FUBUKI XF Neurovascular Long Sheath
Device Facts
| Record ID | K213589 |
|---|---|
| Device Name | FUBUKI XF Neurovascular Long Sheath |
| Applicant | Asahi Intecc Co., Ltd. |
| Product Code | QJP · Cardiovascular |
| Decision Date | Mar 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
This product is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. This product is also intended to be used for injection of contrast media. This product is intended for use only in the neurovasculature.
Device Story
FUBUKI XF Neurovascular Long Sheath is a single-lumen catheter system comprising a long sheath and dilator; designed for neurointerventional procedures. Device facilitates introduction of guidewires and therapeutic devices to neurovascular sites; enables contrast media injection. Used in clinical settings by trained physicians. Outer surface features hydrophilic coating for lubricity; inner lumen lined with fluoropolymer to reduce friction. System includes rotating hemostasis valve (RHV). Device is provided sterile via ethylene oxide. Operates as a mechanical conduit for interventional tools; provides physician with access to neurovascular lesions. Benefits include improved navigation and delivery of therapeutic devices during minimally invasive procedures.
Clinical Evidence
Bench testing only. Performance verified via visual inspection, air/liquid leakage, burst pressure, corrosion resistance, dimensional verification, kink resistance, radio-detectability, slidability, tensile strength, flowrate, power injection, tip flexibility, and torque strength. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity, and thrombogenicity).
Technological Characteristics
Single-lumen catheter (sheath and dilator). Materials: fluoropolymer inner liner, hydrophilic outer coating. Sterilization: Ethylene Oxide (ISO 11135-1). Shelf life: 3 years. Dimensions: 8Fr (2.70mm outer diameter, 0.090 inch inner diameter). Accessories: Rotating Hemostasis Valve (RHV).
Indications for Use
Indicated for patients requiring percutaneous intravascular neurovascular procedures; used to guide interventional devices to lesions or procedural sites and for contrast media injection. Intended for neurovascular use only.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters (K141981)
Submission Summary (Full Text)
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March 24, 2022
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ASAHI INTECC Co., Ltd. % Cynthia Valenzuela Director, Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K213589
Trade/Device Name: FUBUKI XF Neurovascular Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: OJP, DOY Dated: February 18, 2022 Received: February 22, 2022
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
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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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) K213589
Device Name FUBUKI XF Neurovascular Long Sheath
#### Indications for Use (Describe)
This product is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. This product is also intended to be used for injection of contrast media. This product is intended for use only in the neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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### 510(K) Summary [as required by 21 CFR §807.92(c)]
# 510(k) K213589
| DATE PREPARED: | 21 March 2022 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | ASAHI INTECC CO., LTD.<br>3-100 Akatsuki-cho, Seto<br>Aichi 489-0071, Japan |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela<br>Director, Regulatory Affairs<br>ASAHI INTECC USA, INC.<br>3002 Dow Avenue, Suite 212<br>Tustin, California 92780<br>Phone: (949) 413 0071<br>Email: cynthiav@asahi-intecc-us.com |
| SECONDARY CONTACT: | Mr. Hiroshi Obara<br>Manager, Regulatory Affairs<br>ASAHI INTECC CO., LTD.<br>3-100 Akatsuki-cho<br>Seto, Aichi, Japan 489-0071<br>Email: hiroshi.obara@asahi-intecc.com |
| TRADE NAME: | FUBUKI XF Neurovascular Long Sheath |
| DEVICE CLASSIFICATION: | Class II, 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE: | QJP - Catheter, Percutaneous, Neurovasculature<br>DQY - Catheter, Percutaneous |
| PREDICATE DEVICE(S): | ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters<br>(K141981) |
### Intended Use/Indications for Use:
This product is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. This product is also intended to be used for injection of contrast media. This product is intended for use only in the neurovasculature.
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# Device Description:
The FUBUKI XF Neurovascular Long Sheath consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft.
The FUBUKI XF Neurovascular Long Sheath is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of the long sheath is coated with a hydrophilic polymer to provide high lubricity when the surface is wet. The inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the quide wire and other devices.
The dilator consists of two parts: (1) a shaft and (2) a connector.
The FUBUKI XF Neurovascular Long Sheath is composed of a long sheath and a dilator packed in a sterile package. This sterile package is packed in an outer box with the Instructions for Use.
### Accessories:
The FUBUKI XF Neurovascular Long Sheath is packaged with a rotating hemostasis valve (RHV).
### Comparison with Predicate Device:
The FUBUKI XF Neurovascular Long Sheath subject to this submission has the same intended use and similar technological characteristics, such as components, design, materials, sterilization method, shelf life and operating principles as the predicate device.
