Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a balloon guide catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No.
The device facilitates the insertion and guidance of other catheters and provides temporary vascular occlusion; it does not directly treat a disease or condition.

Diagnostic

No

The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and for temporary vascular occlusion, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with a balloon, lumens, and other hardware components. The performance studies also focus on physical properties and bench testing of the hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used within the body for facilitating catheter insertion, guidance, temporary vascular occlusion, and retrieval of devices. This is an interventional procedure, not a diagnostic test performed on samples outside the body.
Device Description: The description details a catheter with lumens, a balloon, and features for insertion into blood vessels. This aligns with an interventional device, not a device for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Performance Studies: The performance studies described are bench tests evaluating the physical and mechanical properties of the catheter, which are relevant to its function as an interventional device. They do not involve evaluating the accuracy or performance of a diagnostic test.

In summary, the BOSS™ 8F Balloon Guide Catheter is an interventional medical device used within the body, not an in vitro diagnostic device used to perform tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

QJP, DQY

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Nonclinical Performance Bench Testing Summary:

Visual Inspection and Dimensional Verification: To demonstrate that the product meets the dimensional specifications. Reference Standard: ISO 10555-1:2013. Results: Pass, All samples met the pre-determined acceptance criteria.
Surface Inspection: To demonstrate the product satisfies the visual surface requirements. Reference Standard: ISO 10555-1:2013. Results: 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. Reference Standard: FDA guidance PTCA Catheters:2010 §VIII.A.10. Results: 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. Reference Standard: ISO 10555-1:2013, FDA guidance PTCA Catheters:2010 §VIII.A.7, 8. Results: Pass, All samples met the pre-determined acceptance criteria.
Kink Resistance: To demonstrate that the product has acceptable kink resistance. Reference Standard: FDA Guidance PTCA:2010 §VIII.A.9 Kink Test. Results: Pass, All samples met the pre-determined acceptance criteria.
Catheter Lubricity: Pad friction test to compare coated to uncoated samples. Reference Standard: Characterization only. Results: 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. Reference Standard: AAMI TIR42:10, USP . Results: Pass, All samples met the pre-determined acceptance criteria.
Radiopacity: To determine the radiopaque characteristics of the device. Reference Standard: ISO 10555-1:2013. Results: 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. Reference Standard: ISO 10555-1:2013. Results: 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. Reference Standard: ISO 10555-1:2013. Results: Pass, All samples met the pre-determined acceptance criteria.
System Leak - Aspiration: To demonstrate that the product meets the hub aspiration air leakage requirements. Reference Standard: ISO 10555-1:2013. Results: 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. Reference Standard: N/A. Results: Pass, All samples met the pre-determined acceptance criteria.
Corrosion Resistance: To demonstrate the product satisfies the corrosion resistance requirements. Reference Standard: ISO 10555-1:2013. Results: 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. Reference Standard: ISO 10555-1:2013. Results: Pass, All samples met the pre-determined acceptance criteria.
Balloon Inflation / Deflation: To demonstrate balloon meets the inflation and deflation time specifications. Reference Standard: ISO 10555-4:2013. Results: 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. Reference Standard: ISO 10555-4:2013. Results: 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. Reference Standard: ISO 10555-4:2013. Results: 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. Reference Standard: ISO 10555-4:2013. Results: 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. Reference Standard: ISO 80369-7: 2016. Results: 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. Reference Standard: FDA Guidance Human Factors and Usability Engineering 2016, IEC 62366:2015. Results: 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). Reference Standard: Evaluation of device following accelerated aging to a 6-month shelf life equivalent. Results: Pass, All samples met the pre-determined acceptance criteria.
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 6-month shelf life equivalent (T=6). Reference Standard: ISTA procedure 3A (2018), ASTM D4169-16, ASTM F1980-16, ASTM F88-15, ASTM F2096-11, ASTM 1929-15. Results: 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. Reference Standard: N/A. Results: 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. Results: Pass, Noncytotoxic according to the predetermined acceptance criteria.
Intracutaneous Irritation: Tested in accordance with ISO 10993-10:2010. Results: 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. Results: Pass, Did not elicit a sensitization response according to the predetermined acceptance criteria.
Systemic Toxicity: Tested in accordance with ISO 10993-11:2017. Results: 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 Pyrogen Test. Results: Pass, Nonpyrogenic, met the predetermined acceptance criteria.
Hemolysis: Tested in accordance with ASTM F756-17 and ISO 10993-4. Results: Pass, Non-hemolytic, met the predetermined acceptance criteria.
Complement Activation: Tested in accordance with ISO 10993-4:2017, SC5b-9 Complement Activation. Results: 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. Results: Pass, Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria.

Sterilization and Shelf Life:
Validated in accordance with ISO 11135-1:2014 to achieve a SAL of 10^-6. EO and ECH residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels (BET) were below 2.15 EU/device in accordance with ANSI AAMI ST72:2011/(R)2016. Baseline and accelerated shelf-life testing demonstrated the device would perform as intended for a 6-month shelf-life.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

BOSS Balloon Guide Catheter, K200910

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 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

1

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

2

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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3

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
email	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.

4

| Feature | Predicate Device
BOSS Balloon Guide Catheter System | Subject Device
BOSS 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 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. | Same |
| Anatomical Locations | Peripheral and neurovasculature | Same |
| 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.
Operation includes the direct access use
option without an introducer sheath | Same |
| Material | Commonly used medical
grade plastics and stainless steel | Same |
| Reinforced Catheter Shaft
Reinforcement | 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 distal
to the balloon. | Marker band 1.3 mm, 2 mm from
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, polyurethane | Same |
| Labeled Shaft
Outer Diameter | 0.123-in (max)
(3.1mm) 9.4Fr | 0.111" (2.8 mm) 8F
Similar differences do not raise |
| | Predicate Device | Subject Device |
| Feature | BOSS Balloon Guide Catheter System | BOSS 8F Balloon Guide Catheter System |
| Labeled Shaft
Inner
Dimension | 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 cm
Similar, differences do not raise new questions of safety and efficacy. |
| Tip Shape | Straight | Same |
| Maximum
Balloon 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 |
| Internal
Construction | Coaxial Lumen | Same |
| Supplied items
/ accessories | Dilator is provided | Same |
| How Supplied | Sterile, single use | Same |
| Sterilization
Method | EtO | Same |
| Sterility
Assurance Level | 10-6 | Same |

5

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:

6

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,
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
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 rated 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
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

7

8

Performance Bench Testing Summary
Study Name	Description	Reference Standard	Results
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 to the rated burst
volume	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 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, and
Shelf-Life Aging	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

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

9

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
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
Test Name	Test Method	Results
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

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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.