(142 days)
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.
This document describes the regulatory submission for the EMBOGUARD™ Balloon Guide Catheter (K212340). As such, the "acceptance criteria" and "device performance" refer to the results of bench and animal testing demonstrating substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm. Therefore, many of the requested fields are not applicable in this context.
Here's a breakdown of the provided information, addressing your points where relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The submission details numerous performance tests to demonstrate substantial equivalence to a predicate device. The general acceptance criterion for all of these tests is "Pass," meaning the device met the pre-determined specifications or demonstrated comparable performance to the predicate. The reported device performance for all listed tests is "Pass," indicating that all samples met the pre-determined acceptance criteria.
| Study Name | Acceptance Criteria | Reported Device Performance (all samples) |
|---|---|---|
| Visual Inspection and Dimensional Verification | Met visual & dimensional specifications | Pass |
| Visual Surface Inspection | Met visual surface requirements | Pass |
| Torque Durability | Capable of 360 degrees hub rotation | Pass |
| Torque to Failure | Met pre-determined acceptance criteria | Pass (characterized only) |
| Torque Transmission | Torque transmission characterized | Pass (characterized successfully after min 720° hub rotation) |
| Tensile Strength | Met tensile strength requirements | Pass |
| Flexibility and Kink Resistance | Acceptable flexibility & kink resistance | Pass |
| Kink to Failure | Determined bend radius at which kink occurs | Pass (characterized at different sections down to 2.5mm mandrel) |
| Catheter Lubricity and Durability | Met coating lubricity & durability specifications | Pass |
| Coating Length and Location | Met coating length & location specifications | Pass |
| Particulates | Particulates comparable to cleared controls | Pass (characterized only) |
| Coating Integrity | Coating characterized pre- & post-simulated use | Pass (characterized only) |
| Radiopacity | Met radiopaque characteristics requirements | Pass |
| Simulated Use | Demonstrated device performance in simulated anatomy | Pass |
| Simulated Clot Retrieval Testing | Demonstrated device performance (incl. clot retrieval) | Pass |
| User Evaluation | Demonstrated device performance in simulated anatomy | Pass |
| Catheter Deliverability and Withdrawal Force | Met required tracking force specification | Pass |
| Catheter Luer Hub Dimensional and Performance Testing | Met requirements for small bore connectors | Pass |
| Inner Lumen Integrity - Pressure | Met pressure requirements | Pass |
| Inner Lumen Integrity - Aspiration | Met aspiration air leakage requirements | Pass |
| Hub Shaft Pressure Integrity | Met minimum inner diameter specification | Pass |
| Introducer Sheath Compatibility (Insertion and Withdrawal) | Met required insertion & withdrawal force | Pass |
| Introducer Sheath Compatibility (Re-insertion and Re-withdrawal) | Device integrity maintained post re-insertion & re-withdrawal | Pass |
| Tip Stiffness | Similar to predicate device | Pass |
| Balloon Location | Met balloon location specification | Pass |
| Balloon Inflation / Deflation | Met inflation & deflation time specifications | Pass |
| Balloon Fatigue | No degradation after 20 inflation cycles | Pass |
| Balloon OD and Compliance | Met max recommended inflation volume vs. balloon diameter specifications | Pass |
| Balloon Concentricity | Met balloon diameter specifications on each side | Pass |
| Balloon Burst | Capable of withstanding 2x and 2.5x recommended inflation volume | Pass |
| Conditioning, Distribution, and Shelf Life Aging - Device | Met all specifications at baseline & after 1-year aging | Pass |
| Conditioning, Distribution, and Shelf Life Aging - Packaging | Maintained packaging strength & integrity | Pass |
| Visual Inspection Packaging and Labeling | Met packaging & labeling visual & adherence requirements | Pass |
| System Visual Inspection (Dilator) | Met visual & dimensional specifications | Pass |
| Effective Length, Outer Diameter, Inner Diameter, Taper Diameter (Dilator) | Met visual & dimensional specifications | Pass |
| Tensile Strength (Dilator) | Withstood peak tensile strength | Pass |
| Kink Resistance (Dilator) | No kinks, defects, or damage | Pass |
| Luer Dimensional (Dilator Hub) | Met dimensional specifications | Pass |
| Fluid Leakage by Pressure Decay (Dilator Hub) | No leakage under pressure | Pass |
| Sub-atmospheric Pressure Air Leakage (Dilator Hub) | No air leakage | Pass |
| Stress Cracking (Dilator Hub) | No cracking under axial force & torque | Pass |
| Resistance to Separation from Axial Load (Dilator Hub) | No separation from reference connector | Pass |
