(147 days)
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.
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.
Here's an analysis of the provided 510(k) Summary, focusing on acceptance criteria and the study proving the device meets them:
Acceptance Criteria and Device Performance for CELLO Balloon Guide Catheter (K120781)
1. Table of Acceptance Criteria and Reported Device Performance
The device under review is primarily mechanical, and the "acceptance criteria" are embodied in the results of the non-clinical and biocompatibility tests conducted. The reported device performance is indicated by whether each test passed, failed, or was for informational purposes only.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Nonclinical Tests (CELLO Balloon Guide Catheters) | |||
| Surface | Free from extraneous matter, process and surface defects. | Acceptable surface finish, no defects. | Pass |
| Force at Break | All joints meet reliability/confidence requirements in statistical confidence limits test | Joints must withstand specific force without breaking, within statistical limits. | Pass |
| Freedom from Leakage | Shall not leak liquid when inflated. Air shall not leak into the hub during aspiration. | No leakage of liquid when inflated, no air leakage into hub during aspiration. | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly finished. | Distal tip must be atraumatic. | Pass |
| Hubs | Comply with ISO 594-1 and ISO 594-2 | Hubs must conform to specified ISO standards. | Pass |
| Freedom from Leakage and Damage on Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | No leakage or damage (herniation, bursting) during inflation. | Pass |
| Dimensional Verification | All dimensions meet reliability/confidence requirements in statistical confidence limits test | All dimensions must be within specified tolerances, within statistical limits. | 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. | Successful navigation through tortuous path, deployment and retraction of other devices, and full device retraction without damage. | Pass |
| Balloon Rated Burst Pressure (RBP) | All balloons meet reliability/confidence requirements in statistical confidence limits test | Balloons must withstand RBP without bursting, within statistical limits. | Pass |
| Balloon Fatigue | All balloons withstand 20 cycles of inflation | Balloons must withstand 20 inflation cycles without failure. | Pass |
| Balloon Compliance | All balloons have predictable change in size with pressure | Balloons should exhibit consistent and predictable size changes with pressure application. | FIO* |
| Balloon Inflation-Deflation Time | All balloons inflate and deflate predictably | Balloons should inflate and deflate within acceptable, predictable timeframes. | FIO* |
| Flexibility and Kink | All catheters meet reliability/confidence requirements in statistical confidence limits test | Catheters must maintain integrity and function without kinking, within statistical limits. | Pass |
| Torque Strength | All models can be torqued at least 180° when the distal tip is fixed in a tortuous path model | Catheters must transmit torque effectively in a tortuous path without failure. | FIO* |
| Radiopacity | Radiopaque markers are visible during angiography under a variety of conditions | Radiopaque markers must be clearly visible during angiography in various conditions. | FIO* |
| Nonclinical Tests (Dilator) | |||
| Surface | Free from extraneous matter, process and surface defects. | Acceptable surface finish, no defects. | Pass |
| Force at Break | All joints meet reliability/confidence requirements in statistical confidence limits test | Joints must withstand specific force without breaking, within statistical limits. | Pass |
| Freedom from Leakage | Shall not leak liquid when inflated. Air shall not leak into the hub during aspiration. | No leakage of liquid when inflated, no air leakage into hub during aspiration. (Likely refers to the dilator's hub functionality, if applicable to aspiration) | Pass |
| Tip Configuration | Distal tip smooth, rounded, tapered or similarly finished. | Distal tip must be atraumatic. | Pass |
| Hubs | Comply with ISO 594-1 and ISO 594-2 | Hubs must conform to specified ISO standards. | Pass |
| Freedom from Leakage and Damage on Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | No leakage or damage (herniation, bursting) during inflation. (Likely refers to any balloon on the dilator, if applicable, or general structural integrity) | Pass |
| Biocompatibility (CELLO Balloon Guide Catheters & Dilator) | |||
| L29 MEM Elution Test-ISO | Non-Cytotoxic | No evidence of cytotoxicity. | Pass |
| Kligman Maximization Test | No Sensitization | No evidence of sensitization. | Pass |
| Intracutaneous Injection Test | Non-Irritant | No evidence of irritation. | Pass |
| Systemic Injection Test-ISO | No acute toxicity | No evidence of acute toxicity. | Pass |
| Rabbit Pyrogen Test (Material Mediated) - ISO | Non-pyrogenic | No evidence of pyrogenicity. | Pass |
| Hemolysis- Direct Contact | Non-hemolytic | No evidence of hemolysis (direct contact). | Pass |
| Hemolysis-Rabbit Blood-ASTM Indirect Contact | Non-hemolytic | No evidence of hemolysis (indirect contact). | Pass |
| Complement Activation-Direct Contact | Non-Complement Activation | No evidence of complement activation (direct). | Pass |
| Complement Activation Assay-ISO Indirect Contact | Non-Complement Activation | No evidence of complement activation (indirect). | Pass |
| In-vivo Thrombogenicity (Catheter) | Patent vessels, No thrombus | Better thrombo-resistance than control. | Pass (Better than control) |
| In-vivo Thrombogenicity (Dilator) | Less thrombus than control | Better thrombo-resistance than control. | Pass (Better than control) |
*FIO: For Information Only - These tests were performed, but the results were provided for informational purposes and not necessarily as pass/fail acceptance criteria in the same way as the others. However, the presence of these results implies an expected functional characteristic.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the exact sample sizes used for each nonclinical or biocompatibility test. It mentions "All joints," "All dimensions," and "All balloons" meeting reliability/confidence requirements in "statistical confidence limits test," which implies that a statistically significant number of samples were tested. However, the specific number of units tested for each criterion is not provided.
