(275 days)
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.
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.
This document is a 510(k) summary for the Zenith Flex System, a medical device for revascularization in acute ischemic stroke. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and animal) testing rather than clinical study. Thus, it does not describe a study involving an AI component or complex ground truth establishment for diagnostic output.
Here's an analysis based on the provided text, addressing your points where information is available:
1. A table of Acceptance Criteria and Reported Device Performance
The document provides extensive tables summarizing non-clinical testing. Here's a consolidated and simplified version of the information, focusing on the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Pyrogenicity | Test article extracts must not cause a febrile reaction > 0.5°C in any individual subject. | Met acceptance criteria. (Leveraged from K171672, as materials/manufacturing are equivalent). |
| Cytotoxicity (MEM Elution) | Cultures treated with the test article must not have a reactivity grade > 2. | Met acceptance criteria. (Leveraged from K171672 for Catheter, and directly tested for Aspiration Tubing Set). |
| Hemolysis | Hemolytic index above negative control article must be < 5%. | Met acceptance criteria. (Leveraged from K171672). |
| Unactivated Partial | No statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control. | Met acceptance criteria. (Leveraged from K171672). |
| Thromboplastin Time (UPTT) | ||
| Complement Activation | No statistical increase between C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to negative and untreated controls. | Met acceptance criteria. (Leveraged from K171672). |
| Thromboresistance | Test articles must receive a thrombus formation score less than or equal to that of the control. | Met acceptance criteria. (Leveraged from K171672). |
| Maximization Sensitization | Test article must elicit a positive response in < 10% of the test animals. | Met acceptance criteria. (Leveraged from K171672 for Catheter, and directly tested for Aspiration Tubing Set). |
| Intracutaneous Toxicity | Test article extracts must not induce a significantly greater biological reaction than the control. | Met acceptance criteria. (Leveraged from K171672 for Catheter, and directly tested for Aspiration Tubing Set). |
| Acute Systemic Toxicity | Test article extracts must not induce a significantly greater biological reaction than the control. | Met acceptance criteria. (Leveraged from K171672). |
| Physical/Mechanical Performance (Zenith Flex Catheter) | ||
| Chemical Compatibility | Product shall withstand exposure to chemicals without degradation. | Met acceptance criteria. |
| Radiographic Detectability | Product shall be visible under fluoro imaging. | Met acceptance criteria. |
| Visual Inspection | Test samples should meet visual inspection specifications. | Met acceptance criteria. |
| Working Length | Test samples should be within existing working length specification. | Met acceptance criteria. |
| Hub Compatibility | Hub shall meet existing Luer specifications. | Met acceptance criteria. (Leveraged from K171672). |
| Outside Diameter | Test samples should be within existing outside diameter specification. | Met acceptance criteria. |
| Leak - Air | Test samples should be within existing Air - Leak specifications. | Met acceptance criteria. |
| Leak - Liquid | Test samples should be within existing Leak - Liquid specifications. | Met acceptance criteria. |
| Particulates | Test samples should be within existing Particulate specifications. | Met acceptance criteria. |
| Simulated Use - Bench | Test samples must meet predetermined user needs. | Met acceptance criteria. |
| Catheter Burst | Test sample burst pressures must meet or exceed existing minimum burst pressure specification. | Met acceptance criteria. |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Met acceptance criteria. |
| Corrosion | Test samples shall exhibit no evidence of corrosion. | Met acceptance criteria. (Leveraged from K152202). |
| Packaging - Dye Leak | Test sample shall not exhibit any visual leaks or channels. | Met acceptance criteria. (Leveraged from K171672 for Catheter, and directly tested for Catheter and Aspiration Tubing Set). |
| Packaging - Peel | Test sample tensile strength must meet or exceed existing tensile strength specifications. | Met acceptance criteria. (Leveraged from K171672 for Catheter, and directly tested for Catheter and Aspiration Tubing Set). |
| Kink Resistance | Test sample kink resistance must meet or exceed existing Kink Resistance specifications. | Met acceptance criteria. |
| Torque | Test sample torque results must meet or exceed existing torque specifications. | Met acceptance criteria. |
| PTFE Liner Inspection | Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications. | Met acceptance criteria. |
| Hydrophilic Coating | Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. | Met acceptance criteria. |
| Integrity | ||
| Lumen Patency | Test sample results must meet or exceed existing lumen patency specifications. | Met acceptance criteria. |
| Tip Flexibility | Zenith Flex tip flexibility results were compared to predicate device results. | Performed comparatively against the predicate device. |
| Friction Force | Zenith Flex friction force results were compared to predicate device results. | Performed comparatively against the predicate device. |