| Resistance to Separation from Unscrewing (Dilator Hub) | No overriding of threads | Pass |
| Resistance to Overriding (Dilator Hub) | No overriding of threads | Pass |
| Torque Durability (Dilator Hub) | No separation/embolization after 1 rotation | Pass |
| Visual Inspection (Luer Activated Valve) | Met visual specifications | Pass |
| Leak Test (Luer Activated Valve) | No leakage during inflation/deflation | Pass |
| Activation (Luer Activated Valve) | Allowed flow, no leakage when activated, prevented flow when syringe removed | Pass |
| LAV Male & Female Luer Dimensional (Luer Activated Valve) | Met dimensional specifications | Pass |
| Fluid Leakage by Pressure Decay, Sub-atmospheric Pressure Air Leakage (LAV) | No leakage under pressure | Pass |
| Stress Cracking (LAV) | No cracking under axial force & torque | Pass |
| Resistance to Separation from Axial Load (LAV) | No separation from reference connector | Pass |
| Resistance to Separation from Unscrewing (LAV) | No separation from reference connector | Pass |
| Resistance to Overriding (LAV) | No overriding of threads | Pass |
| Visual Inspection (Rotating Hemostasis Valve) | Met visual specifications | Pass |
| ID (Male Luer) (Rotating Hemostasis Valve) | Met ID specification | Pass |
| ID (Compression Seal) (Rotating Hemostasis Valve) | Met ID specification | Pass |
| ID (Side Port) (Rotating Hemostasis Valve) | Met ID specification | Pass |
| Seal Integrity (Pressure) (Rotating Hemostasis Valve) | No leakage or collapse under pressure | Pass |
| Seal Integrity (Aspiration) (Rotating Hemostasis Valve) | No leakage or collapse under aspiration | Pass |
| Gauging (RHV Hub Luer) | Met conical part of lock fitting | Pass |
| Liquid Leakage (RHV Hub Luer) | No leakage sufficient to form a falling drop | Pass |
| Air Leakage (RHV Hub Luer) | No continued formation of air bubbles | Pass |
| Separation Force / Unscrewing Torque (RHV Hub Luer) | Fitting remained attached to reference fitting | Pass |
| Ease of Assembly (RHV Hub Luer) | Met requirements for small bore connectors | Pass |
| Resistance to Overriding (RHV Hub Luer) | No overriding of threads or lugs | Pass |
| Stress Cracking (RHV Hub Luer) | Withstood stress cracking | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The specific sample sizes for each bench test are not explicitly stated in the document. However, the results consistently state "All samples met the pre-determined acceptance criteria," implying that a sufficient number of samples were tested to gain confidence in the results according to the referenced standards. The data provenance is from internal testing conducted by Neuravi Ltd.
- Animal Studies: The document mentions "Acute animal study has been performed." The specific number of animals is not provided. The model used was a swine model. This is prospective data from animal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a medical catheter, and its performance is evaluated through physical and biological testing, not by expert interpretation of images or other data that would require "ground truth" to be established by experts in the context of an AI study.
4. Adjudication Method for the Test Set
This information is not applicable. The device is a medical catheter, and its performance is evaluated through physical and biological testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. This device is a physical medical device, not an AI algorithm requiring human reader performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through adherence to recognized international standards, internal specifications, and comparison to a predicate device. For example:
- Biocompatibility: Based on established biological response criteria defined in ISO 10993 series standards (e.g., non-cytotoxic, non-sensitizing, non-pyrogenic).
- Bench Testing: Based on pre-determined product performance specifications derived from relevant ISO standards (e.g., ISO 10555, ISO 11070) and FDA guidance documents.
- Animal Studies: Based on evaluation of usability, effectiveness, safety (histological evaluation), and comparison to the predicate device in a swine model.
There is no "expert consensus," "pathology," or "outcomes data" in the sense of a medical diagnostic ground truth for an AI algorithm.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a physical medical device, not an AI algorithm.
Summary for this specific device:
The K212340 submission for the EMBOGUARD™ Balloon Guide Catheter focuses on demonstrating substantial equivalence to an existing predicate device (8F FlowGate Balloon Guide Catheter, K153729) through extensive non-clinical testing.
- Acceptance Criteria: For all tests, the acceptance criteria were pre-determined specifications, often derived from international standards (e.g., ISO 10993, ISO 10555, ISO 11070, ISO 80369) and FDA guidance documents. For comparison studies, the criterion was similarity or equivalence to the predicate device.