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# Comparison with Predicate Device
| | Comparison with Predicate Device | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Device | ASAHI FUBUKI Guide<br>Catheters (8Fr)<br>Predicate Device<br>K141981 | FUBUKI XF Neurovascular Long<br>Sheath<br>Subject Device<br>K213589 |
| Regulatory Status | | |
| Regulation Number | 21 CFR §870.1250 | 21 CFR §870.1250 |
| Device Classification<br>Name | Catheter, Percutaneous | Catheter, Percutaneous,<br>Neurovasculature |
| Regulatory Class | II | II |
| Product Code | DQY | QJP<br>DQY |
| Indications for Use | This product is intended to be<br>used to guide interventional<br>devices for Neurovascular<br>therapy to a lesion or a<br>procedural site for a<br>percutaneous intravascular<br>procedure in the<br>Neurovasculature. This<br>catheter is also intended to be<br>used for injection of contrast<br>media. Do not use this<br>product other than for use in<br>the Neurovasculature. | This product is intended to be used<br>to guide interventional devices for<br>neurovascular therapy to a lesion<br>or a procedural site for a<br>percutaneous intravascular<br>procedure in the neurovasculature.<br>This product is also intended to be<br>used for injection of contrast media<br>This product is intended for use<br>only in the neurovasculature. |
| Product Information: | | |
| Labeled Shaft Outer<br>Diameter of Long<br>Sheath | 2.70mm (8 Fr, 0.106 inch) | 2.70mm (8 Fr, 0.106 inch) |
| Labeled Shaft Inner<br>Diameter of Long<br>Sheath | 0.090 inch (6.8Fr, 2.28mm) | 0.090 inch (6.8Fr, 2.28mm) |
| Long Sheath<br>Effective Length | 800mm, 900mm, 1000mm,<br>1100mm | 800mm, 900mm, 1000mm,<br>1100mm |
| Dilator Effective<br>Length | 925mm, 1025mm, 1125mm,<br>1225mm | 1020mm, 1120mm, 1220mm |
| Dilator Outer<br>Diameter (Proximal) | 2.21mm (6.6Fr, 0.087 inch) | 2.24mm (6.7Fr, 0.088 inch) |
| Tip Shape | Straight | Straight, Angled |
| Long Sheath Distal<br>Coating | Hydrophilic (50mm) | Hydrophilic (80mm) |
| Construction | Soft tip, soft tube and shaft,<br>protector, connector | Soft tip, soft tube and shaft,<br>protector, connector |
| Long Sheath Inner<br>Lumen | PTFE | PTFE |
| Accessories | None | Hemostasis Valve |
| Sterilization Method | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Sterilization Level | SAL 10-6 | SAL 10-6 |
| Shelf Life | 3 years | 3 years |
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# NON-CLINICAL TESTING / PERFORMANCE DATA:
The following non-clinical bench testing was performed on the FUBUKI XF Neurovascular Long Sheath (long sheath and dilator) to determine substantial equivalence:
| Long Sheath | | | |
|--------------------------------------------|----------------------------|--|--|
| Test | Result | | |
| Visual Inspection | Pass | | |
| Air Leakage | Pass | | |
| Burst Pressure Under Static Condition | Pass | | |
| Corrosion Resistance | Pass | | |
| Dimensional Verification | Pass | | |
| Kink Resistance | Pass | | |
| Liquid Leakage | Pass | | |
| Radio-Detectability | Pass | | |
| Slidability | Pass | | |
| Tensile Strength | Pass | | |
| Tensile Strength (Distal Tip) | Pass | | |
| Coating Integrity / Particulate Evaluation | (Characterization<br>Only) | | |
| Simulated Use Test | Pass | | |
| Flowrate | Pass | | |
| Power Injection Test | Pass | | |
| Tip Flexibility | Pass | | |
| Torque Strength | Pass | | |
#### Dilator
| Test | Result |
|--------------------------|--------|
| Visual Inspection | Pass |
| Corrosion Resistance | Pass |
| Dimensional Verification | Pass |
| Radio-Detectability | Pass |
| Tensile Strength | Pass |
The bench tests performed on finished sterilized product demonstrated that the FUBUKI XF Neurovascular Long Sheath is substantially equivalent to the cleared predicate K141981. No new questions of safety and effectiveness were identified with the design change. The acceptance criteria were based on ISO standards identified, as applicable, and were identical to the acceptance criteria used for the predicate ASAHI FUBUKI Guide Catheters (K141981).
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# BIOCOMPATIBILITY:
Biocompatibility testing was performed in accordance to ISO 10993. All testing performed met the requirements as specified within the applicable standard.
Per ISO 10993-1, the FUBUKI XF Neurovascular Long Sheath was categorized as an externally communicating device with circulating blood contact for a limited duration (<24 hours).