| System Performance (Zenith Flex System) | ||
| Aspiration | Successfully removed the thrombi. | Met acceptance criteria. |
| Simulated Use - Usability | Test samples must meet predetermined user needs. | Met acceptance criteria. |
| Sterilization | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | Met acceptance criteria. |
| Shelf Life | Aged test samples must meet or exceed existing specifications. | Met acceptance criteria. |
| Aspiration Tubing Set Specific | ||
| Visual Inspection | Test samples should meet visual inspection specifications. | Met acceptance criteria. |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Met acceptance criteria. |
| Leak - Liquid | Test samples should be within existing Leak - Liquid specifications. | Met acceptance criteria. |
| Leak - Air (Tubing & Control Switch) | Test samples should be within existing Air - Leak specifications. | Met acceptance criteria. |
| Luer Compatibility | Hub shall meet existing Luer specifications. | Met acceptance criteria. |
| Suction Connector | Test sample results must meet or exceed existing force specifications. | Met acceptance criteria. |
| Separation Force | ||
| Vacuum Drop / Suction | Test sample results must meet or exceed existing pressure specifications. | Met acceptance criteria. |
| Connector Secure Attachment | ||
| Lumen Patency | Test sample results must meet or exceed existing lumen patency specifications. | Met acceptance criteria. |
| Dimensions | Test samples should be within existing dimensional specifications. | Met acceptance criteria. |
| Labeling | ||
| Labeling Legibility | Test samples shall demonstrate text legibility. | Met acceptance criteria. (Leveraged from K171672). |
| Barcode | Test samples shall demonstrate readily readable barcodes. | Met acceptance criteria. (Leveraged from K171672). |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not explicitly state numerical sample sizes for each non-clinical test (e.g., "N=X catheters were tested"). It refers to "test samples" for bench testing and describes animal testing involving "several arteries of swine." For some tests, it states that results were "leveraged" from a previous submission (K171672 or K152202), implying a previous sample size was deemed sufficient for those components/materials.
- Data Provenance: The data is primarily from non-clinical (bench and animal) testing.
- Animal Testing: Performed on "swine." There's no indication of country of origin for the animal study, but given the FDA submission, it's presumed to be from a facility following GLP (Good Laboratory Practices). The study was prospective in nature for this device.
- Bench Testing: Performed in a lab setting. No country of origin is specified, but again, standard practice for FDA submissions implies testing in a controlled environment.
- Leveraged Data: Some results are leveraged from previous 510(k) submissions (K171672 for Zenith Catheter, and K152202 for Corrosion, for an "Intermediate Catheter"). This suggests the data was generated at an earlier time for similar or identical components/processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of "experts" in the context of establishing ground truth for a test set in the way one would for an AI/diagnostic device. The "ground truth" here is based on:
- Standardized Test Methods: Adherence to ISO, ASTM, and USP standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F1929-12, USP 788, etc.). These methods define the criteria and procedures for measuring various physical, chemical, and biological properties.
- Animal Model Outcomes: In the animal study, effectiveness was assessed via "angiographic assessment of revascularization" and safety via "angiographic assessment and histopathological assessment." These assessments would be performed by qualified veterinary or medical professionals (e.g., veterinarians, pathologists), but their specific number or qualifications are not provided here.
- Physician Feedback: For "Simulated Use - Bench" and "Simulated Use - Usability" tests, it states "simulated use testing by a physician in a benchtop model." The number and specific qualifications of these physicians are not detailed.
4. Adjudication Method for the Test Set
Not applicable in the context of this submission. Adjudication typically applies to human interpretation of diagnostic data, which is not the primary focus here. The assessment of non-clinical tests relies on quantitative measurements against pre-defined acceptance criteria, or expert observation (e.g., pathologist reading histology slides), but not formal adjudication of conflicting expert opinions for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic imaging, which is not relevant for this device. The submission explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device, the Zenith Flex System (catheter, aspiration tubing, pump), is a physical medical device, not a software algorithm or AI tool. Therefore, "standalone" performance in the sense of an algorithm operating independently is not applicable. Its performance is measured through its physical and functional properties, and its interaction with biological systems (in the animal model).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Quantitative Measurements: Direct measurements of physical properties against engineering specifications (e.g., diameter, length, tensile strength, burst pressure, leak rates).
