(354 days)
The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.
This balloon guide catheter is a variable stiffness catheter that has a radio-opaque marker at the distal end of the balloon and a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and the recommended balloon injection volume are indicated on the product label. The balloon guide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the guidewire and other devices through the section.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is not mentioned:
It's important to note that this document is a 510(k) premarket notification, which demonstrates substantial equivalence to existing devices, usually through non-clinical bench testing. It is not typically a clinical study involving human patients or complex AI performance metrics like those for image analysis.
Acceptance Criteria and Device Performance
This submission is for a medical device (Balloon Guide Catheter), not an AI/ML imaging device. As such, the "reported device performance" refers to the results of non-clinical bench testing, which are primarily pass/fail against engineering and design specifications.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Air Leakage Into Hub Assembly During Aspiration | Pass |
| Balloon Diameter to Inflation Pressure | Pass |
| Balloon Inflation and Deflation Times | Pass |
| Balloon Maximum Diameter | Pass |
| Burst Pressure | Pass |
| Coating Integrity/Particulate Evaluation | (Characterization Only) |
| Design Verification – Simulated Use | Pass |
| Dimensional Analysis | Pass |
| Freedom from Leakage and Damage on Inflation | Pass |
| Kink Resistance Test | Pass |
| Liquid Leakage Under Pressure | Pass |
| Lumen Collapse Under Maximum Aspiration | Pass |
| Luer Hub Testing | Pass |
| Peak Tensile Strength - Tip | Pass |
| Peak Tensile Strength - Tube Junction | Pass |
| Radio-detectability | Pass |
| Tip Flexibility | Pass |
| Torque Strength | Pass |
| Visual Inspection - Distal Tip | Pass |
| Visual Inspection - Surface | Pass |
Biocompatibility Testing
| Acceptance Criteria (Test summary for "Conclusion") | Reported Device Performance (Conclusion) |
|---|---|
| Systemic Toxicity - Rabbit Pyrogen Test | Non-pyrogenic |
| Systemic Toxicity - Systemic Injection | No acute systemic toxicity |
| Cytotoxicity - L929 cells/MEM Elution Test | Non-cytotoxic |
| Sensitization - Guinea Pig Maximization Test | Non-sensitizing |
| Irritation - Intracutaneous Injection Test | Non-irritant |
| Hemocompatibility - Hemolysis | Non-hemolytic |
| Hemocompatibility - Partial Thromboplastin Time Assay (PTT) | Minimal Activator |
| Hemocompatibility - Complement Activation Assay (SC5b-9) | Non-Potential Activator |
| Hemocompatibility – Thrombogenicity | No Thrombosis |
Study Details (Applicable to Non-Clinical Bench Testing)
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each test, but standard engineering testing involves sufficient samples to achieve statistical confidence for each specific test (e.g., multiple units for burst pressure, tensile strength, etc.).
- Data Provenance: The submission is from "ASAHI INTECC CO., LTD" in "Aichi 489-0071, Japan". This indicates the testing was conducted by or on behalf of the manufacturer, likely in Japan or a contracted laboratory. The nature of these tests (bench tests) means they are not "retrospective or prospective" in the sense of patient data.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is a non-clinical device performance study (bench testing), not a study assessing AI performance or diagnostic accuracy. Therefore, "experts" in the context of establishing ground truth for data interpretation (like radiologists for image analysis) are not applicable. The "ground truth" for these tests is defined by engineering specifications and standards (e.g., how much pressure a balloon should withstand).
-
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1 voting) are used in clinical studies or studies where human interpretation of complex data (like medical images) is involved. Bench tests have objective pass/fail criteria based on measured physical properties.
-
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:
- No. This is not an AI/ML imaging device and thus no MRMC study was conducted.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is based on engineering specifications, recognized industry standards (e.g., ISO), and physical measurements designed to ensure the device meets its intended performance characteristics and safety profile.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device submission.
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December 10, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ASAHI INTECC Co., Ltd % Cynthia Valenzuela Director, Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue. Suite 212 Tustin, California 92780
Re: K203723
Trade/Device Name: Branchor Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 4, 2021 Received: November 8, 2021
Dear Cynthia Valenzuela:
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
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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-reportingcombination-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, 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) K203723
Device Name Branchor Balloon Guide Catheter
Indications for Use (Describe)
The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.
| 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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[as required by 21 CFR §807.92(c)]
510(K) K203723
| DATE PREPARED: | 10 December 2021 |
|---|---|
| SUBMITTER: | ASAHI INTECC CO., LTD |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071, Japan | |
| Telephone: +81 561 48 5551 | |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela |
| Director, Global Regulatory Affairs | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, California 92780 | |
| Phone: (714) 442 0575 | |
| Email: cynthiav@asahi-intecc-us.com | |
| TRADE NAME: | Branchor Balloon Guide Catheter |
| DEVICE CLASSIFICATION: | Class II, 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE: | QJP, Catheter, Percutaneous, Neurovasculature |
| DQY, Catheter, Percutaneous | |
| PREDICATE DEVICE: | Primary Predicate Device: |
| CELLO Balloon Guide Catheter (K120781; August 9, | |
| 2012) | |
| Reference Predicate Device: | |
| 8F FlowGate Balloon Guide Catheter (K153729; | |
| January 27, 2016) |
Device Description:
This balloon guide catheter is a variable stiffness catheter that has a radio-opaque marker at the distal end of the balloon and a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and the recommended balloon injection volume are indicated on the product label. The balloon guide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the guidewire and other devices through the section.
