(28 days)
The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.
The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads 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, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.
This document describes the non-clinical performance testing for the BOSS 8F Balloon Guide Catheter, a medical device. There is no information regarding a study of an AI device. As such, I cannot provide details on factors like sample size, ground truth, expert qualifications, or comparative effectiveness studies related to AI.
However, I can provide the acceptance criteria and reported device performance based on the non-clinical bench testing for the BOSS 8F Balloon Guide Catheter.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is uniformly reported as "Pass" for all tests, indicating that "All samples met the pre-determined acceptance criteria" or similar outcomes for biocompatibility (e.g., "Noncytotoxic," "Non-hemolytic"). The reference standards listed for each test effectively serve as the basis for the acceptance criteria.
| Study Name | Description | Reference Standard (Basis for Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Performance Bench Testing Summary | |||
| Visual Inspection and Dimensional Verification | To demonstrate that the product meets the dimensional specifications | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Surface Inspection | To demonstrate the product satisfies the visual surface requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Torque Testing | To demonstrate that the product is capable of 360 degrees of rotation about the central lumen axis without failure. | FDA guidance PTCA Catheters:2010 §VIII.A.10 | Pass (All samples met the pre-determined acceptance criteria) |
| Tensile | To demonstrate the product satisfies the tensile strength requirements for bonds and tip pull test | ISO 10555-1:2013, FDA guidance PTCA Catheters:2010 §VIII.A.7, 8 | Pass (All samples met the pre-determined acceptance criteria) |
| Kink Resistance | To demonstrate that the product has acceptable kink resistance | FDA Guidance PTCA:2010 §VIII.A.9 Kink Test | Pass (All samples met the pre-determined acceptance criteria) |
| Catheter Lubricity | Pad friction test to compare coated to uncoated samples | Characterization only | Pass (Results show a 97% reduction in friction compared to uncoated samples) |
| Particulates, Coating Integrity | This study was conducted to determine the quantity and size of particles generated during simulated use | AAMI TIR42:10, USP <788> | Pass (All samples met the pre-determined acceptance criteria) |
| Radiopacity | To determine the radiopaque characteristics of the device. | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Push/Track, Simulated Use, Device Compatibility | To demonstrate that the device is deliverable through tortuous path model without kinking or buckling, is able inflate, deflate balloon at target, is compatible with treatment devices and removed without damage. | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| System Leak - Liquid Leak | To demonstrate that the product meets the liquid leakage under pressure requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| System Leak - Aspiration | To demonstrate that the product meets the hub aspiration air leakage requirements | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Tip Stiffness | To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices. | N/A | 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) |
| Catheter Burst Pressure Under Static Conditions | To demonstrate the catheter does not leak or rupture up to rated internal pressure. | ISO 10555-1:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Inflation / Deflation | To demonstrate balloon meets the inflation and deflation time specifications | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Fatigue | To demonstrate that there is no degradation of the balloon after 10 inflation cycles. | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Diameter / Volume | To demonstrate that the product meets the inflation volume vs balloon diameter specifications | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Balloon Rated Burst Volume | To demonstrate that the balloon is capable of withstanding an injection volume to the rated burst volume | ISO 10555-4:2013 | Pass (All samples met the pre-determined acceptance criteria) |
| Small Bore Connector Compliance with Standard | To demonstrate that the product meets the requirements for small bore connectors | ISO 80369-7: 2016 | Pass (All samples met the pre-determined acceptance criteria) |
| Usability Study / Simulated Use | Evaluation of device performance to meet the user needs under simulated use conditions with accessories and treatment devices | FDA Guidance Human Factors and Usability Engineering 2016, IEC 62366:2015 | Pass (All samples met the pre-determined acceptance criteria) |
| Conditioning, Distribution, and Shelf-life Aging | To demonstrate the device met all specifications at both baseline (T=0) and following accelerated aging to a 6-month shelf life equivalent (T=6) | Evaluation of device following accelerated aging to a 6-month shelf life equivalent | Pass (All samples met the pre-determined acceptance criteria) |
