K Number

Device Name

CELLO II Balloon Guide Catheter

Manufacturer

Fuji Systems Corporation

Date Cleared

2022-12-09

(46 days)

Product Code

QJP DQY

Regulation Number

870.1250

Intended 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 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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K120781

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (a balloon guide catheter) and its materials, dimensions, and performance testing. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.

Therapeutic

No
The device is used to facilitate the insertion and guidance of other catheters and to provide temporary vascular occlusion, not to directly treat a condition.

Diagnostic

The device is a guide catheter designed to facilitate the insertion and guidance of other intravascular catheters and for temporary vascular occlusion. Its function is interventional, not diagnostic.

SaMD (Software as a Medical Device)

The device description clearly details a physical catheter with a balloon, made of materials like polyurethane, polyamide, stainless steel, and urethane. It also includes accessories like inserters, a Y-Connector, stopcocks, and syringes. This is a hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
Device Function: The CELLO II Balloon Guide Catheter is an invasive surgical device used inside the body to facilitate the insertion and guidance of other catheters and to temporarily occlude blood vessels during procedures. It does not analyze or test any bodily fluids or tissues.
Intended Use: The intended use clearly describes a procedural function within the vascular system, not a diagnostic test performed on a sample.

The information provided about the device's function, intended use, and how it interacts with the body all point to it being a surgical/interventional device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

QJP, DQY

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral and neuro vasculature 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 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 were performed:

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 Leakage: Shall not leak liquid when pressurized per methods in ISO 10555-1, Annex C. 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 Leakage and Damage upon 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 tortuous 3D vessel model where other devices can be deployed distally and retracted; all devices could be retracted without damage. Pass.
Balloon Rated Burst 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. For Information Only.
Balloon Inflation-Deflation Time: All balloons inflate and deflate predictably. For Information Only.
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. For Information Only.
Radiopacity: Radiopaque markers are visible during angiography under a variety of conditions. For Information Only.
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 Durability: There was no damage after application of pressure of 300 PSI. Pass.

Biocompatibility tests were performed:

Cytotoxicity: ISO 10993-5:2009 L929 MEM Elution Test. Non-Cytotoxic. Pass.
Sensitization: ISO10993-10:2010 Guinea Pig Maximization Test. Non-Sensitizing. Pass.
Irritation/Intracutaneous Reactivity: ISO10993-10:2010 Intracutaneous Injection Test. Non-Irritant. Pass.
Acute Systemic Toxicity: ISO10993-11:2017 Systemic Injection Test. No Acute Toxicity. Pass.
Material-Mediated Pyrogenicity: ISO10993-11:2017 Rabbit Pyrogen Test. Non-Pyrogenic. Pass.
Hemocompatibility: ASTM F756-17 Hemolysis-Rabbit Blood (Direct and Indirect contact). Non-Hemolytic. Pass.
Hemocompatibility: ASTM F2382-18 Partial Thromboplastin Time Test (Direct contact). Hemocompatible. Pass.
Hemocompatibility: ISO10993-4:2017 Platelet and leukocyte Binding- (Direct contact). Hemocompatible. Pass.
Hemocompatibility: ISO10993-4:2017 Complement Activation Assay (Direct contact). Non-Complement Activation. Pass.
Hemocompatibility: ISO10993-4:2017 Thrombogenicity Study in Dog. Non-Thrombogenic. Pass.

No clinical testing was deemed necessary.

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

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

Not Found

Predicate Device(s)

K120781

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

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

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

Indications for Use

510(k) Number (if known) K223275

Device Name

CELLO II Balloon Guide Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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
200-2, Aza-Ohira, Odakura, Nishigo,
Nishi Shirakawa Gun, Fukushima
961-8061 Japan
TEL: +81-248-25-4501
FAX: +81-248-25-3779
Contact:	Yoshiyuki Suzuki
Regulatory Affairs Manager
Date of Preparation:	November 16, 2022
Predicate Device:	CELLO Balloon Guide Catheter (K120781)

Device Description

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.