- Device Performance: The device "Passed" all listed biocompatibility, sterilization/shelf-life, and bench tests, indicating it met the pre-determined acceptance criteria for each.
- Study Types: The studies included:
- Biocompatibility Testing: Covering cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, hemocompatibility (hemolysis, complement activation, thrombogenicity), and genotoxicity.
- Sterilization and Shelf Life Studies: Validation of EtO sterilization and 1-year shelf life.
- Bench Testing: A comprehensive suite of physical and mechanical tests covering visual inspection, dimensions, torque, tensile strength, flexibility, kink resistance, lubricity, coating, particulates, radiopacity, simulated use (including clot retrieval), user evaluation, compatibility with ancillary devices, lumen integrity, and balloon performance. All these were direct physical tests of the device.
- Animal Studies: An acute animal study in a swine model to assess usability, effectiveness, safety, and histological response compared to the predicate device.
- No clinical studies were performed.
- The document does not detail any AI component, and thus questions related to AI-specific metrics (sample sizes for training/test sets, expert ground truth, MRMC studies) are not relevant to this submission. The "ground truth" here refers to the validated physical and biological properties of the device as measured against established scientific and regulatory standards.
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December 17, 2021
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neuravi Ltd. Niall Fox Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway, H91 K5YD Ireland
Re: K212340
Trade/Device Name: EMBOGUARD Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: November 16, 2021 Received: November 17, 2021
Dear Niall Fox:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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-regulatoryassistance/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,
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) K212340
Device Name EMBOGUARD™ Balloon Guide Catheter
Indications for Use (Describe)
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
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
K212340
l. SUBMITTER:
510(k) Owner: Neuravi Ltd.
Block 3, Ballybrit Business Park, Galway H91 K5YD, Ireland
Contact Person: Niall Fox
Director Regulatory Affairs
Tel: +353-91-394123
E-mail: nfox5@its.jnj.com
Date Prepared: December 17, 2021
II. DEVICE
Trade Name of Device: EMBOGUARD™ Balloon Guide Catheter
Common Name of Device: Catheter, Percutaneous
Classification Name: 21 CFR 870.1250 - Class II
Product Code: QJP
PREDICATE DEVICE III.
8F FlowGate Balloon Guide Catheter (K153729)
IV. DEVICE DESCRIPTION
EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.
V. INDICATIONS FOR USE
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of the technological characteristics of the EMBOGUARD Balloon Guide Catheter device in comparison to those of the predicate device is presented below.
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| Predicate Device | Subject Device | ||
|---|---|---|---|
| Characteristics | 8F FlowGate BalloonGuide Catheter(K153729) | EMBOGUARD™Balloon Guide Catheter(K212340) | Comparison |
| Classification | Class II (21CFR870.1250) | Class II (21CFR870.1250) | Same |
| Device ClassificationName | Catheter, Percutaneous | Catheter, Percutaneous | Same |
| ClassificationProduct Code | DQY | QJP | Similar |
| Indications for Use | FlowGate Balloon GuideCatheters areindicated for use infacilitating the insertionand guidance of anintravascular catheterinto a selected bloodvessel in the peripheraland neuro vascularsystems. The balloonprovides temporaryvascular occlusionduring these and otherangiographic procedures.The Balloon GuideCatheter is also indicatedfor use as a conduit forRetrievaldevices. | EMBOGUARDBalloon GuideCatheters are indicatedfor use in facilitating theinsertion andguidance of anintravascular catheterinto a selected bloodvessel in theneurovascular system.The balloon providestemporary vascularocclusion duringangiographicprocedures. The BalloonGuide Catheter is alsoindicated for use as aconduit forRetrieval Devices. | SimilarThe subject device isindicated for use onlyin theneurovasculature. |
| Material | Commonly used medicalgrade plastics (nylon,PTFE, polyolefin,polyamide) and stainlesssteel | Commonly used medicalgrade plastics (nylon,PTFE, polycarbonate,polyurethane,polyolefin, polyblend)and stainless steel | SimilarThe differences donot raise newquestions of safetyand effectiveness.This is confirmedthroughbiocompatibilityand performancetesting. |
| Reinforced CatheterShaft | Stainless steel braid | Stainless steel braid | Same |
