(53 days)
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.
This request concerns the InNeuroCo Zenith Support Catheter, a percutaneous catheter used for introducing interventional devices into the peripheral and neuro vasculature. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for novel device acceptance criteria.
The information primarily revolves around non-clinical data and justifications for not re-testing certain parameters due to the device's similarity to its predicate. Therefore, detailed information on ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available as this type of submission typically relies on a comparison to an already approved device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "SUMMARY OF NON-CLINICAL DATA" (page 8, "Table 1: Non-Clinical Testing Analysis") which serves this purpose. Many tests were not re-tested for the Zenith Support Catheter because no material changes were made from the predicate device (Zenith 074) and manufacturing processes were identical or within the predicate's tolerance.
| Test | Acceptance Criteria | Reported Device Performance (Analysis/Outcome) |
|---|---|---|
| Biocompatibility | No re-testing for Zenith Support Catheter: "There are no material changes from the predicate device. Manufacturing process is identical to the predicate. Only the segment lengths were changed and pitch adjustments were within the predicate device's tolerance." This applies to all biocompatibility tests below. | |
| - Material Mediated Pyrogen | The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject. | Not re-tested. |
| - Cytotoxicity MEM Elution | The cultures treated with the test article must not have a reactivity grade greater than 2. | Not re-tested. |
| - Hemolysis (ASTM Method, extract human blood) | The hemolytic index above the negative control article must be less than 5%. | Not re-tested. |
| - Hemolysis (ASTM method, direct contact human blood) | The hemolytic index above the negative control article must be less than 5%. | Not re-tested. |
| - Unactivated Partial Thromboplastin Time | There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control. | Not re-tested. |
| - Complement Activation | 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. | Not re-tested. |
| - Dog Thromboresistance | The test articles must receive a thrombus formation score less than or equal to that of the control. | Not re-tested. |
| - Maximization Sensitization | The test article must elicit a positive response in less than 10% of the test animals. | Not re-tested. |
| - Intracutaneous Toxicity/Reactivity | The test article extracts must not induce a significantly greater biological reaction than the control. | Not re-tested. |
| - Acute Systemic Toxicity Test | The test article extracts must not induce a significantly greater biological reaction than the control. | Not re-tested. |
| Animal Testing - Angiographic Evaluation | No units tested can cause vessel injury. | Not re-tested. "The tips, materials, and transitions are identical to the predicate, and the initial evaluation for the predicate included the use of the device without the Scout Introducer." |
| Chemical Compatibility | Chemicals have no negative effect on the catheter or accessories. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Radiographic Detectability | Product shall be visible under fluoro imaging. | Not re-tested. "The marker bands are identical to the predicate." |
| Visual Inspection | Catheter shall appear free from damage, including a rounded tip and smooth transition points. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Working Length | Test samples should be within existing working length specification. | Not re-tested. "The segment lengths do not impact the cut to length step in addition the working length test compares the output to the target length." |
| Hub compatibility | Hub shall meet existing Luer specifications. | Not re-tested. "The hub is identical to the predicate device." |
| Outside Diameter | Test samples should be within existing outside diameter specifications. | Not re-tested. "OD is unaffected by the working length change." |
| Leak – Air | Test samples should be within existing Air - Leak specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Leak – Liquid | Test samples should be within existing Leak - Liquid specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Particulates | Test samples should be within existing Particulate specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Simulated Use - Bench | Test samples must meet predetermined user needs. | Re-tested Yes. "Zenith Support Catheter test samples met the acceptance criteria for Simulated Use-Bench to demonstrate that it is substantially equivalent to the predicate device." |
| Catheter Burst | Test sample burst pressures must meet or exceed existing minimum burst pressure specification. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Tensile | Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications. | Not re-tested. "The bonds and joints are the same as the predicate Zenith 074 device. Any pitch adjustments are within the tolerance of the predicate device." |
| Corrosion | Test samples shall exhibit no evidence of corrosion. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Packaging - Dye Leak | Test sample shall not exhibit any visual leaks or channels. | Not re-tested. "The packaging is identical to the cleared reference SDA device." (Note: The reference here is to an "SDA device," not the Zenith 074 predicate, indicating identical packaging to another cleared device.) |
| Packaging - Peel | Test sample tensile strength must meet or exceed existing tensile strength specifications. | Not re-tested. "The packaging is identical to the cleared reference SDA device." (Again, referring to SDA device for packaging.) |