- Data Provenance: The studies are nonclinical (benchtop and in vitro/in vivo biocompatibility) and were conducted by the manufacturer, Fuji Systems Corporation, or their designated testing laboratories. The country of origin for the data is not explicitly stated, but the manufacturer is based in Japan. These are retrospective data collected as part of the device development and regulatory submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission pertains to a mechanical medical device (catheter) and focuses on engineering performance and biocompatibility. There is no "ground truth" established by human experts in the context of diagnostic accuracy found in AI/imaging device submissions. The "ground truth" for these tests is defined by the objective measurement criteria and standards outlined in the test protocols (e.g., ISO standards, ASTM standards, internal reliability requirements).
4. Adjudication Method for the Test Set
Not applicable. This is a nonclinical study involving objective measurements and standardized tests, not subjective interpretations requiring adjudication by multiple readers/experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a submission for a mechanical medical device, not a diagnostic imaging or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests is based on:
- Objective Measurement: Adherence to specified dimensions, force limits, inflation pressures, deployment characteristics, and physical properties.
- Standardized Protocols: Compliance with international standards (e.g., ISO 594-1, ISO 594-2, ISO biocompatibility tests, ASTM methods).
- Pre-defined Pass/Fail Criteria: Each test had distinct criteria that determined a "Pass" or "Fail" outcome (or "For Information Only").
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device; it does not involve machine learning algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 | ProductCode | Trade Name | Model No. |
|---|---|---|---|---|
| 21 CFR870.1250Class II | DQY | CELLOBalloon GuideCatheter | 1610560 (6 F) | |
| 1610561 (6 F) | ||||
| PercutaneousCatheter | 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
. ..
| Device | Proposed | Predicate | Consideration |
|---|---|---|---|
| Device Name | CELLO Balloon GuideCatheter | Concentric Balloon GuideCatheter | (N/A) |
| DeviceDescription * | The CELLO Balloon GuideCatheter is a coaxial-lumen,braid-reinforced, variablestiffness catheter with tworadiopaque markers onboth the distal and proximalends of the balloon and abifurcated luer hub on theproximal end. A compliantsilicone balloon is mountedon the distal end. BalloonGuide Catheter dimensionsand the recommendedballoon inflation volumesare indicated on productlabel.A dilator is provided witheach catheter. | Concentric and MerciBalloon Guide catheters arecoaxial lumen, braid-reinforced, variable stiffnesscatheters with a radiopaquemarker on the distal endand a bifurcated luer hubon the proximal end. Acompliant balloon is flushmounted on the distal end.Balloon Guide catheterdimensions and maximumrecommended ballooninflation volume areindicated on product label.If indicated on productlabel, a dilator is provided. | Similartechnologicalcharacteristics |
| Size | 6F, 7F, 8F, 9F | 8F, 9F | 8F and 9F arethe same |
| Effective length | 920 mm to 1020 mm | 800 to 950 | Overlap from920 to 950 mm |
| Material/Shaft | Polyurethane, Polyamide,Stainless steel, PFA | Polyurethane, Stainlesssteel | Similarmaterials |
| 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.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 surfacedefects. | Pass |
| Force at Break | All joints meet reliability/confidence requirementsin 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 similarlyfinished. | Pass |
| Hubs | Comply with ISO 594-1 and ISO 594-2 | Pass |
| Freedom from Leakage andDamage on Inflation | No leakage or evidence of damage, such asherniation 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 (MaterialMediated) - ISO | Non-pyrogenic | Pass |
| Hemolysis- Direct Contact | Non-hemolytic | Pass |
| Hemolysis-Rabbit Blood-ASTMIndirect Contact | Non-hemolytic | Pass |
| Complement Activation-DirectContact | Non-ComplementActivation | Pass |
| Complement Activation Assay-ISOIndirect Contact | Non-ComplementActivation | Pass |
| In-vivo Thrombogenicity | Patent vesselsNo thrombus | Better thrombo-resistancethan 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 (MaterialMediated)-ISO | Non-pyrogenic | Pass |
| Hemolysis- Direct Contact | Non-hemolytic | Pass |
| Hemolysis-Rabbit Blood--ASTMIndirect Contact | Non-hemolytic | Pass |
| Complement Activation-DirectContact | Non-ComplementActivation | Pass |
| Complement Activation Assay-ISOIndirect Contact | Non-ComplementActivation | Pass |
| In-vivo Thrombogenicity | Less thrombus thancontrol | Better thrombo-resistancethan 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
{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_
§ 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).