(208 days)
The BOBBY Balloon Guide Catheter is intended: For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end. The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.
The provided text describes the acceptance criteria and study proving the device meets those criteria for the BOBBY Balloon Guide Catheter. It's important to note that this is a medical device (catheter), not an AI/algorithm-based device, so the usual metrics for AI performance (like sensitivity, specificity, MRMC studies, training/test sets for AI) are not applicable here.
The "acceptance criteria" for this device are established through various performance and biocompatibility tests designed to ensure its safety and effectiveness for its intended use. The "study that proves the device meets the acceptance criteria" refers to the results of these performance and biocompatibility tests.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comprehensive table under "Performance Testing Summary" and "Biocompatibility Testing Summary." The "Acceptance Criteria" for each test are implied by the "Reference Standard" and the "Results" section confirming that "All samples met the pre-determined acceptance criteria" or similar statements of compliance.
Key:
- Acceptance Criteria (Implied): Meeting the requirements of the stated reference standard or pre-determined specifications.
- Reported Device Performance: "Pass" indicating that all samples tested met the criteria.
| Performance Test Study Name | Description | Reference Standard / Implied Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Conditioning, Distribution, and Shelf Life Aging Verification | To demonstrate packaging strength and integrity following accelerated aging to 1-year shelf life equivalent. | ASTM F88 Seal Strength, ASTM F2096 Gross Leaks | Pass (All samples met pre-determined acceptance criteria) |
| Packaging Visual Inspection | To demonstrate product meets packaging visual inspection requirements. | N/A (Internal visual inspection requirements implied) | Pass (All samples met pre-determined acceptance criteria) |
| Visual Surface Requirements | To demonstrate product satisfies visual surface requirements. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Dimensional/Physical Attributes Inspection | To demonstrate product meets dimensional specifications. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Inflation Volume vs Balloon Diameter | To demonstrate product meets inflation volume vs balloon diameter specifications. | In consideration of ISO 10555-4:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Balloon Burst Volume | To demonstrate Balloon is capable of withstanding an injection volume above the maximum fill volume. | In consideration of ISO 10555-4:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Tip Stiffness | To demonstrate stiffness of distal end is similar to other marketed devices. | N/A (Comparative to predicate implied) | Pass (All samples met pre-determined acceptance criteria) |
| Torque Testing | To demonstrate product is capable of 720 degrees of rotation about central lumen axis without failure. | N/A (Internal functional requirement implied) | Pass (All samples met pre-determined acceptance criteria) |
| Force at Break | To demonstrate product satisfies force at break requirements. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Small Bore Connector Compliance with Standard | To demonstrate product meets requirements. | ISO 80369-7 2016 | Pass (All samples met pre-determined acceptance criteria) |
| Radiopacity | To determine radiopaque characteristics. | ISO 10555-1:2013, ASTM F640-12 | Pass (All samples met pre-determined acceptance criteria) |
| Particulate, Coating Integrity | To determine quantity and size of particles generated during simulated use. | USP <788> Particulate Matter in Injections | Pass (All samples met pre-determined acceptance criteria) |
| Freedom from Liquid Leakage | To demonstrate product meets liquid leakage requirements. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Hub Aspiration Air Leakage | To demonstrate product meets hub aspiration air leakage requirements. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Balloon Fatigue Test | To demonstrate no degradation of Balloon after repetitive inflation cycles. | In consideration of ISO 10555-4:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Simulated Use | Simulated use under in vitro conditions in a cerebral vascular model. | In consideration of ISO 10555-4:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Flexural Fatigue | To demonstrate product does not lose structural integrity when used in tortuous path model. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Kink Resistance | To demonstrate device has similar kink resistance compared to predicate device. | N/A (Comparative to predicate implied) | Pass (All samples met pre-determined acceptance criteria) |
| Lubricity and durability of the hydrophilic coating | To demonstrate hydrophilic coating is lubricious and durable. | N/A (Internal functional requirement implied) | Pass (All samples met pre-determined acceptance criteria) |
| Guidewire lumen burst pressure (Static, dynamic) | To demonstrate device does not burst below rated burst pressure. | ISO 10555-1:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Balloon Deflation Time | To demonstrate device has similar balloon deflation time compared to predicate device. | ISO10555-4:2013 | Pass (All samples met pre-determined acceptance criteria) |
| Lumen Collapse | To demonstrate guidewire lumen does not collapse under aspiration. | N/A (Internal functional requirement implied) | Pass (All samples met pre-determined acceptance criteria) |
Biocompatibility Tests:
| Test Name | Test Method / Implied Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Cytotoxicity | ISO 10993-5 (Noncytotoxic) | Pass (Noncytotoxic according to predetermined acceptance criteria) |
| Sensitization | ISO 10993-10, Kligman Maximization Test (No sensitization response) | Pass (Did not elicit a sensitization response according to predetermined acceptance criteria) |
| Intracutaneous Irritation | ISO 10993-10 (Test requirements for intracutaneous reactivity met) | Pass (Test requirements for intracutaneous reactivity were met according to predetermined acceptance criteria) |
| Systemic Toxicity: Systemic Injection Test | ISO 10993-11 (Test requirements for systemic toxicity met) | Pass (Test requirements for systemic toxicity were met according to predetermined acceptance criteria) |
| Systemic Toxicity: Material Mediated Pyrogenicity | ISO 10993-11, USP NF 36:2018 <151> Pyrogen Test (Non-pyrogenic) | Pass (Non-pyrogenic, met the predetermined acceptance criteria) |
| Hemocompatibility: Hemolysis | ASTM F756-17, ISO 10993-4 (Non-hemolytic) | Pass (Non-hemolytic, met the predetermined acceptance criteria) |
| Hemocompatibility: Complement Activation | ISO 10993-4, SC5b-9 Complement Activation (Does not activate complement system) | Pass (Does not activate the complement system, met the predetermined acceptance criteria) |
| Hemocompatibility: Thrombogenicity | ISO 10994-4, ASTM F2888-19 (Demonstrates similar thromboresistance characteristics as control device) | Pass (Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria) |
| Hemocompatibility: In Vitro Hemocompatibility | ISO 10993-4 (Not expected to result in adverse effects in vivo) | Pass (Not expected to result in adverse effects in vivo, met the predetermined acceptance criteria) |
| Hemocompatibility: Partial Thromboplastin Time | ISO 10994-4, ASTM F2382-18 (Does not have an effect on coagulation of human plasma) | Pass (Does not have an effect on coagulation of human plasma, met the predetermined acceptance criteria) |
2. Sample size used for the test set and the data provenance
The document states "All samples met the pre-determined acceptance criteria" implying multiple samples were tested for each performance test. However, the specific sample sizes for each test are not explicitly provided in this summary.
Data Provenance: The tests are described as in vitro (benchtop testing) and in vitro biocompatibility tests, some conducted in a "cerebral vascular model." It is retrospective in the sense that the results are being reported after the tests were conducted. The country of origin for the data is not specified but would typically be where MicroVention, Inc. conducts its R&D and testing, likely in the USA given their address is Tustin, California.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device submission. The "ground truth" for this medical device is established by physical and chemical properties and performance characteristics measured against recognized international standards (e.g., ISO, ASTM, USP) and internal specifications, rather than by human expert review of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no human-in-the-loop assessment requiring adjudication for this device's performance testing. The tests are objective measurements against set standards.
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
This question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The BOBBY Balloon Guide Catheter is a physical medical device, not an AI or imaging device, and does not involve human readers interpreting data assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm-only or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance and biocompatibility is based on established engineering and material science standards (ISO, ASTM, USP), verified physical/chemical measurements, and the device's ability to consistently meet predefined specifications for functionality and safety in a laboratory setting. For comparison, the predicate device's characteristics also serve as a comparative ground.
8. The sample size for the training set
This question is not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no AI training set.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2020
MicroVention, Inc. Stephanie Onstot Senior Regulatory Affairs Specialist 1311 Valencia Avenue Tustin, CA 92780
Re: K193607
Trade/Device Name: BOBBY Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 25, 2020 Received: June 26, 2020
Dear Stephanie Onstot:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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 (Acting) 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) K193607
Device Name BOBBY Balloon Guide Catheter
Indications for Use (Describe) The BOBBY Balloon Guide Catheter is intended:
For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other 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
510(k) Owner Information:
| 510(k) Owner: | MicroVention, Inc. | |
|---|---|---|
| Address: | 1311 Valencia Ave | |
| Tustin, California, USA | ||
| Telephone: | 714-247-8000 | |
| Fax: | 714-247-8014 | |
| Contact Person | Stephanie Onstot | |
| Telephone | 714-247-8000 x 8317 | |
| Date Prepared: | June 25, 2020 | |
| Device Trade Name: | BOBBY™ Balloon Guide Catheter | |
| Classification: | Class II | |
| Classification Name: | Percutaneous Catheter | |
| Product Code(s): | DQY, QJP | |
| Regulation Number(s) | 870.1250 | |
| Predicate Devices: | Concentric Medical, FlowGate2™ (K153729) | |
Indication for Use:
The BOBBY Balloon Guide Catheter is intended:
For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Device Description
The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end.
