The BOSS 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.

Device Description

The BOSS Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The BOSS Balloon Guide Catheter is a 90 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 Balloon Guide Catheter uses a distal hydrophilic coating to provide lubricity and reduce friction between the catheter shaft and the vessel wall. The BOSS 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.

AI/ML Overview

This document is a 510(k) Summary for the BOSS™ Balloon Guide Catheter, a medical device. It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices, which means no clinical studies were required. Therefore, the information typically associated with AI/ML device studies (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance) is not applicable here as this is a medical device, not an AI/ML diagnostic tool.

The "acceptance criteria" for this device are the pre-determined thresholds for various physical, functional, and biocompatibility tests, as detailed in the "NONCLINICAL PERFORMANCE TESTING SUMMARY" and "Biocompatibility Testing Summary" sections. The "study that proves the device meets the acceptance criteria" refers to the successful completion of all these non-clinical (bench and animal) tests.

Here's a breakdown of the requested information based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Study Name	Description	Reference Standard	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Visual Inspection and Dimensional Verification	To demonstrate that the product meets the dimensional specifications	ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Meeting pre-determined specifications	Pass: All samples met the pre-determined acceptance criteria
Surface Inspection	To demonstrate the product satisfies the visual surface requirements	ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Meeting pre-determined requirements	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	360 degrees rotation without failure, meeting pre-determined criteria	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	Meeting tensile strength requirements	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	Acceptable kink resistance, meeting pre-determined criteria	Pass: All samples met the pre-determined acceptance criteria
Catheter Lubricity	Pad friction test to compare coated to uncoated samples	Characterization only	Characterization: Implied reduction in friction desired	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 Evaluation of particulates associated with vascular medical devices, USP <788> Particulate Matter in Injections	Meeting pre-determined acceptance criteria for particulate quantity and size	Pass: All samples met the pre-determined acceptance criteria
Radiopacity	To determine the radiopaque characteristics of the device.	ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Meeting pre-determined acceptable radiopaque characteristics	Pass: All samples met the pre-determined acceptance criteria
Push/Track, 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 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Deliverability, proper inflation/deflation, compatibility, removal without damage, meeting pre-determined criteria	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 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Meeting liquid leakage requirements	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 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Meeting hub aspiration air leakage requirements	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 (Comparative, not a standard test)	Stiffness similar to other marketed devices, meeting pre-determined criteria	Pass: All samples met the pre-determined acceptance criteria
Corrosion Resistance	To demonstrate the product satisfies the corrosion resistance requirements	ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	Meeting corrosion resistance requirements	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 300 psi of internal pressure.	ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements	No leak or rupture at up to 300 psi	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 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters	Meeting inflation and deflation time specifications	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 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters	No degradation after 10 inflation cycles	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 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters	Meeting inflation volume vs. balloon diameter specifications	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 of 1.5 ml.	ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters	Withstanding 1.5 ml injection volume	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 Small-bore connectors for liquids and gases in healthcare applications - Part 7, Connectors for intravascular or hypodermic applications.	Meeting requirements for small bore connectors	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	Meeting user needs under simulated use conditions	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 12-month shelf life equivalent (T=12)	Evaluation of device following accelerated aging to a 12-month shelf life equivalent; ISTA procedure 3A (2018), ASTM D4169-16, ASTM F1980-16, ASTM F88-15, ASTM F2096-11 (for packaging)	Meeting all specifications at T=0 and T=12-month AA equivalent	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	Meeting visual and adherence requirements for packaging and labeling	Pass: All samples met the pre-determined acceptance criteria
Biocompatibility Testing
Cytotoxicity	To demonstrate non-cytotoxicity	ISO 10993-5:2009	Non-cytotoxic	Pass: Noncytotoxic according to the predetermined acceptance criteria
Intracutaneous Irritation	To demonstrate acceptable intracutaneous reactivity	ISO 10993-10:2010	Meeting test requirements for intracutaneous reactivity	Pass: Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria
Sensitization	To demonstrate no sensitization response	ISO 10993-10:2010, Kligman Maximization Test	No sensitization response	Pass: Did not elicit a sensitization response according to the predetermined acceptance criteria
Systemic Toxicity	To demonstrate acceptable systemic toxicity	ISO 10993-11:2017	Meeting test requirements for systemic toxicity	Pass: Test requirements for systemic toxicity were met according to the predetermined acceptance criteria
Material Mediated Pyrogenicity	To demonstrate non-pyrogenicity	ISO 10993-11:2017, USP 40 <151> Pyrogen Test	Non-pyrogenic	Pass: Nonpyrogenic, met the predetermined acceptance criteria
Hemolysis	To demonstrate non-hemolytic properties	ASTM F756-17, ISO 10993-4	Non-hemolytic	Pass: Non-hemolytic, met the predetermined acceptance criteria
Complement Activation	To demonstrate similar complement activation characteristics as control device	ISO 10993-4:2017, SC5b-9 Complement Activation	Similar complement activation characteristics to control device	Pass: Demonstrates similar complement activation characteristics as the control device, met the predetermined acceptance criteria
In vivo Thromboresistance	To demonstrate similar thromboresistance characteristics as control device	ISO 10993-4:2017	Similar thromboresistance characteristics to control device	Pass: Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" or similar for the non-clinical bench tests. While the exact numerical sample size for each test is not explicitly listed, it implies that a sufficient number of devices were tested to meet the requirements of the referenced standards (e.g., ISO 10555-1, FDA guidances). For the animal study, the sample size is not specified but it states "an acute porcine model."
Data Provenance:
- Country of Origin: Not specified for the bench tests. The animal study used an "acute porcine model."
- Retrospective or Prospective: All testing was prospective, designed specifically to evaluate the device against established standards and criteria for regulatory 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. The "ground truth" for this medical device 510(k) submission is established by the performance standards (e.g., ISO, ASTM, FDA guidances) and the physical properties of the device itself (e.g., dimensions, strength, material characteristics). Experts were involved in setting these standards and conducting the tests, but not in the "ground truth" establishment in the sense of labeling data for an AI/ML model for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of results in the context of an AI/ML model. The "adjudication" is inherent in whether the device "passes" or "fails" the pre-defined engineering and performance criteria.