| Package Testing: Conditioning, Distribution, Shelf-Life | Evaluation of packaging strength and integrity at both baseline (T=0) and following accelerated aging to a 6-month shelf life equivalent (T=6) | ISTA procedure 3A (2018), ASTM D4169-16, ASTM F1980-16, ASTM F88-15, ASTM F2096-11, ASTM 1929-15 | Pass (All samples met the pre-determined acceptance criteria) |
| Visual Inspection Packaging and Labeling | To demonstrate that the product meets the packaging and labeling visual and adherence requirements | N/A | Pass (All samples met the pre-determined acceptance criteria) |
| Biocompatibility Testing Summary | |||
| Cytotoxicity | Tested in accordance with ISO 10993-5:2009, Neutral Red Uptake Method | ISO 10993-5:2009 (noncytotoxic according to predetermined acceptance criteria) | Pass (Noncytotoxic according to the predetermined acceptance criteria) |
| Intracutaneous Irritation | Tested in accordance with ISO 10993-10:2010 | ISO 10993-10:2010 (test requirements for intracutaneous reactivity met) | Pass (Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria) |
| Sensitization | Tested in accordance with ISO 10993-10, Kligman Maximization Test | ISO 10993-10 (did not elicit a sensitization response) | Pass (Did not elicit a sensitization response according to the predetermined acceptance criteria) |
| Systemic Toxicity | Tested in accordance with ISO 10993-11:2017 | ISO 10993-11:2017 (test requirements for systemic toxicity met) | Pass (Test requirements for systemic toxicity were met according to the predetermined acceptance criteria) |
| Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11:2017 and USP 40 <151> Pyrogen Test | ISO 10993-11:2017, USP 40 <151> (nonpyrogenic, met predetermined acceptance criteria) | Pass (Nonpyrogenic, met the predetermined acceptance criteria) |
| Hemolysis | Tested in accordance with ASTM F756-17 and ISO 10993-4 (Direct and Indirect Methods) | ASTM F756-17, ISO 10993-4 (non-hemolytic, met predetermined acceptance criteria) | Pass (Non-hemolytic, met the predetermined acceptance criteria) |
| Complement Activation | Tested in accordance with ISO 10993-4:2017 (SC5b-9 Complement Activation) | ISO 10993-4:2017 (demonstrates similar complement activation characteristics as the control device, met predetermined acceptance criteria) | Pass (Demonstrates similar complement activation characteristics as the control device, met the predetermined acceptance criteria) |
| In vivo Thromboresistance | Tested in accordance with ISO 10993-4:2017 | ISO 10993-4:2017 (demonstrates similar thromboresistance characteristics as the control device, met predetermined acceptance criteria) | Pass (Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria) |
The following information is Not Applicable (N/A) as the provided document describes non-clinical performance testing for a physical medical device (catheter), not an AI/Software as a Medical Device (SaMD).
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is bench testing of a physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would refer to objective material properties or performance under specified conditions, measured by instrumentation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's testing is implicitly defined by the quantifiable limits and observable characteristics specified in the referenced ISO and FDA standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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 a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2021
Marblehead Medical, LLC Kristin Mortenson Director of Quality and Regulatory 753 Fox Chase Road SW Rochester, Minnesota 55902-8749
Re: K203840
Trade/Device Name: BOSS 8F Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 29, 2020 Received: December 31, 2020
Dear Kristin Mortenson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203840
Device Name BOSS 8F Balloon Guide Catheter
Indications for Use (Describe)
The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these 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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BOSS™ 8F Balloon Guide Catheter 510(k) Summary
SUBMITTER [807.92(a)(1)]
| Submitter's Name: | Marblehead Medical, LLC |
|---|---|
| Address: | 753 Fox Chase Rd SW, Rochester MN 55902-8749 |
| Contact Person: | Kristin Mortenson |
| Telephone: | (612) 202-1142 |
| Mortenson.Kristin@MarbleheadMedical.com | |
| Date Prepared: | Jan 25, 2021 |
| DEVICE [807.92(a)(2)] | |
| Device Trade Name: | BOSS™ 8F Balloon Guide Catheter |
| Common Name: | Balloon Guide Catheter |
| Classification Name: | Percutaneous Catheter |
| Product Code: | QJP, DQY |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| PREDICATE [807.92(a)(3)] | |
| Primary Predicate Device: | BOSS Balloon Guide Catheter, K200910 |
DEVICE DESCRIPTION [807.92(a)(4)]
The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS 8F Balloon Guide Catheter is an 85 and 95 cm long, variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and a radiopaque marker band at the tip distal to the balloon. The catheter shaft has an annular inflation lumen and a coaxial central lumen with stainless steel coil and is braid reinforced. The hub central port leads 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, connecting to the annular inflation lumen, and is used to facilitate inflating and deflating the balloon with a syringe. The BOSS 8F Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 8F Balloon Guide Catheter is packaged with the 6F dilator to facilitate the option of direct access into the blood vessel without the use of an introducer sheath.