| Kink Resistance | Test sample kink resistance must meet or exceed existing Kink Resistance specifications. | Not re-tested. "All transitions are the same, only the location of the transition changes, in addition, the pitch adjustments are within the Zenith 074 tolerance." |
| Torque | Test sample torque results must meet or exceed existing torque specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| PTFE Liner Inspection | Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Hydrophilic Coating Integrity | Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications. | Not re-tested. "There are no material changes from the predicate device, and pitch adjustments are within the tolerance of the predicate device." |
| Labeling Legibility | Test samples shall demonstrate text legibility. | Not re-tested. "The label is almost identical to the predicate device, except that the Scout Introducer is removed from the labeling." |
| Barcode | Test samples shall demonstrate readily readable barcodes. | Not re-tested. "Barcodes are similar to the predicate." |
| Sterilization | Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads. | Not re-tested. "The Zenith Support Catheter was adopted into the Zenith Family Sterilization Cycle." |
| Shelf Life | Aged test samples must meet or exceed existing specifications. | Not re-tested. "There are no material changes from the predicate device, therefore shelf life testing conducted for the Zenith 074 still applies." |
2. Sample Size Used for the Test Set and the Data Provenance
Due to the nature of a 510(k) summary relying on substantial equivalence, specific sample sizes for re-tested parameters (like Simulated Use - Bench) are not explicitly stated. For most tests, the data provenance is essentially inherited from the predicate device (Zenith 074) and another reference device (InNeuroCo SDA) because the new device's materials and manufacturing are identical or within tolerance. The document indicates these are non-clinical studies (benchtop and animal models for predicate devices). The geographical origin of the data is not specified beyond the manufacturer being based in Florida, USA. All studies are retrospective in relation to the current device's testing, as they refer to data from predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. For non-clinical tests, "ground truth" is typically established by laboratory procedures and measurements against defined standards (e.g., ISO, ASTM). For the "Simulated Use - Bench" test, it states it was conducted "by a physician," implying at least one expert, but qualifications and number are not detailed.
4. Adjudication Method for the Test Set
Not applicable/not provided. This type of detail (e.g., 2+1, 3+1 consensus) is typical for clinical studies, especially those involving expert interpretation of medical images, which is not the focus of this non-clinical submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or performed for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the majority of the non-clinical tests not re-performed, the "ground truth" (or accepted performance) is based on:
- Established performance of the predicate device (Zenith 074): This implies that the predicate device previously met these standards.
- International Standards (ISO 10993, ISO 10555-1, ISO 594-1, ISO 594-2, ISO 11135) and ASTM standards (ASTM F1929-12, ASTM F88-09, ASTM F1980): These standards define methodologies and acceptable ranges for material properties, biocompatibility, and device functionality.
- USP 788: For particulates.
For the re-tested "Simulated Use - Bench" test, the ground truth was "predetermined user needs," likely established through design validation or clinical input.
8. The Sample Size for the Training Set
Not applicable. The Zenith Support Catheter is a physical medical device. The concept of "training set" is relevant for AI/machine learning models, which this device is not.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no "training set" for this physical 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). 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.
January 26, 2018
InNeuroCo, Inc. Marianne Grunwaldt Director, Quality Assurance and Regulatory Affairs 4635 NW 103rd Avenue Sunrise, Florida 33351
Re: K173709
Trade/Device Name: Zenith Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DTL, DYB Dated: January 4, 2018 Received: January 5, 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,
William J. Heetderks -A 2018.01.26 16:50:00 -05'00'
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
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Indications for Use
510(k) Number (if known) K173709
Device Name Zenith Support Catheter
Indications for Use (Describe)
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
ADMINISTRATIVE INFORMATION
| Date of Summary Preparation: | December 1st, 2017 |
|---|---|
| CONTACT INFORMATION | |
| Submitter/Manufacturer | InNeuroCo Inc4635 NW 103rd AvenueSunrise, Florida 33351Tel: 1-954-742-5988Fax: 1-954-742-5989 |
| Primary Submission Contact | Marianne GrunwaldtCell:1-305-495-3883Fax: 1-954-742-5988Email: Marianne@InNeuroCo.com |
| Secondary Submission Contact | Ming Cheng ChewRegulatory Consultant, Libra Medical,8401 73rd Ave North, Suite 63Brooklyn Park, MN 55428Cell: 763-232-3701Fax: 763-477-6357Email: mcchew@libramed.com |
DEVICE INFORMATION
Device Trade or Proprietary Name Zenith Support Catheter
Device Common or Classification Name: Catheter, Percutaneous, 21 CFR 870.1250, Class II Hemostasis Valve, 21 CFR 870.4290, Class II Catheter Introducer, 21 CFR 870.1340, Class II
Product Code: DQY (Catheter) DTL (Hemostasis Valve) DYB (Catheter Introducer) Inc.
