(246 days)
The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.
The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
This document is a 510(k) Summary for a medical device called the "Neurovascular Access System Family." It details the device's characteristics, intended use, and compares it to legally marketed predicate devices to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Name | Objective | Test Method / Standard or Guidance | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|---|
| Visual Surface Requirements | To demonstrate that the device meets the visual surface requirements. | ISO 10555-1 2013, Section 4.4 | Device meets visual surface requirements. | Pass |
| Dimensional Verification | To demonstrate that the device meets the dimensional requirements. | ISO 10555-1 2013, Section 4.5 | Device meets dimensional requirements. | Pass |
| Liquid Leakage Under Pressure | To demonstrate that the device passes the liquid leakage under pressure test. | ISO 10555-1 2013, Section 4.7.1, Annex C | Device passes liquid leakage test. | Pass |
| Hub Aspiration Air Leakage | To demonstrate that the device passes the hub aspiration air leakage test. | ISO 10555-1 2013, Section 4.7.2, Annex D | Device passes hub aspiration test. | Pass |
| Simulated Use and Usability | To demonstrate that the device passes testing specified in the simulated use test protocol. Simulated use testing includes usability assessment with multiple physicians. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Device passes simulated use and usability protocols. | Pass |
| Flex Fatigue | To demonstrate that the device passes the flex fatigue test. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions", April 2023 | Device passes flex fatigue test. | Pass |
| Torque Test | To demonstrate the torque strength of the device. | FDA guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Device demonstrates adequate torque strength. | Pass |
| Tip Deflection | To demonstrate that the tip deflection is comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Tip deflection is comparable to predicate. | Pass |
| Device Removal Forces | To demonstrate that the removal forces are comparable to the predicate device. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" April 2023 | Removal forces are comparable to predicate. | Pass |
| Peak Tensile Strength Testing | To demonstrate that the device passes the peak tensile strength testing including all bonds and joints. | ISO 10555-1 2013, Section 4.6, Annex B | Device passes peak tensile strength testing. | Pass |
| Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | ISO 10555-1 2013: Section 4.9 | Flow rate is comparable to predicate. | Pass |
| Corrosion Resistance | To demonstrate that the device has no visual evidence of corrosion. | ISO 10555-1 2013, Section 4.5, Annex A | No visual evidence of corrosion. | Pass |
| Radiopacity | To demonstrate that the distal marker band is clearly visible under typical fluoroscopic imaging conditions. | ISO 10555-1 2013, Section 4.2; ASTM F640-12 | Distal marker band is clearly visible. | Pass |
| Kink Resistance | To demonstrate that shaft kink resistance is comparable to the predicate device and clinically relevant for the intended anatomical locations for use. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Shaft kink resistance is comparable to predicate and clinically relevant. | Pass |
| Particulates and Coating Integrity | To demonstrate the quantity and size of particles generated during simulated use are comparable to the predicates and reference devices. | FDA Guidance: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" | Particulates and coating integrity are comparable to predicates. | Pass |
| Dynamic Burst | To demonstrate that the device withstands dynamic burst strength. | ISO 10555-1 2103, Annex G | Device withstands dynamic burst strength. | Pass |
| Static Burst | To demonstrate that the device passes static burst pressure as specified in the test protocol. | ISO 10555-1 2013, Section F | Device passes static burst pressure. | Pass |
| Shelf Life | Repeated bench tests after accelerated aging to demonstrate that the device performance is maintained over the proposed shelf-life (6 months). | ASTM D4332-22, ASTM D4169-22, ASTM F1980-21, ASTM F1886 / F1866M-16, ASTM 2096-11 (2019), ASTM F88/F88M:21 | Device performance maintained over 6-month shelf-life. | Pass |
Biocompatibility Tests:
