(60 days)
This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.
The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition. In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.
The provided text describes a 510(k) premarket notification for various microcatheters (ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus, ASAHI Tellus C3). This document serves as a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria for an AI/ML medical device.
Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device cannot be extracted from this document. The document primarily focuses on the mechanical, material, and biocompatibility performance of a physical medical device (microcatheter) and its substantial equivalence to existing devices.
However, I can extract the information related to the performance testing and acceptance criteria for the physical microcatheter device as detailed in the document.
Acceptance Criteria and Device Performance (for the physical microcatheter device)
The document details non-clinical laboratory testing and biocompatibility testing conducted to demonstrate the substantial equivalence of the ASAHI microcatheters.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from 'Result' column for non-clinical) / Explicit for Biocompatibility | Reported Device Performance |
|---|---|---|
| Non-Clinical Laboratory Testing | ||
| Appearance/Dimensions/Tip Shape | Met specified requirements | Pass |
| Corrosion resistance | Met specified requirements | Pass |
| Peak tensile Strength | Met specified requirements | Pass |
| Tip Flexibility | Met specified requirements | Pass |
| Liquid leakage | Met specified requirements | Pass |
| Radio-detectability | Met specified requirements | Pass |
| Air Leakage | Met specified requirements | Pass |
| Burst Pressure | Met specified requirements | Pass |
| Flow Rate | Met specified requirements | Pass |
| Power Injection | Met specified requirements | Pass |
| Kink Resistance | Met specified requirements | Pass |
| Slidability | Met specified requirements | Pass |
| Connector | Met specified requirements | Pass |
| Coat integrity / Particulate Evaluation in a clinically relevant model | For characterization only (not a pass/fail acceptance) | This testing is for characterization only. |
| Torque Strength | Met specified requirements | Pass |
| Biocompatibility Testing (for ASAHI Tellus, representative model) | ||
| Cytotoxicity (MEM Elution Test) | No signs of cellular reactivity (Grade 0) for both negative control and medium control | Non-cytotoxic |
| Sensitization (KLIGMAN Maximization Test) | No evidence of causing delayed dermal contact sensitization in guinea pig | Non-Sensitizing |
| Irritation (Intracutaneous Injection Test) | Test extract and negative control must exhibit similar edema and erythema scores | Non-Irritant |
| Systemic Toxicity (Acute Systemic Toxicity Test) | Must not show significantly greater biological activity than the control | No Systemic Toxicity |
| Systemic Toxicity (Rabbit Pyrogen Test - material mediated) | Not increase rectal temperature of any animals by more than 0.5 degrees Celsius | Non-pyrogenic |
| Hemocompatibility (Rabbit Blood Hemolysis Test) | Non-hemolytic | Non-hemolytic |
| Hemocompatibility (Unactivated Partial Thromboplastin Time Test) | UPTT of plasma exposed to test article extract should not significantly decreased compared to untreated and negative controls | Minimal activator |
| Hemocompatibility (Complement Activation Assay - SC5b-9) | No significant increase in SC5b-9 when compared to activated NHS and negative control after 60 minutes exposure | Not an Activator |
| Hemocompatibility (Thrombogenicity Study in Dogs) | Compare results of test article to predicate control for Thrombogenic response. Determine acceptability as part of risk management. | Thromboresistant |
Regarding the AI/ML-specific details (Items 2-9 from your prompt):
The provided document is a 510(k) summary for a physical medical device (microcatheter), not an AI/ML-driven software device. Therefore, information related to:
- Sample size for test set and data provenance: Not applicable. Tests were bench/in-vitro and animal studies for device performance and biocompatibility.
- Number of experts and qualifications for ground truth: Not applicable. Performance data is from physical tests. Biocompatibility standards are specific laboratory tests.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading.
- Standalone (algorithm only) performance: Not applicable. This is a physical device.
- Type of ground truth used: For non-clinical tests, the ground truth is the physical measurement and functional assessment against specified engineering criteria. For biocompatibility, it's defined by the specific ISO standards and their pass/fail criteria.
- Sample size for training set: Not applicable (no AI/ML model training).
- How ground truth for training set was established: Not applicable.