- Biocompatibility Standards: Adherence to ISO 10993 guidelines, which define acceptable biological responses.
- Angiographic and Histopathological Assessment: For the animal study, the "effectiveness" (revascularization) and "safety" (tissue response, thrombus formation) endpoints were evaluated using these clinical and pathological methods. This is the closest to "outcomes data" or "pathology" in your list.
- Physician Feedback: For simulated use, "predetermined user needs" served as the criteria.
8. The Sample Size for the Training Set
Not applicable. This is a traditional medical device (catheter system), not an AI/machine learning device. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
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 68Reperfusion 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 DevicePenumbra 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 intendedfor use in the revascularization ofpatients with acute ischemic strokesecondary to intracranial largevessel occlusive disease (within theinternal carotid, middle cerebral- M1 and M2 segments, basilar,and vertebral arteries) within 8hours of symptom onset. | The Zenith Flex System, includingthe Zenith Flex Catheter, AspirationTubing Set, and VC-701 CliqAspirator Pump, is indicated in therevascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who failed IV t-PA therapy are candidatesfor treatment. |
| Components Supplied | Penumbra Reperfusion Catheter,Aspiration Pump, Pump/CanisterTubing, Aspiration Tubing,Separator | Zenith Flex Catheter, Peel AwayIntroducer, Hemostasis Valve,Scout Introducer, VC-701 CliqAspirator Pump, AspirationTubing 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, polyethylenesupport tube, packaging card, SBScarton | 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 theSeparator with a torque device | Peelaway to aid in catheter tipintroduction into hemostasisvalve Scout to help with thenavigation |
| Hemostasis Valve | Polycarbonate, Silicone O-Ring, SidePort | 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 DevicePenumbra Aspiration Tubing | InNeuroCo, Inc.Zenith Flex System(Aspiration Tubing Set) | |
| Components Supplied | Tubing, Flow Control Switch, LuerFittings, Vacuum connector | SAME |
| Control Switch identifiesON/OFF | Yes | SAME |
| Materials | Biocompatible, commonly utilizedfor 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 DevicePenumbra 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 asystem | 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 thepump can operate whileproducing pressures that areclinically significant | After 4 hours of continuous use,measured pressures ranges areretained | SAME |
| Insulated handle | Yes | SAME |
| Pressure gage range | 0-760 mm Hg | SAME |
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Summary of Non-Clinical Data
Biocompatibility tests conducted with the Zenith Flex Catheter and its accessories were selected in accordance with ISO 10993-1 quidelines (Biological Evaluation of Medical Devices) for limited duration (< 24 hours), external communicating devices, contacting circulating blood. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Zenith Flex Catheter to be biocompatible and non-pyrogenic.
Biocompatibility tests conducted with the Aspiration Tubing Set were selected in accordance with ISO 10993-1 quidelines (Biological Evaluation of Medical Devices) for a surface device in contact with intact skin for limited (< 24 hours) duration. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Aspiration Tubing Set to be biocompatible.
The conclusions drawn from the physical, mechanical, and performance testing of the subject Zenith Flex System demonstrates that the product is Substantially Equivalent to the legally marketed predicate device.
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Animal Testing
Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the Zenith Flex Catheter and the contralateral side was treated with predicate device. The study included two follow up evaluations: 3 days and 30 days. There were 3 endpoints of the study: angiographic assessment of revascularization to establish effectiveness, angiographic assessment and histopathological assessment to demonstrate safety. As testing included the predicate device, results were compared to demonstrate substantial equivalence.
