CELLO II Balloon Guide Catheter
Device Facts
| Record ID | K223275 |
|---|---|
| Device Name | CELLO II Balloon Guide Catheter |
| Applicant | Fuji Systems Corporation |
| Product Code | QJP · Cardiovascular |
| Decision Date | Dec 9, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The CELLO II Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravasular 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 II Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter used in hospitals/clinics by trained personnel for peripheral and neurovascular procedures. It facilitates insertion/guidance of intravascular catheters and provides temporary vascular occlusion via a distal compliant urethane balloon. The device features a bifurcated Luer hub and radiopaque ring marker for visualization. During angiographic procedures, the clinician advances the catheter to the target vessel; the balloon is inflated to occlude the vessel, aiding in the placement of other interventional devices. The device is supplied with accessories including inserters, Y-connector, 3-way stopcocks, and syringes. It benefits patients by enabling controlled access and occlusion during complex vascular interventions.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing including surface inspection, force at break, leakage testing (ISO 10555-1), balloon fatigue/burst/compliance, torque strength, radiopacity, and comprehensive biocompatibility testing (ISO 10993 series, ASTM F756, ASTM F2382).
Technological Characteristics
Coaxial-lumen, braid-reinforced catheter. Materials: polyurethane, polyamide, stainless steel, fluorine resin, urethane balloon. Dimensions: 8F/9F. Connectivity: None. Sterilization: Ethylene oxide (SAL 10^-6). Hubs comply with ISO 80369-7. Mechanical design includes variable stiffness shaft and radiopaque markers.
Indications for Use
Indicated for patients undergoing percutaneous interventional procedures in peripheral and neurovascular systems requiring catheter guidance and temporary vascular occlusion.
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
- CELLO Balloon Guide Catheter (K120781)
Submission Summary (Full Text)
{0}------------------------------------------------
December 9, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Fuji Systems Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services 1000 Westgate Drive. Suite #510k Saint Paul, Minnesota 55114
Re: K223275
Trade/Device Name: CELLO II Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 26, 2022 Received: November 28, 2022
Dear Prithul Bom:
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
{1}------------------------------------------------
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 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-reporting-
combination-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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K223275
Device Name
CELLO II Balloon Guide Catheter
#### Indications for Use (Describe)
The CELLO II Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravasular 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.
Type of Use (Select one or both, as applicable)
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
## 510(k) Summary K223275
| Device Trade Name: | CELLO II Balloon Guide Catheter |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Number: | 1650908, 1650909, 1651008, 1651009 |
| Classification: | Class II |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 870.1250 |
| Product Code: | QJP, DQY |
| Submitter: | Fuji Systems Corporation<br>200-2, Aza-Ohira, Odakura, Nishigo,<br>Nishi Shirakawa Gun, Fukushima<br>961-8061 Japan<br>TEL: +81-248-25-4501<br>FAX: +81-248-25-3779 |
| Contact: | Yoshiyuki Suzuki<br>Regulatory Affairs Manager |
| Date of Preparation: | November 16, 2022 |
| Predicate Device: | CELLO Balloon Guide Catheter (K120781) |
### Device Description
The CELLO II Balloon Guide Catheter is a coaxial-lumen, braid-reinforced, variable stiffness catheter with one radiopaque ring marker on the distal end of the balloon and a bifurcated Luer hub on the proximal end. A compliant urethane balloon is mounted on the distal end. Balloon Guide Catheter dimensions and recommended balloon volumes are indicated on the product label. Each catheter is supplied with inserters, a Y-Connector, 3-way stopcocks and syringes.
The CELLO II Balloon Guide Catheters are intended for use in hospitals or other health care facilities which are equipped with trained personnel and specialized equipment to perform peripheral and neurovascular procedures.
The CELLO II Balloon Guide Catheter is intended for facilitating the insertion and guidance of intravascular catheters into selected blood vessels in the peripheral and neuro vasculature systems. The tip of the catheter features a balloon of urethane rubber. Radiopaque ring marker identifies the distal end of the balloon. The shaft is a dual lumen type with coaxial structure featuring a built-in braided stainless steel coil.
{4}------------------------------------------------
The materials of construction are similar to those used in many other similar catheters. The shaft is made of polyurethane, polyamide, stainless steel, and fluorine resin; the balloon is made of urethane. Patient contact is of limited duration, less than 24 hours.
### Indications for use
The CELLO II 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.
