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 AI/ML.

Therapeutic

No.
This device is designed to facilitate procedures and temporarily occlude blood vessels, which are interventional actions, not therapeutic ones in themselves.

Diagnostic

No

The BOBBY Balloon Guide Catheter is intended for facilitating the insertion and guidance of other intravascular catheters and for temporary vascular occlusion. It is a tool used during procedures, not a device that independently diagnoses a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with a balloon, lumens, radiopaque markers, and a hub. It is a hardware device used for physical intervention in blood vessels.

IVD (In Vitro Diagnostic)

Based on the provided information, the BOBBY Balloon Guide Catheter is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states the device is for facilitating the insertion and guidance of catheters within the body (intravascular), providing temporary vascular occlusion, and acting as a conduit for retrieval devices. These are all in vivo procedures, meaning they are performed on a living organism.
Device Description: The description details a physical catheter designed to be inserted into blood vessels. It describes features like lumens for guidewires and inflation, a balloon for occlusion, and a hydrophilic coating for insertion. These are all characteristics of a device used directly within the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are used to provide information about a patient's health status through the analysis of such specimens.

Therefore, the BOBBY Balloon Guide Catheter is an invasive medical device used for interventional procedures within the vascular system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BOBBY Balloon Guide Catheter is intended: 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.

Product codes

DQY, QJP

Device Description

The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end.

The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral and neuro vascular 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)

Performance Testing Summary includes:

Conditioning, Distribution, and Shelf Life Aging Verification: Pass. All samples met the pre-determined acceptance criteria.
Packaging Visual Inspection: Pass. All samples met the pre-determined acceptance criteria.
Visual Surface Requirements: Pass. All samples met the pre-determined acceptance criteria.
Dimensional/Physical Attributes Inspection: Pass. All samples met the pre-determined acceptance criteria.
Inflation Volume vs Balloon Diameter: Pass. All samples met the pre-determined acceptance criteria.
Balloon Burst Volume: Pass. All samples met the pre-determined acceptance criteria.
Tip Stiffness: Pass. All samples met the pre-determined acceptance criteria.
Torque Testing: Pass. All samples met the pre-determined acceptance criteria.
Force at Break: Pass. All samples met the pre-determined acceptance criteria.
Small Bore Connector Compliance with Standard: Pass. All samples met the pre-determined acceptance criteria.
Radiopacity: Pass. All samples met the pre-determined acceptance criteria.
Particulate, Coating Integrity: Pass. All samples met the pre-determined acceptance criteria.
Freedom from Liquid Leakage: Pass. All samples met the pre-determined acceptance criteria.
Hub Aspiration Air Leakage: Pass. All samples met the pre-determined acceptance criteria.
Balloon Fatigue Test: Pass. All samples met the pre-determined acceptance criteria.
Simulated Use: Simulated use under in vitro conditions in a cerebral vascular model. Pass. All samples met the pre-determined acceptance criteria.
Flexural Fatigue: Pass. All samples met the pre-determined acceptance criteria.
Kink Resistance: Pass. All samples met the pre-determined acceptance criteria.
Lubricity and durability of the hydrophilic coating: Pass. All samples met the pre-determined acceptance criteria.
Guidewire lumen burst pressure (Static, dynamic): Pass. All samples met the pre-determined acceptance criteria.
Balloon Deflation Time: Pass. All samples met the pre-determined acceptance criteria.
Lumen Collapse: Pass. All samples met the pre-determined acceptance criteria.

Biocompatibility Testing Summary includes:

Cytotoxicity: Pass. Noncytotoxic according to the predetermined acceptance criteria.
Sensitization: Pass. Did not elicit a sensitization response according to the predetermined acceptance criteria.
Intracutaneous Irritation: Pass. Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria.
Systemic Toxicity: Systemic Injection Test: Pass. Test requirements for systemic toxicity were met according to the predetermined acceptance criteria.
Systemic Toxicity: Material Mediated Pyrogenicity: Pass. Non-pyrogenic, met the predetermined acceptance criteria.
Hemocompatibility: Hemolysis: Pass. Non-hemolytic, met the predetermined acceptance criteria.
Hemocompatibility: Complement Activation: Pass. Does not activate the complement system, met the predetermined acceptance criteria.
Hemocompatibility: Thrombogenicity: Pass. Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria.
Hemocompatibility: In Vitro Hemocompatibility: Pass. Not expected to result in adverse effects in vivo, met the predetermined acceptance criteria.
Hemocompatibility: Partial Thromboplastin Time: Pass. Does not have an effect on coagulation of human plasma, met the predetermined acceptance criteria.