In conclusion, this document demonstrates the safety and effectiveness of a microcatheter through standard predicate comparison, non-clinical bench testing, and biocompatibility studies, which are typical requirements for such devices. It does not contain any information about an AI/ML component or its associated validation studies.
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June 25, 2024
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, Quality Systems, Regulatory Affairs/Compliance 3002 Dow Avenue, Suite 212 Tustin. California 92780
Re: K241158
Trade/Device Name: ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 25, 2024 Received: April 26, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary
and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K241158
Device Name
ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus, ASAHI Tellus C3
Indications for Use (Describe)
This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.
| 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 [as required by 21 CFR 807.92(c)]
ASAHI Veloute, ASAHI Veloute C3 ASAHI Tellus, ASAHI Tellus C3 510(k) K241158
| DATE PREPARED: | April 25, 2024 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071 | |
| Japan | |
| CONTACT | Mrs. Cynthia Valenzuela |
| Director, Quality Systems, Regulatory Affairs/Compliance | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Ave, Suite 212 | |
| Tustin, CA 92780 USA | |
| Phone: (714) 442 0575 | |
| Fax: (949) 377 3255 | |
| Email: cynthiav@asahi-intecc-us.com | |
| TRADE NAME: | ASAHI Veloute, ASAHI Veloute C3 |
| ASAHI Tellus, ASAHI Tellus C3 | |
| DEVICE CLASSIFICATION: | Class II per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY |
| PREDICATE DEVICE: | Excelsior SL-10 (K013789) |
| REFERENCE DEVICE: | Echelon Micro Catheter (K031992) |
| Renegade STC 18 (K023681) | |
| Headway Duo Microcatheter (K120917) | |
| ASAHI FUBUKI 043 and ASAHI FUBUKI (K141981) |
INDICATIONS FOR USE:
This microcatheter is a medical device intended for angiography and/or infusion of various substances including diagnosis, embolization and treatment in the peripheral vasculature using an appropriate guide catheter and guide wire. The microcatheter is not intended for use in neurovasculature, coronary arteries and carotid arteries.
DESCRIPTION:
The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 Microcatheters are sterile single use devices designed for use in the peripheral vasculature. The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 consist of a catheter shaft that is reinforced with braid wires to enhance pushability and maintain patency of the inner lumen. A radiopaque marker is fixed on the distal end of the catheter shaft to facilitate location of the catheter during angiography. The distal portion of the catheter shaft is flexible and available in two shapes, straight and angled, to provide improved trackability in tortuous vessels. A hydrophilic coating is applied on the outer surface of the catheter to provide a smooth transition.
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In addition, accessories, including either a stylet, syringe and RHV (rotating hemostasis valve), or a stylet, syringe, inserter and hemostasis valve are available for use with the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 to the predicate and reference device show that the technological characteristics of the subject device such as the design, materials, sterilization method, and operating principle are similar to currently marketed predicate devices. The minor differences between the subject and predicate and reference device do not raise any new questions of safety or effectiveness.
The indications for use of the subject device are a subset of that of its primary predicate.