| Test Name | Objective (Implied) | Test Method / Standard or Guidance | Acceptance Criteria (Implied by "Results") | Reported Device Performance |
|---|---|---|---|---|
| Cytotoxicity | Assess cell toxicity. | ISO 10993-5 | No reactivity observed. | Non-cytotoxic |
| Sensitization | Assess potential for allergic reactions. | ISO10993-10 | No evidence of delayed dermal contact sensitization. | Non-sensitizing |
| Intracutaneous Reactivity | Assess localized irritation. | ISO 10993-23 | Scores from test article extracts were acceptable (<1.0 for sesame seed oil). | Non-irritant |
| Acute Systemic Toxicity | Assess systemic toxic effects. | ISO 10993-11 | No mortality or evidence of systemic toxicity. | Non-toxic |
| Material Mediated Pyrogenicity | Assess fever-inducing substances. | ISO 10993-11 | No rabbit temperature rise ≥ 0.5 °C. | Non-pyrogenic |
| Hemolysis - Direct Contact and Extract Method | Assess red blood cell damage. | ISO 10993-4 | Mean blank corrected % hemolysis < 2%. | Non-hemolytic |
| Complement Activation | Assess immune system activation. | ISO 10993-4 | Results within acceptable range compared to controls. | Not a Sc5b-9 complement activator |
| Thrombogenicity | Assess potential for blood clot formation. | ISO 10993-4 | No adverse effects/clinical signs, no thrombus score ≥ 2, similar to comparator/negative controls in PTT and platelet/leukocyte counts. | Non-thrombogenic |
Sterility Testing:
| Test Name | Objective (Implied) | Test Method / Standard or Guidance | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Sterilization Validation | Ensure device is sterile. | ISO 11135:2014 | Sterility Assurance Level (SAL) of 1x10⁻⁶ achieved. | Pass |
| EO and ECH Residuals | Ensure residuals are below toxic levels. | ISO 10993-7:2008 | Residuals below specified limits. | Pass |
| Bacterial Endotoxin Levels | Ensure endotoxin levels are safe. | FDA's sterility guidance | Levels below 2.15 EU/device. | Pass |
| Shelf-Life (Sterility) | Maintain sterility over proposed shelf-life. | (Implicitly part of validation) | Sterility maintained over 6 months. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Performance Data" in Section VII and "Biocompatibility" in Section VIII.
- Performance Data: The specific sample sizes for each performance test (e.g., visual, dimensional, burst, fatigue) are not explicitly stated in this summary table. The document only indicates "Pass" for each test. The methods refer to ISO standards and FDA guidance documents, which typically define appropriate sample sizes for such tests.
- Biocompatibility Data: Similarly, the sample sizes for the various biocompatibility tests (e.g., number of cells, animals for in vivo tests) are not explicitly stated.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. These are typically bench and laboratory tests performed by the manufacturer or contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the "Simulated Use and Usability" test, the objective states an "usability assessment with multiple physicians." The exact number of physicians and their specific qualifications are not provided in this summary.
- For all other tests, ground truth is established by objective measurements against specified standards (ISO, ASTM, FDA guidance), rather than expert consensus on images or outcomes. Therefore, "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy are not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is an access catheter, and the performance criteria are based on engineering, mechanical, and biological testing, not on interpretation of clinical data requiring adjudication by experts.
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 diagnostic algorithm. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance testing is based on:
- Established Industry Standards: ISO 10555-1, ISO 10993 series, ASTM standards.
- FDA Guidance Documents: "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions."
- Objective Measurements: Such as dimensional measurements, pressure thresholds, tensile strength, flow rates, visual inspection for corrosion or particulates, and biological responses in biocompatibility tests.
- Simulated Use: Involving usability assessment (implied to be clinical feedback from physicians during simulated use).
Essentially, the ground truth is adherence to predefined physical, chemical, mechanical, and biological specifications and performance metrics.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device submission.
