(46 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the CELLO II Balloon Guide Catheter, based on the provided document:
This document describes a medical device, a catheter, and the tests performed to demonstrate its safety and effectiveness. It is not an AI/ML device, so many of the requested fields regarding AI performance, expert review, training sets, and comparative effectiveness studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Tests: CELLO II Balloon Guide Catheter | ||
| 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 (For Information Only) |
| Balloon Inflation-Deflation Time | All balloons inflate and deflate predictably. | FIO (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. | FIO (For Information Only) |
| Radiopacity | Radiopaque markers are visible during angiography under a variety of conditions. | FIO (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: CELLO II Balloon Guide Catheters | ||
| Cytotoxicity | Non-Cytotoxic based on ISO 10993-5:2009 L929 MEM Elution Test. | Non-Cytotoxic (Pass) |
| Sensitization | Non-Sensitizing based on ISO10993-10:2010 Guinea Pig Maximization Test. | Non-Sensitizing (Pass) |
| Irritation/Intracutaneous Reactivity | Non-Irritant based on ISO10993-10:2010 Intracutaneous Injection Test. | Non-Irritant (Pass) |
| Acute Systemic Toxicity | No Acute Toxicity based on ISO10993-11:2017 Systemic Injection Test. | No Acute Toxicity (Pass) |
| Material-Mediated Pyrogenicity | Non-Pyrogenic based on ISO10993-11:2017 Rabbit Pyrogen Test. | Non-Pyrogenic (Pass) |
| Hemocompatibility (Hemolysis) | Non-Hemolytic based on ASTM F756-17 Hemolysis-Rabbit Blood (Direct and Indirect contact). | Non-Hemolytic (Pass) |
| Hemocompatibility (PTT) | Hemocompatible based on ASTM F2382-18 Partial Thromboplastin Time Test (Direct contact). | Hemocompatible (Pass) |
| Hemocompatibility (Platelet & Leukocyte Binding) | Hemocompatible based on ISO10993-4:2017 Platelet and leukocyte Binding- (Direct contact). | Hemocompatible (Pass) |
| Hemocompatibility (Complement Activation) | Non-Complement Activation based on ISO10993-4:2017 Complement Activation Assay (Direct contact). | Non-Complement Activation (Pass) |
| Hemocompatibility (Thrombogenicity) | Non-Thrombogenic based on ISO10993-4:2017 Thrombogenicity Study in Dog. | Non-Thrombogenic (Pass) |
| Biocompatibility: Y-Connector | ||
| Cytotoxicity | Non-Cytotoxic based on ISO 10993-5:2009 L929 MEM Elution Test. | Non-Cytotoxic (Pass) |
| Sensitization | Non-Sensitizing based on ISO10993-10:2010 Guinea Pig Maximization Test. | Non-Sensitizing (Pass) |
| Irritation/Intracutaneous Reactivity | Non-Irritant based on ISO10993-10:2010 Intracutaneous Injection Test. | Non-Irritant (Pass) |
| Acute Systemic Toxicity | No Acute Toxicity based on ISO10993-11:2017 Systemic Injection Test. | No Acute Toxicity (Pass) |
| Material-Mediated Pyrogenicity | Non-Pyrogenic based on ISO10993-11:2017 Rabbit Pyrogen Test. | Non-Pyrogenic (Pass) |
| Hemocompatibility (Hemolysis) | Non-Hemolytic based on ASTM F756-17 Hemolysis-Rabbit Blood (Direct and Indirect contact). | Non-Hemolytic (Pass) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a sample size for each individual non-clinical or biocompatibility test. These tests are typically performed on a statistically significant number of manufactured units or material samples to ensure representativeness and reliability of the results. The provenance is likely from the manufacturer's internal testing facilities, as these are in vitro and in vivo (animal studies for biocompatibility) tests, not human data. The document implies these tests were conducted as part of the regulatory submission (premarket notification).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (catheter) and not an AI/ML device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests comes from established scientific methods, standards (e.g., ISO, ASTM), and laboratory measurements.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI/ML evaluations where multiple human readers assess cases and a consensus or tie-breaker is needed. These are laboratory and material tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC studies were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No AI algorithm is involved.
7. The type of ground truth used
The ground truth for the nonclinical and biocompatibility tests is based on:
- Established industry standards: Such as ISO 10555-1, ISO 80369-7, ISO 10993 series, and ASTM F756-17, ASTM F2382-18.
- Quantitative measurements: Measuring physical properties (e.g., force, dimensions, burst volume, inflation/deflation time, torque, particle count).
- Qualitative observations: Visual inspection (e.g., surface, damage, tip configuration, radiopacity).
- Biological assays/animal studies: For biocompatibility endpoints (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility experiments using rabbit blood and in vivo thrombogenicity study in dogs).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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
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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)
| ☑ 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 Corporation200-2, Aza-Ohira, Odakura, Nishigo,Nishi Shirakawa Gun, Fukushima961-8061 JapanTEL: +81-248-25-4501FAX: +81-248-25-3779 |
| Contact: | Yoshiyuki SuzukiRegulatory 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.
