemostasis
valve Scout to help with the
navigation |
| Hemostasis Valve | Polycarbonate, Silicone O-Ring, Side
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
Penumbra Aspiration Tubing | InNeuroCo, Inc.
Zenith Flex System
(Aspiration Tubing Set) |
| Components Supplied | Tubing, Flow Control Switch, Luer
Fittings, Vacuum connector | SAME |
| Control Switch identifies
ON/OFF | Yes | SAME |
| Materials | Biocompatible, commonly utilized
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
Penumbra Ace 68 | InNeuroCo, Inc.
Zenith Flex System
(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
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
pump can operate while
producing pressures that are
clinically significant | After 4 hours of continuous use,
measured pressures ranges are
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 (