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November 20, 2024
Q'Apel Medical, Inc. % Wanda Carpinella Regulatory Consultant Insight Medical, LLC 7 Barrows Road Shrewsbury, Massachusetts 01545
Re: K240746
Trade/Device Name: Neurovascular Access System Family Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: October 25, 2024 Received: October 25, 2024
Dear Wanda Carpinella:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sara S. Thompson -S
for Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240746
Device Name
Neurovascular Access System Family
Indications for Use (Describe)
The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.
Type of Use (Select one or both, as applicable)
| Residential Use (Part of OFF-SITE Septic System) |
|---|
| Commercial Use |
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
Traditional Premarket Notification 510(k) Summary Neurovascular Access System Family 510(k) Number K240746
Date Prepared: November 18, 2024
l. SUBMITTER
Q'Apel Medical, Inc. 4245 Technology Drive Fremont, CA 94538 United States
Contact Person
Jim Talbot Vice President Regulatory, Quality and Clinical 4245 Technology Drive Fremont, CA 94538 United States Tel: 650-793-8250 jtalbot@qapelmedical.com
II. DEVICE
| Name of Device: | Neurovascular Access System Family |
|---|---|
| Common or Usual Name: | Neurovascular Access Catheter |
| Classification Regulation: | 21 CFR § 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Product Codes: | QJP, DQY |
| Regulatory Class: | II |
lll. PREDICATES
Primary predicate
-
Benchmark Intracranial Access System, K212838
Secondary predicate -
SelectFlex Neurovascular Access System Family, K211893
IV. DEVICE DESCRIPTION
The subject Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Access Tool, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy.
V. INDICATIONS FOR USE
The Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neuro vasculature. It is not intended for use in coronary arteries.
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COMPARISION OF TECHNOLOGICAL CHARACTERISICS WITH PREDICATES VI.
The following table compares key features of the subject and predicate devices.
| Subject Device | Primary PredicateDevice BenchmarkIntracranial AccessSystemK212838 | Secondary PredicateDeviceSelectFlexNeurovascularAccess SystemFamilyK211893 | Comparison | |
|---|---|---|---|---|
| Indication forUse | The NeurovascularAccess System Family isindicated for theintroduction ofinterventional devicesinto the peripheral andneurovasculature. It isnot intended for use incoronary arteries. | The BenchmarkIntracranial AccessSystem is indicated forthe introduction ofinterventional devicesinto the periphral,coronary, andneurovasculature. | The SelectFlexNeurovascular AccessSystem Family isindicated for theintroduction ofinterventionaldevices into theperipheral andneurovasculature. | Similar, the subjectdevice limits theindications tointroduction ofinterventional devicesinto the peripheraland neurovascular anperipheral, which arewithin the currentlycleared indicationstatement of thepredicate. Differencedoes not raise newquestions of safetyand effectiveness. |
| Product Code | DQY, QJP | DQY, QJP | DQY, QJP | Same |
| Classification | Class II | Class II | Class II | Same |
| Material | Catheter Body: Variabledurometer outerpolymer jacket thatdelivers a flexible distalshaft and transition tostiffer proximal section.Inner Liner: PTFE | Catheter Body:Variable durometerouter polymer jacketthat delivers a flexibledistal shaft andtransition to stifferproximal section. | Catheter Body:Variable durometerouter polymer jacketthat delivers aflexible distal shaftand transition tostiffer proximalsection.Inner Liner: PTFEUser selectedtracking and supportmodes | Similar, differencesdo not raise newquestions of safetyand effectiveness |
| Catheter ShaftReinforcement | Laser cut stainless steelhypotube | Stainless steel coil | Stainless steel coil &nitinol scaffold | Similar, differencesdo not raise newquestions of safetyand effectiveness |
| HydrophilicCoating | Yes – Distal portion | Yes – Distal portion | Yes – Distal portion | Same |