The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic
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procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.
Performance Testing Summary:
The BOBBY Balloon Guide Catheter has successfully completed the following relevant performance testing demonstrating that the device is suitable for its intended use.
| Performance Test Summary | |||
|---|---|---|---|
| Study Name | Description | Reference Standard | Results |
| Conditioning,Distribution, and ShelfLife Aging Verification | To demonstrate that the productmeets the packaging strength andpackaging integrity followingaccelerated aging to a 1-yearshelf life equivalent | ASTM F88 SealStrength of FlexibleBarrier materialsASTM F2096 StandardTest Method forDetecting Gross Leaksin Medical Packaging | PassAll samples met the pre-determined acceptancecriteria |
| Packaging VisualInspection | To demonstrate that the productmeets the packaging visualinspection requirements given | N/A | PassAll samples met the pre-determined acceptancecriteria |
| Visual SurfaceRequirements | To demonstrate the productsatisfies the visual surfacerequirements | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Dimensional/PhysicalAttributes Inspection | To demonstrate that the productmeets the dimensionalspecifications | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Inflation Volume vsBalloon Diameter | To demonstrate that the productmeets the inflation volume vsballoon diameter specifications | In consideration ofISO 10555-4:2013Intravascular Catheters- Sterile and Single-Use Catheters - Part 4:Balloon DilationCatheters | PassAll samples met the pre-determined acceptancecriteria |
| Balloon Burst Volume | To demonstrate that the Balloonis capable of withstanding aninjection volume above themaximum fill volume. | In consideration ofISO 10555-4:2013Intravascular Catheters- Sterile and Single-Use Catheters - Part 4:Balloon DilationCatheters | PassAll samples met the pre-determined acceptancecriteria |
| Tip Stiffness | To demonstrate that the stiffnessof the distal end of the product issimilar to other marketed devices. | N/A | PassAll samples met the pre-determined acceptancecriteria |
| Torque Testing | To demonstrate that the productis capable of 720 degrees ofrotation about the central lumenaxis without failure. | N/A | PassAll samples met the pre-determined acceptancecriteria |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| Force at Break | To demonstrate the productsatisfies the force at breakrequirements | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Small Bore ConnectorCompliance withStandard | To demonstrate that the productmeets the requirements | ISO 80369-7 2016,Small-bore connectorsfor liquids and gases inhealthcare applications- Part 7, Connectorsfor intravascular orhypodermicapplications. | PassAll samples met the pre-determined acceptancecriteria |
| Radiopacity | To determine the radiopaquecharacteristics of the device. | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirementsASTM F640-12Standard Test Methodsfor DeterminingRadiopacity forMedical Use | PassAll samples met the pre-determined acceptancecriteria |
| Particulate, CoatingIntegrity | This study was conducted todetermine the quantity and size ofparticles generated duringsimulated use | USP <788> ParticulateMatter in Injections | PassAll samples met the pre-determined acceptancecriteria |
| Freedom from LiquidLeakage | To demonstrate that the productmeets the liquid leakagerequirements given in ISO10555- 1. | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Hub Aspiration AirLeakage | To demonstrate that the productmeets the hub aspiration airleakage requirements given inISO 10555-1. | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Balloon Fatigue Test | To demonstrate that there is nodegradation of the Balloon afterrepetitive inflation cycles. | In consideration ofISO 10555-4:2013Intravascular Catheters- Sterile and Single-Use Catheters - Part 4:Balloon DilationCatheters | PassAll samples met the pre-determined acceptancecriteria |
| Simulated Use | Simulated use under in vitroconditions in a cerebral vascularmodel | In consideration ofISO 10555-4:2013Intravascular Catheters- Sterile and Single-Use Catheters - Part 4:Balloon DilationCatheters | PassAll samples met the pre-determined acceptancecriteria |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| Flexural Fatigue | To demonstrate that the productdoes not lose structural integritywhen used in the tortuous pathmodel. | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Kink Resistance | To demonstrate that the devicehas similar kink resistancecompared to the predicate device. | N/A | PassAll samples met the pre-determined acceptancecriteria |
