(238 days)
No
The device description focuses on the physical construction and materials of a guide wire, and the performance studies are bench tests comparing it to predicate devices. There is no mention of AI, ML, image processing, or data sets for training/testing.
No.
The device is a guide wire used to direct a catheter during diagnostic or interventional procedures, not to treat a disease or condition itself.
No
The device is a guide wire designed to direct a catheter, which is used during diagnostic or interventional procedures. The guide wire itself does not perform diagnostic functions.
No
The device description clearly outlines a physical guide wire made of various materials (nitinol, stainless steel, platinum-nickel) with coatings, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is designed to "direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures." This describes a device used within the body for procedural guidance, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guide wire with specific materials and coatings, designed for insertion into blood vessels. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for guiding catheters within the body, not an IVD.
N/A
Intended Use / Indications for Use
This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.
Product codes (comma separated list FDA assigned to the subject device)
DOX, DQX
Device Description
The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426). All sizes are available with a straight and a pre-shaped design.
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 CROSSLEAD 0.014inch to determine substantial equivalence. The following testing/assessments were performed: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Integrity, Catheter Compatibility, Visual Inspection, Corrosion Resistance, Kink Resistance, Radio - Detectability, Dimensional Verification, Coating Integrity / Acute Particulate Characterization. The in vitro bench tests demonstrated the CROSSLEAD 0.014inch met all acceptance criteria and performed similarly to the predicate and reference devices. Performance data demonstrates the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K230377, K190176, K153443/K163426
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
February 6, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. The logo is simple and professional, conveying the organization's role in regulating food and drugs.
Asahi Intecc Co., Ltd. Cynthia Valenzuela Director, Quality Systems, Regulatory Affairs/Compliance Asahi Intecc USA. Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K241702
Trade/Device Name: CROSSLEAD 0.014inch Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: January 7, 2025 Received: January 7, 2025
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"
1
(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
3
Indications for Use
510(k) Number (if known) K241702
Device Name Crosslead 0.014 inch
Indications for Use (Describe)
This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.
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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4
510(k) Summary [as required by 21CFR § 807.92(c)]
ΔΣΛΗΙ ΙΝΤΕCC CO.,LTD.
Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : +81-561-48-5551 FAX : +81-561-48-5552 http://www.asahi-intecc.co.jp/
CROSSLEAD 0.014inch
510(k) _______________________________________________________________________________________________________________________________________________________________________ K241702
| DATE PREPARED: | 11 JUNE 2024 |
|---|---|
| APPLICANT: | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071, Japan | |
| PRIMARY CONTACT: | Cynthia Valenzuela |
| Director, Quality and Regulatory | |
| ASAHI INTECC USA, Inc. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, CA 92780 | |
| Tel: (949) 745-1617 | |
| e-mail: cynthiav@asahi-intecc-us.com | |
| TRADE NAME: | CROSSLEAD |
| DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 |
| CLASSIFICATION NAME: | Catheter Guide Wire |
| PRODUCT CODE: | DQX |
| PREDICATE DEVICE(S): | ASAHI Gladius (K150445/K163426) |
| REFERENCE DEVICE(S): | CROSSLEAD Penetration (K230377) |
| MINAMO (K190176) | |
| Astato XS 40 (K153443/K163426) |
Intended Use/Indications for Use:
This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.
5
Device Description:
The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426).
All sizes are available with a straight and a pre-shaped design.
6
COMPARISON WITH PREDICATE AND REFERENCE DEVICES:
Comparisons of the CROSSLEAD 0.014inch and predicate / reference devices show that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate and reference devices. The intended use of the subject device and its predicates are the same.
| Name of Devices | CROSSLEAD
0.014inch | ASAHI Gladius | CROSSLEAD
Penetration | MINAMO | Astato XS 40 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject | Predicate | | Reference | |
| 510(k) | TBD | K150445/K163426 | K230377 | K190176 | K153443/K163426 |
| Intended Use and
Indications | This product is
designed to direct a
catheter to the desired
anatomical location in
the peripheral
vasculature during
diagnostic or
interventional
procedures. Do not
use the guide wire in
neurovascular. | This product is intended
to facilitate the
placement and
exchange of diagnostic
and therapeutic devices
during intravascular
procedures. This device
is intended for
peripheral vascular use
only. | This product is designed
to direct a catheter to the
desired anatomical
location in the peripheral
vasculature during
diagnostic or
interventional procedures. | PCI Guide Wires are
intended to facilitate the
placement of balloon
dilatation catheters during
percutaneous coronary
intervention (PCI) and
percutaneous transluminal
angioplasty (PTA).
The PCI Guide Wires are
not intended for use in the
neurovasculature. | This product is intended
to facilitate the
placement and
exchange of diagnostic
and therapeutic
devices during
intravascular
procedures. This device
is intended for
peripheral vascular use
only. |
| Nominal OD | 0.36 mm (0.014") | 0.36mm (0.014")
0.46mm (0.018") | 0.36mm (0.014")
0.46mm (0.018") | 0.36 mm (0.014") | 0.36 mm (0.014")
tapering to 0.023
(0.009") Tip |
| Overall Length | 100cm, 200cm,
235cm, 300 cm | 200cm, 235cm, 300cm | 200cm, 235cm, 300cm | 190 cm, 300 cm | 200 cm, 300 cm |
| Outer Coil | Platinum-Nickel | Platinum-Nickel and
Stainless Steel | Platinum-Nickel | Platinum-Nickel and
Stainless Steel | Platinum-Nickel |
7
| Name of Devices | CROSSLEAD
0.014inch | ASAHI Gladius | CROSSLEAD
Penetration | MINAMO | Astato XS 40 |
|----------------------|----------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|
| Tapered Core
Wire | Nitinol and
Stainless steel | Stainless Steel | Stainless Steel | Nitinol and
Stainless steel | Stainless steel |
| Inner Coil | Stainless steel | Stainless steel | N/A | Stainless steel | N/A |
| Tip Shape | Straight, Pre-shape | Straight, Pre-shape | Straight, Pre-shape | Straight, Pre-shape,
J shape | Straight |
| Coating | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic |
| Sterilization | Provided sterile via
Ethylene Oxide | Provided sterile via
Ethylene Oxide | Provided sterile via
Ethylene Oxide | Provided sterile via
Ethylene Oxide | Provided sterile via
Ethylene Oxide |
The following technological differences exist between the subject and predicate devices:
- Coil structure .
- Core shape •
8
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the CROSSLEAD 0.014inch to determine substantial equivalence. The following testing/assessments were performed:
- . Tensile Strength
- Torque Strength
- . Torqueability
- . Tip Flexibility
- Coating Integrity
- Catheter Compatibility •
- Visual Inspection
- Corrosion Resistance
- Kink Resistance
- Radio - Detectability
- Dimensional Verification
- Coating Integrity / Acute Particulate Characterization .
The in vitro bench tests demonstrated the CROSSLEAD 0.014inch met all acceptance criteria and performed similarly to the predicate and reference devices Performance data demonstrates the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices.
BIOCOMPATIBILITY:
The biocompatibility of the CROSSLEAD 0.014inch had been confirmed in regards to the following aspects.
- Cytotoxicity
- Sensitization
- Intracutaneous Irritation ●
- Systemic Toxicity ●
- Material Mediated Pyrogenicity ●
- Hemolysis
- . Partial Thromboplastin Time
- In Vivo Thromboresistance ●
- Sc5b-9 Complement Activation
CONCLUSION:
The CROSSLEAD 0.014inch has the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended.
Therefore, the CROSSLEAD 0.014inch is substantially equivalent to the predicate.