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

Not applicable. This is a medical device (catheter) and the submission is based on non-clinical performance and substantial equivalence to predicate devices, not an AI/ML diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

Established international and national standards for medical devices (e.g., ISO 10555 series, ISO 10993 series, AAMI, ASTM).
FDA guidance documents for specific device types (e.g., PTCA Catheters).
Pre-determined engineering specifications and performance criteria for the device.
Results from a non-GLP (Good Laboratory Practice) animal study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 2, 2020

Regulatory Technology Services LLC Prithul Bom Responsible Third Party Official 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114

Re: K200910

Device Name: BOSS™ Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP, DOY Dated: April 4, 2020 Received: April 6, 2020

Dear Prithul Bom:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. 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) K200910

Device Name BOSS Balloon Guide Catheter

Indications for Use (Describe)

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™ Balloon Guide Catheter 510(k) Summary

SUBMITTER [807.92(a)(1)]

Submitter's Name:	Marblehead Medical, LLC
Address:	11600 96th Ave N Maple Grove, MN 55369
Contact Person:	Kristin Mortenson
Telephone:	(612) 202-1142
email	Mortenson.Kristin@MarbleheadMedical.com
Date Prepared:	April 24, 2020
DEVICE [807.92(a)(2)]
Device Trade Name:	BOSS™ 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:	8F FlowGate2™ Balloon Guide Catheter, K153729
Secondary Predicate Device:	Neuron™ MAX System, K111380

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATION FOR USE [807.92(a)(5)]

The BOSS 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

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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 Balloon Guide Catheter System to the predicate devices.

