(112 days)
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.
The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:
- 087 Balloon Guide Catheter
- 1cc Inflation Syringe
- 8Fr Peel Away Introducer
- Hub Extension
- Three Way Stopcock
The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
The provided document is a 510(k) Premarket Notification summary for the Q'Apel Medical LLC 087 Balloon Guide Catheter System. It describes the device, its indications for use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The entire submission focuses on demonstrating the substantial equivalence of a new medical device (a catheter system) to an already legally marketed predicate device, rather than proving the efficacy of a new AI/software-based medical device. Therefore, many of the requested points related to AI/MRMC studies, expert ground truth adjudication, and training set details are not applicable to this document. The "studies" here are primarily benchtop and biocompatibility tests on a physical medical device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "Pass" indicating that "All samples met the pre-determined acceptance criteria" for each listed test. The reported performance is a statement of compliance with these criteria.
| Performance Test Study Name | Description | Reference Standard | Acceptance Criteria & Reported Device Performance |
|---|---|---|---|
| Conditioning, Distribution, and Shelf Life Aging Verification | To demonstrate that the product meets the packaging strength and packaging integrity following accelerated aging to a 6-month shelf life equivalent. | ASTM F88, ASTM F2096 | Pass: All samples met the pre-determined acceptance criteria. |
| Packaging Visual Inspection | To demonstrate that the product meets the packaging visual inspection requirements given. | N/A (Internal protocol likely) | Pass: All samples met the pre-determined acceptance criteria. |
| Visual Surface Requirements | To demonstrate the product satisfies the visual surface requirements. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Dimensional Inspection | To demonstrate that the product meets the dimensional specifications. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Inflation Volume vs Balloon Diameter | To demonstrate that the product meets the inflation volume vs balloon diameter specifications. | In consideration of ISO 10555-4:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Balloon Burst Volume | To demonstrate that the Balloon is capable of withstanding an injection volume of 1.0 CC. | In consideration of ISO 10555-4:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Tip Deflection, FG 00100 | To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices. | N/A (Comparison to predicate likely) | Pass: All samples met the pre-determined acceptance criteria. |
| Torque Testing | To demonstrate that the product is capable of 720 degrees of rotation about the central lumen axis without failure. | N/A (Internal protocol likely) | Pass: All samples met the pre-determined acceptance criteria. |
| Peak Tensile | To demonstrate the product satisfies the peak tensile requirements. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Small Bore Connector Compliance with Standard | To demonstrate that the product meets the requirements. | ISO 80369-7:2016 | Pass: All samples met the pre-determined acceptance criteria. |
| Corrosion Resistance | To demonstrate the product satisfies the corrosion resistance requirements. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Radiopacity | To determine the radiopaque characteristics of the device. | ISO 10555-1:2013, ASTM F640-12 | Pass: All samples met the pre-determined acceptance criteria. |
| Hub Extension Liquid Leakage Under Pressure | To demonstrate that the product meets the liquid leakage requirements. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Hub Extension Hub Aspiration Air Leakage | To demonstrate that the product meets the liquid leakage requirements. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Particulates, Coating Integrity | This study was conducted to determine the quantity and size of particles generated during simulated use. | AAMI TIR42:10, USP <788>, FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015 | Pass: All samples met the pre-determined acceptance criteria. |
| Liquid Leakage Under Pressure | To demonstrate that the product meets the liquid leakage requirements given in ISO 10555-1. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Hub Aspiration Air Leakage | To demonstrate that the product meets the hub aspiration air leakage requirements given in ISO 10555-1. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Balloon Inflation Fatigue | To demonstrate that there is no degradation of the Balloon after 20 inflation cycles. | In consideration of ISO 10555-4:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Simulated Use | Evaluation of device performance under simulated use conditions compared to the predicate device. | In consideration of ISO 10555-4:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Flex Fatigue | To demonstrate that the product does not lose structural integrity when used in the tortuous path model. | ISO 10555-1:2013 | Pass: All samples met the pre-determined acceptance criteria. |
| Simulated Use Evaluation of the Q'Apel Balloon Guide Catheter | Simulated use under in vitro conditions in a cerebral vascular model. | N/A (Internal protocol likely) | Pass: All samples met the pre-determined acceptance criteria. |
Biocompatibility Testing Summary:
| Test Name | Test Method | Acceptance Criteria & Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Pass: Noncytotoxic according to the predetermined acceptance criteria. |
| Intracutaneous Irritation | ISO 10993-10 | Pass: Test requirements for intracutaneous reactivity were met. |
| Sensitization | ISO 10993-10 (Kligman Maximization Test) | Pass: Did not elicit a sensitization response. |
| Systemic Toxicity | ISO 10993-11 | Pass: Test requirements for systemic toxicity were met. |
| Material Mediated Pyrogenicity | ISO 10993-11, USP 40 <151> Pyrogen Test | Pass: Nonpyrogenic. |
| Hemolysis | ASTM F756-17, ISO 10993-4 | Pass: Non-hemolytic. |
| In Vitro Hemocompatibility | ISO 10993-4 | Pass: Not expected to result in adverse effects in vivo. |
| Complement Activation | ISO 10993-4 (SC5b-9 Complement Activation) | Pass: Does not activate the complement system. |
| Un-activated Partial Thromboplastin Time | ISO 10994-4, ASTM F2382-04 | Pass: Does not have an effect on coagulation of human plasma. |
| Thrombogenicity | ISO 10994-4 | Pass: Demonstrates similar thromboresistance characteristics as the control device. |
Study Details (Applicability to a Physical Medical Device, Not AI/Software)
-
Sample sizes used for the test set and the data provenance:
- The document states "All samples met the pre-determined acceptance criteria" for each test. However, the specific number of samples tested for each benchtop performance or biocompatibility test is not explicitly provided in the summary.
