Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon guide catheter, with no mention of AI or ML capabilities.

Therapeutic

No.
The device facilitates the insertion and guidance of catheters and provides temporary vascular occlusion, which are procedural aids rather than direct treatments for a disease or condition.

Diagnostic

No

The device is described as a guide catheter with a balloon for temporary vascular occlusion, and its intended use is to facilitate the insertion and guidance of other catheters or to act as a conduit for retrieval devices during angiographic procedures. These functions are procedural and interventional, rather than diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical catheter with a balloon, radiopaque marker, and luer hub, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device is a catheter used to facilitate the insertion and guidance of other catheters within blood vessels. It also uses a balloon for temporary vascular occlusion.
Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and procedural within the vascular system.

The device is an invasive medical device used for interventional procedures within the body, not for analyzing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Concentric 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 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 (comma separated list FDA assigned to the subject device)

DQY

Device Description

Like the predicate device, the Modified FlowGate™ Balloon Guide Catheter is a coaxiallumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

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)

The following tests were performed and successfully evaluated on the subject device and accessories:
Dimensional Verification: the ability of the device to meet predetermined dimensional requirements
Simulated Use Testing: the ability of the device and accessories to be used per procedural instructions outlined in the Instructions for Use in a neurovascular model
Balloon Testing: the symmetry and compliance of the distal balloon; balloon inflation and deflation rates; balloon fatigue strength; constrained balloon burst and leakage
Tensile Testing: the mechanical integrity of the device under tensile loads
Distal Shaft Flexibility Testing: the force to flex the distal shaft of the device
Soft Tip Deflection Testing: the force to deflect the distal edge of the soft tip
Tip Patency Testing: the ability of the device distal tip to maintain patency under aspiration
Kink Resistance: the ability of the device shaft to resist kinking
Hub Luer Fitting Testing: compatibility of the Extension Tubing accessory with the hub luer fitting
Extension Tubing Aspiration: the ability to aspirate using the Extension Tubing Accessory
Packaging Verification: the ability of the packaging to protect the finished device following climatic conditioning and distribution simulation
Shelf life testing (Product and Packaging)

Biocompatibility tests were performed on the predicate devices (K112404 and K122581).
For Predicate Device K122581:
Sensitization (Kligman Maximization Test - ISO): Non-sensitizer.
Cytotoxicity (L929 MEM Elution Test): Non-cytotoxic.
Intracutaneous Reactivity (Intracutaneous Injection Test): Non-irritant.
Systemic Toxicity (Acute) (Systemic Injection Test): No acute systemic toxicity.
Systemic Toxicity (Rabbit Pyrogen Test, Material Mediated): Non-pyrogenic.
Hemocompatibility (Hemolysis - Rabbit Blood - ASTM Direct and Indirect Contact): Non-hemolytic.
Hemocompatibility (Complement Activation Assay): Minimal complement activation potential.
Hemocompatibility (Thrombogenicity Study in Dogs): No significant thrombosis.

For Subject Device K131492 (Biocompatibility Screening Tests):
Cytotoxicity (L929 MEM Elution Test): Non-cytotoxic.
Hemocompatibility (ASTM Hemolysis (Direct contact and extract test)): Non-hemolytic.
Fourier Transform Infrared (FTIR) Scan (+ control sample): Materials for test article and control sample are equivalent (97.90% match).
Physicochemical Tests (Plastics (USP )): Met USP requirements.

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.

K112404, K122581

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

510(k) Summary

Trade Name:	Modified Balloon Guide Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 Class II
Product Code:	DQY
Submitter:	Concentric Medical, Inc.
301 E. Evelyn Avenue
Mountain View, CA 94041
Tel 650-938-2100
Fax 650-237-5230
Facility Registration #2954917
Contact:	Rhoda Santos
Principal Regulatory Affairs Specialist
Date Prepared:	September 27, 2013
Predicate Device:	Concentric Balloon Guide Catheter (K112404)
Modified Concentric Balloon Guide Catheter (K122581)

Device Description

Like the predicate device, the Modified FlowGate™ Balloon Guide Catheter is a coaxiallumen, braid-reinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.

Accessories

The Modified FlowGate™ Balloon Guide Catheter is packaged with a Dilator, Rotating Hemostasis Valve, Tuohy Borst Valve with sideport, Peel Away Sheaths, Luer-Activated Valve, and Extension tubing.

1

Indications for Use

The Indications for Use are the identical to that of the predicate device and are as follows:

The Concentric 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 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.

Technological Characteristics and Product Feature Comparison:

The subject device, Modified FlowGate Balloon Guide Catheters is substantially equivalent to the predicate device in terms of:

indications for use materials fundamental scientific technology fundamental design materials and processes for packaging and sterilization of devices

A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below.

2

.

:

.