| Lubricity and durability ofthe hydrophilic coating | To demonstrate that thehydrophilic coating is lubriciousand durable. | N/A | PassAll samples met the pre-determined acceptancecriteria |
| Guidewire lumen burstpressure (Static, dynamic) | To demonstrate that the devicedoes not burst below rated burstpressure. | ISO 10555-1:2013Intravascular catheters- Sterile and single-usecatheters - Part 1:General requirements | PassAll samples met the pre-determined acceptancecriteria |
| Balloon Deflation Time | To demonstrate that the devicehas similar balloon deflation timecompared to the predicate device. | ISO10555-4:2013Intravascular catheters- Sterile and single-usecatheters – Part 4:Balloon dilationcatheters | PassAll samples met the pre-determined acceptancecriteria |
| Lumen Collapse | To demonstrate that theguidewire lumen does notcollapse under aspiration. | N/A | PassAll samples met the pre-determined acceptancecriteria |
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No animal or clinical studies were required to demonstrate substantial equivalence.
Biocompatibility Testing Summary
Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (< 24 hours), per ISO 10993-1, the following testing was conducted:
| Test Name | Test Method | Results | |
|---|---|---|---|
| Cytotoxicity | Tested in accordance with ISO 10993-5, BiologicalEvaluation of Medical Devices – Part 5: Tests for invitro cytotoxicity | PassNoncytotoxic according to thepredetermined acceptance criteria | |
| Sensitization | Tested in accordance with ISO 10993-10, BiologicalEvaluation of Medical Devices – Part 10 Tests forIrritation and Skin Sensitization, KligmanMaximization Test | PassDid not elicit a sensitization responseaccording to the predeterminedacceptance criteria | |
| IntracutaneousIrritation | Tested in accordance with ISO 10993-10, BiologicalEvaluation of Medical Devices – Part 10: Tests forIrritation and Skin Sensitization | PassTest requirements forintracutaneous reactivity were metaccording to the predeterminedacceptance criteria |
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| Test Name | Test Method | Results |
|---|---|---|
| Systemic Toxicity:Systemic InjectionTest | Tested in accordance with ISO 10993-11, BiologicalEvaluation of Medical Devices - Part 11: Tests forSystemic Toxicity | PassTest requirements for systemictoxicity were met according to thepredetermined acceptance criteria |
| Systemic Toxicity:Material MediatedPyrogenicity | Tested in accordance with ISO 10993-11, BiologicalEvaluation of Medical Devices – Part 11: Tests forSystemic Toxicity and USP NF 36:2018 <151>Pyrogen Test | PassNon-pyrogenic, met thepredetermined acceptance criteria |
| Hemocompatibility:Hemolysis | Tested in accordance with ASTM F756-17,Standard Practice for Assessment of HemolyticProperties of Materials and ISO 10993-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood. Tests forHemolytic Properties, Direct and Indirect Methods | PassNon-hemolytic, met thepredetermined acceptance criteria |
| Hemocompatibility:ComplementActivation | Tested in accordance with ISO 10993-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood, SC5b-9Complement Activation | PassDoes not activate the complementsystem, met the predeterminedacceptance criteria |
| Hemocompatibility:Thrombogenicity | Tested in accordance with ISO 10994-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood, and ASTMF2888-19, Standard Practice for Platelet LeukocyteCount-An In Vitro Measure for HemocompatibilityAssessment of Cardiovascular Materials | PassDemonstrates similarthromboresistance characteristics asthe control device, met thepredetermined acceptance criteria |
| Hemocompatibility:In VitroHemocompatibility | Tested in accordance with ISO 10993-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood,Hemocompatibility, Direct Contact Method | PassNot expected to result in adverseeffects in vivo, met thepredetermined acceptance criteria |
| Hemocompatibility:PartialThromboplastin Time | Tested in accordance with ISO 10994-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood and ASTM F2382-18, Standard Test Method for Assessment ofIntravascular Medical Device Materials on PartialThromboplastin Time (PTT) | PassDoes not have an effect oncoagulation of human plasma, metthe predetermined acceptancecriteria |
Predicate Device Comparison
The following table provides a comparison of the key characteristics of the BOBBY Balloon Guide Catheter to the predicate device.