Zenith Flex Performance Testing
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
|---|---|---|---|
| Zenith Flex Catheter& its accessoriesBiocompatibility-Material MediatedPyrogen | Testing completed perISO 10993-11 | The test article extracts mustnot cause a febrile reactiongreater than 0.5°C in anyindividual subject. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles met theacceptance criteria. |
| Zenith Flex Catheter& its accessoriesBiocompatibility-Cytotoxicity MEMElution | Testing completed perISO 10993-5 | The cultures treated with thetest article must not have areactivity grade greater than2. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles met theacceptance criteria. |
| Zenith Flex Catheter & itsaccessoriesBiocompatibility- HemolysisASTM Method, extracthuman blood | Testing completed perISO 10993-4 | The hemolytic indexabove the negative controlarticle must be less than5%. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Zenith Flex Catheter &its accessoriesBiocompatibility-Hemolysis, ASTM | Testing completed perISO 10993-4 | The hemolytic indexabove the negative controlarticle must be less than5%. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
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| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
|---|---|---|---|
| Zenith Flex Catheter & itsaccessoriesBiocompatibility-Unactivated PartialThromboplastin Time | Testing completed perISO 10993-4 | There must be nostatistical decreasebetween the UPTT ofplasma exposed to the testarticle and to the negativeor untreated control. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Zenith FlexCatheter & itsaccessoriesBiocompatibility-ComplementActivation | Testing completed perISO 10993-4 | There must be no statisticalincrease between either theC3a or SC5b-9concentrations in plasmaexposed to the test article ascompared to the negative anduntreated controls. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Zenith Flex Catheter &its accessoriesBiocompatibility-DogThromboresistance | Testing completed perISO 10993-4 | The test articles must receivea thrombus formation scoreless than or equal to that ofthe control. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Zenith Flex Catheter & itsaccessoriesBiocompatibility-Maximization Sensitization | Testing completed perISO 10993-10 | The test article must elicit apositive response in less than10% of the test animals. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheteras the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Zenith Flex Catheter& its accessoriesBiocompatibility-IntracutaneousToxicity/Reactivity | Testing completed perISO 10993-10 | The test article extractsmust not induce asignificantly greaterbiological reaction than thecontrol. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Zenith Flex Catheter & itsaccessoriesBiocompatibility-AcuteSystemic Toxicity Test | Testing completed perISO 10993-11 | The test article extractsmust not induce asignificantly greaterbiological reaction than thecontrol. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Chemical Compatibility(Zenith Flex Catheter) | Catheter exposed tochemicals readilyavailable in a clinicalsetting. | Productshallwithstandexposuretochemicalswithout degradation. | Zenith Flex Catheter testsamples met the acceptancecriteria for ChemicalCompatibility to demonstratethat the Zenith Flex Catheter issubstantially equivalent to thepredicate device. |
| RadiographicDetectability(Zenith FlexCatheter) | Testing completed perISO 10555-1 | Product shall be visibleunder fluoro imaging. | Zenith Flex Catheter testsamples met the acceptancecriteria for RadiographicDetectability to demonstratethat the Zenith Flex Catheter issubstantially equivalent to thepredicate device. |
| Visual Inspection(Zenith FlexCatheter) | Testing completed perISO 10555-1 | Test samples should meetvisual inspectionspecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Visual Inspection todemonstrate that the ZenithFlex is substantially equivalentto the predicate device. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Working Length(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test samples should bewithin existing workinglength specification. | Zenith Flex Catheter testsamples met the acceptancecriteria for Working Length todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Hub compatibility(Zenith Flex Catheter) | Testing completed perISO 594-1 and ISO594-2 | Hub shall meet existingLuer specifications. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles met theacceptance criteria. |
| Outside diameter(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test samples should bewithin existing outsidediameter specification. | Zenith Flex Catheter testsamples met the acceptancecriteria for Outside diameter todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Leak - Air(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test samples should bewithin existing Air - Leakspecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Leak - Air todemonstrate that the ZenithFlex Catheter issubstantially equivalent tothe predicate device. |
| Leak - Liquid(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test samples should bewithin existing Leak - Liquidspecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Leak – Liquid todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Particulates(Zenith Flex Catheter) | Samples conditioned inbenchtop anatomicalmodel.Testing completed perUSP 788 | Test samples should be withinexisting Particulatespecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Particulates todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Simulated Use - Bench(Zenith Flex Catheter) | Zenith Flex underwentsimulated use testing bya physician in abenchtop model | Test samples must meetpredetermined user needs | Zenith Flex Catheter testsamples met the acceptancecriteria for Simulated Use- Bench to demonstrate thatthe Zenith Flex Catheter issubstantially equivalent to thepredicate device. |