## Biocompatibility Test Results for Long Sheath
| Test | Standard | Acceptance Criteria | Results |
|-------------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Cytotoxicity<br>MEM Elution Test | ISO 10993-5<br>No deviations | The test system is considered suitable if no signs of<br>cellular reactivity (Grade 0) are noted for both the<br>negative control article and the medium control. | Non-Toxic |
| Sensitization<br>Kligman Maximization<br>Test | ISO 10993-10<br>No deviations | The extracts should show no evidence of causing delayed<br>dermal contact sensitization in the quinea pig. | Non-Sensitizing |
| Irritation<br>Intracutaneous<br>Injection Test | ISO 10993-10<br>No deviations | The test article sites should not show a significantly<br>greater biological reaction than the sites injected with the<br>control article. | Non-Irritant |
| Systemic Toxicity<br>Acute Systemic<br>Toxicity Test | ISO 10993-11<br>No deviations | The test article must not show significantly greater<br>biological activity than the control. | No Systemic Toxicity |
| Hemocompatibility<br>Rabbit Blood<br>Hemolysis Test | ISO 10993-4<br>No deviations | The test article in direct contact with blood and test article<br>extract must be non-hemolytic. | Non-Hemolytic |
| Material Mediated<br>Pyrogenicity<br>Rabbit Pyrogen Test | ISO10993-11<br>No deviations | The test article should not increase the temperature of<br>any of the animals by more than 0.5 degrees Celsius. | Non-Pyrogenic |
| Hemocompatibility<br>Unactivated Partial<br>Thromboplastin Time<br>Test | ISO 10993-4<br>No deviations | The UPTT of the plasma exposed to test article extract<br>should not be significantly decreased when compared<br>the UPTT of the plasma exposed to the negative control<br>or the untreated control. | Not an Activator |
| Hemocompatibility<br>Complement<br>Activation Assay<br>(SC5b-9) | ISO 10993-4<br>No deviations | The plasma exposed to test article must exhibit no<br>significant increase in SC5b-9 when compared to<br>activated NHS and negative control after 60 minutes<br>exposure. | Not an Activator |
| Thrombogenicity<br>Thrombogenicity<br>Study in Dogs | ISO 10993-4<br>No deviations | Compare results of test article to predicate control for<br>Thrombogenic response. Determine acceptability of<br>results as part of risk management. | Comparable<br>thromboresistance<br>with control |
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# Biocompatibility Test Results for Dilator
| Test | Standard | Acceptance Criteria | Results |
|-------------------------------------------------------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Cytotoxicity<br>MEM Elution Test | ISO 10993-5<br>No deviations | The test system is considered suitable if no signs of<br>cellular reactivity (Grade 0) are noted for both the<br>negative control article and the medium control. | Non-Toxic |
| Sensitization<br>Kligman Maximization<br>Test | ISO 10993-10<br>No deviations | The extracts should show no evidence of causing delayed<br>dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation<br>Intracutaneous<br>Injection Test | ISO 10993-10<br>No deviations | The test article sites should not show a significantly<br>greater biological reaction than the sites injected with the<br>control article. | Non-Irritant |
| Systemic Toxicity<br>Acute Systemic<br>Toxicity Test | ISO 10993-11<br>No deviations | The test article must not show significantly greater<br>biological activity than the control. | No Systemic Toxicity |
| Hemocompatibility<br>Rabbit Blood<br>Hemolysis Test | ISO 10993-4<br>No deviations | The test article in direct contact with blood and test article<br>extract must be non-hemolytic. | Non-Hemolytic |
| Material Mediated<br>Pyrogenicity<br>Rabbit Pyrogen Test | ISO10993-11<br>No deviations | The test article should not increase the temperature of<br>any of the animals by more than 0.5 degrees Celsius. | Non-Pyrogenic |
| Hemocompatibility<br>Unactivated Partial<br>Thromboplastin Time<br>Test | ISO 10993-4<br>No deviations | The UPTT of the plasma exposed to test article extract<br>should not be significantly decreased when compared<br>the UPTT of the plasma exposed to the negative control<br>or the untreated control. | Not an Activator |
| Hemocompatibility<br>Complement<br>Activation Assay<br>(SC5b-9) | ISO 10993-4<br>No deviations | The plasma exposed to test article must exhibit no<br>significant increase in SC5b-9 when compared to<br>activated NHS and negative control after 60 minutes<br>exposure. | Not an Activator |
| Thrombogenicity<br>Thrombogenicity<br>Study in Dogs | ISO 10993-4<br>No deviations | Compare results of test article to predicate control for<br>Thrombogenic response. Determine acceptability of<br>results as part of risk management. | Comparable<br>thromboresistance<br>with control |
# STERILIZATION and SHELF LIFE:
The FUBUKI XF Neurovascular Long Sheath 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.
### CONCLUSION:
The FUBUKI XF Neurovascular Long Sheath has similar intended use and similar technological characteristics, such as components, design, materials, sterilization method, shelf life and operating principles, as the predicate device ASAHI FUBUKI Guide Catheters. Performance data demonstrate that the device functions as intended. Therefore, the FUBUKI XF Neurovascular Long Sheath is considered substantially equivalent to the predicate device.
