Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (a catheter) and its mechanical components and function. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.

Therapeutic

No

The device is indicated for facilitating the insertion and guidance of other catheters and providing temporary vascular occlusion, rather than directly treating a disease or condition.

Diagnostic

No

The device is a guide catheter designed to facilitate the insertion and guidance of other intravascular catheters and to provide temporary vascular occlusion. It is a tool used during interventional procedures, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with lumens, a balloon, a hub, and a coating, indicating it is a hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The BOSS Balloon Guide Catheter is an invasive medical device used inside the body (in vivo) to facilitate the insertion and guidance of other catheters and to provide temporary vascular occlusion. It is a tool used during a medical procedure, not a device that analyzes biological samples.

The description clearly outlines its use in the peripheral and neurovascular systems for guiding catheters and occluding vessels, which are all in-vivo procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

OJP, DOY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy (inferred from radiopacity testing)

Anatomical Site

Peripheral and neurovascular systems

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Nonclinical Performance Testing Summary:
Study Type: Bench testing to evaluate physical integrity, functionality, and performance.
Sample Size: Not explicitly stated for each test, but "All samples" met acceptance criteria.
Standalone Performance: Not applicable as it's a medical device, not a diagnostic or AI/ML device.
Key Results:

Visual Inspection and Dimensional Verification: Pass; All samples met pre-determined acceptance criteria.
Surface Inspection: Pass; All samples met pre-determined acceptance criteria.
Torque Testing: Pass; All samples met the pre-determined acceptance criteria.
Tensile: Pass; All samples met the pre-determined acceptance criteria.
Kink Resistance: Pass; All samples met the pre-determined acceptance criteria.
Catheter Lubricity: Results show a 97% reduction in friction compared to uncoated samples.
Particulates, Coating Integrity: Pass; All samples met the pre-determined acceptance criteria.
Radiopacity: Pass; All samples met the pre-determined acceptance criteria.
Push/Track, Device Compatibility: Pass; All samples met the pre-determined acceptance criteria.
System Leak - Liquid Leak: Pass; All samples met the pre-determined acceptance criteria.
System Leak - Aspiration: Pass; All samples met the pre-determined acceptance criteria.
Tip Stiffness: Pass; All samples met the pre-determined acceptance criteria.
Corrosion Resistance: Pass; All samples met the pre-determined acceptance criteria.
Catheter Burst Pressure Under Static Conditions: Pass; All samples met the pre-determined acceptance criteria.
Balloon Inflation / Deflation: Pass; All samples met the pre-determined acceptance criteria.
Balloon Fatigue: Pass; All samples met the pre-determined acceptance criteria.
Balloon Diameter / Volume: Pass; All samples met the pre-determined acceptance criteria.
Balloon Rated Burst Volume: Pass; All samples met the pre-determined acceptance criteria.
Small Bore Connector Compliance with Standard: Pass; All samples met the pre-determined acceptance criteria.
Usability Study / Simulated Use: Pass; All samples met the pre-determined acceptance criteria.
Conditioning, Distribution, and Shelf life Aging: Pass; All samples met the pre-determined acceptance criteria.
Package Testing (Conditioning, Distribution, and Shelf Life Aging): Pass; All samples met the pre-determined acceptance criteria.
Visual Inspection Packaging and Labeling: Pass; All samples met the pre-determined acceptance criteria.

Biocompatibility Testing Summary:

Cytotoxicity: Pass; Noncytotoxic according to the predetermined acceptance criteria.
Intracutaneous Irritation: Pass; Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria.
Sensitization: Pass; Did not elicit a sensitization response according to the predetermined acceptance criteria.
Systemic Toxicity: Pass; Test requirements for systemic toxicity were met according to the predetermined acceptance criteria.
Material Mediated Pyrogenicity: Pass; Nonpyrogenic, met the predetermined acceptance criteria.
Hemolysis: Pass; Non-hemolytic, met the predetermined acceptance criteria.
Complement Activation: Pass; Demonstrates similar complement activation characteristics as the control device, met the predetermined acceptance criteria.
In vivo Thromboresistance: Pass; Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria.

Animal Testing:
Study Type: Non-GLP animal test in an acute porcine model.
Key Results: 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.

Key Metrics

Not Found (For performance studies, only pass/fail or comparative results were provided, not specific numerical metrics like AUC, sensitivity, specificity, PPV, NPV for diagnostic purposes.)

Predicate Device(s)

8F FlowGate2™ Balloon Guide Catheter, K153729, Neuron™ MAX System, K111380

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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

2

Indications for Use

510(k) Number (if known) K200910

Device Name BOSS Balloon Guide Catheter

Indications for Use (Describe)

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.

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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3

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)]

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.