| Radiopaque MarkerBand | Distal tip Pt-Ir markerband | Distal tip Pt-Ir markerband | Same |
| Radiopaque Markerlocation from DistalTip | 0.75mm | 1.3mm | SimilarDifferences do not raisenew questions of safetyand effectiveness, and donot impact visibilityunder fluoroscopy. This isconfirmed throughradiopaque markervisualization as part ofperformance testing. |
| Radiopaque MarkerLength | 0.020" | 0.031" | SimilarDifferences do not raisenew questions of safetyand effectiveness, and donot impact visibilityunder fluoroscopy. This isconfirmed throughradiopaque markervisualization as part ofperformance testing. |
| Compliant Balloon | Yes, silicone | Yes, polyblend | SimilarDifferences do not raisenew questions of safetyand effectiveness. Bothmaterials are used forcompliant balloons forintravascular use. |
| Effective Length | 85 cm95 cm | 85 cm95 cm | Same |
| Labelled Shaft OuterDiameter | 8F (2.7 mm) | 8F (2.8 mm) | SimilarThe differences do notraise new questions ofsafety and effectiveness.Compatibility with |
| ancillary devices hasbeen verified through | |||
| the performance testing. | |||
| Labelled Shaft InnerDiameter | 6.4F (0.084") | 6.6F (0.087") | SimilarThe differences do notraise new questions ofsafety and effectiveness.Compatibility withancillary devices hasbeen verified throughthe performance testing. |
| Tip Shape | Straight | Straight | Same |
| Outer Coating | Not applicable | Hydrophilic Coating –Distal portion of theshaft | The difference does notraise new questions ofsafety and effectiveness.Hydrophilic coatings arecommonly used toenhance lubricity ofintravascular catheters. |
| Balloon InflationLumen | Coaxial | Non-coaxial | The difference does notraise new questions onsafety and effectiveness.The balloon inflationlumen design andballoon performancehave been evaluatedthroughperformance testing. |
| Accessory DevicesProvided | Dilator (1)Rotating HemostasisValve (1)Tuohy Borst Valve withSideport (1)Peel Away Sheath (1)Luer-Activated Valve (1)Extension Tubing (1) | Dilator (1)Rotating HemostasisValve (1)Tuohy Borst Valve withSideport (1)Peel Away Sheath (1)Luer-Activated Valve(1) | SimilarThe differences do notraise new questions ofsafety and effectiveness. |
| How Supplied | Sterile, Single Use | Sterile, Single Use | Same |
| Sterilization Method | EtO | EtO | Same |
| Sterility AssuranceLevel | 10-6 | 10-6 | Same |
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VII. PERFORMANCE DATA Biocompatibility Testing:
The biocompatibility evaluation for the EMBOGUARD Balloon Guide Catheter device was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" and FDA biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
The EMBOGUARD Balloon Guide Catheter device is categorized as an external communicating device with limited exposure with circulating blood (≤ 24 hours) per ISO 10993-1.
| Test Name | Test Method | Results |
|---|---|---|
| Cytotoxicity | Tested in accordance with ISO 10993-5, Biological Evaluation of MedicalDevices - Part 5: Tests for in vitrocytotoxicity. | PassNon-cytotoxic according to thepre-determined acceptancecriteria. |
| Sensitization | Tested in accordance with ISO 10993-10, Biological Evaluation of MedicalDevices – Part 10: Tests for Irritationand Skin Sensitization. Kligman andMagnusson Maximisation Test. | PassDid not elicit a sensitizationresponse according to thepre-determined acceptancecriteria. |
| IntracutaneousIrritation | Tested in accordance with ISO 10993-10, Biological Evaluation of MedicalDevices - Part 10: Tests for Irritationand Skin Sensitization. | PassTest requirements forintracutaneous reactivitywere met according to thepre-determined acceptancecriteria. |
| Systemic Toxicity:Systemic InjectionTest | Tested in accordance with ISO 10993-11, Biological Evaluation of MedicalDevices – Part 11: Tests for SystemicToxicity. | PassTest requirements forsystemic toxicity were met,according to thepre-determined acceptancecriteria. |
| Systemic Toxicity:MaterialMediatedPyrogenicity | Tested in accordance with ISO 10993-11, Biological Evaluation of MedicalDevices – Part 11: Tests for SystemicToxicity, and USP <151> Pyrogen Test. | PassNon-pyrogenic, met thepre-determined acceptancecriteria. |
| Hemocompatibility:Hemolysis Study | Tested in accordance with ASTM F756-17, Standard Practice for Assessmentof Hemolytic Properties of Materialsand ISO 10993-4, Biological Evaluationof Medical Devices – Part 4: Selectionof Tests for Interactions with Blood.Tests for Hemolytic Properties, Directand Indirect Methods. | PassNon-hemolytic, met thepre-determined acceptancecriteria. |
| Hemocompatibility:ComplementActivation Study | Tested in accordance with ISO 10993-4, Biological Evaluation of MedicalDevices - Part 4: Selection of Testsfor Interactions with Blood. SC5b-9Complement Activation. | PassDoes not activate thecomplement system, met thepre-determined acceptancecriteria. |
