(48 days)
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.
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 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 from the FDA for the 087 Balloon Guide Catheter System. This document outlines the regulatory review of a medical device, focusing on demonstrating substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on your request:
1. A table of acceptance criteria and the reported device performance
The document presents a "Nonclinical Performance Testing Summary" which serves as the primary evidence for meeting acceptance criteria. Each "Study Name" implicitly defines an acceptance criterion (e.g., "Conditioning, Distribution, and Shelf Life Aging Verification" implies a criterion for packaging strength and integrity). The reported device performance for all tests is simply "Pass" with the statement "All samples met the pre-determined acceptance criteria."
| Acceptance Criteria (Derived from Study Description) | Reported Device Performance |
|---|---|
| Product meets packaging strength and packaging integrity after accelerated aging (6-month shelf life equivalent) | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets packaging visual inspection requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Product satisfies visual surface requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets dimensional specifications | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets inflation volume vs. balloon diameter specifications | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon is capable of withstanding an injection volume of 1.0CC | Pass (All samples met the pre-determined acceptance criteria) |
| Stiffness of the distal end of the product is similar to other marketed devices | Pass (All samples met the pre-determined acceptance criteria) |
| Product is capable of 720 degrees of rotation about the central lumen axis without failure | Pass (All samples met the pre-determined acceptance criteria) |
| Product satisfies peak tensile requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Flow rate is comparable to the predicate device | Pass (All samples met the pre-determined acceptance criteria) |
| Product meets the requirements for small-bore connectors (ISO 80369-7) | Pass (All samples met the pre-determined acceptance criteria) |
| Product satisfies corrosion resistance requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Radiopaque characteristics of the device meet requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Hub Extension Liquid Leakage Under Pressure meets requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Hub Extension Hub Aspiration Air Leakage meets requirements | Pass (All samples met the pre-determined acceptance criteria) |
| Quantity and size of particles generated during simulated use are acceptable | Pass (All samples met the pre-determined acceptance criteria) |
| Liquid Leakage Under Pressure meets requirements (ISO 10555-1) | Pass (All samples met the pre-determined acceptance criteria) |
| Hub Aspiration Air Leakage meets requirements (ISO 10555-1) | Pass (All samples met the pre-determined acceptance criteria) |
| No degradation of the Balloon after 20 inflation cycles | Pass (All samples met the pre-determined acceptance criteria) |
| Product does not lose structural integrity when used in a tortuous path model | Pass (All samples met the pre-determined acceptance criteria) |
| Product has acceptable kink resistance | Pass (All samples met the pre-determined acceptance criteria) |
| Device performance under simulated use conditions (including stent retrievers) compared to predicate device is acceptable | Pass (All samples met the pre-determined acceptance criteria) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence." The entire submission relies on non-clinical performance bench test data.
- Sample Size: The document does not specify the numerical sample size for any of the individual bench tests. It consistently reports "All samples met the pre-determined acceptance criteria," implying that a specific sample size was tested for each criterion, but the exact number is not provided.
- Data Provenance: The data is from non-clinical bench testing. There is no information about the country of origin of the data as these are laboratory tests. It is inherently retrospective in the sense that the testing was performed and then reported for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The "ground truth" for the non-clinical performance bench tests is established by technical standards and pre-determined acceptance criteria (e.g., ASTM, ISO standards, or internal specifications). There's no indication that human experts were used to establish ground truth for these device performance metrics.
4. Adjudication method for the test set
This is not applicable. Since the ground truth for the bench tests is based on objective measurements against pre-defined numerical or qualitative criteria (e.g., "Pass/Fail" based on whether a specification is met), there is no need for expert adjudication.
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
There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (catheter), not an AI/software device that assists human readers with interpretation. Therefore, questions regarding AI assistance and effect size are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As mentioned above, this is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical performance bench tests is based on established engineering and material science standards (e.g., ISO and ASTM standards) and pre-determined internal acceptance criteria. For example:
- ASTM F88 for Seal Strength
- ASTM F2096 for Detecting Gross Leaks
- ISO 10555-1 for General requirements of intravascular catheters
- ISO 10555-4 for Balloon Dilatation Catheters
- ISO 80369-7 for Small-bore connectors
- AAMI TIR42 and USP <788> for particulates
- DIN EN 13868 for kink resistance
- FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015 (for particulates)
These standards define the methodologies and acceptable limits for various physical and functional characteristics of catheters.