| Comparison Chart | ||||
|---|---|---|---|---|
| Feature | Subject Device | Predicate device | Comparison | |
| BOBBY BalloonGuide CatheterK193607 | 8F FlowGate2™Balloon Guide CatheterK153729 | |||
| FDA Classification | Class II | Class II | Same | |
| Product Code(s) | DQY, QJP | DQY | Same | |
| Regulation Number | 870.1250 | 870.1250 | Same | |
| Regulation Name | Percutaneous Catheter | Percutaneous Catheter | Same | |
| Anatomical Locations | Peripheral and neuro vasculature | Peripheral and neuro vasculature | Same | |
| Comparison Chart | ||||
| Feature | Subject DeviceBOBBY BalloonGuide CatheterK193607 | Predicate device8F FlowGate™Balloon Guide CatheterK153729 | Comparison | |
| Material | Commonly usedmedical grade plastics(e.g. nylon, PTFE,polyethylene,polyolefin) andstainless steel | Commonly usedmedical grade plastics(e.g. nylon, PTFE,polyethylene,polyolefin) andstainless steel | Similar, minordifferences do notraise new questionsof safety andefficacy, confirmedthroughbiocompatibility andperformance testing | |
| Reinforced CatheterShaft | Stainless steel braidand coil reinforcedshaft | Stainless steel braidreinforced shaft | Similar, minordifferences do notraise new questionsof safety andefficacy | |
| Injection Port | Yes | Yes | Same | |
| Radiopacity | Yes, shaft is visibledue to distal tip Pt-Irmarker bands | Yes, shaft materialcontains bariumsulfate, distal tip Pt-Irmarker band | Similar, minordifference does notraise new questionsregarding safety andefficacy, bothdevices areradiopaque | |
| Radiopaque MarkerBands | 2 | 1 | Similar, minordifference does notraise new questionsregarding safety andefficacy, bothdevices utilizeradiopaque markerbands | |
| Compliant Balloon | Yes, polyurethane | Yes, silicone | Similar, materialdifferences do notraise new questionsof safety andefficacy, bothmaterials are usedfor compliantballoons forintravascular use | |
| Labeled Shaft OuterDiameter | 0.110 in (2.8 mm)8Fr | 0.106 in (2.7 mm)8Fr | Similar, minordifferences do notraise new questionsof safety andefficacy | |
| Comparison Chart | ||||
| Feature | Subject DeviceBOBBY BalloonGuide CatheterK193607 | Predicate device8F FlowGate2™Balloon Guide CatheterK153729 | Comparison | |
| Labeled Shaft InnerDiameter | 0.086 in (2.18 mm)6.5Fr | 0.084 in (2.1 mm)6.4Fr | Similar, minordifferences do notraise new questionsof safety andefficacy | |
| Effective length | 95 cm(37.4 in) | 85 cm, 95cm(33.5, 37.4 in) | Similar, minordifferences do notraise new questionsof safety andefficacy | |
| Tip Shape | Straight | Straight | Same | |
| Coating | Hydrophilic Coating -Distal portion of shaft | None | Difference does notraise new questionsof safety andefficacy.Hydrophilic coatingsare commonly usedto lubricate vascularcatheters. | |
| Internal Construction | Coaxial lumen | Coaxial lumen | Same | |
| Accessories Supplied | Peel Away Sheath | Dilator, RotatingHemostasis Valve,Tuohy Borst Valvewith sideport, PeelAway Sheaths, Luer-Activated Valves | Similar, minordifferences do notraise new questionsof safety andefficacy. | |
| How Supplied | Sterile, single use | Sterile, single use | Same | |
| Sterilization Method | EtO | EtO | Same | |
| Sterility AssuranceLevel | 10-6 | 10-6 | Same |
{8}------------------------------------------------
{9}------------------------------------------------
Conclusion:
MicroVention, Inc. concludes through a review of the benchtop assessments, the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility that the BOBBY Balloon Guide Catheter is substantially equivalent to the predicate device, FlowGate2™ Balloon Guide Catheter. Any differences are minor and do not raise different questions of safety and effectiveness.
§ 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).