{5}------------------------------------------------
| Comparison of Technological Characteristics to the Predicate |
|--------------------------------------------------------------|
|--------------------------------------------------------------|
| Device | Proposed K223275 | Predicate K120781 | Consideration |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Fuji Systems Corporation | Fuji Systems Corporation | Same |
| Device Name | CELLO II Balloon Guide<br>Catheter | CELLO Balloon Guide Catheter | Similar name |
| 510(k) No. | K223275 | K120781 | (N/A) |
| Classification | Class II | Class II | Same |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 | Same |
| Regulation<br>Name | Percutaneous Catheter | Percutaneous Catheter | Same |
| Product Code | QJP, DQY | DQY | Same |
| Anatomical<br>Sites | Peripheral and neuro<br>vasculature | Peripheral and neuro<br>vasculature | Same |
| Intended<br>Patient<br>Population | Patients undergoing<br>percutaneous interventional<br>procedures | Patients undergoing<br>percutaneous interventional<br>procedures | Same |
| Device<br>Description* | The CELLO II Balloon Guide<br>Catheter is a coaxial-lumen, braid-<br>reinforced, variable<br>stiffness catheter with<br>one radiopaque ring<br>marker on the distal<br>end of the balloon<br>and a bifurcated Luer<br>hub on the proximal<br>end. A compliant urethane<br>balloon is mounted<br>on the distal end.<br>Balloon Guide<br>Catheter dimensions<br>and the<br>recommended<br>balloon inflation<br>volumes are indicated<br>on the product label. | The CELLO Balloon Guide<br>Catheter is a coaxial-lumen, braid-<br>reinforced, variable<br>stiffness catheter with<br>two radiopaque<br>markers on both the<br>distal and proximal<br>ends of the balloon<br>and a bifurcated Luer<br>hub on the proximal<br>end. A compliant silicone<br>balloon is mounted on<br>the distal end.<br>Balloon Guide<br>Catheter dimensions<br>and the recommended<br>balloon inflation<br>volumes are indicated<br>on the product label. | Similar<br>technological<br>characteristics,<br>minor differences<br>do not raise new<br>questions of<br>safety and<br>effectiveness. |
| Device | Proposed K223275 | Predicate K120781 | Consideration |
| Indications for use | The CELLO II Balloon Guide<br>Catheter is indicated for use<br>in facilitating the insertion<br>and guidance of<br>intravascular catheters into a<br>selected blood vessel in the<br>peripheral and neuro<br>vasculature systems. The<br>balloon provides temporary<br>vascular occlusion during<br>these and other<br>angiographic procedures. | The CELLO Balloon Guide<br>Catheter is indicated for use<br>in facilitating the insertion<br>and guidance of<br>intravascular catheters into<br>a selected blood vessel in<br>the peripheral and neuro<br>vasculature systems. The<br>balloon provides temporary<br>vascular occlusion during<br>these and other<br>angiographic procedures. | Same |
| Product Code | 1650908, 1650909, 1651008,<br>1651009 | 1610560, 1610570,<br>1610580, 1610590 | (N/A) |
| Size | 8F, 9F | 6F, 7F, 8F, 9F | 8F and 9F are<br>same |
| Labeled Shaft<br>Outer Diameter | 8F: 2.67 mm<br>9F: 3.00 mm | 8F: 2.60 mm<br>9F: 3.00 mm | Similar, minor<br>differences do not<br>raise new<br>questions of<br>safety and<br>effectiveness. |
| Labeled Shaft Inner<br>Diameter | 8F: 2.16 mm<br>9F: 2.32 mm | 8F: 1.90 mm<br>9F: 2.15 mm | Similar, minor<br>differences do not<br>raise new<br>questions of<br>safety and<br>effectiveness. |
| Effective length | 90 cm and 100 cm | 92 cm to 102 cm | Similar, minor<br>differences do not<br>raise new<br>questions of<br>safety and<br>effectiveness. |
| Device | Proposed K223275 | Predicate K120781 | Consideration |
| Tip Shape | Straight | Straight | Same |
| Coating | None | None | Same |
| Material/Shaft | Polyurethane, Polyamide,<br>Stainless steel, Fluorine resin | Polyurethane, Polyamide,<br>Stainless steel, Fluorine resin | Same |
| Material/Balloon | Urethane rubber | Silicone rubber | Similar technology, material<br>differences do not<br>raise new<br>questions<br>of safety and<br>effectiveness,<br>both<br>materials are used<br>for compliant<br>balloons for<br>intravascular use |
| Accessories<br>Supplied | Inserters, Y-Connector,<br>3-way stopcock, Syringe | Dilator, Inserter | Similar, the<br>differences do not<br>raise new<br>questions of<br>safety and<br>effectiveness. |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |
| Sterility Assurance<br>Level | SAL=10-6 | SAL=10-6 | Same |
{6}------------------------------------------------
## Comparison of Technological Characteristics to the Predicate (continued).
{7}------------------------------------------------
### Comparison of Technological Characteristics to the Predicate (continued).
{8}------------------------------------------------
## Nonclinical Tests: CELLO II Balloon Guide Catheter
| Test | Results | Conclusion |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Surface | Free from extraneous matter, process and surface defects. | Pass |
| Force at Break | Tip and all joints meet reliability/confidence requirements in statistical confidence limits test. | Pass |
| Freedom from<br>Leakage | Shall not leak liquid when pressurized per methods in ISO 10555-1, Annex C.<br>Shall not leak air when aspirated per methods in ISO 10555-1, Annex D. | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly finished. | Pass |
| Hubs | Comply with ISO 80369-7. | Pass |
| Freedom from<br>Leakage and Damage<br>upon Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | Pass |
| Dimensional<br>Verification | All dimensions meet reliability/confidence requirements in statistical confidence limits test. | Pass |
| Balloon Preparation,<br>Deployment and<br>Retraction | Catheters can be advanced to intended sites within a tortuous 3D vessel model where other devices can be deployed distally and retracted; all devices could be retracted without damage. | Pass |
| Balloon Rated Burst<br>Volume | All balloons met 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 volume of contrast solution. | FIO* |
| Balloon Inflation-<br>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 135° when the distal tip is fixed in a tortuous 3D vessel model. | FIO* |
| Radiopacity | Radiopaque markers are visible during angiography under a variety of conditions. | FIO* |
| Particulate testing | All catheters meet the particle generation criteria and exhibit similar size and quantity of particulates in comparison to the predicate device. | Pass |
| Tip Flexibility | The tips of catheters meet the tip flexibility criteria. | Pass |
| Contrast Agent<br>Durability | There was no damage after application of pressure of 300 PSI | Pass |
| Test | Results | Conclusion |
| Hubs | Comply with ISO 80369-7. | Pass |
* For Information Only
{9}------------------------------------------------
### Nonclinical Tests: Y-Connector
## Biocompatibility: CELLO II Balloon Guide Catheters
| Endpoint | Test | Results | Conclusion |
|-----------------------------------------|-------------------------------------------------------------------------|------------------------------|------------|
| Cytotoxicity | ISO 10993-5:2009<br>L929 MEM Elution Test | Non-Cytotoxic | Pass |
| Sensitization | ISO10993-10:2010<br>Guinea Pig Maximization Test | Non-Sensitizing | Pass |
| Irritation/Intracutaneous<br>Reactivity | ISO10993-10:2010<br>Intracutaneous Injection Test | Non-Irritant | Pass |
| Acute Systemic<br>Toxicity | ISO10993-11:2017<br>Systemic Injection Test | No Acute Toxicity | Pass |
| Material-Mediated<br>Pyrogenicity | ISO10993-11:2017<br>Rabbit Pyrogen Test | Non-Pyrogenic | Pass |
| Hemocompatibility | ASTM F756-17<br>Hemolysis-Rabbit Blood<br>(Direct and Indirect contact) | Non-Hemolytic | Pass |
| | ASTM F2382-18<br>Partial Thromboplastin Time<br>Test (Direct contact) | Hemocompatible | Pass |
| | ISO10993-4:2017<br>Platelet and leukocyte<br>Binding- (Direct contact) | Hemocompatible | Pass |
| | ISO10993-4:2017<br>Complement Activation Assay<br>(Direct contact) | Non-Complement<br>Activation | Pass |
| | ISO10993-4:2017<br>Thrombogenicity Study in<br>Dog | Non-Thrombogenic | Pass |
{10}------------------------------------------------
### Biocompatibility: Y-Connector
| Endpoint | Test | Results | Conclusion |
|-----------------------------------------|-------------------------------------------------------------------------|-------------------|------------|
| Cytotoxicity | ISO 10993-5:2009<br>L929 MEM Elution Test | Non-Cytotoxic | Pass |
| Sensitization | ISO10993-10:2010<br>Guinea Pig Maximization Test | Non-Sensitizing | Pass |
| Irritation/Intracutaneous<br>Reactivity | ISO10993-10:2010<br>Intracutaneous Injection Test | Non-Irritant | Pass |
| Acute Systemic<br>Toxicity | ISO10993-11:2017<br>Systemic Injection Test | No Acute Toxicity | Pass |
| Material-Mediated<br>Pyrogenicity | ISO10993-11:2017<br>Rabbit Pyrogen Test | Non-Pyrogenic | Pass |
| Hemocompatibility | ASTM F756-17<br>Hemolysis-Rabbit Blood<br>(Direct and Indirect contact) | Non-Hemolytic | Pass |
### Clinical Tests
No clinical testing was deemed necessary to support this premarket notification.
### Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the CELLO II Balloon Guide Catheter is substantially equivalent to the legally marketed predicate device.
The design of the CELLO II Balloon Guide Catheter is similar to that of the predicate: each catheter shaft includes an internal stainless steel braid surrounded by polymer. The balloon is made from urethane rubber and its position can be identified during angiography because of radiopaque markers. Although the material of the balloon is different from the predicate, the results of each balloon non-clinical tests confirmed that the subject device is substantially equivalent to the predicate.
The indications for use of the CELLO II Balloon Guide Catheter are the same as that of the predicate.
The patient population of the CELLO II Balloon Guide Catheter is the same as that of the predicate.
The CELLO II Balloon Guide Catheter is intended for use in the same anatomical sites as the predicate.