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IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS BEING CLAIMED
| Name of Predicate Device | Name of Manufacturer | 510(k) Number |
|---|---|---|
| Zenith 074 | InNeuroCo | K171672 |
DEVICE DESCRIPTION
The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.
INDICATIONS FOR USE / INTENDED USE
The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
| Predicate DeviceInNeuroCo, Inc.Zenith 074 | ReferenceDeviceInNeuroCo SDA | InNeuroCo, Inc.Zenith Support | |
|---|---|---|---|
| 510(k) Number | K171672 | K161262 | K173709 |
| Classification | 21CFR870.1250,Class II | 21CFR870.1250,Class II | 21CFR870.1250,Class II |
| Product Code | DQY | DQY | DQY |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular |
| Predicate DeviceInNeuroCo, Inc.Zenith 074 | ReferenceDeviceInNeuroCo SDA | InNeuroCo, Inc.Zenith Support | |
| Indications ForUse | The Zenith isindicated for theintroduction ofinterventional devicesinto the peripheral andneuro vasculature. | The Super DistalAccess (SDA) isindicated for theintroduction ofinterventionaldevices into theperipheral andneuro vasculature. | The ZenithSupport Catheteris indicated forthe introductionof interventionaldevices into theperipheral andneuro vasculature. |
| ComponentsSupplied | Zenith Catheter, PeelAway Introducers,Hemostasis Valve,Scout Introducer | Catheter, PeelAway Introducer,HemostasisValve | Zenith SupportCatheter, PeelAway Introducer,Hemostasis Valve |
| Catheter ShaftMaterial | Polymeric Catheter | PolymericCatheter | PolymericCatheter |
| Inner Liner | PTFE | PTFE | PTFE |
| Catheter ShaftReinforcement | Stainless Steel | StainlessSteel/Nitinol | Stainless Steel |
| Reinforcementpattern | Cross Coil | Braid | Cross Coil |
| LubriciousCoating | Hydrophilic Coating | HydrophilicCoating | HydrophilicCoating |
| RadiopaqueMarker Band | Platinum/ Iridium | Platinum/ Iridium | Platinum/ Iridium |
| Packaging | Tyvek/Nylon Pouch,polyethylene supporttube, packaging card,SBS carton | Tyvek/NylonPouch,polyethylenesupport tube,packaging card,SBS carton | Tyvek/NylonPouch,polyethylenesupport tube,packaging card,SBS carton |
| WorkingLengths | 115, 125, 132 cm | 105, 115, 125 cm | 95, 105, 115 cm |
| Predicate DeviceInNeuroCo, Inc.Zenith 074 | ReferenceDeviceInNeuroCo SDA | InNeuroCo, Inc.Zenith Support | |
| ProximalInternalDiameter (ID) | 0.074 inches | 0.062 inches | 0.074 inches |
| Distal ID | 0.074 inches | 0.060 inchesdistal | 0.074 inches |
| Proximal OuterDiameter | 0.086 inches | 0.079 inches | 0.086 inches |
| Distal OuterDiameter | 0.086 inches | 0.072 | 0.086 inches |
| Peel AwayIntroducer | Aid in catheter tipintroduction intohemostasis valve | Aid in catheter tipintroduction intohemostasis valve | Aid in catheter tipintroduction intohemostasis valve |
| HemostasisValve | Minimizes blood loss | Minimizes bloodloss | Minimizes bloodloss |
| Luer TaperedHub | Yes | Yes | Yes |
| CompatibleGuidewire | 0.038 inches | 0.038 inches | 0.038 inches |
| ScoutIntroducer | Yes | No | No |
| Sterilization | EO SAL 10-6 | EO SAL 10-6 | EO SAL 10-6 |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Nonpyrogenic |
| Biocompatibility | Meets ISO 10993-1:2009 | Meets ISO10993-1:2009 | Meets ISO10993-1:2009 |
COMPARISON TO THE PREDICATE DEVICE
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SUMMARY OF NON-CLINICAL DATA
Each non-clinical test was analyzed to determine whether or not re-testing should be conducted for the Zenith Support Catheter. The results of the analysis and re-testing showed that the Zenith Support Catheter is substantially equivalent to the predicate device.
