Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical catheter device and its mechanical properties. There is 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 catheters and provides temporary vascular occlusion, which are procedural aids rather than direct treatments for a disease or condition.

Diagnostic

No
The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and to provide temporary vascular occlusion. It does not perform diagnostic functions such as detecting, monitoring, or predicting diseases.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical catheter with a balloon, radiopaque markers, and a luer hub. It also mentions nonclinical performance studies related to the physical properties of the catheter and balloon. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly describes a device used within the body to facilitate the insertion and guidance of catheters and provide temporary vascular occlusion during angiographic procedures. This is an in vivo application, meaning it's used on a living organism.
Device Description: The description details a physical catheter with a balloon, designed for insertion into blood vessels.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside the body to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of these specimens.

Therefore, the CELLO Balloon Guide Catheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

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

DQY

Device Description

The CELLO Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with two radiopaque markers on both the distal and proximal ends of the balloon and a bifurcated luer hub on the proximal end. A compliant silicone balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended inflation volumes are indicated on the product label. Each catheter is supplied with an appropriately-size Dilator.

The CELLO Balloon Guide Catheters are used in hospitals or other health care facilities which are equipped with trained personnel and specialized equipment to perform peripheral and/or neurovascular procedures.

The CELLO Balloon Guide Catheter is used for facilitating the insertion and guidance of intravascular catheters into selected blood vessels in the peripheral and neurovasculature. The tip of the catheter features a balloon of silicone rubber. Radiopaque markers identify the proximal and distal ends of the balloon. The shaft is a dual lumen type with coaxial structure featuring a built-in braided stainless steel coil.

The materials of construction resemble those used in many other similar catheters. The shaft is made of polyurethane, polyamide, stainless steel and PFA; the balloon is silicone. Patient contact is of limited duration, less than 24 hrs.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

selected blood vessel in the peripheral and neurovasculature systems.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospitals or other health care facilities which are equipped with trained personnel and specialized equipment to perform peripheral and/or neurovascular procedures.

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)

Nonclinical Tests, CELLO Balloon Guide Catheters:

Surface: Free from extraneous matter, process and surface defects. Pass.
Force at Break: All joints meet reliability/confidence requirements in statistical confidence limits test. Pass.
Freedom from Leakage: Shall not leak liquid when inflated. Air shall not leak into the hub during aspiration. Pass.
Tip Configuration: Distal tip smooth, rounded, tapered or similarly finished. Pass.
Hubs: Comply with ISO 594-1 and ISO 594-2. Pass.
Freedom from Leakage and Damage on Inflation: No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. Pass.
Dimensional Verification: All dimensions meet reliability/confidence requirements in statistical confidence limits test. Pass.
Balloon Preparation, Deployment and Retraction: Catheters can be advanced to intended sites within a realistic tortuous path model where other devices can be deployed distally and retracted; all devices could be retracted without damage. Pass.
Balloon Rated Burst Pressure (RBP): All balloons meet reliability/confidence requirements in statistical confidence limits test. Pass.
Balloon Fatigue: All balloons withstand 20 cycles of inflation. Pass.
Balloon Compliance: All balloons have predictable change in size with pressure. FIO*.
Balloon Inflation-Deflation Time: All balloons inflate and deflate predictably. FIO*.
Flexibility and Kink: All catheters meet reliability/confidence requirements in statistical confidence limits test. Pass.
Torque Strength: All models can be torqued at least 180° when the distal tip is fixed in a tortuous path model. FIO*.
Radiopacity: Radiopaque markers are visible during angiography under a variety of conditions. FIO*.

Nonclinical Tests, Dilator:

Surface: Free from extraneous matter, process and surface defects. Pass.
Force at Break: All joints meet reliability/confidence requirements in statistical confidence limits test. Pass.
Freedom from Leakage: Shall not leak liquid when inflated. Air shall not leak into the hub during aspiration. Pass.
Tip Configuration: Distal tip smooth, rounded, tapered or similarly finished. Pass.
Hubs: Comply with ISO 594-1 and ISO 594-2. Pass.
Freedom from Leakage and Damage on Inflation: No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. Pass.

Biocompatibility, CELLO Balloon Guide Catheters:

L29 MEM Elution Test-ISO: Non-Cytotoxic. Pass.
Kligman Maximization Test: No Sensitization. Pass.
Intracutaneous Injection Test: Non-Irritant. Pass.
Systemic Injection Test-ISO: No acute toxicity. Pass.
Rabbit Pyrogen Test (Material Mediated) - ISO: Non-pyrogenic. Pass.
Hemolysis- Direct Contact: Non-hemolytic. Pass.
Hemolysis-Rabbit Blood-ASTM Indirect Contact: Non-hemolytic. Pass.
Complement Activation-Direct Contact: Non-Complement Activation. Pass.
Complement Activation Assay-ISO Indirect Contact: Non-Complement Activation. Pass.
In-vivo Thrombogenicity: Patent vessels No thrombus. Better thrombo-resistance than control.

