CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
Device Facts
| Record ID | K120781 |
|---|---|
| Device Name | CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH |
| Applicant | Fuji Systems Corp. |
| Product Code | DQY · Cardiovascular |
| Decision Date | Aug 9, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
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.
Device Story
CELLO Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter; features distal silicone rubber balloon and radiopaque markers for visualization. Used in hospitals by trained personnel for peripheral and neurovascular procedures. Device facilitates insertion/guidance of intravascular catheters; balloon provides temporary vascular occlusion during angiography. Supplied with dilator. Operates via manual manipulation by physician; provides mechanical support and occlusion. Benefits include improved access to tortuous vasculature and controlled vascular occlusion during diagnostic or interventional procedures.
Clinical Evidence
No clinical data. Substantial equivalence supported by nonclinical bench testing including surface inspection, force at break, leakage, tip configuration, hub compliance (ISO 594-1/2), balloon burst pressure, fatigue, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, and in-vivo thrombogenicity).
Technological Characteristics
Coaxial-lumen, braid-reinforced catheter; materials: polyurethane, polyamide, stainless steel, PFA, silicone rubber balloon. Dimensions: 6F-9F. Radiopaque markers. Sterilization: Ethylene oxide. Hubs comply with ISO 594-1/2. No software or electronic components.
Indications for Use
Indicated for patients requiring intravascular catheter insertion and guidance in peripheral and neurovascular systems, and temporary vascular occlusion during angiographic procedures.
Regulatory Classification
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.
Predicate Devices
- Concentric Balloon Guide Catheter (K021899)
Submission Summary (Full Text)
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# 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<br>Code | Trade Name | Model No. |
|--------------------------|--------------------------------|-----------------|------------------------------------|---------------|
| | 21 CFR<br>870.1250<br>Class II | DQY | CELLO<br>Balloon Guide<br>Catheter | 1610560 (6 F) |
| | | | | 1610561 (6 F) |
| Percutaneous<br>Catheter | | | | 1610570 (7 F) |
| | | | | 1610571 (7 F) |
| | | | | 1610580 (8 F) |
| | | | | 1610590 (9 F) |
# Predicate Device
Concentric Balloon Guide Catheter, K021899
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#### 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.
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K120781
P. 3 of 6
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| Device | Proposed | Predicate | Consideration |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Device Name | CELLO Balloon Guide<br>Catheter | Concentric Balloon Guide<br>Catheter | (N/A) |
| Device<br>Description * | The CELLO Balloon Guide<br>Catheter is a coaxial-lumen,<br>braid-reinforced, variable<br>stiffness catheter with two<br>radiopaque markers on<br>both the distal and proximal<br>ends of the balloon and a<br>bifurcated luer hub on the<br>proximal end. A compliant<br>silicone balloon is mounted<br>on the distal end. Balloon<br>Guide Catheter dimensions<br>and the recommended<br>balloon inflation volumes<br>are indicated on product<br>label.<br><br>A dilator is provided with<br>each catheter. | Concentric and Merci<br>Balloon Guide catheters are<br>coaxial lumen, braid-<br>reinforced, variable stiffness<br>catheters with a radiopaque<br>marker on the distal end<br>and a bifurcated luer hub<br>on the proximal end. A<br>compliant balloon is flush<br>mounted on the distal end.<br>Balloon Guide catheter<br>dimensions and maximum<br>recommended balloon<br>inflation volume are<br>indicated on product label.<br><br>If indicated on product<br>label, a dilator is provided. | Similar<br>technological<br>characteristics |
| Size | 6F, 7F, 8F, 9F | 8F, 9F | 8F and 9F are<br>the same |
| Effective length | 920 mm to 1020 mm | 800 to 950 | Overlap from<br>920 to 950 mm |
| Material/Shaft | Polyurethane, Polyamide,<br>Stainless steel, PFA | Polyurethane, Stainless<br>steel | Similar<br>materials |
| Material/Balloon | Silicone rubber | Silicone rubber | Same |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |
Comparison of Technological Characteristics, compared to the Predicate
*Verbatim from each device's IFU.
-
'
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# 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.<br>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
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# Nonclinical Tests, Dilator
ﺮ
| Test | Results | Conclusion |
|-------------------------------------------------|----------------------------------------------------------------------------------------------|------------|
| Surface | Free from extraneous matter, process and surface<br>defects. | Pass |
| Force at Break | All joints meet reliability/confidence requirements<br>in statistical confidence limits test | Pass |
| Freedom from Leakage | Shall not leak liquid when inflated.<br>Air shall not leak into the hub during aspiration. | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly<br>finished. | Pass |
| Hubs | Comply with ISO 594-1 and ISO 594-2 | Pass |
| Freedom from Leakage and<br>Damage on Inflation | No leakage or evidence of damage, such as<br>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<br>Mediated) - ISO | Non-pyrogenic | Pass |
| Hemolysis- Direct Contact | Non-hemolytic | Pass |
| Hemolysis-Rabbit Blood-ASTM<br>Indirect Contact | Non-hemolytic | Pass |
| Complement Activation-Direct<br>Contact | Non-Complement<br>Activation | Pass |
| Complement Activation Assay-ISO<br>Indirect Contact | Non-Complement<br>Activation | Pass |
| In-vivo Thrombogenicity | Patent vessels<br>No thrombus | Better thrombo-resistance<br>than control |
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### 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<br>Mediated)-ISO | Non-pyrogenic | Pass |
| Hemolysis- Direct Contact | Non-hemolytic | Pass |
| Hemolysis-Rabbit Blood--ASTM<br>Indirect Contact | Non-hemolytic | Pass |
| Complement Activation-Direct<br>Contact | Non-Complement<br>Activation | Pass |
| Complement Activation Assay-ISO<br>Indirect Contact | Non-Complement<br>Activation | Pass |
| In-vivo Thrombogenicity | Less thrombus than<br>control | Better thrombo-resistance<br>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.
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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
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## 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
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# 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_
