(60 days)
No
The description focuses on the physical characteristics and intended use of a microcatheter, with no mention of AI or ML capabilities.
Yes
The device is intended for "infusion of various substances including diagnosis, embolization and treatment". Treatment and embolization are therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the microcatheter is "intended for angiography and/or infusion of various substances including diagnosis".
No
The device description clearly details physical components like a catheter shaft, braid wires, a radiopaque marker, and a hydrophilic coating, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Description and Intended Use: The description clearly states this is a microcatheter used within the peripheral vasculature for angiography and infusion. This is an in vivo procedure, meaning it's performed inside the living body.
- No Mention of Specimen Analysis: The document does not mention the analysis of any biological specimens.
Therefore, based on the provided information, this microcatheter is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DQY
Device 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Appearance/Dimensions/Tip Shape, Corrosion resistance, Peak tensile Strength, Tip Flexibility, Liquid leakage, Radio-detectability, Air Leakage, Burst Pressure, Flow Rate, Power Injection, Kink Resistance, Slidability, Connector, Coat integrity / Particulate Evaluation in a clinically relevant model, Torque Strength. All tests passed, with Coat integrity / Particulate Evaluation being for characterization only.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K031992, K023681, K120917, K141981
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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).
1
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
2
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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3
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.
4
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.
5
Comparison with Predicate Device
| Name of
Device | ASAHI Veloute
ASAHI Veloute C3 | ASAHI Tellus
ASAHI Tellus C3 | Excelsior SL-10 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K241158 | | K013789 |
| Classification
Regulation | 21 CFR 870.1250 | | 21 CFR 870.1250 |
| Common Name | | Percutaneous Catheter | Percutaneous Catheter |
| Product Code | | DQY | DQY |
| Classification
Regulation | 21 CFR 870.1250 | | 21 CFR 870.1250 |
| 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. | | The Excelsior SL-10
Microcatheter is intended
to assist in the delivery of
diagnostic agents, such as
contract media, and
therapeutic agents, such
as occlusion coils, into the
peripheral, coronary and
neurovasculature. |
| Max Guide Wire
Diameter | OD: 0.41 mm (0.016") | | OD: 0.36mm (0.014") |
| Guide catheter
Compatibility | 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 Tube
Outer 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 | Straight
Pre-Shaped 45
Pre-Shaped 90
Pre-Shaped J
Pre-Shaped C
Pre-Shaped S |
| Distal Coating | Hydrophilic | | Hydrophilic |
| Radiopaque | Yes | | Yes |
| Single Use | Yes | | Yes |
| Sterilization | Provided sterile via Ethylene Oxide | | Provided sterile via
Ethylene Oxide |
6
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 a | |
| clinically relevant model | This testing is for |
| characterization 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.
7
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 |
|---|---|---|---|
| Cytotoxicity | |||
| MEM Elution Test | ISO 10993-5 | ||
| No deviations | The test system is considered suitable if no signs of | ||
| cellular reactivity (Grade 0) are noted for both the | |||
| negative control article and the medium control. | Non-cytotoxic | ||
| Sensitization | |||
| KLIGMAN | |||
| Maximization Test | ISO 10993-10 | ||
| No deviations | The extracts should show no evidence of causing | ||
| delayed dermal contact sensitization in the guinea pig. | Non-Sensitizing | ||
| Irritation | |||
| Intracutaneous | |||
| Injection Test | ISO 10993-10 | ||
| No deviations | The test extract and the negative control must exhibit | ||
| similar edema and erythema scores. | Non-Irritant | ||
| Systemic Toxicity | |||
| Acute Systemic | |||
| Toxicity Test | ISO 10993-11 | ||
| No deviations | The test article must not show significantly greater | ||
| biological activity than the control. | No Systemic | ||
| Toxicity | |||
| Systemic Toxicity | |||
| Rabbit Pyrogen Test | |||
| (material mediated) | ISO 10993-11 | ||
| No deviations | The test article should not increase the rectal | ||
| temperature of any of the animals by more than 0.5 | |||
| degrees Celsius. | Non-pyrogenic | ||
| Hemocompatibility | |||
| Rabbit Blood | |||
| Hemolysis Test | ISO 10993-4 | ||
| No deviations | Test article in direct contact with blood and test article | ||
| extract must be non-hemolytic. | Non-hemolytic | ||
| Hemocompatibility | |||
| Unactivated Partial | |||
| Thromboplastin Time | |||
| Test | ISO 10993-4 | ||
| No deviations | The UPTT of the plasma exposed to test article extract | ||
| should not significantly decreased when compared to | |||
| untreated and negative controls. | Minimal activator | ||
| Hemocompatibility | |||
| Complement | |||
| Activation Assay | |||
| (SC5b-9) | ISO 10993-4 | ||
| No deviations | The 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 | ||
| Hemocompatibility | |||
| Thrombogenicity | |||
| Study in Dogs | ISO 10993-4 | ||
| No deviations | Compare results of test article to predicate control for | ||
| Thrombogenic response. Determine acceptability of | |||
| results as part of risk management. | Thromboresistant |
8
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.