Product Feature Comparison of Subject Device with Predicate Devices (K112404 and
K122581)

| | Feature | Predicate Device,
K112404 | Results | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | | | Predicate Device,
K122581 | Subject Device,
K131492 |
| | Indications for
Use | The 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 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. | Same with reference to
marketed name as
FlowGate™ Balloon
Guide Catheter | Same as predicate
device, K122581 |
| | Device
Description | The Concentric Balloon
Guide Catheter is a
coaxial-lumen, braided
shaft, variable stiffness
catheter with a
radiopaque marker on the
distal end and a
bifurcated luer hub on the
proximal end. A
compliant balloon is
mounted on the distal
end. BGC dimensions
and maximum
recommended balloon
inflation volume are
indicated on product
label. If indicated on the
product label, a dilator is
provided for transition to
the guidewire. | Same with reference to
marketed name as
FlowGate™ Balloon
Guide Catheter | Same as predicate
device, K122581 |
| | Outer/Inner
Jacket | Pebax | Same with revisions to
transition lengths and
material durometers | Same material durometers
as K122581, with
revisions to transition
lengths |
| | Results | | | |
| Feature | Predicate Device,
K112404 | Predicate Device,
K122581 | Subject Device,
K131492 | |
| Distal Tip | Pebax | Same with different
durometer material than
predicate device,
K112404 | Same with different
durometer material than
predicate devices | |
| Balloon.
Material | Silicone | Same with different
material durometer than
predicate device,
K112404 | Same with same material
durometer as predicate
device, K112404 | |
| Braid | Stainless Steel | Same | Same | |
| Braid distal end
securement | PET heat shrink | Acrylic (Acrylated
Urethane) | Cyanoacrylate, with
different viscosity than
Cyanoacrylate used on
predicate devices | |
| Marker Band | Platinum/Iridium | Same | Same | |
| Catheter Hub | Polyurethane | Same | Same | |
| Strain Relief | Polyolefin | Same | Additional Pebax strain
relief included with
subject device | |
| Labeled Shaft
Inner / Outer
Diameter
(nominal) | Inner Diameter:
0.059" (7F), 0.078" (8F)
or 0.085" (9F)

Outer Diameter:
0.088 "(7F), 0.104 "(8F)
or 0.116" (9F) | Inner Diameter:
0.084in

.

3

Product Feature Comparison of Subject Device with Predicate Devices (K112404 and K122581)

4

Product Feature Comparison of Subject Device with Predicate Devices (K112404 and K122581)

Risk Assessment

Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined the modifications to the predicate devices raise no new questions of safety or effectiveness.

Results of verification and validation testing have demonstrated the Modified FlowGate Balloon Guide Catheters are substantially equivalent to the predicate devices. Furthermore, the modifications did not result in any new failure modes nor were there any changes to existing failure modes.

5

Testing Summary

The results of verification and validation conducted on the subject device demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate devices. Specifically, the following tests were performed and successfully evaluated on the subject device and accessories:

Dimensional Verification: the ability of the device to meet predetermined dimensional requirements

Simulated Use Testing: the ability of the device and accessories to be used per procedural instructions outlined in the Instructions for Use in a neurovascular model

Balloon Testing: the symmetry and compliance of the distal balloon; balloon inflation and deflation rates; balloon fatigue strength; constrained balloon burst and leakage

Tensile Testing: the mechanical integrity of the device under tensile loads

Distal Shaft Flexibility Testing: the force to flex the distal shaft of the device

Soft Tip Deflection Testing: the force to deflect the distal edge of the soft tip

Tip Patency Testing: the ability of the device distal tip to maintain patency under aspiration

Kink Resistance: the ability of the device shaft to resist kinking

Hub Luer Fitting Testing: compatibility of the Extension Tubing accessory with the hub luer fitting

Extension Tubing Aspiration: the ability to aspirate using the Extension Tubing Accessory

Packaging Verification: the ability of the packaging to protect the finished device following climatic conditioning and distribution simulation

Shelf life testing (Product and Packaging)

6

The subject device uses the same materials and processes as the predicate devices (K112404 and K122581). Biocompatibility tests were performed on the predicate devices (K112404 and K122581); results for all tests met the acceptance criteria and apply to the subject device. In addition, some biocompatibility screening tests were also performed on the subject device. The biocompatibility tests conducted on the predicate device K122581 and the subject device are summarized in the tables below:

| ISO 10993

Standard	Test	Results	Conclusion
ISO 10993-10	Sensitization
Kligman Maximization
Test - ISO	The USP 0.9% Sodium Chloride
for injection (NaCl) and
Cottonseed Oil (CSO) extracts of
the test article showed no
evidence of causing delayed
dermal contact sensitization.	Non-sensitizer
ISO 10993-5	Cytotoxicity
L929 MEM Elution Test	No biological activity (Grade 0) was
observed in the L929 mammalian cells
at 48 hours post exposure to the test
article extract. The observed cellular
response obtained from the positive
control article extract (Grade 4) and
negative control article extract (Grade

