(132 days)
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.
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.
The provided document describes the non-clinical testing and biocompatibility assessments for the FUBUKI XF Neurovascular Long Sheath, but it does not describe a study involving an AI device or algorithm to establish acceptance criteria or performance.
The document is a 510(k) summary for a medical device (a long sheath and dilator) and focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility.
Therefore, most of the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
However, I can provide the acceptance criteria and performance data for the device itself (the FUBUKI XF Neurovascular Long Sheath) based on the non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
A. Non-Clinical Bench Testing for Long Sheath and Dilator
The document states: "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)." The results below are reported as "Pass" against these unnamed ISO standard criteria.
| Test (Long Sheath) | Reported Device Performance |
|---|---|
| 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 Only |
| Simulated Use Test | Pass |
| Flowrate | Pass |
| Power Injection Test | Pass |
| Tip Flexibility | Pass |
| Torque Strength | Pass |
| Test (Dilator) | Reported Device Performance |
|---|---|
| Visual Inspection | Pass |
| Corrosion Resistance | Pass |
| Dimensional Verification | Pass |
| Radio-Detectability | Pass |
| Tensile Strength | Pass |
B. Biocompatibility Testing for Long Sheath and Dilator
(Note: The acceptance criteria and results are identical for both long sheath and dilator in the document.)
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Cytotoxicity (MEM Elution Test) | ISO 10993-5 | No signs of cellular reactivity (Grade 0) for both the negative control article and the medium control. | Non-Toxic |
| Sensitization (Kligman Maximization Test) | ISO 10993-10 | Extracts should show no evidence of causing delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| Irritation (Intracutaneous Injection Test) | ISO 10993-10 | Test article sites should not show a significantly greater biological reaction than the sites injected with the control article. | Non-Irritant |
| Systemic Toxicity (Acute Systemic Toxicity Test) | ISO 10993-11 | Test article must not show significantly greater biological activity than the control. | No Systemic Toxicity |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | ISO 10993-4 | Test article in direct contact with blood and test article extract must be non-hemolytic. | Non-Hemolytic |
| Material Mediated Pyrogenicity (Rabbit Pyrogen Test) | ISO 10993-11 | Test article should not increase the temperature of any of the animals by more than 0.5 degrees Celsius. | Non-Pyrogenic |
| Hemocompatibility (Unactivated Partial Thromboplastin Time) | ISO 10993-4 | UPTT of the plasma exposed to test article extract should not be significantly decreased when compared to the UPTT of the plasma exposed to the negative control or the untreated control. | Not an Activator |
| Hemocompatibility (Complement Activation Assay (SC5b-9)) | ISO 10993-4 | Plasma exposed to test article must exhibit no significant increase in SC5b-9 when compared to activated NHS and negative control after 60 minutes exposure. | Not an Activator |
| Thrombogenicity (Thrombogenicity Study in Dogs) | ISO 10993-4 | Compare results of test article to predicate control for Thrombogenic response. Determine acceptability of results as part of risk management. | Comparable thromboresistance with control |
Information Not Present in the Document:
The provided document does not contain any information related to an AI device or algorithm. Therefore, the following points cannot be answered:
- 2. Sample size used for the test set and the data provenance (Not applicable, no AI test set)
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable, no AI test set)
- 4. Adjudication method for the test set (Not applicable, no AI test set)
- 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, no AI component)
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable, no AI component)
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc) (Not applicable, no AI component)
- 8. The sample size for the training set (Not applicable, no AI component)
- 9. How the ground truth for the training set was established (Not applicable, no AI component)
The document focuses on the safety and effectiveness of a physical medical device (FUBUKI XF Neurovascular Long Sheath) through engineering bench tests and biological compatibility tests, rather than the performance of an AI algorithm.