INDICATION FOR USE [807.92(a)(5)]
The BOSS 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.
PREDICATE DEVICE COMPARISON [807.92(a)(6)]
The following table provides a comparison of the key characteristics of the BOSS 8F Balloon Guide Catheter System to the predicate devices.
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| Feature | Predicate DeviceBOSS Balloon Guide Catheter System | Subject DeviceBOSS 8F Balloon Guide Catheter System |
|---|---|---|
| FDA Classification | Same | Same |
| Product Code(s) | QJP, DQY | Same |
| Regulation Number | Same | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Indications for Use | The BOSSTM Balloon Guide Catheter isindicated for use in facilitating the insertionand guidance of an intravascular catheterinto a selected blood vessel in the peripheraland neurovascular systems. The balloonprovides temporary vascular occlusionduring these procedures. The balloon guidecatheter is also indicated for use as a conduitfor retrieval devices. | Same |
| Anatomical Locations | Peripheral and neurovasculature | Same |
| Principle of Operation | The Balloon Guide Catheter is used tofacilitate the selective placement ofinterventional devices. After needle accessand insertion of up to a 0.038" guidewire intothe femoral artery, the device is inserted intothe artery through an introducer sheath overthe guidewire. The lumen of device is usedfor insertion and guidance of an intravascularcatheter and / or retrieval devices into aselected blood vessel for treatment.Operation includes the direct access useoption without an introducer sheath | Same |
| Material | Commonly used medicalgrade plastics and stainless steel | Same |
| Reinforced Catheter ShaftReinforcement | Stainless Steel coil and braid reinforced | Same |
| Marker Band / Location | Radiopaque marker 0.08-in (2 mm) wide,0.02-in (0.5mm) from the distal tip edge distalto the balloon. | Marker band 1.3 mm, 2 mm fromdistal tip edge distal to the balloon.Similar, difference does not raisenew questions regarding safety andefficacy, all devices utilizeradiopaque marker bands |
| Compliant Balloon | Yes, polyurethane | Same |
| Labeled ShaftOuter Diameter | 0.123-in (max)(3.1mm) 9.4Fr | 0.111" (2.8 mm) 8FSimilar differences do not raise |
| Predicate Device | Subject Device | |
| Feature | BOSS Balloon Guide Catheter System | BOSS 8F Balloon Guide Catheter System |
| Labeled ShaftInnerDimension | 0.088-in (2.24 mm) 6.7F | 0.0870" (2.2 mm)Similar, differences do not raise new questions of safety and efficacy. |
| Effective length | 90 cm | 85 and 95 cmSimilar, differences do not raise new questions of safety and efficacy. |
| Tip Shape | Straight | Same |
| MaximumBalloon Volume | 0.6 mL | Same |
| Radiopaque | Distal Tip has radiopaque marker bands, stainless steel reinforcement in the catheter shaft renders the shaft visible on fluoroscopy | Same |
| Coating | Coating is on the distal portion proximal to the balloon | Same |
| InternalConstruction | Coaxial Lumen | Same |
| Supplied items/ accessories | Dilator is provided | Same |
| How Supplied | Sterile, single use | Same |
| SterilizationMethod | EtO | Same |
| SterilityAssurance Level | 10-6 | Same |
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The differences between the subject device and predicates described in the comparison table above are not critical to the intended therapeutic or surgical use of the device, do not raise questions of safety and effectiveness, and as shown through testing and analysis, do not affect the safety and effectiveness of the device when used as labeled.