| Catheter Burst(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test sample burst pressuresmust meet or exceed existingminimum burst pressurespecification. | Zenith Flex Catheter testsamples met the acceptancecriteria for Catheter Burst todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Tensile(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test sample ultimate tensilestrength must meet orexceed existing tensilestrength specifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Tensile todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Corrosion(Zenith Flex Catheter) | Testing completed perISO 10555-1 | Test samples shall exhibitno evidence of corrosion. | Test results for the IntermediateCatheter (K152202) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles met theacceptance criteria. |
| Packaging - Dye Leak(Zenith Flex Catheter) | Testing completed perASTM F1929-12 | Test sample shall notexhibit any visual leaks orchannels | Test results for the Zenith(K171672) were leveraged forthe Zenith Flex Catheter asthe materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Packaging - Peel(Zenith Flex Catheter) | Testing completed perASTM F88-09 | Test sample tensilestrength must meet orexceed existing tensilestrength specifications. | Test results for the Zenith(K171672) were leveraged forthe Zenith Flex Catheter asthe materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Kink Resistance(Zenith Flex Catheter) | Samples are subjectedto different diametersuntil kink is observed. | Test sample kink resistancemust meet or exceedexisting Kink Resistancespecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Kink Resistance todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Torque(Zenith Flex Catheter) | Conditioned samples aretorqued to failure | Test sample torque resultsmust meet or exceedexisting torquespecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Torque todemonstrate that the ZenithFlex Catheter issubstantiallyequivalent to the predicatedevice. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| PTFE Liner inspection(Zenith Flex Catheter) | Zenith Flex waschallenged todemonstrate lineradherence. | Test sample liner adhesionmust meet or exceedexisting PTFE Linerinspection specifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for PTFE Linerinspection to demonstrate thatthe Zenith Flex Catheter issubstantially equivalent to thepredicate device. |
| Hydrophilic CoatingIntegrity(Zenith Flex Catheter) | Conditioned sampleswere repeatedly exposedto friction and introducedinto an anatomical modelto demonstrate that thehydrophilic coating is notaffected. | Test sample results mustmeet or exceed existingHydrophilic Coating Integrityspecifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for Hydrophilic CoatingIntegrity to demonstrate thatthe Zenith Flex Catheter issubstantially equivalent to thepredicate device. |
| Aspiration(Zenith Flex System) | Using a simulatedmodel, the samplesretrieved thrombi withan aspiration pump | Successfully removed thethrombi | Zenith Flex System testsamples met the acceptancecriteria for Aspiration todemonstrate that the ZenithFlex System is substantiallyequivalent to the predicatedevice |
| Labeling Legibility | Label is legible afterprinting. | Test samples shalldemonstrate textlegibility. | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith FlexCatheter as the materials andmanufacturing processes areequivalent. Test articles met theacceptance criteria. |
| Barcode | Barcode is readablewith a standard barcodereader. | Test samples shalldemonstrate readilyreadable barcodes | Test results for the ZenithCatheter (K171672) wereleveraged for the Zenith Flexas the materials andmanufacturing processes areequivalent. Test articles metthe acceptance criteria. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Sterilization(Zenith Flex Catheter &Aspiration Tubing Set) | ISO 11135 andAAMI TIR 28 | Sterilization load shall posean equal or lesser challengeto sterilize than existingsterile product loads. | Sterilization loads met theacceptance criteria forsterilization to demonstratethat the Zenith Flex and theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Shelf Life(Zenith Flex Catheter &Aspiration Tubing Set) | ASTM F1980 | Agedtest samples mustor exceed existingmeetspecifications | Zenith Flex Catheter &Aspiration Tubing Set testsamples met the acceptancecriteria for shelf life todemonstrate that the ZenithFlex Catheter & AspirationTubing Set are substantiallyequivalent to the predicatedevice. |
| Toque Strength(Zenith Flex Catheter) | Samples were placed inanatomical model andtorqued until failure | Test sample results mustmeet or exceed existingtorque specifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for torque todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Kink Resistance(Zenith Flex Catheter) | Reduction in flow wasevaluated while sampleswere exposed toappropriate tortuosity | Test sample results mustmeet or exceed existing kinkresistance specifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for kink resistance todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Lumen Patency(Zenith Flex Catheter) | Samples were placedin benchtopanatomical model andevaluated for lumencollapse duringaspiration | Test sample results mustmeet or exceed existinglumen patency specifications. | Zenith Flex Catheter testsamples met the acceptancecriteria for lumen patency todemonstrate that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Tip Flexibility(Zenith Flex Catheter) | Samples weredeflected, andassociated forceswere measured | Zenith Flex tip flexibility resultswere compared to predicatedevice results. | Zenith Flex Catheter testsamples performedcomparatively aqainst thepredicate devicedemonstrating that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Friction Force(Zenith Flex Catheter) | Samples were trackedthrough benchtopanatomical model andfrictional forces weremeasured | Zenith Flex friction forceresults were compared topredicate device results. | Zenith Flex Catheter testsamples performedcomparatively against thepredicate devicedemonstrating that the ZenithFlex Catheter is substantiallyequivalent to the predicatedevice. |