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Comparison with Predicate Device
| Name ofDevice | ASAHI VelouteASAHI Veloute C3 | ASAHI TellusASAHI Tellus C3 | Excelsior SL-10 |
|---|---|---|---|
| 510(k) | K241158 | K013789 | |
| ClassificationRegulation | 21 CFR 870.1250 | 21 CFR 870.1250 | |
| Common Name | Percutaneous Catheter | Percutaneous Catheter | |
| Product Code | DQY | DQY | |
| ClassificationRegulation | 21 CFR 870.1250 | 21 CFR 870.1250 | |
| Indications forUse | This microcatheter is a medical device intended forangiography and/or infusion of various substancesincluding diagnosis, embolization and treatment inthe peripheral vasculature using an appropriateguide catheter and guide wire. The microcatheter isnot intended for use in neurovasculature, coronaryarteries and carotid arteries. | The Excelsior SL-10Microcatheter is intendedto assist in the delivery ofdiagnostic agents, such ascontract media, andtherapeutic agents, suchas occlusion coils, into theperipheral, coronary andneurovasculature. | |
| Max Guide WireDiameter | OD: 0.41 mm (0.016") | OD: 0.36mm (0.014") | |
| Guide catheterCompatibility | Minimum ID:1.05mm (0.041") (Veloute, Tellus)0.85mm (0.033") (Veloute C3, Tellus C3) | Minimum ID: 1.00mm(0.038") | |
| Effective Length | 105, 125, 150cm | 150cm | |
| Shaft TubeOuter Diameter | Distal 0.58mm (1.7Fr,0.023")Proximal 0.94mm(2.8Fr, 0.037") | Distal 0.63mm(1.9Fr, 0.025")Proximal 0.94mm(2.8Fr, 0.037") | Distal 0.60mm (1.7Fr,0.023")Proximal 0.80mm (2.4Fr,0.031") |
| Proximal(C3) 0.80mm(2.4Fr, 0.031") | Proximal(C3) 0.80mm(2.4Fr, 0.031") | ||
| Tip Shape | Straight, Angle | StraightPre-Shaped 45Pre-Shaped 90Pre-Shaped JPre-Shaped CPre-Shaped S | |
| Distal Coating | Hydrophilic | Hydrophilic | |
| Radiopaque | Yes | Yes | |
| Single Use | Yes | Yes | |
| Sterilization | Provided sterile via Ethylene Oxide | Provided sterile viaEthylene Oxide |
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Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 to determine substantial equivalence. The following testing/assessments were performed:
| Test | Result |
|---|---|
| Appearance/Dimensions/Tip Shape | Pass |
| Corrosion resistance | Pass |
| Peak tensile Strength | Pass |
| Tip Flexibility | Pass |
| Liquid leakage | Pass |
| Radio-detectability | Pass |
| Air Leakage | Pass |
| Burst Pressure | Pass |
| Flow Rate | Pass |
| Power Injection | Pass |
| Kink Resistance | Pass |
| Slidability | Pass |
| Connector | Pass |
| Coat integrity / Particulate Evaluation in aclinically relevant model | This testing is forcharacterization only. |
| Torque Strength | Pass |
The in vitro bench tests demonstrated that the ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 met all acceptance criteria. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices.
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BIOCOMPATIBILITY:
The ASAHI Tellus was tested in accordance with ISO 10993, and found to be biocompatible.
The following tests were performed:
| Test Method | 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-cytotoxic |
| SensitizationKLIGMANMaximization Test | ISO 10993-10No deviations | The extracts should show no evidence of causingdelayed dermal contact sensitization in the guinea pig. | Non-Sensitizing |
| IrritationIntracutaneousInjection Test | ISO 10993-10No deviations | The test extract and the negative control must exhibitsimilar edema and erythema scores. | Non-Irritant |
| Systemic ToxicityAcute SystemicToxicity Test | ISO 10993-11No deviations | The test article must not show significantly greaterbiological activity than the control. | No SystemicToxicity |
| Systemic ToxicityRabbit Pyrogen Test(material mediated) | ISO 10993-11No deviations | The test article should not increase the rectaltemperature of any of the animals by more than 0.5degrees Celsius. | Non-pyrogenic |
| HemocompatibilityRabbit BloodHemolysis Test | ISO 10993-4No deviations | Test article in direct contact with blood and test articleextract must be non-hemolytic. | Non-hemolytic |
| HemocompatibilityUnactivated PartialThromboplastin TimeTest | ISO 10993-4No deviations | The UPTT of the plasma exposed to test article extractshould not significantly decreased when compared tountreated and negative controls. | Minimal 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 |
| HemocompatibilityThrombogenicityStudy in Dogs | ISO 10993-4No deviations | Compare results of test article to predicate control forThrombogenic response. Determine acceptability ofresults as part of risk management. | Thromboresistant |
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Sterilization and Shelf Life:
The ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus and ASAHI Tellus C3 sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135: 2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008.
Bacterial Endotoxin Levels were below the level of 20 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 ASAHI Veloute, ASAHI Veloute C3, ASAHI Tellus C3 have the similar intended use and indications, and the same or similar technological characteristics such as design, materials, sterilization method, performance, and operating principles as the predicate and reference device. Performance data demonstrates that the device functions as intended.
§ 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).