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Accessories
The Branchor Balloon Guide Catheter is packaged with a peel-away to protect the balloon during catheter introduction, a syringe for balloon inflation, and a three-way stopcock to connect the syringe for inflation and deflation of the balloon.
Intended Use/Indications for Use
The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.
Comparison of Technological Characteristics:
The Branchor Balloon Guide Catheter has similar
- Indications for use, .
- Fundamental scientific technology, .
- Fundamental design, .
- Packaging and sterilization of devices .
as the marketed predicate devices. A tabular comparison of the specific technological characteristics between the predicate devices and the subject device is provided below. The technological differences do not raise new questions of safety and effectiveness.
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Table 1: Comparison Table
| Name of Device | CELLO Balloon Guide Catheter | 8F FlowGate Balloon Guide Catheter | Branchor Balloon Guide Catheter |
|---|---|---|---|
| 510(K) Number: | K120781 | K153729 | SUBJECT DEVICEK203723 |
| Intended Useand Indications | The CELLO Balloon Guide Catheteris indicated for use in facilitating theinsertion and guidance ofintravascular catheters into aselected blood vessel in theperipheral and neuro vasculaturesystems. The balloon providestemporary vascular occlusion duringthese and other angiographicprocedures. | FlowGate Balloon Guide Catheters areindicated for use in facilitating theinsertion and guidance of anintravascular catheter into a selectedblood vessel in the peripheral and neurovascular systems. The balloon providestemporary vascular occlusion duringthese and other angiographicprocedures. The Balloon Guide Catheteris also indicated for use as a conduit forRetrieval devices. | The Branchor Balloon GuideCatheter is indicated for use tofacilitate the insertion andguidance of an intravascularcatheter into a selected bloodvessel in the neuro vasculature,and injection of contrast media.The balloon provides temporaryvascular occlusion during theseprocedures.The Branchor Balloon GuideCatheter can also be used as aconduit for retrieval devices. |
| Device Description | The CELLO Balloon Guide Catheteris a coaxial-lumen, braid-reinforced,variable stiffness catheter with tworadiopaque markets on both thedistal and proximal ends of theballoon and a bifurcated luer hub onthe proximal end. A compliantsilicone balloon is mounted on thedistal end. Balloon Guide Catheterdimensions and the recommendedballoon inflation volumes areindicated on product label. | The FlowGate Balloon Guide Catheterare coaxial-lumen, braid- reinforced,variable stiffness catheters designed foruse in facilitating the insertion andguidance of an intravascular catheterinto a selected blood vessel in theperipheral and neuro vascular systems.A radiopaque market is included on thedistal end for angiographic visualization.A compliant balloon is mounted on thedistal end to provide temporary vascularocclusion during angiographicprocedures. A bifurcated luer hub on theproximal end allows attachments forflushing, inflation and aspiration. BalloonGuide Catheter dimensions andmaximum recommended balloon inflationvolume are indicated on product label. | This balloon guide catheter is avariable stiffness catheter that hasa radio-opaque marker at thedistal end of the balloon tofacilitate fluoroscopic visualizationand indicate the balloon position,a branched connector at theproximal end, and is equipped witha braid reinforced coaxial lumen. Aballoon is attached to the distalend, and the dimensions of thisballoon guide catheter andrecommended balloon injectionvolume are provided on theproduct label.The outer surface of this balloonguide catheter is coated with ahydrophilic coating for enhancedlubricity when the surface is wet. |
| Name of Device | CELLO Balloon GuideCatheter | 8F FlowGate Balloon GuideCatheter | Branchor Balloon Guide Catheter |
| The shaft lumen is provided withPTFE coating, with the exceptionof the connector section tofacilitate the passage of theguidewire and other devicesthrough the section. | |||
| Regulatory Status: | |||
| Regulation Number: | 21 CFR § 870.1250 | 21 CFR § 870.1250 | 21 CFR § 870.1250 |
| RegulationDescription: | Percutaneous Catheter | Percutaneous Catheter | Catheter, Percutaneous,Neurovasculature |
| Regulatory Class: | II | II | II |
| Product Code: | DQY | DQY | QJPDQY |
| Product Information: | |||
| Size | 6F, 7F, 8F, 9F | Shaft OD: 8F; Shaft ID: 6.4F | Shaft OD: 9F; Shaft ID: 6.84F |
| Effective Length | 92cm to 102cm | 95cm and 85cm | 90cm, 100cm |
| Balloon Material | Silicone Rubber | Silicone Elastomer | Polyurethane Elastomer |