No animal or clinical studies were required to demonstrate substantial equivalence.

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

Not Found

Predicate Device(s)

Concentric Medical, FlowGate2 (K153729)

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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 21, 2020

MicroVention, Inc. Stephanie Onstot Senior Regulatory Affairs Specialist 1311 Valencia Avenue Tustin, CA 92780

Re: K193607

Trade/Device Name: BOBBY Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 25, 2020 Received: June 26, 2020

Dear Stephanie Onstot:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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,

Naira Muradyan, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193607

Device Name BOBBY Balloon Guide Catheter

Indications for Use (Describe) The BOBBY Balloon Guide Catheter is intended:

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.

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

510(K) SUMMARY

510(k) Owner Information:

510(k) Owner:	MicroVention, Inc.
Address:	1311 Valencia Ave
	Tustin, California, USA
Telephone:	714-247-8000
Fax:	714-247-8014
Contact Person	Stephanie Onstot
Telephone	714-247-8000 x 8317
Date Prepared:		June 25, 2020
	Device Trade Name:	BOBBY™ Balloon Guide Catheter
	Classification:	Class II
	Classification Name:	Percutaneous Catheter
	Product Code(s):	DQY, QJP
	Regulation Number(s)	870.1250
	Predicate Devices:	Concentric Medical, FlowGate2™ (K153729)

Indication for Use:

The BOBBY Balloon Guide Catheter is intended:

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.

Device Description

The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end.

The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic

4

procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position.

Performance Testing Summary:

The BOBBY Balloon Guide Catheter has successfully completed the following relevant performance testing demonstrating that the device is suitable for its intended use.