| Visibility underfluoroscopy | YesAccess Catheter markerbandAccess Tool Distal Tip | YesAccess Cathetermarker band5F Select CatheterDistal Tip | YesAccess Cathetermarker band | Same |
| WorkingLength | 074 Access Catheter:80, 95, 105, 115 cm087 Access Catheter:80, 95, and 105 cm | 95, 105, 115 cm | 95, 105, and 115 cm | Similar, differencesdo not raise newquestions of safety |
| Subject Device | Primary PredicateDevice BenchmarkIntracranial AccessSystemK212838 | Secondary PredicateDeviceSelectFlexNeurovascularAccess SystemFamilyK211893 | Comparison | |
| OuterDiameter | 6French (F) and 7F | 6F | 7F | Same |
| InnerDiameter | 0.074 and 0.087 inch | 0.071 inch | 0.072 inch | Similar, differencesdo not raise newquestions of safety oreffectiveness |
| Tip ShapesOffered | Straight | Straight & Multi-purpose | Straight | Same |
| AccessoriesSupplied | - Peel awayintroducer,- 5F and 6F Dilator,- 5F Access Tool inSimmons 2 andBerenstein distalshape | - 5F Select Catheter inBerenstein, H1, andSimmons distalshape | - 7 F IntroducerSheath,- 3cc syringe,- Luer- Activated Valve,- Dilator | Similar, the 074and 087NeurovascularAccess Systemincludes a Dilator,like the secondarypredicate. |
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PERFORMANCE DATA VII.
The results of verification and validation testing conducted on the Neurovascular Access System Family demonstrate that it performs as designed and is substantially equivalent to the predicate. A summary of the tests performed is provided in the table below:
| Test Name | Objective | Test Method / Standard orGuidance | Result |
|---|---|---|---|
| Visual SurfaceRequirements | To demonstrate that thedevice meets the visualsurface requirements. | ISO 10555-1 2013,Section 4.4 | Pass |
| Dimensional Verification | To demonstrate that thedevice meets the dimensionalrequirements. | ISO 10555-1 2013,Section 4.5 | Pass |
| Liquid Leakage UnderPressure | To demonstrate that thedevice passes the liquidleakage under pressure test. | ISO 10555-1 2013,Section 4.7.1, Annex C | Pass |
| Hub Aspiration Air Leakage | To demonstrate that thedevice passes the hubaspiration air leakage test. | ISO 10555-1 2013,Section 4.7.2, Annex D | Pass |
| Simulated Use and Usability | To demonstrate that thedevice passes testingspecified in the simulated usetest protocol. Simulated usetesting includes usabilityassessment with multiplephysicians. | FDA guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions", April2023 | Pass |
| Test Name | Objective | Test Method / Standard orGuidance | Result |
| Flex Fatigue | demonstrate that theTodevice passes the flex fatiguetest. | FDA guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions", April2023 | Pass |
| Torque Test | To demonstrate the torquestrength of the device. | FDA guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions" April2023 | Pass |
| Tip Deflection | To demonstrate that the tipdeflection is comparable tothe predicate device. | FDA Guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions" April2023 | Pass |
| Device Removal Forces | To demonstrate that theremoval forces arecomparable to the predicatedevice. | FDA Guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions" April2023 | Pass |
| Peak Tensile Strength Testing | To demonstrate that thedevice passes the peaktensile strength testingincluding all bonds andjoints. | ISO 10555-1 2013,Section 4.6, Annex B | Pass |
| Flow Rate | To demonstrate that the flowrate is comparable to thepredicate device. | ISO 10555-1 2013:Section 4.9 | Pass |
| Corrosion Resistance | To demonstrate that thedevice has no visual evidenceof corrosion. | ISO 10555-1 2013,Section 4.5, Annex A | Pass |
| Radiopacity | To demonstrate that thedistal marker band is clearlyvisible under typicalfluoroscopic imagingconditions. | ISO 10555-1 2013,Section 4.2ASTM F640-12 | Pass |
| Kink Resistance | To demonstrate that shaftkink resistance is comparableto the predicate device andclinically relevant for theintended anatomicallocations for use. | FDA Guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions" | Pass |
| Test Name | Objective | Test Method / Standard orGuidance | Result |