| Hemocompatibility:ThrombogenicityStudy | Tested in accordance with ISO 10993-4, Biological Evaluation of MedicalDevices - Part 4: Selection of Testsfor Interactions with Blood. | PassDemonstrates similarthromboresistancecharacteristics as the controldevice, met thepre-determined acceptancecriteria. |
| Genotoxicity:Bacterial ReverseMutation Study | Tested in accordance with ISO 10993-3, Biological Evaluation of MedicalDevices - Part 3: Tests forGenotoxicity, Carcinogenicity andReproductive Toxicity, and OECD 471,Guideline for Testing of Chemicals,Bacterial Reverse Mutation Test. | PassNon-mutagenic according tothepre-determined acceptancecriteria. |
| Genotoxicity:Mouse LymphomaAssay | Tested in accordance with ISO 10993-3, Biological Evaluation of MedicalDevices - Part 3: Tests forGenotoxicity, Carcinogenicity andReproductive Toxicity, and OECDGuideline for the Testing ofChemicals. | PassNon-mutagenic according tothepre-determined acceptancecriteria. |
The biocompatibility evaluation included the following tests:
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All biocompatibility tests completed met the pre-determined acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards.
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Sterilization and Shelf Life:
The EMBOGUARD Balloon Guide Catheter device is labelled as a single-use, sterile device, with a shelf life of 1 year. The sterilization process for the EMBOGUARD Balloon Guide Catheter device has been successfully validated and process monitoring controls are in place to assure that the device is EO-sterilized to achieve a minimum SAL of 10-6.
Shelf life studies have been conducted for the EMBOGUARD Balloon Guide Catheter device and establish that the product and packaging remain functional and sterile for the shelf life period of 1 year.
Bench Testing:
The results of design verification and validation testing conducted on the EMBOGUARD Balloon Guide Catheter device demonstrate that it performs as designed, fulfils all pre-determined product performance specification requirements, and is suitable for its intended use. The verification and validation test results demonstrate that EMBOGUARD Balloon Guide Catheter is substantially equivalent to the predicate device.
| Performance Bench Testing Summary | |||
|---|---|---|---|
| Study Name | Description | Reference Standard | Results |
| VisualInspectionandDimensionalVerification | To demonstrate thatthe product meetsthe visual anddimensionalspecifications. | ISO 10555-1:2013, Intravascularcatheters - Sterile and single-usecatheters - Part 1: GeneralrequirementsISO 10555-4:2013, Intravascularcatheters - Sterile and single-usecatheters - Part 4: Balloondilatation cathetersISO 11070:2014/AMD 1:2018,Sterile Single-Use IntravascularIntroducers, Dilators andGuidewires | PassAll samples metthe pre-determinedacceptancecriteria. |
| Visual SurfaceInspection | To demonstrate theproduct satisfies thevisual surfacerequirements. | ISO 10555-1:2013ISO 10555-4:2013ISO 11070:2014/AMD 1:2018 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Torque | To demonstrate | Pass | |
| TorqueDurability | To demonstratethat the product iscapable of 360degrees ofrotation of the hubwhile the distal tipis fixed in position. | FDA guidance for CertainPercutaneous TransluminalCoronary Angioplasty (PTCA)Catheters:2010; §VIII.A.10Torque Strength | All samples metthe pre-determinedacceptancecriteria. |
| Torque toFailure | The number ofrotations of theproximal hubrequired to initiatedevice failure,includingseparation, whenthe distal end isheld stationary. | Characterization onlyFDA guidance Certain PTCACatheters:2010 §VIII.A.10Torque Strength | PassThe testsamples metthe pre-determinedacceptancecriteria. |
| TorqueTransmission | To determine thetorquetransmission ratio. | Characterization onlyFDA guidance Certain PTCACatheters:2010 §VIII.A.10Torque Strength | The torquetransmission atthe tip has beencharacterizedsuccessfully aftera minimum 720°hub rotation. |
| TensileStrength | To demonstrate theproduct satisfies thetensile strengthrequirements forbondsand tip pull test. | ISO 10555-1:2013ISO 11070:2014/AMD 1:2018FDA guidance Certain PTCACatheters:2010 §VIII.A.7, CatheterBond Strength, A.8, Tip Pull Test | PassAll samples metthe pre-determinedacceptancecriteria. |
| Flexibility andKinkResistance | To demonstrate thatthe product hasacceptableflexibility and kinkresistancewhen wrappedaround a series ofmandrels | FDA guidance Certain PTCACatheters:2010§VIII.A.9 Flexibility and Kink Test | PassAll samples metthe pre-determinedacceptancecriteria. |