	Primary Predicate device	Secondary Predicate device	Subject Device
Feature	FlowGate2TM Balloon Guide Catheter (K153720)	NeuronTM MAX System (K111380)	BOSS Balloon Guide Catheter System
FDA Classification	Class II	Class II	Same
Product Code(s)	DQY	DQY	QJP, DQY
Regulation Number	870.1250	870.1250	Same
Regulation Name	Percutaneous Catheter	Percutaneous Catheter	Same
Indications for Use	FlowGateTM Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.	The NeuronTM MAX System is indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.	The primary predicate and subject device have the same indications for use, except the primary predicate includes "and other angiographic" and the subject device does not include angiographic procedures. The primary predicate and subject device do not include coronary vasculature like the secondary predicate. The secondary predicate is included to support the direct vascular access and the hydrophilic coating. The secondary predicate does not include a balloon, therefore does not include temporary vascular occlusion. In addition, the secondary predicate does not indicate use as conduit for retrieval devices, a more specific use within the intended use.
	Primary Predicate device	Secondary Predicate device	Subject Device
Feature	FlowGate2TM Balloon Guide Catheter (K153720)	NeuronTM MAX System (K111380)	BOSS Balloon Guide Catheter System
			These differences in wording between the subject device and the predicates are not critical to the intended therapeutic or surgical use of the device, the introduction and guidance of intravascular devices into selected vasculature. The differences in wording do not affect the safety and effectiveness of the device when the device is used as labeled.
Anatomical Locations	Peripheral and neuro vasculature	Peripheral, coronary and neuro vascular systems	Same as primary predicate
Principle of Operation	The Balloon Guide Catheter is used to facilitate the selective placement of interventional devices. After needle access and insertion of up to a 0.038" guidewire into the femoral artery, the device is inserted into the artery through an introducer sheath over the guidewire. The lumen of device is used for insertion and guidance of an intravascular catheter and / or retrieval devices into a selected blood vessel for treatment.	Same as primary predicate except includes the direct access use option without an introducer sheath	Same as secondary predicate. Subject device includes a direct access use option whereas the primary predicate does not.
Material	Commonly used medical grade plastics and stainless steel	Not listed	Same as primary predicate
Reinforced Catheter Shaft Reinforcement	Stainless Steel coil and braid reinforced	Stainless steel braid reinforced	Same as primary predicate
Marker Band /	0.02-in (0.5 mm) wide	Radiopaque marker is	0.08-in (2 mm) wide
	Primary Predicate device	Secondary Predicatedevice	Subject Device
Feature	FlowGate2™ BalloonGuide Catheter(K153720)	Neuron™ MAX System(K111380)	BOSS Balloon GuideCatheter System
Location	0.03-in (0.75 mm) from thedistal tip edge	included on the distalend, width andlocation not listed	0.02-in (0.5mm) from thedistal tip edge distal tothe balloon. Similar,difference does not raisenew questions regardingsafety and efficacy, alldevices utilizeradiopaque markerbands
CompliantBalloon	Yes, silicone	N/A	Yes, polyurethane.Similar to primarypredicate, materialdifferences do not raisenew questions of safetyand efficacy, bothmaterials are used forintravascular use.
Labeled ShaftOuterDiameter	0.108-in (max)(2.7mm) 8Fr	0.110-in (max)(2.8mm) 8F	0.123-in (max)(3.1mm) 9.4FrSimilar, differences donot raise new questionsof safety and efficacy.
Labeled ShaftInnerDimension	0.084-in (2.21mm) 6.4Fr	0.088-in (2.24 mm)6.7F	Same as secondarypredicate
Effectivelength	85 and 95 cm	80 and 90 cm	90 cm, same assecondary predicate
Tip Shape	Straight	Straight	Same
MaximumBalloonVolume	0.6ml	N/A	Same as primarypredicate
Radiopaque	Distal Tip has radiopaquemarker bands, stainlesssteel reinforcement in thecatheter shaft renders theshaft visible onfluoroscopy	Distal Tip hasradiopaque zone	Same as primarypredicate
Coating	N/A	Hydrophilic Coating –distal shaft	Same as the secondarypredicate. Coating is on
Feature	Primary Predicate device	Secondary Predicate device	Subject Device
	FlowGate2TM BalloonGuide Catheter(K153720)	NeuronTM MAX System(K111380)	BOSS Balloon GuideCatheter System
InternalConstruction	Coaxial Lumen	Single lumen	the distal portionproximal to the balloonSame as primarypredicate
Supplied items/ accessories	Dilator, RotatingHemostasis Valve, TuohyBorst Valve with Sideport,Peel Away Sheaths, Luer-Activated Valves	Dilator, RotatingHemostasis Valve(RHV), Extensiontubing	Dilator is provided, sameas both predicates. Theadditional accessoriesare commerciallyavailable devices.Differences do not raisenew questions of safetyand efficacy.
How Supplied	Sterile, single use	Sterile, single use	Same
SterilizationMethod	EtO	EtO	Same
SterilityAssuranceLevel	10-6	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 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 Balloon 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
VisualInspection andDimensionalVerification	To demonstrate that theproduct meets thedimensionalspecifications	ISO 10555-1:2013Intravascular catheters -Sterile and single-usecatheters - Part 1: Generalrequirements	PassAll samples met thepre-determinedacceptance criteria
SurfaceInspection	To demonstrate theproduct satisfies thevisual surfacerequirements	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 of360 degrees 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, FDAguidance PTCACatheters: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
CatheterLubricity	Pad friction test tocompare coated touncoated samples	Characterization only	Results show a 97%reduction in frictioncompared touncoated samples
Particulates,CoatingIntegrity	This study wasconducted to determinethe quantity and size ofparticles generatedduring simulated use	AAMI TIR42:10 Evaluationof particulates associatedwith vascular medicaldevices, USP <788>Particulate Matter inInjections	PassAll samples met thepre-determinedacceptance criteria
Radiopacity	To determine theradiopaquecharacteristics of thedevice.	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,DeviceCompatibility	To demonstrate that thedevice is deliverablethrough tortuous pathmodel without kinkingor buckling, is ableinflate, deflate balloonat target, is compatiblewith treatment devicesand removed withoutdamage.	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 distalend of the product issimilar to othermarketed 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 thecatheter does not leak orrupture up to 300 psi ofinternal 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 timespecifications	ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters	PassAll samples met thepre-determinedacceptance criteria
Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
Balloon Fatigue	To demonstrate thatthere is no degradationof the balloon after 10inflation cycles.	ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters	PassAll samples met thepre-determinedacceptance criteria
BalloonDiameter /Volume	To demonstrate that theproduct meets theinflation volume vsballoon diameterspecifications	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 aninjection volume of 1.5ml.	ISO 10555-4:2013Intravascular Catheters -Sterile and Single-UseCatheters - Part 4: BalloonDilatation Catheters	PassAll samples met thepre-determinedacceptance criteria
Small BoreConnectorCompliancewith Standard	To demonstrate that theproduct meets therequirements for smallbore connectors	ISO 80369-7 2016 Small-bore connectors forliquids and gases inhealthcare applications -Part 7, Connectors forintravascular orhypodermic applications.	PassAll samples met thepre-determinedacceptance criteria
Usability Study /Simulated Use	Evaluation of deviceperformance to meetthe user needs undersimulated useconditions withaccessories andtreatment devices	FDA Guidance HumanFactors and UsabilityEngineering 2016, IEC62366:2015	PassAll samples met thepre-determinedacceptance criteria
Conditioning,Distribution,and Shelf lifeAging	To demonstrate thedevice met allspecifications at bothbaseline (T=0) andfollowing acceleratedaging to a 12-monthshelf life equivalent(T=12)	Evaluation of devicefollowing acceleratedaging to a 12-month shelflife equivalent	PassAll samples met thepre-determinedacceptance criteria
Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
Package Testing
Conditioning,Distribution,and Shelf LifeAging	Evaluation of packagingstrength and integrity atboth baseline (T=0) andfollowing acceleratedaging to a 12-monthshelf life equivalent(T=12)	ISTA procedure 3A (2018),ASTM D4169-16, ASTMF1980-16,ASTM F88-15, ASTMF2096-11	PassAll samples met thepre-determinedacceptance criteria
VisualInspectionPackaging andLabeling	To demonstrate that theproduct meets thepackaging and labelingvisual and adherencerequirements	N/A	PassAll samples met thepre-determinedacceptance criteria