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
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
Name	Percutaneous Catheter	Percutaneous Catheter	Same
Product Code	QJP, DQY	DQY	Same
Anatomical
Sites	Peripheral and neuro
vasculature	Peripheral and neuro
vasculature	Same
Intended
Patient
Population	Patients undergoing
percutaneous interventional
procedures	Patients undergoing
percutaneous interventional
procedures	Same
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 the
recommended
balloon inflation
volumes are indicated
on the product label.	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 the product label.	Similar
technological
characteristics,
minor differences
do not raise new
questions of
safety and
effectiveness.
Device	Proposed K223275	Predicate K120781	Consideration
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.	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.	Same
Product Code	1650908, 1650909, 1651008,
1651009	1610560, 1610570,
1610580, 1610590	(N/A)
Size	8F, 9F	6F, 7F, 8F, 9F	8F and 9F are
same
Labeled Shaft
Outer Diameter	8F: 2.67 mm
9F: 3.00 mm	8F: 2.60 mm
9F: 3.00 mm	Similar, minor
differences do not
raise new
questions of
safety and
effectiveness.
Labeled Shaft Inner
Diameter	8F: 2.16 mm
9F: 2.32 mm	8F: 1.90 mm
9F: 2.15 mm	Similar, minor
differences do not
raise new
questions of
safety and
effectiveness.
Effective length	90 cm and 100 cm	92 cm to 102 cm	Similar, minor
differences do not
raise new
questions of
safety and
effectiveness.
Device	Proposed K223275	Predicate K120781	Consideration
Tip Shape	Straight	Straight	Same
Coating	None	None	Same
Material/Shaft	Polyurethane, Polyamide,
Stainless steel, Fluorine resin	Polyurethane, Polyamide,
Stainless steel, Fluorine resin	Same
Material/Balloon	Urethane rubber	Silicone rubber	Similar technology, material
differences do not
raise new
questions
of safety and
effectiveness,
both
materials are used
for compliant
balloons for
intravascular use
Accessories
Supplied	Inserters, Y-Connector,
3-way stopcock, Syringe	Dilator, Inserter	Similar, the
differences do not
raise new
questions of
safety and
effectiveness.
Sterilization	Ethylene oxide	Ethylene oxide	Same
Sterility Assurance
Level	SAL=10-6	SAL=10-6	Same

Comparison of Technological Characteristics to the Predicate (continued).

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
Leakage	Shall not leak liquid when pressurized per methods in ISO 10555-1, Annex C.
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
Leakage and Damage
upon 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 tortuous 3D vessel model where other devices can be deployed distally and retracted; all devices could be retracted without damage.	Pass
Balloon Rated Burst
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-
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
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

Nonclinical Tests: Y-Connector

Biocompatibility: CELLO II Balloon Guide Catheters

Endpoint	Test	Results
Cytotoxicity	ISO 10993-5:2009
L929 MEM Elution Test	Non-Cytotoxic	Pass
Sensitization	ISO10993-10:2010
Guinea Pig Maximization Test	Non-Sensitizing	Pass
Irritation/Intracutaneous
Reactivity	ISO10993-10:2010
Intracutaneous Injection Test	Non-Irritant	Pass
Acute Systemic
Toxicity	ISO10993-11:2017
Systemic Injection Test	No Acute Toxicity	Pass
Material-Mediated
Pyrogenicity	ISO10993-11:2017
Rabbit Pyrogen Test	Non-Pyrogenic	Pass
Hemocompatibility	ASTM F756-17
Hemolysis-Rabbit Blood
(Direct and Indirect contact)	Non-Hemolytic	Pass
	ASTM F2382-18
Partial Thromboplastin Time
Test (Direct contact)	Hemocompatible	Pass
	ISO10993-4:2017
Platelet and leukocyte
Binding- (Direct contact)	Hemocompatible	Pass
	ISO10993-4:2017
Complement Activation Assay
(Direct contact)	Non-Complement
Activation	Pass
	ISO10993-4:2017
Thrombogenicity Study in
Dog	Non-Thrombogenic	Pass

Biocompatibility: Y-Connector

Endpoint	Test	Results
Cytotoxicity	ISO 10993-5:2009
L929 MEM Elution Test	Non-Cytotoxic	Pass
Sensitization	ISO10993-10:2010
Guinea Pig Maximization Test	Non-Sensitizing	Pass
Irritation/Intracutaneous
Reactivity	ISO10993-10:2010
Intracutaneous Injection Test	Non-Irritant	Pass
Acute Systemic
Toxicity	ISO10993-11:2017
Systemic Injection Test	No Acute Toxicity	Pass
Material-Mediated
Pyrogenicity	ISO10993-11:2017
Rabbit Pyrogen Test	Non-Pyrogenic	Pass
Hemocompatibility	ASTM F756-17
Hemolysis-Rabbit Blood
(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.