| Kink to Failure | To determine thebend radius at whichcatheter kink occurs,as it is bent aroundmandrels ofdecreasing radii. | Characterization onlyFDA guidance Certain PTCACatheters:2010§VIII.A.9 Flexibility and Kink Test | The kink tofailure has beencharacterized atdifferentsections down toa 2.5mmmandrel. |
| CatheterLubricity andDurability | To demonstrate thatthe product meetscoating lubricity anddurabilityspecifications. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| Coating Lengthand Location | To demonstrate thatthe product meetscoating length andlocationspecifications. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| Particulates | This study wasconducted todetermine thequantity and size ofparticles generatedduring simulated use. | Characterization onlyAAMI TIR42:2010, Evaluation ofParticulates Associated withVascular Medical DevicesASTM F2743-11: 2010, StandardGuide for Coating Inspection andAcute ParticulateCharacterization of Coated Drug-Eluting Vascular Stent SystemsUSP <788> Particulate Matter inInjections | PassThe particulatesfrom the subjectdevice andcleared controlswere evaluatedand foundcomparable. |
| CoatingIntegrity | To characterize thecoating underspecifiedmagnification pre-and post-simulateduse. | Characterization onlyFDA guidance Certain PTCACatheters:2010§VIII.A.12 Coating Integrity | Coating has beencharacterizedunder specifiedmagnificationpre- and post-simulated use. |
| Radiopacity | To determine theradiopaquecharacteristics of thedevice and dilator. | ASTM F640-20, Standard TestMethods for DeterminingRadiopacity for Medical Use | PassAll samples metthe pre-determinedacceptancecriteria. |
| Simulated Use | To evaluate device performance in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | PassAll samples met the pre-determined acceptance criteria. |
| SimulatedClot RetrievalTesting | To evaluate device performance (including clot retrieval performance) in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | PassAll samples met the pre-determined acceptance criteria. |
| UserEvaluation | To evaluate device performance in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | PassAll samples met the pre-determined acceptance criteria. |
| CatheterDeliverabilityandWithdrawalForce | To demonstrate that the device meets the required tracking force specification. | N/A | PassAll samples met the pre-determined acceptance criteria. |
| Cather LuerHubDimensionalandPerformanceTesting | To demonstrate that the product meets the requirements for small bore connectors. | ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 7, Connectors for intravascular or hypodermic applicationsISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methodsISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirementsISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings | PassAll samples met the pre-determined acceptance criteria. |
| Inner LumenIntegrity -Pressure | To demonstrate thatthe product meetsthe pressurerequirements. | ISO 10555-1:2013FDA guidance Certain PTCACatheters:2010§VIII.B.1 Catheter Body BurstPressure | PassAll samples metthe pre-determinedacceptancecriteria. |
| Inner LumenIntegrity -Aspiration | To demonstrate thatthe product meetsthe aspiration airleakagerequirements andwill not collapseunder aspiration. | ISO 10555-1:2013 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Hub ShaftPressureIntegrity | To demonstrate thatthe device shaftmeets theminimum innerdiameterspecification up to1138kPa internalpressure throughhub's inflation luer. | ISO 10555-1:2013FDA guidance Certain PTCACatheters:2010§VIII.B.1 Catheter Body BurstPressure | PassAll samples metthe pre-determinedacceptancecriteria. |
| IntroducerSheathCompatibility(InsertionandWithdrawal) | To demonstrate thatthe product meetsthe requiredinsertion andwithdrawal forcewithout productdamage. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| IntroducerSheathCompatibility(Re-insertionand Re-withdrawal) | To demonstratedevice integrity ismaintained post re-insertion and re-withdrawal. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| Tip Stiffness | To demonstrate thatthe stiffness of thedistal end of the | N/A | PassAll samples metthe pre- |
| product is similar topredicate device. | determinedacceptancecriteria. | ||
| BalloonLocation | To demonstrateballoon meets theballoon locationspecification. | ISO 10555-4:2013 | PassAll samples metthe pre-determinedacceptancecriteria. |
| BalloonInflation /Deflation | To demonstrateballoon meets theinflation anddeflation timespecifications. | ISO 10555-4:2013FDA guidance Certain PTCACatheters:2010§VIII.A.6 Balloon Inflationand Deflation Time | PassAll samples metthe pre-determinedacceptancecriteria. |