confirmed the suitability of the test
system. | Non-cytotoxic |
| ISO 10993-10 | Intracutaneous Reactivity
Intracutaneous Injection
Test | The sites injected with the USP 0.9%
Sodium Chloride for Injection (NaCl)
and Cottonseed Oil (CSO) extracts of
the test article did not show a
significantly greater biological
reaction than the sites injected with
the control extracts. The difference of
the overall mean score between the
test article and the control article was
0.0. | Non-irritant |
| ISO 10993-11 | Systemic Toxicity (Acute)
Systemic Injection Test | The 0.9% Sodium Chloride for
Injection (NaCl) and Cottonseed Oil
(CSO) extracts of the test article did
not induce a significantly greater
biological reaction than the control
extracts, when tested in Swiss Albino
mice. | No acute
systemic
toxicity |

Biocompatibility Tests, Results, Conclusions (Predicate device, K122581)

7

| ISO 10993

Standard	Test	Results	Conclusion
ISO 10993-11
USP 34	Systemic Toxicity
Rabbit Pyrogen Test,
Material Mediated	No rabbit injected with the USP 0.9%
Sodium Chloride for Injection (NaCl)
extract of the test article showed an
individual rise in temperature of 0.5°C
or more above the baseline
temperature.	Non-pyrogenic
ASTM F756	Hemocompatibility
Hemolysis - Rabbit Blood

ASTM Direct and
Indirect Contact | The test article exhibited 0.17%
hemolysis above the level of
hemolysis exhibited by the negative
control via the direct method and
0.12% hemolysis above the level of
hemolysis exhibited by the negative
control via the indirect method. | Non-hemolytic |
| ISO 10993-4 | Hemocompatibility
Complement
Activation Assay | The plasma exposed to test article
exhibited no statistically significant
increase in C3a when compared to
the untreated control and the negative
control after 90 minute exposure.
The plasma exposed to test article
exhibited a statistically significant
increase in SC5b-9 when compared to
the untreated control and the negative
control after 90 minute exposure. | Minimal
complement
activation
potential |
| ISO 10993-4 | Hemocompatibility
Thrombogenicity Study in
Dogs | No significant thrombosis with a Grade
of 0 (a very small clot is acceptable)
was observed in 1 out of 2 test sites
and 1 out of 2 control sites. Minimal
thrombosis with a Grade of 1
(thrombus found at one location) was
observed in 1 out of 2 test sites and 1
out of 2 control sites. | No significant
thrombosis |

Biocompatibility Tests Results Conclusions (Predicate device, K122581), continued

:

.

:

,

8

| ISO 10993

Standard	Test	Results	Conclusion
ISO 10993-5	Cytotoxicity
L929 MEM Elution Test	No cytotoxicity or cell lysis was noted
in any of the test wells. No pH shift
was observed at 48 hours. The
reagent control, negative control and
the positive control performed as
anticipated.	Non-cytotoxic
ISO 10993-4	Hemocompatibility
ASTM Hemolysis (Direct
contact and extract test)	The hemolytic index for the test article
in direct contact with blood was 0.0%
and the hemolytic index for the test
article extract was 0.4%	Non-hemolytic
ISO 10993-18	Fourier Transform
Infrared (FTIR) Scan
(+ control sample)	The distal 1mm white tip was scanned
and compared to the control sample.
The samples had a match of 97.90%.	Materials for
test article and
control sample
are equivalent.
ISO 10993-18	Physicochemical Tests
Plastics (USP )	Non-volatile residue: 1 mg
Residue on ignition:
requirements

・

.

Biocompatibility Screening Tests. Results, Conclusions (Subject device, K131492)

:

The biocompatibility results demonstrate that the subject device is biocompatible.

:

9

Summary of Substantial Equivalence

The subject device, Modified FlowGate Balloon Guide Catheter, is substantially equivalent to the predicate devices with regard to device design, materials, intended use, and patient population. The conclusions drawn from the risk assessments, verification and validation testing conducted demonstrate that the subject device performs as designed, is as safe, as effective, and performs as well as or better than the predicate devices.

10

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

October 3, 2013

Concentric Medical, Inc. % Ms. Rhoda Santos Principal Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, CA 94041

Re: K131492

Trade/Device Name: Modified FlowGate™ Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 21, 2013 Received: August 22, 2013

Dear Ms. Santos:

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. 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 complics 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 (reporting of medical

11

Page 2 - Ms. Rhoda Santos

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

Victor Krauthamer, Ph.D. for Acting Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

12

Indications for Use

510(k) Number (if known): K131492

Device Name: Modified FlowGate™ Balloon Guide Catheter

Indications For Use:

The Concentric 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 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.

Prescription Use كي__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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