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The results of these tests provide reasonable assurance that the BOSS Balloon Guide Catheter 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 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 MedicalDevices – Part 5: Tests for in vitro toxicity,Neutral Red Uptake Method	PassNoncytotoxic according tothepredeterminedacceptance criteria
IntracutaneousIrritation	Tested in accordance with ISO 10993-10:2010, Biological Evaluation of MedicalDevices – Part 10: Tests for Irritation andSkin Sensitization	PassTest requirements forintracutaneous reactivitywere met according to thepredeterminedacceptance criteria
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 asensitizationresponse according to thepredeterminedacceptance criteria
Test Name	Test Method	Results
Systemic Toxicity	Tested in accordance with ISO 10993-11:2017, Biological Evaluation of MedicalDevices - Part 11: Tests for SystemicToxicity	PassTest requirements forsystemic toxicity weremet according to thepredeterminedacceptance criteria
Material MediatedPyrogenicity	Tested in accordance with ISO 10993-11:2017, BiologicalEvaluation of Medical Devices - Part 11:Tests for Systemic Toxicity and USP 40<151> Pyrogen Test	PassNonpyrogenic, met thepredeterminedacceptance criteria
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 forHemolytic Properties, Direct and IndirectMethods	PassNon-hemolytic, met thepredeterminedacceptance criteria
ComplementActivation	Tested in accordance with ISO 10993-4,Biological Evaluation of Medical Devices -Part 4:2017: Selection of Tests forInteractions with Blood, SC5b-9Complement Activation	PassDemonstrates similarcomplement activationcharacteristics as thecontrol device, met thepredeterminedacceptance criteria
In vivoThromboresistance	Tested in accordance with ISO 10993-4:2017, Biological Evaluation of MedicalDevices - Part 4: Selection of Tests forInteractions with Blood	PassDemonstrates similarthromboresistancecharacteristics as thecontrol device, met thepredeterminedacceptance criteria

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Sterilization and Shelf Life

The BOSS 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 shelf life testing were conducted (T = 0 and T = 12-month AA (accelerated aging)) demonstrating the device will perform as intended to support the proposed 12-month shelf-life.

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Animal Testing

A non-GLP animal test was conducted to evaluate the in vivo performance of the device in an acute porcine model. Trackability and handling of the guide catheter, balloon inflation / deflation, temporary vascular occlusion, radiopacity, and catheter compatibility were assessed. The results for the subject device were comparable to the primary predicate device, demonstrating acceptable results.

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 Balloon Guide Catheter System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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).