| BalloonFatigue | To demonstrate thatthere is nodegradation of theballoon after 20inflation cycles. | ISO 10555-4:2013FDA guidance CertainPTCA Catheters:2010§VIII.A.4 Balloon Fatigue | PassAll samples metthe pre-determinedacceptancecriteria. |
| BalloonOD andCompliance | To demonstrate thatthe product meetsthe maximumrecommendedinflation volume vsballoon diameterspecifications. | ISO 10555-4:2013FDA guidance Certain PTCACatheters:2010§VIII.A.5 Balloon Compliance | PassAll samples met thepre- determinedacceptance criteria. |
| BalloonConcentricity | To demonstrate thatthe product meetsthe balloon diameterspecifications oneach side at therecommendedinflation volumewhen rotated 360°. | ISO 10555-4:2013 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Balloon Burst | To demonstrate thatthe balloon iscapable ofwithstanding aninjection volume of2x and 2.5xrecommendedinflation volume. | ISO 10555-4:2013 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Conditioning,Distribution,and Shelf LifeAging-Device | To demonstrate thedevice met allspecifications at bothbaseline andfollowing acceleratedaging to a 1-yearshelf life equivalent. | Evaluation of devicefollowing acceleratedaging to a 1-year shelf lifeequivalent | PassAll samples met thepre- determinedacceptance criteria. |
| Conditioning,Distribution,and Shelf LifeAging-Packaging | Evaluation ofpackaging strengthand integrity at bothbaseline andfollowing acceleratedaging to a 1-yearshelf life equivalent. | ASTM D4169-16, StandardPractice for PerformanceTesting of ShippingContainers and SystemsASTM F88/F88M-15,Standard Test Method forSeal Strength of FlexibleBarrier MaterialsASTM F1929-15, StandardTest Method for DetectingSeal Leaks in Porous MedicalPackaging by DyePenetration | PassAll samples met thepre- determinedacceptance criteria. |
| VisualInspectionPackaging andLabeling | To demonstrate thatthe product meetsthe packaging andlabeling visual andadherenceRequirements. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| System VisualInspection | To demonstrate thatthe product meetsthe visual anddimensional.specifications. | DilatorISO 10555-1ISO 10555-4 | PassAll samples metthe pre-determinedacceptancecriteria. |
| EffectiveLengthOuter DiameterInner DiameterTaper Diameter | To demonstrate thatthe product meetsthe visual anddimensionalspecifications. | ISO 11070 | PassAll samples metthe pre-determinedacceptancecriteria. |
| TensileStrength | To demonstrate thatthe dilatorwithstands peaktensile strength. | ISO 10555-1ISO 11070FDA guidance Certain PTCACatheters:2010 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Kink Resistance | To demonstrate thatthere are no kinks,defects or damage. | FDA guidance Certain PTCACatheters:2010 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Dilator Hub Luer Dimensional & Performance Requirements | |||
| LuerDimensional | To demonstrate thatthe product meetsthedimensionalspecifications. | ISO 80369-7 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Fluid Leakageby PressureDecay | To demonstrate thatthe luer lockconnector does notleak while subjectedto applied pressure. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Sub-atmosphericPressure AirLeakage | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. | |
| Stress Cracking | To demonstrate thatthe luer lockconnector does notcrack when subjectedto axial force andtorque. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Resistance toSeparationfrom Axial Load | To demonstrate thatthe luer lock connectordoes not separate fromthe referenceconnector whilesubjected to adisconnection appliedaxial force | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| To demonstrate that | Pass | ||
| Resistance toSeparationfromUnscrewing | the luer lockconnector does notoverride the threadsof a referenceconnector whilesubjected tounscrewing torque. | ISO 80369-20 | All samples metthe pre-determinedacceptancecriteria. |
| Resistance toOverriding | To demonstrate thatthe luer lockconnector does notoverride the threadsof a referenceconnector whilesubjected to appliedtorque. | ISO 80369-20 | All samples metthe pre-determinedacceptancecriteria. |
| TorqueDurability | To demonstrate thatthere is noseparation of thedilator hub from theshaft or embolizationafter one completerotation of the hub. | FDA guidance Certain PTCACatheters:2010Coronary, Peripheral, andNeurovascular Guidewires –Performance Tests andRecommended Labeling | All samples metthe pre-determinedacceptancecriteria. |
| Luer Activated Valve (LAV) | |||
| VisualInspection | To demonstrate thatthe LAV meetsthe visualspecifications. | ISO 10555-1ISO 10555-4ISO 11070 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Leak Test | To demonstrate thatthe LAV does notleak when used toinflate/deflate theballoon. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| Activation | To demonstrate thatthat the LAV allowsflow and does notleak when activated.To demonstrate thatthe LAV preventsflow and maintainsballoon inflationwhen the syringe isremoved. | N/A | PassAll samples metthe pre-determinedacceptancecriteria. |