Performance Test Summary
Study Name	Description	Reference Standard	Results
Conditioning,
Distribution, and Shelf
Life Aging Verification	To demonstrate that the product
meets the packaging strength and
packaging integrity following
accelerated aging to a 1-year
shelf life equivalent	ASTM F88 Seal
Strength of Flexible
Barrier materials
ASTM F2096 Standard
Test Method for
Detecting Gross Leaks
in Medical Packaging	Pass
All samples met the pre-
determined acceptance
criteria
Packaging Visual
Inspection	To demonstrate that the product
meets the packaging visual
inspection requirements given	N/A	Pass
All samples met the pre-
determined acceptance
criteria
Visual Surface
Requirements	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 |
| Dimensional/Physical
Attributes Inspection | 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 |
| Inflation Volume vs
Balloon Diameter | To demonstrate that the product
meets the inflation volume vs
balloon diameter specifications | In consideration of
ISO 10555-4:2013
Intravascular Catheters
Sterile and Single-
Use Catheters - Part 4:
Balloon Dilation
Catheters | Pass
All samples met the pre-
determined acceptance
criteria |
| Balloon Burst Volume | To demonstrate that the Balloon
is capable of withstanding an
injection volume above the
maximum fill volume. | In consideration of
ISO 10555-4:2013
Intravascular Catheters
Sterile and Single-
Use Catheters - Part 4:
Balloon Dilation
Catheters | 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 |
| Torque Testing | To demonstrate that the product
is capable of 720 degrees of
rotation about the central lumen
axis without failure. | N/A | Pass
All samples met the pre-
determined acceptance
criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Force at Break | To demonstrate the product
satisfies the force at break
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 |
| Small Bore Connector
Compliance with
Standard | To demonstrate that the product
meets the requirements | 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 |
| Radiopacity | To determine the radiopaque
characteristics of the device. | ISO 10555-1:2013
Intravascular catheters
Sterile and single-use
catheters - Part 1:
General requirements
ASTM F640-12
Standard Test Methods
for Determining
Radiopacity for
Medical Use | Pass
All samples met the pre-
determined acceptance
criteria |
| Particulate, Coating
Integrity | This study was conducted to
determine the quantity and size of
particles generated during
simulated use | USP Particulate
Matter in Injections | Pass
All samples met the pre-
determined acceptance
criteria |
| Freedom from Liquid
Leakage | To demonstrate that the product
meets the liquid leakage
requirements given in ISO
10555- 1. | ISO 10555-1:2013
Intravascular catheters
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met the pre-
determined acceptance
criteria |
| Hub Aspiration Air
Leakage | To demonstrate that the product
meets the hub aspiration air
leakage requirements given in
ISO 10555-1. | 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 Fatigue Test | To demonstrate that there is no
degradation of the Balloon after
repetitive inflation cycles. | In consideration of
ISO 10555-4:2013
Intravascular Catheters
Sterile and Single-
Use Catheters - Part 4:
Balloon Dilation
Catheters | Pass
All samples met the pre-
determined acceptance
criteria |
| Simulated Use | Simulated use under in vitro
conditions in a cerebral vascular
model | In consideration of
ISO 10555-4:2013
Intravascular Catheters
Sterile and Single-
Use Catheters - Part 4:
Balloon Dilation
Catheters | Pass
All samples met the pre-
determined acceptance
criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Flexural Fatigue | To demonstrate that the product
does not lose structural integrity
when used in the tortuous path
model. | ISO 10555-1:2013
Intravascular catheters
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met the pre-
determined acceptance
criteria |
| Kink Resistance | To demonstrate that the device
has similar kink resistance
compared to the predicate device. | N/A | Pass
All samples met the pre-
determined acceptance
criteria |
| Lubricity and durability of
the hydrophilic coating | To demonstrate that the
hydrophilic coating is lubricious
and durable. | N/A | Pass
All samples met the pre-
determined acceptance
criteria |
| Guidewire lumen burst
pressure (Static, dynamic) | To demonstrate that the device
does not burst below rated burst
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 Deflation Time | To demonstrate that the device
has similar balloon deflation time
compared to the predicate device. | ISO10555-4:2013
Intravascular catheters
Sterile and single-use
catheters – Part 4:
Balloon dilation
catheters | Pass
All samples met the pre-
determined acceptance
criteria |
| Lumen Collapse | To demonstrate that the
guidewire lumen does not
collapse under aspiration. | N/A | Pass
All samples met the pre-
determined acceptance
criteria |

5

6

No animal or clinical studies were required to demonstrate substantial equivalence.

Biocompatibility Testing Summary

Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (vitro cytotoxicity | Pass
Noncytotoxic 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 |
| Intracutaneous
Irritation | | Tested in accordance with ISO 10993-10, 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 |

7

Test Name	Test Method	Results
Systemic Toxicity:
Systemic Injection
Test	Tested in accordance with ISO 10993-11, 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
Systemic Toxicity:
Material Mediated
Pyrogenicity	Tested in accordance with ISO 10993-11, Biological
Evaluation of Medical Devices – Part 11: Tests for
Systemic Toxicity and USP NF 36:2018
Pyrogen Test	Pass
Non-pyrogenic, met the
predetermined acceptance criteria
Hemocompatibility:
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
Hemocompatibility:
Complement
Activation	Tested in accordance with ISO 10993-4, Biological
Evaluation of Medical Devices - Part 4: Selection of
Tests for Interactions with Blood, SC5b-9
Complement Activation	Pass
Does not activate the complement
system, met the predetermined
acceptance criteria
Hemocompatibility:
Thrombogenicity	Tested in accordance with ISO 10994-4, Biological
Evaluation of Medical Devices - Part 4: Selection of
Tests for Interactions with Blood, and ASTM
F2888-19, Standard Practice for Platelet Leukocyte
Count-An In Vitro Measure for Hemocompatibility
Assessment of Cardiovascular Materials	Pass
Demonstrates similar
thromboresistance characteristics as
the control device, met the
predetermined acceptance criteria
Hemocompatibility:
In Vitro
Hemocompatibility	Tested in accordance with ISO 10993-4, Biological
Evaluation of Medical Devices - Part 4: Selection of
Tests for Interactions with Blood,
Hemocompatibility, Direct Contact Method	Pass
Not expected to result in adverse
effects in vivo, met the
predetermined acceptance criteria
Hemocompatibility:
Partial
Thromboplastin Time	Tested in accordance with ISO 10994-4, Biological
Evaluation of Medical Devices - Part 4: Selection of
Tests for Interactions with Blood and ASTM F2382-
18, Standard Test Method for Assessment of
Intravascular Medical Device Materials on Partial
Thromboplastin Time (PTT)	Pass
Does not have an effect on
coagulation of human plasma, met
the predetermined acceptance
criteria

Predicate Device Comparison

The following table provides a comparison of the key characteristics of the BOBBY Balloon Guide Catheter to the predicate device.