NONCLINICAL PERFORMANCE TESTING SUMMARY [807.92(b)]
Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data. The BOSS 8F 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 BOSS 8F Guide Catheter. A summary of the tests performed is provided in the table below:
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| Performance Bench Testing Summary | |||
|---|---|---|---|
| Study Name | Description | Reference Standard | Results |
| Visual Inspectionand DimensionalVerification | To demonstrate that theproduct meets thedimensional specifications | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| SurfaceInspection | To demonstrate theproduct satisfies the visualsurface requirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| Torque Testing | To demonstrate that theproduct is capable of 360degrees of rotationabout the central lumenaxis without failure. | FDA guidance PTCACatheters:2010 §VIII.A.10 | PassAll samples metthe pre-determinedacceptance criteria |
| Tensile | To demonstrate theproduct satisfies thetensile strengthrequirements for bondsand tip pull test | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements, FDA guidancePTCA Catheters:2010§VIII.A.7, 8 | PassAll samples met thepre-determinedacceptance criteria |
| Kink Resistance | To demonstrate that theproduct has acceptablekink resistance | FDA Guidance PTCA:2010§VIII.A.9 Kink Test | PassAll samples met thepre-determinedacceptance criteria |
| Catheter Lubricity | Pad friction test tocompare coated touncoated samples | Characterization only | Results show a 97%reduction in frictioncompared touncoated samples |
| Particulates,Coating Integrity | This study was conductedto determine the quantityand size of particlesgenerated duringsimulated use | AAMI TIR42:10 Evaluation ofparticulates associated withvascular medical devices,USP <788> ParticulateMatter in Injections | PassAll samples met thepre-determinedacceptance criteria |
| Radiopacity | To determine theradiopaque characteristicsof the device. | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| Performance Bench Testing Summary | |||
| Study Name | Description | Reference Standard | Results |
| Push/Track,Simulated Use,DeviceCompatibility | To demonstrate that thedevice is deliverablethrough tortuous pathmodel without kinking orbuckling, is able inflate,deflate balloon at target, iscompatible with treatmentdevices and removedwithout damage. | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| System Leak -Liquid Leak | To demonstrate that theproduct meets the liquidleakage under pressurerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| System Leak -Aspiration | To demonstrate that theproduct meets the hubaspiration air leakagerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| Tip Stiffness | To demonstrate that thestiffness of the distal endof the product is similar toother marketed devices. | N/A | PassAll samples metthe pre-determinedacceptance criteria |
| CorrosionResistance | To demonstrate theproduct satisfies thecorrosion resistancerequirements | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| Catheter BurstPressure UnderStatic Conditions | To demonstrate the catheterdoes not leak or rupture upto rated internal pressure. | ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements | PassAll samples met thepre-determinedacceptance criteria |
| Balloon Inflation /Deflation | To demonstrate balloonmeets the inflation anddeflation time specifications | ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters | PassAll samples met thepre-determinedacceptance criteria |
| Balloon Fatigue | To demonstrate that thereis no degradation of theballoon after 10 inflationcycles. | ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters | PassAll samples met thepre-determinedacceptance criteria |
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| Performance Bench Testing Summary | |||||
|---|---|---|---|---|---|
| Study Name | Description | Reference Standard | Results | ||
| Balloon Diameter/ Volume | To demonstrate that theproduct meets theinflation volume vs balloondiameter specifications | ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters | PassAll samples met thepre-determinedacceptance criteria | ||
| Balloon RatedBurst Volume | To demonstrate that theballoon is capable ofwithstanding an injectionvolume to the rated burstvolume | ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters | PassAll samples met thepre-determinedacceptance criteria | ||
| Small BoreConnectorCompliance withStandard | To demonstrate that theproduct meets therequirements for smallbore connectors | ISO 80369-7: 2016 Small-bore connectors for liquidsand gases in healthcareapplications - Part 7,Connectors for intravascularor hypodermic applications. | PassAll samples met thepre-determinedacceptance criteria | ||
| Usability Study /Simulated Use | Evaluation of deviceperformance to meet theuser needs undersimulated use conditionswith accessories andtreatment devices | FDA Guidance HumanFactors and UsabilityEngineering 2016, IEC62366:2015 | PassAll samples met thepre-determinedacceptance criteria | ||
| Conditioning,Distribution, andShelf-life Aging | To demonstrate the devicemet all specifications atboth baseline (T=0) andfollowing acceleratedaging to a 6-month shelflife equivalent (T=6) | Evaluation of devicefollowing accelerated agingto a 6-month shelf lifeequivalent | PassAll samples met thepre-determinedacceptance criteria | ||
| Package Testing | |||||
| Conditioning,Distribution, andShelf-Life Aging | Evaluation of packagingstrength and integrity atboth baseline (T=0) andfollowing acceleratedaging to a 6-month shelflife equivalent (T=6) | ISTA procedure 3A (2018),ASTM D4169-16, ASTMF1980-16,ASTM F88-15, ASTM F2096-11, ASTM 1929-15 | PassAll samples met thepre-determinedacceptance criteria | ||
| Visual InspectionPackaging andLabeling | To demonstrate that theproduct meets thepackaging and labelingvisual and adherencerequirements | N/A | PassAll samples met thepre-determinedacceptance criteria |
The results of these tests provide reasonable assurance that the BOSS 8F Balloon Guide Catheter has been designed and tested to assure conformance to the requirements for its intended use and
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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 devices.