| LAV Luer Dimensional & Performance Requirements | |||
| LAV Male & Female Luer | |||
| Dimensional | To demonstrate thatthe LAV meetsthedimensionalspecifications. | ISO 80369-7 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Fluid Leakageby PressureDecaySub-atmosphericPressure AirLeakage | To demonstrate thatthe LAV connectordoes not leak underapplied pressure. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Stress Cracking | To demonstrate theLAV connector doesnot crack underspecified axial forceand torque. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Resistance toSeparationfrom Axial Load | To demonstrate theLAV connector doesnot separate fromthe referenceconnector whilesubjected to adisconnectionapplied axial force. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Resistance toSeparationfromUnscrewing | To demonstrate theLAV connector doesnot separate fromthe referenceconnector whilesubjected tospecified unscrewingtorque. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Resistance toOverriding | To demonstrate thatthe luer lockconnector does notoverride the threadsof a referenceconnector whilesubjected to anapplied torque. | ISO 80369-20 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Rotating Hemostasis Valve (RHV) | |||
| Visual | To demonstrate that | Pass | |
| Inspection | |||
| Inspection | the RHV meetsthe visualspecifications. | ISO 10555-1ISO 10555-4ISO 11070 | All samples metthe pre-determinedacceptancecriteria. |
| ID (Male Luer) | To demonstrate theRHV meets the IDspecification of therigid male luer. | ISO 10555-1ISO 10555-4ISO 11070 | PassAll samples metthe pre-determinedacceptancecriteria. |
| ID (CompressionSeal) | To demonstrate theRHV meets the IDspecification of thecompression seal. | ISO 10555-1ISO 10555-4ISO 11070 | PassAll samples metthe pre-determinedacceptancecriteria. |
| ID (Side Port) | To demonstrate theRHV meets the IDspecification of theside port. | ISO 10555-1ISO 10555-4ISO 11070 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Seal Integrity(Pressure) | To demonstrate theRHV does not leak orcollapse underpressure. | ISO 10555-1 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Seal Integrity(Aspiration) | To demonstrate theRHV does not leak orcollapse underaspiration. | ISO 10555-1 | PassAll samples metthe pre-determinedacceptancecriteria. |
| RHV Hub Luer Dimensional & Performance | |||
| Gauging | To demonstrate thatRHV product meetsthe conical part ofthe lock fitting. | ISO 594-1 | PassAll samples metthe pre-determinedacceptancecriteria. |
| Liquid Leakage | To demonstrate thatthere is no leakagesufficient to form afalling drop | ||
| Air Leakage | To demonstrate thatthere is no sign ofcontinued formationof air bubbles. | ISO 594-2 | PassAll samples metthe pre-determinedacceptancecriteria. |
| SeparationForceUnscrewingTorque | To demonstrate thatthe product fittingremains attached tothe reference fitting. | ||
| Ease ofAssembly | To demonstrate thatthe RHV meets therequirements forsmall boreconnectors. | ||
| Resistance toOverriding | To demonstrate theRHV fitting does notoverride the threadsor lugs of the fitting. | ||
| Stress Cracking | To demonstrate thatthe RHV withstandsstress cracking of thefitting. | ISO 594-2 | PassAll samples metthe pre-determinedacceptancecriteria. |
Specifically, the following bench tests were performed on the subject device:
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Animal Studies:
Acute animal study has been performed to assess the usability, effectiveness and safety of the EMBOGUARD Balloon Guide Catheter device compared to the predicate device in the swine model. Acute performance evaluated on Day 0 showed that the usability and performance of the EMBOGUARD Balloon Guide Catheter device was equivalent to that of the predicate device tested. Histological evaluation performed on treated vessels after 2-3 days demonstrated that the local and end organ tissue response was comparable between the EMBOGUARD Balloon Guide Catheter and the predicate device tested.
Clinical Studies:
No clinical studies were performed to demonstrate substantial equivalence.
CONCLUSIONS
The subject device has similar intended use and technological characteristics as the predicate device. The differences do not raise new questions of safety and effectiveness. Non-clinical studies conducted demonstrate that the EMBOGUARD Balloon Guide Catheter is substantially equivalent to the predicate device.
§ 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).