Biocompatibility, Dilator:

L29 MEM Elution Test-ISO: Non-Cytotoxic. Pass.
Kligman Maximization Test: No Sensitization. Pass.
Intracutaneous Injection Test: Non-Irritant. Pass.
Systemic Injection Test-ISO: No acute toxicity. Pass.
Rabbit Pyrogen Test (Material Mediated)-ISO: Non-pyrogenic. Pass.
Hemolysis- Direct Contact: Non-hemolytic. Pass.
Hemolysis-Rabbit Blood--ASTM Indirect Contact: Non-hemolytic. Pass.
Complement Activation-Direct Contact: Non-Complement Activation. Pass.
Complement Activation Assay-ISO Indirect Contact: Non-Complement Activation. Pass.
In-vivo Thrombogenicity: Less thrombus than control. Better thrombo-resistance than control.

No clinical testing was submitted to support this premarket notification.

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.

K021899

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, K120781

Manufacturer

Fuji Systems Corporation 23-14, Hongo 3-Chome, Bunkyo, Tokyo 113-0033 Japan Phone: +81-5489-1915

Contact

Yoshihiko Semba General Manager, Director International Division

Date of Preparation

July 25, 2012

Product Names

AUG - 9 2012

| Generic Name | Classification | Product
Code | Trade Name | Model No. |
|--------------------------|--------------------------------|-----------------|------------------------------------|---------------|
| | 21 CFR
870.1250
Class II | DQY | CELLO
Balloon Guide
Catheter | 1610560 (6 F) |
| | | | | 1610561 (6 F) |
| Percutaneous
Catheter | | | | 1610570 (7 F) |
| | | | | 1610571 (7 F) |
| | | | | 1610580 (8 F) |
| | | | | 1610590 (9 F) |

Predicate Device

Concentric Balloon Guide Catheter, K021899

1

Device Description

The CELLO Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with two radiopaque markers on both the distal and proximal ends of the balloon and a bifurcated luer hub on the proximal end. A compliant silicone balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended inflation volumes are indicated on the product label. Each catheter is supplied with an appropriately-size Dilator.

The CELLO Balloon Guide Catheters are used in hospitals or other health care facilities which are equipped with trained personnel and specialized equipment to perform peripheral and/or neurovascular procedures.

The CELLO Balloon Guide Catheter is used for facilitating the insertion and guidance of intravascular catheters into selected blood vessels in the peripheral and neurovasculature. The tip of the catheter features a balloon of silicone rubber. Radiopaque markers identify the proximal and distal ends of the balloon. The shaft is a dual lumen type with coaxial structure featuring a built-in braided stainless steel coil.

The materials of construction resemble those used in many other similar catheters. The shaft is made of polyurethane, polyamide, stainless steel and PFA; the balloon is silicone. Patient contact is of limited duration, less than 24 hrs.

Intended Use

The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

2

K120781
P. 3 of 6

. ..

Device	Proposed	Predicate	Consideration
Device Name	CELLO Balloon Guide
Catheter	Concentric Balloon Guide
Catheter	(N/A)
Device
Description *	The CELLO Balloon Guide
Catheter is a coaxial-lumen,
braid-reinforced, variable
stiffness catheter with two
radiopaque markers on
both the distal and proximal
ends of the balloon and a
bifurcated luer hub on the
proximal end. A compliant
silicone balloon is mounted
on the distal end. Balloon
Guide Catheter dimensions
and the recommended
balloon inflation volumes
are indicated on product
label.

A dilator is provided with
each catheter. | Concentric and Merci
Balloon Guide catheters are
coaxial lumen, braid-
reinforced, variable stiffness
catheters with a radiopaque
marker on the distal end
and a bifurcated luer hub
on the proximal end. A
compliant balloon is flush
mounted on the distal end.
Balloon Guide catheter
dimensions and maximum
recommended balloon
inflation volume are
indicated on product label.

Comparison of Technological Characteristics, compared to the Predicate

*Verbatim from each device's IFU.

'

3

Nonclinical Tests, CELLO Balloon Guide Catheters

Test	Results	Conclusion
Surface	Free from extraneous matter, process and surface defects.	Pass
Force at Break	All joints meet reliability/confidence requirements in statistical confidence limits test	Pass
Freedom from Leakage	Shall not leak liquid when inflated.
Air shall not leak into the hub during aspiration.	Pass
Tip Configuration	Distal tip smooth, rounded, tapered or similarly finished.	Pass
Hubs	Comply with ISO 594-1 and ISO 594-2	Pass
Freedom from Leakage and Damage on Inflation	No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon.	Pass
Dimensional Verification	All dimensions meet reliability/confidence requirements in statistical confidence limits test	Pass
Balloon Preparation, Deployment and Retraction	Catheters can be advanced to intended sites within a realistic tortuous path model where other devices can be deployed distally and retracted; all devices could be retracted without damage.	Pass
Balloon Rated Burst Pressure (RBP)	All balloons meet reliability/confidence requirements in statistical confidence limits test	Pass
Balloon Fatigue	All balloons withstand 20 cycles of inflation	Pass
Balloon Compliance	All balloons have predictable change in size with pressure	FIO*
Balloon Inflation-Deflation Time	All balloons inflate and deflate predictably	FIO*
Flexibility and Kink	All catheters meet reliability/confidence requirements in statistical confidence limits test	Pass
Torque Strength	All models can be torqued at least 180° when the distal tip is fixed in a tortuous path model	FIO*
Radiopacity	Radiopaque markers are visible during angiography under a variety of conditions	FIO*

