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.

Device Description

The CROSSLEAD Tracker is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 100cm, 200cm, 235cm and 300cm length. This Guide Wire consists of a hybrid Ni-Ti and stainless-steel core wire with a Pt-Ni inner coil and Pt-Ni and stainless-steel outer coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity 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 material of the CROSSLEAD Tracker are similar to that previously described in the predicate Regalia XS 1.0 (K083146/K163426) and reference devices MINAMO (K190176), ASAHI Gaia Next(K192599) and ASAHI Gladius (K150445/K163426).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (CROSSLEAD Tracker, a guide wire) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance or human reader improvement.

The document details non-clinical laboratory testing performed to demonstrate substantial equivalence to predicate and reference devices, focusing on physical and material properties of the guide wire. These tests are standard for medical devices and are not related to AI/ML or a comparative effectiveness study involving human readers.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML performance and human reader studies because this information is not present in the provided document.

The "Non-clinical testing/performance data" section (Page 8) lists various physical tests:

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

And "Biocompatibility" tests:

Cytotoxicity
Sensitization
Intracutaneous Irritation
Systemic Toxicity
USP Rabbit Pyrogen, Material Mediated
Hemolysis
Partial Thromboplastin Time
In Vivo Thromboresistance
Sc5b-9 Complement Activation

The document states: "The in vitro bench tests demonstrated the CROSSLEAD Tracker met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide the specific numerical acceptance criteria or the reported performance for each of these physical and biocompatibility tests. It also does not discuss any computational or AI-driven aspects, nor does it mention a study involving human readers, sample sizes for test/training sets, or expert ground truth establishment for such studies.

Summary

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Image /page/0/Picture/0 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.

August 14, 2024

Asahi Intecc Co., Ltd. Cynthia Valenzuela Director, Quality Systems, Regulatory Affairs/Compliance 3002 Dow Avenue Suite 212 Tustin, California 92780

Re: K241510

Trade/Device Name: CROSSLEAD Tracker Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: July 15, 2024 Received: July 15, 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"

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(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.

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.

Image /page/1/Picture/7 description: The image shows the name Lydia S. Glaw -S. Next to the name is the text 'Digitally signed by Lydia S. Glaw -S Date: 2024.08.14 16:22:50 -04'00'.' The text indicates that the name is a digital signature. The date of the signature is August 14, 2024.

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices

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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) K241510

Device Name CROSSLEAD Tracker

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K241510

510(k) Summary (as required by 21 CFR § 807.92) ЛЯЛНІ ІNTECC 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 Tracker

510(k)_K241510

Date Prepared:	27 MAY 2024
Applicant:	ASAHI INTECC CO., LTD.3-100 Akatsuki-cho,Seto, Aichi 489-0071 Japan
Contact:	C. Cynthia ValenzuelaDirector, Quality and Regulatory AffairsASAHI INTECC USA, Inc.3002 Dow Avenue, Suite 212Tustin, CA 92780Tel: (949) 745-1617e-mail: cynthiav@asahi-intecc-us-.com
Trade Name:	CROSSLEAD Tracker
Device Classification:	Class 2 per 21 CFR § 870.1330
Classification Name:	Catheter, Guide, Wire
Product Code:	DQX - Catheter Guide Wire
Predicate Device:	Regalia XS 1.0 K083146/K163426
Reference Devices:	MINAMO K190176ASAHI Gaia Next K192599ASAHI Gladius K150445/K163426

INTENDED USE/INDICATIONS FOR USE:

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DEVICE DESCRIPTION:

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COMPARISON WITH PREDICATE AND REFERENCE DEVICES:

Comparisons of the CROSSLEAD Tracker 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 Tracker	Regalia XS 1.0	MINAMO	Gaia Next	ASAHI Gladius
	Subject	Predicate	Reference	Reference	Reference
510(k)	TBD	K083146,K163426	K190176	K192599	K150445,K163426
Intended Use andIndications	This product is designed todirect a catheter to thedesired anatomical locationin the peripheral vasculatureduring diagnostic orinterventional procedures.Do not use the guide wire inneurovascular.	ASAHI Peripheral GuideWires are intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures.This device is intended forperipheral vascular use only.	PCI Guide Wires are intendedto facilitate the placement ofballoon dilatation cathetersduring percutaneous coronaryintervention (PCI) andpercutaneous transluminalangioplasty (PTA).The PCI Guide Wires are notintended for use in theneurovasculature.	ASAHI PTCA Guide Wiresare intended to facilitate theplacement of balloon dilatationcatheters during percutaneoustransluminal coronaryangioplasty (PTCA) andpercutaneous transluminalangioplasty (PTA), includinguse in crossing or assisting incrossing de novo coronarychronic total occlusions (CTO)The ASAHI PTCA GuideWires are not to be used inthe neurovasculature.	ASAHI Peripheral GuideWires are intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures.This device is intended forperipheral vascular useonly.
Nominal OD	0.36mm (0.014inch)	0.36mm (0.014inch)	0.36mm (0.014inch)	0.36mm (0.014inch)	0.46mm(0.018inch)0.36mm(0.014inch)
Overall Length	100, 200, 235,300 cm	180, 300cm	190, 300cm	190 cm	200cm, 235cm,300cm
Outer Coil	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel

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Name of Devices	CROSSLEAD Tracker	Regalia XS 1.0	MINAMO	Gaia Next	ASAHI Gladius
Tapered CoreWire	Nitinol andStainless Steel	Stainless Steel	Nitinol andStainless Steel	Stainless Steel	Stainless Steel
Inner Coil	Platinum-Nickel andStainless Steel		Stainless Steel	Platinum-Nickel andStainless Steel	Stainless Steel
Tip Shape	Straight,Pre-shape	StraightJ-tip	StraightPre-shapeJ-tip	Pre-shape	StraightPre-shape
Coating	HydrophilicHydrophobic	HydrophilicHydrophobic	HydrophilicHydrophobic	HydrophilicHydrophobic	HydrophilicHydrophobic
Sterilization	Provided sterile viaEthylene Oxide	Provided sterile viaEthylene Oxide	Provided sterile viaEthylene Oxide	Provided sterile viaEthylene Oxide	Provided sterile viaEthylene Oxide

The following technological differences exist between the subject and predicate devices:

Coil structure
Core shaft

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NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the CROSSLEAD Tracker 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 Tracker 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:

Testing was performed to assess biocompatibility of the modified coating material. The following tests were performed:

Cytotoxicity .
Sensitization
Intracutaneous Irritation ●
Systemic Toxicity ●
USP Rabbit Pyrogen, Material Mediated ●
Hemolysis ●
Partial Thromboplastin Time .
In Vivo Thromboresistance .
. Sc5b-9 Complement Activation

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CONCLUSION:

The CROSSLEAD Tracker 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 Tracker is substantially equivalent to the predicate and reference devices.

Regulation Number and Section

§ 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.