8. The sample size for the training set
This is not applicable. The device is a physical catheter, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 31, 2019
Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K192525
Device Name: 087 Balloon Guide Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 12, 2019 Received: September 13, 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. 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) K192525
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 intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System 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 Traditional 510(k) As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Q'Apel Medical LLC |
|---|---|
| Address: | 330 Wilshire BoulevardSanta Monica CA 90401 |
| Telephone: | 310-395-3950 |
| Fax: | 310-395-3950 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 17, 2019 |
| Device Trade Name: | 087 Balloon Guide Catheter System |
| Classification: | Class II |
| Classification Name: | Percutaneous Catheter |
| Product Code(s): | DQY |
| Regulation Number(s): | 870.1250 |
| Predicate Device: | Concentric Medical, FlowGate2TM, K153729 |
| Reference Device: | 087 Balloon Guide Catheter System K190749 |
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 neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.
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
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- 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 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
Nonclinical Performance Testing Summary:
Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data. The 087 Balloon Guide Catheter System has successfully completed the following relevant performance testing to demonstrate substantial equivalence. Testing was performed to evaluate physical integrity, functionality, and performance of the 087 Balloon Guide Catheter. A summary of the tests performed is provided in the table below:
| 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 6-monthshelf life equivalent | ASTM F88 SealStrength of FlexibleBarrier materialsASTM F2096 StandardTest Method forDetecting Gross Leaksin Medical Packaging | PassAll samples metthe pre-determinedacceptance criteria |
| Packaging VisualInspection | To demonstrate that the productmeets the packaging visualinspection requirements given | N/A | PassAll samples metthe pre-determinedacceptance criteria |
| Visual SurfaceRequirements | To demonstrate the productsatisfies the visual surfacerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| Dimensional Inspection | To demonstrate that the productmeets the dimensionalspecifications | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1:General requirements | PassAll samples metthe pre-determinedacceptance criteria |
| Inflation Volume vsBalloon Diameter | To demonstrate that the productmeets the inflation volume vsballoon diameter specifications | In consideration of ISO10555-4:2013Intravascular Catheters- Sterile and Single-UseCatheters - Part 4:Balloon DilatationCatheters | PassAll samples metthe pre-determinedacceptance criteria |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| Balloon Burst Volume, | To demonstrate that the Balloonis capable of withstanding aninjection volume of 1.0CC. | In consideration of ISO10555-4:2013Intravascular Catheters- Sterile and Single-UseCatheters - Part 4:Balloon DilatationCatheters | PassAll samples metthe pre-determinedacceptance criteria |
| Tip Deflection, FG 00100 | To demonstrate that the stiffnessof the distal end of the product issimilar to other marketed devices. | N/A | PassAll samples metthe pre-determinedacceptance criteria |
| 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 |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| 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 |
| Particulates, CoatingIntegrity | This study was conducted todetermine the quantity and size ofparticles generated duringsimulated use, including use withstent retrievers | 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 |
| 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 |
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| Kink Resistance | To demonstrate that the producthas acceptable kink resistance | DIN EN 13868:2002,Test methods forkinking of single lumencatheters and medicaltubing | PassAll samples metthe pre-determinedacceptance criteria |
| Simulated Use | Evaluation of device performanceunder simulated use conditions,including stent retrieverscompared to the predicate device | In consideration of ISO10555-4:2013Intravascular Catheters- Sterile and Single-UseCatheters - Part 4:Balloon DilatationCatheters | PassAll samples met thepre-determinedacceptance criteria |
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The results of these tests provide reasonable assurance that the 087 Balloon Guide Catheter System has been designed and tested to assure conformance to the requirements for its intended use and indications for use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate device.
Animal or Clinical Testing: No animal or clinical studies were required to demonstrate substantial equivalence.
Biocompatibility Testing Summary
The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (< 24 hours), per ISO 10993-1. There are no changes to the device materials or manufacturing processes, no additional biocompatibility testing was deemed necessary to implement this change.