Biocompatibility Testing Summary
The device is 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 10993-5:2009,Biological Evaluation of Medical Devices –Part 5: Tests for in vitro toxicity, Neutral RedUptake Method | PassNoncytotoxic according to thepredetermined acceptancecriteria |
| IntracutaneousIrritation | Tested in accordance with ISO 10993-10:2010, Biological Evaluation of MedicalDevices – Part 10: Tests for Irritation and SkinSensitization | PassTest requirements forintracutaneous reactivitywere met according to thepredetermined acceptancecriteria |
| Sensitization | Tested in accordance with ISO 10993-10,Biological Evaluation of Medical Devices –Part 10 Tests forIrritation and Skin Sensitization, KligmanMaximization Test | PassDid not elicit a sensitizationresponse according to thepredetermined acceptancecriteria |
| Systemic Toxicity | Tested in accordance with ISO 10993-11:2017, Biological Evaluation of MedicalDevices - Part 11: Tests for Systemic Toxicity | PassTest requirements forsystemic toxicity were metaccording to thepredetermined acceptancecriteria |
| Material MediatedPyrogenicity | Tested in accordance with ISO 10993-11:2017,Biological Evaluation of Medical Devices – Part11: Tests for Systemic Toxicity and USP 40<151> Pyrogen Test | PassNonpyrogenic, met thepredetermined acceptancecriteria |
| Hemolysis | Tested in accordance with ASTM F756-17,Standard Practice for Assessment ofHemolytic Properties of Materials and ISO10993-4, Biological Evaluation of MedicalDevices – Part 4: Selection of Tests forInteractions with Blood, Tests for HemolyticProperties, Direct and Indirect Methods | PassNon-hemolytic, met thepredetermined acceptancecriteria |
| ComplementActivation | Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices –Part 4:2017: Selection of Tests forInteractions with Blood, SC5b-9 ComplementActivation | PassDemonstrates similarcomplement activationcharacteristics as the controldevice, met thepredetermined acceptancecriteria |
| Test Name | Test Method | Results |
| In vivoThromboresistance | Tested in accordance with ISO 10993-4:2017,Biological Evaluation of Medical Devices –Part 4: Selection of Tests for Interactions withBlood | PassDemonstrates similarthromboresistancecharacteristics as the controldevice, met thepredetermined acceptancecriteria |
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Sterilization and Shelf Life
The BOSS 8F Balloon Guide Catheter sterilization process using 100% Ethylene Oxide (EO) has been validated in accordance with ISO 11135-1:2014 to achieve a SAL of 10°. EO and ECH residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels (BET) were below the level of 2.15 EU/device in accordance with ANSI AAMI ST72:2011/(R)2016. Both baseline and accelerated shelflife testing were conducted (T = 0 and T = 6-month AA (accelerated aging)) demonstrating the device will perform as intended to support the proposed 6-month shelf-life.
Animal Testing
No animal studies were required to demonstrate substantial equivalence.
Clinical Testing
No clinical studies were required to demonstrate substantial equivalence.
Conclusion
Marblehead 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 BOSS 8F 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).