·

For Information Only

4

Nonclinical Tests, Dilator

ﺮ

Test	Results	Conclusion
Surface	Free from extraneous matter, process and surface
defects.	Pass
Force at Break	All joints meet reliability/confidence requirements
in statistical confidence limits test	Pass
Freedom from Leakage	Shall not leak liquid when inflated.
Air shall not leak into the hub during aspiration.	Pass
Tip Configuration	Distal tip smooth, rounded, tapered or similarly
finished.	Pass
Hubs	Comply with ISO 594-1 and ISO 594-2	Pass
Freedom from Leakage and
Damage on Inflation	No leakage or evidence of damage, such as
herniation or bursting of the shaft or balloon.	Pass

Biocompatibility, CELLO Balloon Guide Catheters

.

Test	Results	Conclusion
L29 MEM Elution Test-ISO	Non-Cytotoxic	Pass
Kligman Maximization Test	No Sensitization	Pass
Intracutaneous Injection Test	Non-Irritant	Pass
Systemic Injection Test-ISO	No acute toxicity	Pass
Rabbit Pyrogen Test (Material
Mediated) - ISO	Non-pyrogenic	Pass
Hemolysis- Direct Contact	Non-hemolytic	Pass
Hemolysis-Rabbit Blood-ASTM
Indirect Contact	Non-hemolytic	Pass
Complement Activation-Direct
Contact	Non-Complement
Activation	Pass
Complement Activation Assay-ISO
Indirect Contact	Non-Complement
Activation	Pass
In-vivo Thrombogenicity	Patent vessels
No thrombus	Better thrombo-resistance
than control

5

Biocompatibility, Dilator

Test	Results	Conclusion
L29 MEM Elution Test-ISO	Non-Cytotoxic	Pass
Kligman Maximization Test	No Sensitization	Pass
Intracutaneous Injection Test	Non-Irritant	Pass
Systemic Injection Test-ISO	No acute toxicity	Pass
Rabbit Pyrogen Test (Material
Mediated)-ISO	Non-pyrogenic	Pass
Hemolysis- Direct Contact	Non-hemolytic	Pass
Hemolysis-Rabbit Blood--ASTM
Indirect Contact	Non-hemolytic	Pass
Complement Activation-Direct
Contact	Non-Complement
Activation	Pass
Complement Activation Assay-ISO
Indirect Contact	Non-Complement
Activation	Pass
In-vivo Thrombogenicity	Less thrombus than
control	Better thrombo-resistance
than control

Clinical Tests

No clinical testing was submitted to support this premarket notification.

Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the CELLO Balloon Guide Catheter is substantially equivalent to the legally marketed predicate device.

The design of the CELLO Balloon Guide catheter resembles that of the predicate with regard to its principle of operation: each catheter shaft includes an internal stainless steel braid surrounded by polymer. The balloon is made from silicone rubber and its position can be identified during angiography because of radiopaque markers.

The intended use of the CELLO Balloon Guide Catheter is substantially equivalent to that of the predicate.

The patient population of the CELLO Balloon Guide Catheter is substantially equivalent to that of the predicate.

The CELLO Balloon Guide Catheter is substantially equivalent to the predicate device with respect to the anatomical sites where the device is used.

6

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 9 2012

Fuji Systems Corporation c/o Paul Mason, PhD Consultant 3250 Second Avenue San Diego, CA 92103

Re: K120781

CELLO Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 26, 2012 Received: July, 27, 2012

Dear Dr. Mason:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 210(x) premance is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed press Davice Amendments for use stated in the encrosule) to regary mansted producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval of the Act. The and Cosmetic Act (Act) that do not require apperal controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the geniret for amual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the Act merade requirement.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and be If your device is classified (see adver) mio cimer sits it (epions affecting your device can be
may be subject to additional controls. Exist. Rich 24 - Rollion FDA may may be subject to additional controls: "Laisting Title 21, Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a found in the Code of Federal Regulations, This Levice in the Federal Register.
publish further announcements concerning your and any also any and publish further announcements concerning your ac tree determination does not mean
Please be advised that FDA's issuance of a substantial equivalies with other requirements of Please be advised that FDA's issuance of a substaintial equivalents and the requirements of the Act
that FDA has made a determination that your device complies with other req

7

Page 2 - Paul Mason, PhD

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 devicc-rclated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address

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

Sincerely yours,

CMA Wilhelm

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

Indications for Use Statement

Indications for Use

510(k) Number (if known): K120781

Device Name: CELLO Balloon Guide Catheter

Indications for Use:

The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Prescription Use _ X (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 CDRH, Office of Device Evaluation (ODE)

4

CmS. Willeke

(Division Sign-Off) Division of Cardiovascular Devices

K120781 510(k) Number_