- Data provenance: These are laboratory/benchtop tests and in vitro biocompatibility tests, not data derived from patients or clinical sources. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable. The tests are conducted in a controlled lab environment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a physical device like a catheter, "ground truth" is established by adherence to engineering specifications and international standards (e.g., ISO, ASTM) through objective physical testing, not by expert consensus on interpretations of data.
- Experts, if involved, would be internal engineers, quality control personnel, or third-party testing labs specializing in medical device testing, not typically medical experts like radiologists establishing diagnostic "ground truth."
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading, clinical diagnoses) where multiple experts might disagree. These are objective engineering and biological tests with defined pass/fail criteria.
-
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:
- No, an MRMC study was not done. This type of study is specifically for evaluating the impact of AI algorithms on human performance in diagnostic tasks (e.g., radiology). This submission is for a physical catheter, not an AI software. The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to the performance of an AI algorithm alone. The device is a physical catheter system, not a software algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth for this device is based on engineering specifications, physical measurements, and adherence to established international standards (e.g., ISO 10555-1, ASTM F88, ISO 10993 series). It's objective, quantitative data from benchtop and in vitro (laboratory) tests.
-
The sample size for the training set:
- Not applicable. This concept pertains to machine learning models (AI). There is no "training set" for a physical medical device. The device itself is manufactured to specifications.
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
In summary, the provided document details the testing and acceptance criteria for a physical medical device (a catheter system) to demonstrate its substantial equivalence to a predicate device for FDA 510(k) clearance. It does not involve AI or software, and therefore, many of the questions related to AI validation methodologies (e.g., MRMC studies, expert adjudication, training/test sets) are not relevant to this specific submission.
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July 15, 2019
Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K190749
Device Name: 087 Balloon Guide Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, MJN Dated: June 12, 2019 Received: June 14, 2019
Dear Michele Lucey:
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
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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 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 mediation-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,
Xiaolin Zheng, 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)
Device Name 087 Balloon Guide Catheter System
Indications for Use (Describe)
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.
| 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 As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Q'Apel Medical LLC |
|---|---|
| Address: | 330 Wilshire Boulevard |
| Santa Monica CA 90401 | |
| Telephone: | 310-395-3950 |
| Fax: | 310-395-3950 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | July 15, 2019 |
| Device Trade Name: | 087 Balloon Guide Catheter System |
| Classification: | Class II |
| Classification Name: | Percutaneous Catheter |
| Product Code(s): | DQY, MJN |
| Regulation Number(s): | 870.1250 |
| Predicate Devices: | Concentric Medical, FlowGate2™ (K153729) |
Indication for Use:
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.