| Shaft Material | PolyurethanePolyamideStainless SteelPFA | PebaxPolyamideStainless SteelPTFE | Polyurethane ElastomerPolyamide 12 ElastomerPolyamide 12Stainless SteelPolytetrafluoroethylene |
| Accessories | Unknown | DilatorPeel-away SheathRotating Hemostatic ValveTuohy Borst Valve with SideportLure-Activated Valve | Peel-awaySyringeThree-way Stopcock |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Sterility Level | SAL10-6 | SAL10-6 | SAL10-6 |
| Single Use | Yes | Yes | Yes |
| Radiopaque Markers | Yes | Yes | Yes |
| Anatomical Sites | Peripheral and neuro vascular | Peripheral and neuro vascular | Neuro vascular |
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NON-CLINICAL TESTING / PERFORMANCE DATA:
Non-clinical bench testing was performed on the Branchor Balloon Guide Catheter to determine substantial equivalence. The following testing was performed:
| Test | Result |
|---|---|
| Air Leakage Into Hub Assembly During Aspiration | Pass |
| Balloon Diameter to Inflation Pressure | Pass |
| Balloon Inflation and Deflation Times | Pass |
| Balloon Maximum Diameter | Pass |
| Burst Pressure | Pass |
| Coating Integrity/Particulate Evaluation | (Characterization Only) |
| Design Verification – Simulated Use | Pass |
| Dimensional Analysis | Pass |
| Freedom from Leakage and Damage on Inflation | Pass |
| Kink Resistance Test | Pass |
| Liquid Leakage Under Pressure | Pass |
| Lumen Collapse Under Maximum Aspiration | Pass |
| Luer Hub Testing | Pass |
| Peak Tensile Strength - Tip | Pass |
| Peak Tensile Strength - Tube Junction | Pass |
| Radio-detectability | Pass |
| Tip Flexibility | Pass |
| Torque Strength | Pass |
| Visual Inspection - Distal Tip | Pass |
| Visual Inspection - Surface | Pass |
Table 2: Performance Testing
The in vitro bench tests demonstrated that the Branchor Balloon Guide Catheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices.
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BIOCOMPATIBILITY:
The Branchor Balloon Guide Catheter was tested in accordance with ISO 10993-1, and found to be biocompatible. The following tests were performed:
| Test | Test Summary | Conclusion |
|---|---|---|
| Systemic Toxicity - ISO10993-11 Rabbit Pyrogen Test(material mediated) | The test article should not increase the rectaltemperature of any of the animals by more than0.5 °C. | Non-pyrogenic |
| Systemic Toxicity - ISO10993-11 Systemic Injection | The test article must not show significantlygreater biological activity than the control. | No acute systemic toxicity |
| Cytotoxicity - ISO 10993-5L929 cells/MEM Elution Test | The test system is considered suitable if no signsof cellular reactivity (Grade 0) are noted for boththe negative control article and the mediumcontrol. | Non-cytotoxic |
| Sensitization - ISO 10993-10 Guinea Pig MaximizationTest | The extracts should show no evidence ofcausing delayed dermal contact sensitization inthe guinea pig. | Non-sensitizing |
| Irritation - ISO 10993-10Intracutaneous InjectionTest | The test extract and the negative control mustexhibit similar edema and erythema scores. | Non-irritant |
| Hemocompatibility - ISO10993-4 Hemolysis | Test article in direct contact with blood and testarticle extract must be non-hemolytic. | Non-hemolytic |
| Hemocompatibility - ISO10993-4 PartialThromboplastin Time Assay(PTT) | The PTT of the plasma exposed to test articleextract should not significantly decreased whencompared to untreated and negative controls. | Minimal Activator |
| Hemocompatibility - ISO10993-4Complement ActivationAssay (SC5b-9) | The plasma exposed to test article must exhibitno significant increase in SC5b-9 whencompared to activated NHS and negative controlafter 60 minutes exposure. | Non-Potential Activator |
| Hemocompatibility –ISO 10993-4Thrombogenicity | Compare results of test article to predicatecontrol Thrombogenicity response in NAVImodel.Determine acceptability of results as part of riskmanagement. | No Thrombosis |
Table 2: Biocompatibility Results
STERILIZATION and SHELF LIFE:
The Branchor Balloon Guide Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135-1:2014 to achieve a sterility assurance level (SAL) of 10 ° EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008.
Bacterial Endotoxin Levels were below the level of 2.15 EU/device.
Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 3 year shelf-life
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CONCLUSION:
The Branchor Balloon Guide Catheter has similar technological characteristics, such as components, design, materials, sterilization method, shelf life and operating principles, as the predicate devices. Performance data demonstrate that the device functions as intended. The conclusions drawn from the nonclinical tests demonstrate that the Branchor Balloon Guide Catheter is substantially equivalent to the legally marketed predicate devices.
§ 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).