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| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
|---|---|---|---|---|
| Biocompatibility-MaterialMediatedPyrogen | Testingcompleted perISO 10993-11 | The test articleextracts must notcause a febrilereaction greaterthan 0.5°C in anyindividualsubject. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility- CytotoxicityMEM Elution | Testingcompleted perISO 10993-5 | The culturestreated with thetest article mustnot have areactivity gradegreater than 2. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility-HemolysisASTM Method,extract humanblood | Testingcompleted perISO 10993-4 | The hemolyticindex above thenegative controlarticle must beless than 5%. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility-Hemolysis,ASTM method, | Testingcompleted perISO 10993-4 | The hemolyticindex above thenegative control | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice. |
| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
| direct contact(human blood) | article must beless than 5%. | Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance | ||
| Biocompatibility-UnactivatedPartialThromboplastinTime | Testingcompleted perISO 10993-4 | There must be nostatisticaldecrease betweenthe UPTT ofplasma exposedto the test articleand to thenegative oruntreated control. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility-ComplementActivation | Testingcompleted perISO 10993-4 | There must be nostatistical increasebetween either theC3a or SC5b-9concentrations inplasma exposedto the test articleas compared tothe negative anduntreatedcontrols. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility-DogThromboresistance | Testingcompleted perISO 10993-4 | The test articlesmust receive athrombusformation scoreless than or equalto that of thecontrol. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
| Biocompatibility-MaximizationSensitization | Testingcompleted perISO 10993-10 | The test articlemust elicit apositive responsein less than 10%of the testanimals. | Testing was notrepeated for theZenith SupportCatheter | changed and pitchadjustments werewithin the predicatedevice's toleranceThere are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility-IntracutaneousToxicity/Reactivity | Testingcompleted perISO 10993-10 | The test articleextracts must notinduce asignificantlygreater biologicalreaction than thecontrol. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Biocompatibility-AcuteSystemicToxicity Test | Testingcompleted perISO 10993-11 | The test articleextracts must notinduce asignificantlygreater biologicalreaction than thecontrol. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice.Manufacturingprocess is identicalto the predicate.Only the segmentlengths werechanged and pitchadjustments werewithin the predicatedevice's tolerance |
| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
| AnimalTesting-AngiographicEvaluation | Productevaluatedwithin aporcine modelfor clinicallysignificantinjury. | No units testedcan cause vesselinjury. | Testing was notrepeated for theZenith SupportCatheter | The tips, materials,and transitions areidentical to thepredicate, and theinitial evaluation forthe predicateincluded the use ofthe device withoutthe Scout Introducer |
| ChemicalCompatibility | Catheterexposed tochemicalsreadilyavailable in aclinical setting. | Chemicals haveno negative effecton the catheter oraccessories. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| RadiographicDetectability | Testingcompleted perISO 10555-1 | Product shall bevisible underfluoro imaging. | Testing was notrepeated for theZenith SupportCatheter | The marker bandsare identical to thepredicate |
| VisualInspection | Testingcompleted perISO 10555-1 | Catheter shallappear free fromdamage,including arounded tip andsmooth transitionpoints. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| WorkingLength | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting workinglengthspecification. | Testing was notrepeated for theZenith SupportCatheter | The segment lengthsdo not impact the cutto length step inaddition the workinglength test comparesthe output to thetarget length |
| Hubcompatibility | Testingcompleted perISO 594-1 andISO 594-2 | Hub shall meetexisting Luerspecifications. | Testing was notrepeated for theZenith SupportCatheter | The hub is identicalto the predicatedevice |
| Outsidediameter | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting outside | Testing was notrepeated for theZenith SupportCatheter | OD is unaffected bythe working lengthchange |
| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
| Leak – Air | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting Air -Leakspecifications. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| Leak – Liquid | Testingcompleted perISO 10555-1 | Test samplesshould be withinexisting Leak -Liquidspecifications. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| Particulates | Testingcompleted perUSP 788 | Test samplesshould be withinexistingParticulatespecifications. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| Simulated Use -Bench | Zenithunderwentsimulated usetesting by aphysician in abenchtopmodel | Test samplesmust meetpredetermineduser needs | Yes | Zenith SupportCatheter test samplesmet the acceptancecriteria forSimulated Use-Bench todemonstrate that it issubstantiallyequivalent to thepredicate device |
| Catheter Burst | Testingcompleted perISO 10555-1 | Test sample burstpressures mustmeet or exceedexisting minimumburst pressurespecification. | Testing was notrepeated for theZenith SupportCatheter. | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
| Tensile | Testingcompleted perISO 10555-1 | Test sampleultimate tensilestrength mustmeet or exceedexisting tensilestrengthspecifications. | Testing was notrepeated for theZenith SupportCatheter | The bonds and jointsare the same as thepredicate Zenith 074device. Any pitchadjustments arewithin the toleranceof the predicatedevice. |
| Corrosion | Testingcompleted perISO 10555-1 | Test samples shallexhibit noevidence ofcorrosion. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| Packaging -Dye Leak | Testingcompleted perASTM F1929-12 | Test sample shallnot exhibit anyvisual leaks orchannels | Testing was notrepeated for theZenith SupportCatheter | The packaging isidentical to thecleared referenceSDA device |
| Packaging -Peel | Testingcompleted perASTM F88-09 | Test sampletensile strengthmust meet orexceed existingtensile strengthspecifications. | Testing was notrepeated for theZenith SupportCatheter | The packaging isidentical to thecleared referenceSDA device |
| Kink Resistance | Samples aresubjected todifferentdiameters untilkink isobserved. | Test sample kinkresistance mustmeet or exceedexisting KinkResistancespecifications. | Testing was notrepeated for theZenith SupportCatheter | All transitions arethe same, only thelocation of thetransition changes,in addition, the pitchadjustments arewithin the Zenith074 tolerance |
| Torque | Conditionedsamples aretorqued tofailure | Test sampletorque resultsmust meet orexceed existingtorquespecifications. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| PTFE Linerinspection | Zenith waschallenged to | Test sample lineradhesion must | Testing was notrepeated for the | There are nomaterial changes |
| Test | Test MethodSummary | AcceptanceCriteria | Re-Tested? | Analysis |
| demonstratelineradherence. | meet or exceedexisting PTFELiner inspectionspecifications. | Zenith SupportCatheter | from the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice | |
| HydrophilicCoatingIntegrity | Conditionedsamples wererepeatedlyexposed tofriction todemonstratethat thehydrophiliccoating is notaffected. | Test sampleresults must meetor exceed existingHydrophilicCoating Integrityspecifications. | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, and pitchadjustments arewithin the toleranceof the predicatedevice |
| LabelingLegibility | Label is legibleafter printing. | Test samples shalldemonstrate textlegibility. | Testing was notrepeated for theZenith SupportCathetersubstantiallyequivalent to thepredicate device. | The label is almostidentical to thepredicate device,except that the ScoutIntroducer isremoved from thelabeling |
| Barcode | Barcode isreadable with astandardbarcode reader. | Test samples shalldemonstratereadily readablebarcodes | Testing was notrepeated for theZenith SupportCatheter | Barcodes are similarto the predicate |
| Sterilization | ISO 11135 andAAMI TIR 28 | Sterilization loadshall pose anequal or lesserchallenge tosterilize thanexisting sterileproduct loads. | Testing was notrepeated for theZenith SupportCatheter | The Zenith SupportCatheter wasadopted into theZenith FamilySterilization Cycle |
| Shelf Life | ASTM F1980 | Aged test samplesmust meet orexceed existingspecifications | Testing was notrepeated for theZenith SupportCatheter | There are nomaterial changesfrom the predicatedevice, thereforeshelf life testingconducted for theZenith 074 stillapplies |
Table 1: Non-Clinical Testing Analysis
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§ 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).