| Particulates and CoatingIntegrity | To demonstrate thequantity and size ofparticles generated duringsimulated use arecomparable to thepredicates and referencedevices. | FDA Guidance: "PeripheralPercutaneous TransluminalAngioplasty (PTA) andSpecialty Catheters -Premarket Notification(510(k)) Submissions" | Pass |
| Dynamic Burst | To demonstrate that thedevice withstands dynamicburst strength. | ISO 10555-1 2103,Annex G | Pass |
| Static Burst | To demonstrate that thedevice passes static burstpressure as specified in thetest protocol. | ISO 10555-1 2013,Section F | Pass |
| Shelf Life | Repeated bench testsafter accelerated agingto demonstrate that thedevice performance ismaintained over theproposed shelf-life (6months). | ASTM D4332-22ASTM D4169-22ASTM F1980-21ASTM F1886 / F1866M-16ASTM 2096-11 (2019)ASTM F88/F88M:21 | Pass |
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VIII. BIOCOMPATIBILITY
The subject Neurovascular Access System Family is categorized as an externally communicating device contacting circulating blood for a limited (≤ 24 hours) duration in accordance with ISO 10993-1. The following testing supports biocompatibility and substantial equivalence of the subject device.
| Test Name | Reference Standard | Results | Results |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | No reactivity was observedwith the test article at 24 and48 hours. | Non-cytotoxic |
| Sensitization | ISO10993-10 | The test article extractsshowed no evidence ofdelayed dermal contactsensitization in the guinea pigmaximization test. | Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-23 | The scores from test articleextracts were 0 from thesaline extract and <1.0 fromthe sesame seed oil extract. | Non-irritant |
| Acute Systemic Toxicity | ISO 10993-11 | There was no mortality orevidence of systemic toxicityfrom the extracts injectedinto mice. Each test articleextract met the requirementsof the study. | Non-toxic |
| Material MediatedPyrogenicity | ISO 10993-11 | No rabbit temperature rise ≥0.5 °C. | Non-pyrogenic |
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| Test Name | Reference Standard | Results | Results |
|---|---|---|---|
| Hemolysis - Direct Contactand Extract Method | ISO 10993-4 | The mean blank corrected %hemolysis above the negativecontrol of the test article was< 2% for the extract method. | Non-hemolytic |
| Complement Activation | ISO 10993-4 | Results within acceptablerange as compared to thecontrols. | Not a Sc5b-9 complementactivator |
| Thrombogenicity | ISO 10993-4 | No adverse effects or clinicalsigns during test period andno thrombus score ≥ 2 foreither test or control devicein in vivo thrombogenicitystudy.Performed similar tocomparator and negativecontrols in PartialThromboplastin Time andPlatelet and Leukocyte Countstesting. | Non-thrombogenic |
IX. STERILITY
The subject Neurovascular Access System Family is sterilized with ethylene oxide (EO). The sterilization process has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 1x 10 °. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993 7:2008. Bacterial Endotoxin Levels were below the level of 2.15 endotoxin units (EU)/device in accordance with FDA's sterility guidance. Both baseline and accelerated shelflife testing were conducted demonstrating the device will perform as intended to support the proposed 6-month shelf-life.
X. ANIMAL STUDY
Animal testing was not deemed necessary to support the substantial equivalence of the Neurovascular Access System Family.
XI. Clinical
Clinical testing was not deemed necessary to support the substantial equivalence of the Neurovascular Access System Family.
XII. CONCLUSION
The Neurovascular Access System Family has the same intended use and similar indications for use as the primary predicate and secondary predicate. The technological characteristics of the subject device are similar to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. The performance testing supports that the subject Neurovascular Access System Family is substantially equivalent to the predicate.
§ 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).