Comparison Chart
Feature	Subject Device	Predicate device	Comparison
	BOBBY Balloon
Guide Catheter
K193607	8F FlowGate2™
Balloon Guide Catheter
K153729
FDA Classification	Class II	Class II	Same
Product Code(s)	DQY, QJP	DQY	Same
Regulation Number	870.1250	870.1250	Same
Regulation Name	Percutaneous Catheter	Percutaneous Catheter	Same
Anatomical Locations	Peripheral and neuro vasculature	Peripheral and neuro vasculature	Same
Comparison Chart
Feature	Subject Device
BOBBY Balloon
Guide Catheter
K193607	Predicate device
8F FlowGate™
Balloon Guide Catheter
K153729	Comparison
Material	Commonly used
medical grade plastics
(e.g. nylon, PTFE,
polyethylene,
polyolefin) and
stainless steel	Commonly used
medical grade plastics
(e.g. nylon, PTFE,
polyethylene,
polyolefin) and
stainless steel	Similar, minor
differences do not
raise new questions
of safety and
efficacy, confirmed
through
biocompatibility and
performance testing
Reinforced Catheter
Shaft	Stainless steel braid
and coil reinforced
shaft	Stainless steel braid
reinforced shaft	Similar, minor
differences do not
raise new questions
of safety and
efficacy
Injection Port	Yes	Yes	Same
Radiopacity	Yes, shaft is visible
due to distal tip Pt-Ir
marker bands	Yes, shaft material
contains barium
sulfate, distal tip Pt-Ir
marker band	Similar, minor
difference does not
raise new questions
regarding safety and
efficacy, both
devices are
radiopaque
Radiopaque Marker
Bands	2	1	Similar, minor
difference does not
raise new questions
regarding safety and
efficacy, both
devices utilize
radiopaque marker
bands
Compliant Balloon	Yes, polyurethane	Yes, silicone	Similar, material
differences do not
raise new questions
of safety and
efficacy, both
materials are used
for compliant
balloons for
intravascular use
Labeled Shaft Outer
Diameter	0.110 in (2.8 mm)
8Fr	0.106 in (2.7 mm)
8Fr	Similar, minor
differences do not
raise new questions
of safety and
efficacy
Comparison Chart
Feature	Subject Device
BOBBY Balloon
Guide Catheter
K193607	Predicate device
8F FlowGate2™
Balloon Guide Catheter
K153729	Comparison
Labeled Shaft Inner
Diameter	0.086 in (2.18 mm)
6.5Fr	0.084 in (2.1 mm)
6.4Fr	Similar, minor
differences do not
raise new questions
of safety and
efficacy
Effective length	95 cm
(37.4 in)	85 cm, 95cm
(33.5, 37.4 in)	Similar, minor
differences do not
raise new questions
of safety and
efficacy
Tip Shape	Straight	Straight	Same
Coating	Hydrophilic Coating -
Distal portion of shaft	None	Difference does not
raise new questions
of safety and
efficacy.
Hydrophilic coatings
are commonly used
to lubricate vascular
catheters.
Internal Construction	Coaxial lumen	Coaxial lumen	Same
Accessories Supplied	Peel Away Sheath	Dilator, Rotating
Hemostasis Valve,
Tuohy Borst Valve
with sideport, Peel
Away Sheaths, Luer-
Activated Valves	Similar, minor
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

8

9

Conclusion:

MicroVention, Inc. concludes through a review of the benchtop assessments, the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility that the BOBBY Balloon Guide Catheter is substantially equivalent to the predicate device, FlowGate2™ Balloon Guide Catheter. Any differences are minor and do not raise different questions of safety and effectiveness.