(267 days)
This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).
The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.
The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).
Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.
This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).
Here's how to address your points based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical tests performed:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Torque Strength | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Torqueability | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Tip Flexibility | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Coating Integrity | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Catheter Compatibility | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Visual Inspection | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Corrosion Resistance | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Kink Resistance | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Radio Detectability | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Dimensional Verification | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Coating Integrity / Acute Particulate Characterization | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, USP Rabbit Pyrogen, Hemolysis, Partial Thromboplastin Time, In Vivo Thrombogenicity, Sc5b-9 Complement Activation) | Performed to assess biocompatibility. (Implied to have met criteria, as stated in the overall conclusion). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined engineering specifications.
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
This is not applicable. An MRMC study is designed for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.
8. The sample size for the training set
This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 Asahi Intecc USA, Inc. 3002 Dow Avenue Suite 212 Tustin, California 92780
Re: K241962
Trade/Device Name: Crossloop Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: February 20, 2025 Received: February 20, 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.
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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).
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.
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 Rule"). 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-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 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-regulatory
{2}------------------------------------------------
assistance/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,
Jenny R.
Katsnelson -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
Digitally signed by Jenny R.
Katsnelson -S
Date: 2025.03.27 12:02:30 -04'00'
Enclosure
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Indications for Use
510(k) Number (if known) K241962
Device Name CROSSLOOP
Indications for Use (Describe)
This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).
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)
SAHI INTECC 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/
CROSSLOOP
510(k) K241962
| Date Prepared: | 25 JUNE 2024 | |||||
|---|---|---|---|---|---|---|
| Applicant: | ASAHI INTECC CO., LTD. | |||||
| 3-100 Akatsuki-cho, | ||||||
| Seto, Aichi 489-0071 Japan | ||||||
| Contact: | Mrs. Cynthia Valenzuela | |||||
| Director, Quality and Regulatory Affairs | ||||||
| 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: | CROSSLOOP | |||||
| Common Name: | Guidewire | |||||
| Device Classification: | Class 2 per 21 CFR § 870.1330 | |||||
| Classification Name: | Catheter, Guide, Wire | |||||
| Product Code: | DQX - Catheter Guide Wire | |||||
| Predicate Device: | Astato 30 K071721, K163426 | |||||
| Reference Devices: | CROSSLEAD Penetration | K230377 | ||||
| SION blue | K122468, K163426, K191464 | |||||
| Astato XS 40 | K153443, K163426 | |||||
| V-18 Control Wire | K033742 |
INTENDED USE/INDICATIONS FOR USE:
This product is intended to direct a catheter to the desired anatomical location in the peripheral vasculature (excludinq coronary and cerebral vessels).
DEVICE DESCRIPTION:
The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these
ASAHI INTECC CO., LTD.
{5}------------------------------------------------
surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.
The basic structure, construction and materials of the CROSSLOOP are similar to those of the predicate Astato 30 (K071721, K163426) and reference CROSSLEAD Penetration (K230377) and SION blue (K122468, K163426, K191464).
COMPARISON WITH PREDICATE AND REFERENCE DEVICES:
Comparisons of the CROSSLOOP and predicate / reference devices show that the technological characteristics of the subject device such as the components, design, materials, sterilization method and operating principle are similar to the currently marketed predicate and reference devices. The intended use of the subject device and the predicate is similar.