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| 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 GuideCatheter | 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 |
| RegulationName | Percutaneous Catheter | Percutaneous Catheter | Same |
| Product Code | QJP, DQY | DQY | Same |
| AnatomicalSites | Peripheral and neurovasculature | Peripheral and neurovasculature | Same |
| IntendedPatientPopulation | Patients undergoingpercutaneous interventionalprocedures | Patients undergoingpercutaneous interventionalprocedures | Same |
| DeviceDescription* | The CELLO II Balloon GuideCatheter is a coaxial-lumen, braid-reinforced, variablestiffness catheter withone radiopaque ringmarker on the distalend of the balloonand a bifurcated Luerhub on the proximalend. A compliant urethaneballoon is mountedon the distal end.Balloon GuideCatheter dimensionsand therecommendedballoon inflationvolumes are indicatedon the product label. | The CELLO Balloon GuideCatheter is a coaxial-lumen, braid-reinforced, variablestiffness catheter withtwo radiopaquemarkers on both thedistal and proximalends of the balloonand a bifurcated Luerhub on the proximalend. A compliant siliconeballoon is mounted onthe distal end.Balloon GuideCatheter dimensionsand the recommendedballoon inflationvolumes are indicatedon the product label. | Similartechnologicalcharacteristics,minor differencesdo not raise newquestions ofsafety andeffectiveness. |
| Device | Proposed K223275 | Predicate K120781 | Consideration |
| Indications for use | The CELLO II Balloon GuideCatheter is indicated for usein facilitating the insertionand guidance ofintravascular catheters into aselected blood vessel in theperipheral and neurovasculature systems. Theballoon provides temporaryvascular occlusion duringthese and otherangiographic procedures. | The CELLO Balloon GuideCatheter is indicated for usein facilitating the insertionand guidance ofintravascular catheters intoa selected blood vessel inthe peripheral and neurovasculature systems. Theballoon provides temporaryvascular occlusion duringthese and otherangiographic procedures. | Same |
| Product Code | 1650908, 1650909, 1651008,1651009 | 1610560, 1610570,1610580, 1610590 | (N/A) |
| Size | 8F, 9F | 6F, 7F, 8F, 9F | 8F and 9F aresame |
| Labeled ShaftOuter Diameter | 8F: 2.67 mm9F: 3.00 mm | 8F: 2.60 mm9F: 3.00 mm | Similar, minordifferences do notraise newquestions ofsafety andeffectiveness. |
| Labeled Shaft InnerDiameter | 8F: 2.16 mm9F: 2.32 mm | 8F: 1.90 mm9F: 2.15 mm | Similar, minordifferences do notraise newquestions ofsafety andeffectiveness. |
| Effective length | 90 cm and 100 cm | 92 cm to 102 cm | Similar, minordifferences do notraise newquestions ofsafety andeffectiveness. |
| 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, materialdifferences do notraise newquestionsof safety andeffectiveness,bothmaterials are usedfor compliantballoons forintravascular use |
| AccessoriesSupplied | Inserters, Y-Connector,3-way stopcock, Syringe | Dilator, Inserter | Similar, thedifferences do notraise newquestions ofsafety andeffectiveness. |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |
| Sterility AssuranceLevel | 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 fromLeakage | 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 fromLeakage and Damageupon Inflation | No leakage or evidence of damage, such as herniation or bursting of the shaft or balloon. | Pass |
| DimensionalVerification | All dimensions meet reliability/confidence requirements in statistical confidence limits test. | Pass |
| Balloon Preparation,Deployment andRetraction | 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 BurstVolume | 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 AgentDurability | 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 10993-5:2009L929 MEM Elution Test | Non-Cytotoxic | Pass |
| Sensitization | ISO10993-10:2010Guinea Pig Maximization Test | Non-Sensitizing | Pass |
| Irritation/IntracutaneousReactivity | ISO10993-10:2010Intracutaneous Injection Test | Non-Irritant | Pass |
| Acute SystemicToxicity | ISO10993-11:2017Systemic Injection Test | No Acute Toxicity | Pass |
| Material-MediatedPyrogenicity | ISO10993-11:2017Rabbit Pyrogen Test | Non-Pyrogenic | Pass |
| Hemocompatibility | ASTM F756-17Hemolysis-Rabbit Blood(Direct and Indirect contact) | Non-Hemolytic | Pass |
| ASTM F2382-18Partial Thromboplastin TimeTest (Direct contact) | Hemocompatible | Pass | |
| ISO10993-4:2017Platelet and leukocyteBinding- (Direct contact) | Hemocompatible | Pass | |
| ISO10993-4:2017Complement Activation Assay(Direct contact) | Non-ComplementActivation | Pass | |
| ISO10993-4:2017Thrombogenicity Study inDog | Non-Thrombogenic | Pass |
{10}------------------------------------------------
Biocompatibility: Y-Connector
| Endpoint | Test | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5:2009L929 MEM Elution Test | Non-Cytotoxic | Pass |
| Sensitization | ISO10993-10:2010Guinea Pig Maximization Test | Non-Sensitizing | Pass |
| Irritation/IntracutaneousReactivity | ISO10993-10:2010Intracutaneous Injection Test | Non-Irritant | Pass |
| Acute SystemicToxicity | ISO10993-11:2017Systemic Injection Test | No Acute Toxicity | Pass |
| Material-MediatedPyrogenicity | ISO10993-11:2017Rabbit Pyrogen Test | Non-Pyrogenic | Pass |
| Hemocompatibility | ASTM F756-17Hemolysis-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.
§ 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).