| Simulated Use Testing- Usability(Zenith Flex System) | Zenith Flex underwentsimulated use testing bya physician in abenchtop model | Test samples must meetpredetermined user needs | Zenith Flex System testsamples met the acceptancecriteria for Simulated Use- Usability to demonstrate thatthe Zenith Flex System issubstantially equivalent to thepredicate device. |
| Visual Inspection(Aspiration Tubing Set) | Finished Deviceswere inspected fordamage visually | Test samples should meetvisual inspectionspecifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for Visual Inspection todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Tensile(Aspiration Tubing Set) | Finished devices wereelongated until failure | Test sample ultimate tensilestrength must meet orexceed existing tensilestrength specifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for Tensile todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Leak – Liquid(Aspiration Tubing Set) | Tubing pressurizedwith fluid andinspected for leak | Test samples should bewithin existing Leak - Liquidspecifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for Leak - Liquid todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Leak – Air, Tubing andControl Switch(Aspiration Tubing Set) | Tubing samplesevaluated for air leakduring aspiration | Test samples should bewithin existing Air - Leakspecifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for Leak - Air todemonstrate that the AspirationTubing Set is substantiallyequivalent to the predicatedevice. |
| Luer Compatibility(Aspiration Tubing Set) | Testing completed perISO 80369-7 | Hub shall meet existingLuer specifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for Luer compatibility todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Suction ConnectorSeparation Force(Aspiration Tubing Set) | Force to separatesuction connector fromcannister wasevaluated using forcegauge | Test sample results mustmeet or exceed existing forcespecifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for separation force todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Vacuum Drop / SuctionConnector SecureAttachment(Aspiration Tubing Set) | Vacuum pressuremeasured at sourceand tip to evaluatepressure difference | Test sample results mustmeet or exceed existingpressure specifications. | Aspiration Tubing Set testsamples met theacceptance criteria forvacuum drop todemonstrate that theAspiration Tubing Set issubstantially equivalent tothe predicate device. |
| Test | Test MethodSummary | Acceptance Criteria | Conclusions |
| Lumen Patency(Aspiration Tubing Set) | Samples wereevaluated for lumencollapse duringaspiration | Test sample results mustmeet or exceed existinglumen patency specifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for lumen patency todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Dimensions(Aspiration Tubing Set) | Critical dimensionswere measured. | Test samples should bewithin existing dimensionalspecifications. | Aspiration Tubing Set testsamples met the acceptancecriteria for dimensions todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Packaging – Dye Leak(Zenith Flex Catheter andAspiration Tubing Set) | Testing completed perASTM F1929-12 | Test sample shall notexhibit any visual leaks orchannels | Zenith Flex Catheter andAspiration Tubing Set testsamples met the acceptancecriteria for Packaging - DyeLeak to demonstrate that theZenith Flex Catheter and theAspiration Tubing Set aresubstantially equivalent to thepredicate device |
| Packaging - Peel(Zenith Flex Catheter andAspiration Tubing Set) | Testing completed perASTM F88-09 | Test sample tensilestrength must meet orexceed existing tensilestrength specifications. | Zenith Flex Catheter andAspiration Tubing Set testsamples met the acceptancecriteria for Packaging - Peel todemonstrate that the ZenithFlex and the Aspiration TubingSet are substantially equivalentto the predicate device. |
| Test | TestMethod | Acceptance Criteria | Conclusions |
| Aspiration TubingSet Biocompatibility-Cytotoxicity MEMElution | Testingcompleted perISO 10993-5 | The cultures treated withthe test article must nothave a reactivity gradegreater than 2. | Aspiration Tubing Set Testarticles met the acceptancecriteria for Cytotoxicity todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
| Aspiration TubingSet Biocompatibility-MaximizationSensitization | Testingcompleted perISO 10993-10 | The test article must elicita positive response inless than 10% of the testanimals. | Aspiration Tubing Set Testarticles met the acceptancecriteria for MaximizationSensitization to demonstratethat the Aspiration Tubing Setis substantially equivalent tothe predicate device. |
| Aspiration Tubing SetBiocompatibility-IntracutaneousToxicity/Reactivity | Testingcompleted perISO 10993-10 | The test article extractsmust not induce asignificantly greaterbiological reaction than thecontrol. | Aspiration Tubing Set Testarticles met the acceptancecriteria for IntracutaneousToxicity/Reactivity todemonstrate that theAspiration Tubing Set issubstantially equivalent to thepredicate device. |
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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 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.
§ 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).