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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.3-100 Akatsuki-cho, SetoAichi 489-0071, Japan |
| PRIMARY CONTACT: | Mrs. Cynthia ValenzuelaDirector, Regulatory AffairsASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, California 92780Phone: (949) 413 0071Email: cynthiav@asahi-intecc-us.com |
| SECONDARY CONTACT: | Mr. Hiroshi ObaraManager, Regulatory AffairsASAHI INTECC CO., LTD.3-100 Akatsuki-choSeto, Aichi, Japan 489-0071Email: 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, NeurovasculatureDQY - Catheter, Percutaneous |
| PREDICATE DEVICE(S): | ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters(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 GuideCatheters (8Fr)Predicate DeviceK141981 | FUBUKI XF Neurovascular LongSheathSubject DeviceK213589 |
| Regulatory Status | ||
| Regulation Number | 21 CFR §870.1250 | 21 CFR §870.1250 |
| Device ClassificationName | Catheter, Percutaneous | Catheter, Percutaneous,Neurovasculature |
| Regulatory Class | II | II |
| Product Code | DQY | QJPDQY |
| Indications for Use | This product is intended to beused to guide interventionaldevices for Neurovasculartherapy to a lesion or aprocedural site for apercutaneous intravascularprocedure in theNeurovasculature. Thiscatheter is also intended to beused for injection of contrastmedia. Do not use thisproduct other than for use inthe Neurovasculature. | This product is intended to be usedto guide interventional devices forneurovascular therapy to a lesionor a procedural site for apercutaneous intravascularprocedure in the neurovasculature.This product is also intended to beused for injection of contrast mediaThis product is intended for useonly in the neurovasculature. |
| Product Information: | ||
| Labeled Shaft OuterDiameter of LongSheath | 2.70mm (8 Fr, 0.106 inch) | 2.70mm (8 Fr, 0.106 inch) |
| Labeled Shaft InnerDiameter of LongSheath | 0.090 inch (6.8Fr, 2.28mm) | 0.090 inch (6.8Fr, 2.28mm) |
| Long SheathEffective Length | 800mm, 900mm, 1000mm,1100mm | 800mm, 900mm, 1000mm,1100mm |
| Dilator EffectiveLength | 925mm, 1025mm, 1125mm,1225mm | 1020mm, 1120mm, 1220mm |
| Dilator OuterDiameter (Proximal) | 2.21mm (6.6Fr, 0.087 inch) | 2.24mm (6.7Fr, 0.088 inch) |
| Tip Shape | Straight | Straight, Angled |
| Long Sheath DistalCoating | Hydrophilic (50mm) | Hydrophilic (80mm) |
| Construction | Soft tip, soft tube and shaft,protector, connector | Soft tip, soft tube and shaft,protector, connector |
| Long Sheath InnerLumen | 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 | (CharacterizationOnly) | ||
| 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 |
|---|---|---|---|
| CytotoxicityMEM Elution Test | ISO 10993-5No deviations | The test system is considered suitable if no signs ofcellular reactivity (Grade 0) are noted for both thenegative control article and the medium control. | Non-Toxic |
| SensitizationKligman MaximizationTest | ISO 10993-10No deviations | The extracts should show no evidence of causing delayeddermal contact sensitization in the quinea pig. | Non-Sensitizing |
| IrritationIntracutaneousInjection Test | ISO 10993-10No deviations | The test article sites should not show a significantlygreater biological reaction than the sites injected with thecontrol article. | Non-Irritant |
| Systemic ToxicityAcute SystemicToxicity Test | ISO 10993-11No deviations | The test article must not show significantly greaterbiological activity than the control. | No Systemic Toxicity |
| HemocompatibilityRabbit BloodHemolysis Test | ISO 10993-4No deviations | The test article in direct contact with blood and test articleextract must be non-hemolytic. | Non-Hemolytic |
| Material MediatedPyrogenicityRabbit Pyrogen Test | ISO10993-11No deviations | The test article should not increase the temperature ofany of the animals by more than 0.5 degrees Celsius. | Non-Pyrogenic |
| HemocompatibilityUnactivated PartialThromboplastin TimeTest | ISO 10993-4No deviations | The UPTT of the plasma exposed to test article extractshould not be significantly decreased when comparedthe UPTT of the plasma exposed to the negative controlor the untreated control. | Not an Activator |
| HemocompatibilityComplementActivation Assay(SC5b-9) | ISO 10993-4No deviations | The plasma exposed to test article must exhibit nosignificant increase in SC5b-9 when compared toactivated NHS and negative control after 60 minutesexposure. | Not an Activator |
| ThrombogenicityThrombogenicityStudy in Dogs | ISO 10993-4No deviations | Compare results of test article to predicate control forThrombogenic response. Determine acceptability ofresults as part of risk management. | Comparablethromboresistancewith control |
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Biocompatibility Test Results for Dilator
| Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| CytotoxicityMEM Elution Test | ISO 10993-5No deviations | The test system is considered suitable if no signs ofcellular reactivity (Grade 0) are noted for both thenegative control article and the medium control. | Non-Toxic |
| SensitizationKligman MaximizationTest | ISO 10993-10No deviations | The extracts should show no evidence of causing delayeddermal contact sensitization in the guinea pig. | Non-Sensitizing |
| IrritationIntracutaneousInjection Test | ISO 10993-10No deviations | The test article sites should not show a significantlygreater biological reaction than the sites injected with thecontrol article. | Non-Irritant |
| Systemic ToxicityAcute SystemicToxicity Test | ISO 10993-11No deviations | The test article must not show significantly greaterbiological activity than the control. | No Systemic Toxicity |
| HemocompatibilityRabbit BloodHemolysis Test | ISO 10993-4No deviations | The test article in direct contact with blood and test articleextract must be non-hemolytic. | Non-Hemolytic |
| Material MediatedPyrogenicityRabbit Pyrogen Test | ISO10993-11No deviations | The test article should not increase the temperature ofany of the animals by more than 0.5 degrees Celsius. | Non-Pyrogenic |
| HemocompatibilityUnactivated PartialThromboplastin TimeTest | ISO 10993-4No deviations | The UPTT of the plasma exposed to test article extractshould not be significantly decreased when comparedthe UPTT of the plasma exposed to the negative controlor the untreated control. | Not an Activator |
| HemocompatibilityComplementActivation Assay(SC5b-9) | ISO 10993-4No deviations | The plasma exposed to test article must exhibit nosignificant increase in SC5b-9 when compared toactivated NHS and negative control after 60 minutesexposure. | Not an Activator |
| ThrombogenicityThrombogenicityStudy in Dogs | ISO 10993-4No deviations | Compare results of test article to predicate control forThrombogenic response. Determine acceptability ofresults as part of risk management. | Comparablethromboresistancewith 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.
§ 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).