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| Device name | Subject | Predicate | Reference | |||
|---|---|---|---|---|---|---|
| CROSSLOOP | Astato 30 | CROSSLEAD Penetration | SION blue | Astato XS 40 | V-18 Control Wire | |
| 510(k) | TBD | K071721,K163426 | K230377 | K122468, K163426, K191464 | K153443,K163426 | K033742 |
| Manufacturer | ASAHI INTECC CO., LTD. | Boston Scientific | ||||
| RegulationNumber | 21 CFR 870.1330 | |||||
| RegulationName | Catheter Guide Wire | |||||
| RegulatoryClass | II | |||||
| Product code | DQX | |||||
| Intended and/orIndication forUse | This product isintended todirect a catheterto the desiredanatomicallocation in theperipheralvasculature(excludingcoronary andcerebralvessels). | This product isintended tofacilitate theplacement andexchange ofdiagnostic andtherapeuticdevices duringintravascularprocedures. Thisdevice is intendedfor peripheralvascular use only. | This product isdesigned todirect a catheterto the desiredanatomicallocation in theperipheralvasculatureduringdiagnostic orinterventionalprocedures. | ASAHI PTCAGuide Wires areintended tofacilitate theplacement ofballoon dilatationcatheters duringpercutaneoustransluminalcoronaryangioplasty(PTCA) andpercutaneoustransluminalangioplasty(PTA). TheASAHI PTCAGuide Wires arenot to be used intheneurovasculature | This product isintended tofacilitate theplacement andexchange ofdiagnostic andtherapeuticdevices duringintravascularprocedures. Thisdevice is intendedfor peripheralvascular use only. | The 110cm V-18Control Wire isintended forgeneralintravascular useincluding theplacement of PTAballoon cathetersrequiring an 0.018"guide wire inhemodialysis AVaccessprocedures. Thewire can betorqued to facilitateplacement ofdiagnostic ortherapeuticcatheters. Thisdevice is intendedfor peripheralvascular use only.A torque device isincluded with eachwire to facilitatedirectionalmanipulation of theguide wire. |
| Device name | Subject | Predicate | Reference | |||
| CROSSLOOP | Astato 30 | CROSSLEADPenetration | SION blue | Astato XS 40 | V-18 ControlWire | |
| Nominal OD | 0.46 mm(0.018 inch) | 0.45 mm(0.018 inch)with tapered end | 0.36 mm(0.014 inch)0.46 mm(0.018 inch) | 0.36 mm(0.014 inch) | 0.36 mm(0.014 inch)with tapered end | 0.46 mm(0.018 inch) |
| Overall Length | 200 cm, 235 cm,300 cm | 180 cm, 300 cm | 200 cm, 235 cm,300 cm | 180 cm,190 cm,300 cm | 180 cm, 300 cm | 110 cm |
| Coil | Pt-Ni alloy | Pt-Ni alloy | Pt-Ni alloy | AusteniticStainless SteelPt-Ni alloy | Pt-Ni alloy | unknown |
| Tapered CoreWire | AusteniticStainless Steel | AusteniticStainless Steel | AusteniticStainless Steel | AusteniticStainless Steel | AusteniticStainless Steel | Stainless Steel |
| Tip Shape | Straight, Pre-shape | Straight | Straight, Pre-shape | Straight, J-shape,Pre-shape | Straight | Straight |
| Distal TipStructure | Round | Round | Micro-corn | Round | Round | Round |
| Coating | HydrophilicPTFESilicone | HydrophilicPTFE | HydrophilicPTFE | HydrophilicPTFESilicone | HydrophilicPTFE | HydrophilicPTFE |
| Solder | Ag-SnAu-Sn | Ag-SnAu-Sn | Au-Sn | Ag-SnAu-Sn | Ag-SnAu-Sn | unknown |
| Sterilization | Ethylene oxideSAL 10-6 | Ethylene oxideSAL 10-6 | Ethylene oxideSAL 10-6 | Ethylene oxideSAL 10-6 | Ethylene oxideSAL 10-6 | unknown |
{7}------------------------------------------------
The following technological differences exist between the predicate or the reference devices:
- Coil structure
- Core shaft
- Distal tip structure
{8}------------------------------------------------
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the CROSSLOOP to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strenath ●
- 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 CROSSLOOP 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 device.
BIOCOMPATIBILITY:
Testing was performed to assess biocompatibility of the device. The following tests were performed:
- Cytotoxicity ●
- Sensitization
- Intracutaneous Irritation
- Systemic Toxicity ●
- USP Rabbit Pyrogen, Material Mediated ●
- . Hemolysis
- Partial Thromboplastin Time ●
- In Vivo Thrombogenicity
- Sc5b-9 Complement Activation ●
CONCLUSION:
The CROSSLOOP has the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method and operating principles as the predicate and reference devices. The conclusions drawn from the nonclinical tests demonstrate that the device has a similar safety and effectiveness profile as the predicate device. Therefore, the CROSSLOOP is substantially equivalent to the predicate device.
ASAHI INTECC CO., LTD.
§ 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.