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 of the Subject Device with the Predicate Device | |||
|---|---|---|---|
| Feature | Subject Device087 Balloon GuideCatheter System | Predicate deviceFlowGate2 BalloonGuide Catheter | Comparison |
| Regulatory Clearance/Approval Reference | K192525 | 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 |
| Indications for Use | The 087 Balloon GuideCatheter System isindicated for use infacilitating the insertion andguidance of an intravascularcatheter into a selected | FlowGate™ BalloonGuide Catheters areindicated for use infacilitating the insertionand guidance of anintravascular catheter into | Intended Use is thesame, the subject devicedoes not include anindication for use inangiographicprocedures. This |
| Comparison of the Subject Device with the Predicate Device | |||
| Feature | Subject Device087 Balloon GuideCatheter System | Predicate deviceFlowGate2 BalloonGuide Catheter | Comparison |
| blood vessel in theperipheral andneurovasculature. Theballoon provides temporaryvascular occlusion duringsuch procedures. The 087Balloon Guide CatheterSystem is also indicated foruse as a conduit forretrieval devices. | a selected blood vessel inthe peripheral and neurovascular systems. Theballoon providestemporary vascularocclusion during theseand other angiographicprocedures. The BalloonGuide Catheter is alsoindicated for use as aconduit for Retrievaldevices. | difference does notraise new questions ofsafety and efficacy, | |
| Anatomical Locations | Peripheral and neurovasculature | Peripheral and neurovasculature | Same |
| Material | Commonly used medicalgrade plastics and stainlesssteel, | Commonly used medicalgrade plastics andstainless steel, | Same |
| Reinforced Catheter ShaftReinforcement | Stainless steel coilreinforced | Stainless Steel braidreinforced | Similar, minordifference does notraise new questionsregarding safety andefficacy, both deviceshave reinforced catheterwalls, same as referencedevice |
| Injection Port | Yes | Yes | Same |
| Marker Band Locations | 0.06-in (1.5mm) from thedistal tip edge (distal of theballoon)0.66-in (16.8mm) from thedistal tip edge (proximal ofthe balloon) | 0.08-in (2mm) from thedistal tip edge | Similar, minordifference does notraise new questionsregarding safety andefficacy, both devicesutilize radiopaquemarker bands, same asreference device |
| Compliant Balloon | Yes, low durometerurethane | Yes, silicone | Similar, materialdifferences do not raisenew questions of safetyand efficacy, bothmaterials are used forcompliant balloons forintravascular use, sameas the reference device |
| Labeled Shaft OuterDiameter | 0.110-in (max)(2.79mm)8.4Fr | 0.106-in (max)(2.7mm)8Fr | Similar, minordifferences do not raisenew questions of safetyand efficacy, same asthe reference device |
| Comparison of the Subject Device with the Predicate Device | |||
| Feature | Subject Device087 Balloon GuideCatheter System | Predicate deviceFlowGate2 BalloonGuide Catheter | Comparison |
| Labelled Shaft InnerDimension | .087-in(2.21mm)6.6Fr | .084-in(2.21mm)6.4Fr | Similar, minordifferences do not raisenew questions of safetyand efficacy, same asthe reference device |
| Effective length | 90, 95, 100 cm(35.4, 37.4, 39.4 in) | 90cm, 100 cm(35.4, 39.4 in) | Same |
| Tip Shape | Straight | Straight | Same |
| Maximum BalloonVolume | 0.6ml | 0.6ml | Same |
| Radiopaque | Distal Tip has radiopaquemarker bands, stainlesssteel reinforcement in thecatheter shaft renders theshaft visible on fluoroscopy | Distal Tip has radiopaquemarker bands, stainlesssteel reinforcement in thecatheter shaft renders theshaft visible onfluoroscopy | Same |
| Coating | Hydrophilic Coating –Proximal to the balloon, onthe distal portion | None | Difference does notraise new questions ofsafety and efficacy.Hydrophillic coatingsare commonly used tolubricate vascularcatheters. Both devicesdo not have coating onthe balloon region,same as the referencedevice |
| Internal Construction | Multi Lumen catheter wall | Coaxial Lumen | Differences do not raisenew questions of safetyand efficacy. Bothdesigns are intended tocreate a pathway to theside arm for ballooninflation, same as thereference device |
| Reinforced Shaft | Stainless steel reinforcedshaft | Stainless steel reinforcedshaft | Same |
| Accessories Supplied | 3-Way Stopcock, PeelAway Sheath, Hubextension, 1ml Syringe | Dilator, RotatingHemostasis Valve, TuohyBorst Valve withSideport, Peel AwaySheaths, Luer-ActivatedValves | Similar, minordifferences do not raisenew questions of safetyand efficacy., same asthe reference device |
| How Supplied | Sterile, single use | Sterile, single use | Same |
| Sterilization Method | $EtO$ | $EtO$ | Same |
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Conclusion:
Q'Apel Medical LLC concludes through a review of the benchtop assessments, the comparison of the device classification, intended use, operating principle, technological characteristics, sterility, and biocompatibility that the 087 Balloon Guide Catheter System 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).