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

4

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 Predicate
device	Subject Device
Feature	FlowGate2™ Balloon
Guide Catheter
(K153720)	Neuron™ MAX System
(K111380)	BOSS Balloon Guide
Catheter System
Location	0.03-in (0.75 mm) from the
distal tip edge	included on the distal
end, width and
location not listed	0.02-in (0.5mm) from the
distal tip edge distal to
the balloon. Similar,
difference does not raise
new questions regarding
safety and efficacy, all
devices utilize
radiopaque marker
bands
Compliant
Balloon	Yes, silicone	N/A	Yes, polyurethane.
Similar to primary
predicate, material
differences do not raise
new questions of safety
and efficacy, both
materials are used for
intravascular use.
Labeled Shaft
Outer
Diameter	0.108-in (max)
(2.7mm) 8Fr	0.110-in (max)
(2.8mm) 8F	0.123-in (max)
(3.1mm) 9.4Fr
Similar, differences do
not raise new questions
of safety and efficacy.
Labeled Shaft
Inner
Dimension	0.084-in (2.21mm) 6.4Fr	0.088-in (2.24 mm)
6.7F	Same as secondary
predicate
Effective
length	85 and 95 cm	80 and 90 cm	90 cm, same as
secondary predicate
Tip Shape	Straight	Straight	Same
Maximum
Balloon
Volume	0.6ml	N/A	Same as primary
predicate
Radiopaque	Distal Tip has radiopaque
marker bands, stainless
steel reinforcement in the
catheter shaft renders the
shaft visible on
fluoroscopy	Distal Tip has
radiopaque zone	Same as primary
predicate
Coating	N/A	Hydrophilic Coating –
distal shaft	Same as the secondary
predicate. Coating is on
Feature	Primary Predicate device	Secondary Predicate device	Subject Device
	FlowGate2TM Balloon
Guide Catheter
(K153720)	NeuronTM MAX System
(K111380)	BOSS Balloon Guide
Catheter System
Internal
Construction	Coaxial Lumen	Single lumen	the distal portion
proximal to the balloon
Same as primary
predicate
Supplied items
/ accessories	Dilator, Rotating
Hemostasis Valve, Tuohy
Borst Valve with Sideport,
Peel Away Sheaths, Luer-
Activated Valves	Dilator, Rotating
Hemostasis Valve
(RHV), Extension
tubing	Dilator is provided, same
as both predicates. The
additional accessories
are commercially
available devices.
Differences do not raise
new questions of safety
and efficacy.
How Supplied	Sterile, single use	Sterile, single use	Same
Sterilization
Method	EtO	EtO	Same
Sterility
Assurance
Level	10-6	10-6	Same

5

6

7

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:

8

Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
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	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	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
Intravascular catheters -
Sterile and single-use
catheters - Part 1: General
requirements, 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	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
Particulate Matter in
Injections	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	Pass
All samples met the
pre-determined
acceptance criteria
Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
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	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	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	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
Intravascular catheters -
Sterile and single-use
catheters - Part 1: General
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	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	Pass
All samples met the
pre-determined
acceptance criteria
Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
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	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	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	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.	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 12-month
shelf life equivalent
(T=12)	Evaluation of device
following accelerated
aging to a 12-month shelf
life equivalent	Pass
All samples met the
pre-determined
acceptance criteria
Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
Package Testing
Conditioning,
Distribution,
and Shelf Life
Aging	Evaluation of packaging
strength and integrity at
both baseline (T=0) and
following accelerated
aging to a 12-month
shelf life equivalent
(T=12)	ISTA procedure 3A (2018),
ASTM D4169-16, ASTM
F1980-16,
ASTM F88-15, ASTM
F2096-11	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

9

10

11

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 Medical
Devices – Part 5: Tests for in vitro toxicity,
Neutral Red Uptake Method	Pass
Noncytotoxic according to
the
predetermined
acceptance criteria
Intracutaneous
Irritation	Tested in accordance with ISO 10993-
10:2010, Biological Evaluation of Medical
Devices – Part 10: Tests for Irritation and
Skin Sensitization	Pass
Test requirements for
intracutaneous reactivity
were met according to the
predetermined
acceptance criteria
Sensitization	Tested in accordance with ISO 10993-10,
Biological Evaluation of Medical Devices –
Part 10 Tests for
Irritation and Skin Sensitization, Kligman
Maximization Test	Pass
Did not elicit a
sensitization
response according to the
predetermined
acceptance criteria
Test Name	Test Method	Results
Systemic Toxicity	Tested in accordance with ISO 10993-
11:2017, Biological Evaluation of Medical
Devices - Part 11: Tests for Systemic
Toxicity	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, Biological
Evaluation of Medical Devices - Part 11:
Tests for Systemic Toxicity and USP 40
Pyrogen Test	Pass
Nonpyrogenic, met the
predetermined
acceptance criteria
Hemolysis	Tested in accordance with ASTM F756-17,
Standard Practice for Assessment of
Hemolytic Properties of Materials and ISO
10993-4, Biological Evaluation of Medical
Devices - Part 4: Selection of Tests for
Interactions with Blood, Tests for
Hemolytic Properties, Direct and Indirect
Methods	Pass
Non-hemolytic, met the
predetermined
acceptance criteria
Complement
Activation	Tested in accordance with ISO 10993-4,
Biological Evaluation of Medical Devices -
Part 4:2017: Selection of Tests for
Interactions with Blood, SC5b-9
Complement Activation	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, Biological Evaluation of Medical
Devices - Part 4: Selection of Tests for
Interactions with Blood	Pass
Demonstrates similar
thromboresistance
characteristics as the
control device, met the
predetermined
acceptance criteria

12

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.

13

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.