Device Description
The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:
- 087 Balloon Guide Catheter ●
- 1cc Inflation Syringe ●
- 8Fr Peel Away Introducer ●
- Hub Extension ●
- Three Way Stopcock ●
The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned
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coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
Performance Testing Summary:
The 087 Balloon Guide Catheter System 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 Shelf Life Aging Verification | To demonstrate that the product meets the packaging strength and packaging integrity following accelerated aging to a 6-month shelf life equivalent | ASTM F88 Seal Strength of Flexible Barrier materialsASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging | PassAll samples met the pre-determined acceptance criteria |
| Packaging Visual Inspection | To demonstrate that the product meets the packaging visual inspection requirements given | N/A | PassAll samples met the pre-determined acceptance criteria |
| Visual Surface Requirements | To demonstrate the product satisfies the visual surface requirements | ISO 10555-1:2013Intravascular catheters - Sterile and single-use catheters - Part 1:General requirements | PassAll samples met the pre-determined acceptance criteria |
| Dimensional Inspection | To demonstrate that the product meets the dimensional specifications | ISO 10555-1:2013Intravascular catheters - Sterile and single-use catheters - Part 1:General requirements | PassAll samples met the pre-determined acceptance criteria |
| Inflation Volume vs Balloon Diameter | To demonstrate that the product meets the inflation volume vs balloon diameter specifications | In consideration of ISO 10555-4:2013Intravascular Catheters - Sterile and Single-Use Catheters - Part 4:Balloon Dilatation Catheters | PassAll samples met the pre-determined acceptance criteria |
| Balloon Burst Volume, | To demonstrate that the Balloon is capable of withstanding an injection volume of 1.0 CC. | In consideration of ISO 10555-4:2013Intravascular Catheters - Sterile and Single-Use Catheters - Part 4:Balloon Dilatation Catheters | PassAll samples met the pre-determined acceptance criteria |
| Tip Deflection, FG 00100 | To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices. | N/A | PassAll samples met the pre-determined acceptance criteria |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| Torque Testing | To demonstrate that the product iscapable of 720 degrees of rotationabout the central lumen axiswithout failure. | N/A | PassAll samples metthe pre-determinedacceptance criteria |
| Peak Tensile | To demonstrate the productsatisfies the peak tensilerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| Flow Rate | To demonstrate that the flow rateis comparable to the predicatedevice. | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| 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 metthe pre-determinedacceptance criteria |
| Corrosion Resistance | To demonstrate the productsatisfies the corrosion resistancerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| 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 metthe pre-determinedacceptance criteria |
| Hub Extension LiquidLeakage Under Pressure | To demonstrate that the productmeets the liquid leakagerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| Hub Extension HubAspiration Air Leakage | To demonstrate that the productmeets the liquid leakagerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| Particulates, CoatingIntegrity | This study was conducted todetermine the quantity and size ofparticles generated duringsimulated use | AAMI TIR42:10Evaluation ofparticulates associatedwith vascular medicaldevicesUSP <788> ParticulateMatter in InjectionsFDA CTQ: HydrophilicCoated andHydrophobic CoatedVascular andNeurological Devices,August 2015 | PassAll samples metthe pre-determinedacceptance criteria |
| Liquid Leakage UnderPressure | To demonstrate that the productmeets the liquid leakagerequirements given in ISO 10555-1. | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| 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 metthe pre-determinedacceptance criteria |
| Balloon Inflation Fatigue | To demonstrate that there is nodegradation of the Balloon after20 inflation cycles. | In consideration of ISO10555-4:2013Intravascular Catheters- Sterile and Single-UseCatheters - Part 4:Balloon DilatationCatheters | PassAll samples metthe pre-determinedacceptance criteria |
| Simulated Use | Evaluation of device performanceunder simulated use conditionscompared to the predicate device | In consideration of ISO10555-4:2013Intravascular Catheters- Sterile and Single-UseCatheters - Part 4:Balloon DilatationCatheters | PassAll samples metthe pre-determinedacceptance criteria |
| Flex Fatigue | To demonstrate that the productdoes not loose structural integritywhen used in the tortuous pathmodel. | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| Simulated Use Evaluationof the Q'Apel BalloonGuide Catheter | Simulated use under invitroconditions in a cerebral vascularmodel | N/A | PassAll samples metthe pre-determinedacceptance criteria |
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No animal or clinical studies were required to demonstrate substantial equivalence.
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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 in vitro toxicity, Neutral Red Uptake Method | PassNoncytotoxic according to thepredetermined acceptance 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 |
| 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 sensitizationresponse according to thepredetermined acceptance criteria |
| Systemic Toxicity | 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 |
| Material MediatedPyrogenicity | Tested in accordance with ISO 10993-11, BiologicalEvaluation of Medical Devices - Part 11: Tests forSystemic Toxicity and USP 40 <151> Pyrogen Test | PassNonpyrogenic, met thepredetermined acceptance criteria |
| 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 |
| 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 |
| 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 |
| Un-activated PartialThromboplastin Time | Tested in accordance with ISO 10994-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood and ASTM F2382-04, Standard Test Method for Assessment ofIntravascular Medical Device Materials on PartialThromboplastin Time (UPTT) | PassDoes not have an effect oncoagulation of human plasma, metthe predetermined acceptancecriteria |
| Thrombogenicity | Tested in accordance with ISO 10994-4, BiologicalEvaluation of Medical Devices - Part 4: Selection ofTests for Interactions with Blood | PassDemonstrates similarthromboresistance characteristicsas the control device, met thepredetermined acceptance criteria |
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Predicate Device Comparison
The following table provides a comparison of the key characteristics of the 087 Balloon Guide Catheter System to the predicate device.
| Comparison Chart | |||
|---|---|---|---|
| Feature | Subject Device087 Balloon GuideCatheter System | Predicate devicethe 8F FlowGate2TMBalloon Guide Catheter | Comparison |
| Regulatory Clearance/Approval Reference | K190749 | K153729 | NA |
| FDA Classification | Class II | Class II | Same |
| Product Code(s) | DQY | DQY | Same |
| Regulation Number | 870.1250 | 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Percutaneous Catheter | Same |
| Anatomical Locations | Peripheral and neurovasculature | Peripheral and neurovasculature | Same |
| Material | Commonly used medicalgrade plastics andstainless steel, | Commonly usedmedical grade plasticsand stainless steel | Similar, differencedoes not raise newquestions regardingsafety and efficacy,confirmed throughbiocompatibility andperformance testing |
| Reinforced CatheterShaft Reinforcement | Stainless steel coilreinforced | Stainless steel braidreinforced | Similar, minordifference does notraise new questionsregarding safety andefficacy, bothdevices havereinforced catheterwalls |
| Injection Port | Yes | Yes | Same |
| Radiopacity | Yes, shaft is visible dueto coil reinforcement,distal tip Pt-Ir markerbands | Yes, shaft materialcontains barium sulfate,distal tip Pt-Ir markerband | Similar, minordifference does notraise new questionsregarding safety andefficacy, bothdevices areradiopaque |
| Marker Band Locations | 0.06-in (1.5mm) from thedistal tip edge (distal ofthe balloon)0.66-in (16.8mm) fromthe distal tip edge(proximal of the balloon) | .08-in (2mm) from thedistal tip edge | Similar, minordifference does notraise new questionsregarding safety andefficacy, bothdevices utilizeradiopaque markerbands |
| Compliant Balloon | Yes, low durometerurethane | Yes, silicone | Similar, materialdifferences do not |
| Comparison Chart | |||
| Feature | Subject Device087 Balloon GuideCatheter System | Predicate devicethe 8F FlowGate2TMBalloon Guide Catheter | Comparison |
| raise new questionsof safety andefficacy, bothmaterials are usedfor compliantballoons forintravascular use | |||
| Labeled Shaft OuterDiameter | 0.110-in (max)(2.79mm)8Fr | 0.106 in(2.7mm)8Fr | Similar, minordifferences do notraise new questionsof safety andefficacy |
| Labelled Shaft InnerDimension | .087-in(2.21mm)6.6Fr | 0.084-in(2.11mm)6.4Fr | Similar, minordifferences do notraise new questionsof safety andefficacy |
| Effective length | 90, 95, 100 cm(35.4, 37.4, 39.4 in) | 90cm, 100cm(35.4, 39.4 in) | Same |
| Tip Shape | Straight | Straight | Same |
| Maximum BalloonVolume | 0.6ml | 0.6ml | Same |
| Injection Port | Yes | Yes | Same |
| Radiopaque | Distal Tip has radiopaquemarker bands, stainlesssteel reinforcement in thecatheter shaft renders theshaft visible onfluoroscopy | Distal Tip has aradiopaque markerband, stainless steelreinforcement in thecatheter shaft rendersthe shaft visible onfluoroscopy | Same |
| Coating | Hydrophilic Coating –Proximal to the balloon,on the distal Portion | None | Difference does notraise new questionsof safety andefficacy.Hydrophiliccoatings arecommonly used tolubricate vascularcatheters. Bothdevices do not havecoating on theballoon region |
| Internal Construction | Multi Lumen catheterwall | Coaxial lumen | Differences do notraise new questionsof safety andefficacy |
| Comparison Chart | |||
| Feature | Subject Device087 Balloon GuideCatheter System | Predicate devicethe 8F FlowGate2TMBalloon Guide Catheter | Comparison |
| Reinforced Shaft | Stainless steel reinforcedshaft | Stainless steelreinforced shaft | Same |
| Accessories Supplied | 3-Way Stopcock, PeelAway Sheath, Hubextension, 1ml Syringe | 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 |
| efficacy. Bothdesigns are intendedto create a pathwayto the side arm forballoon inflation |
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Conclusion:
Q'Apel Medical LLC 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 087 Balloon Guide Catheter System is substantially equivalent to the predicate device, the 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).