Predicate Devices

Reference Devices

CROSSLEAD Penetration K230377, SION blue K122468, K163426, K191464, Astato XS 40 K153443, K163426, V-18 Control Wire K033742

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical performance of a steerable guide wire, with no mention of AI or ML technologies.

Therapeutic

No
This device is a guide wire intended to direct a catheter, not to provide therapy itself.

Diagnostic

No

This device is a guidewire intended to navigate catheters through anatomical vasculature; it does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical guide wire made of stainless steel, Pt-Ni alloy, and various coatings, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that this device is a steerable guide wire intended to direct a catheter within the anatomical vasculature. This is an invasive medical device used directly within the body, not for testing samples outside the body.
Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or any other activities typically associated with IVDs.

Therefore, the CROSSLOOP guide wire is a medical device, but it falls under a different category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

Product codes (comma separated list FDA assigned to the subject device)

DQX

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 surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature (excluding coronary and cerebral vessels)

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 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.

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.

Astato 30 K071721, K163426

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.

CROSSLEAD Penetration K230377, SION blue K122468, K163426, K191464, Astato XS 40 K153443, K163426, V-18 Control Wire K033742

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

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.

Summary

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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.

1

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
Regulation
Number	21 CFR 870.1330
Regulation
Name	Catheter Guide Wire
Regulatory
Class	II
Product code				DQX
Intended and/or
Indication for
Use	This product is
intended to
direct a catheter
to the desired
anatomical
location in the
peripheral
vasculature
(excluding
coronary and
cerebral
vessels).	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.	ASAHI PTCA
Guide Wires are
intended to
facilitate the
placement of
balloon dilatation
catheters during
percutaneous
transluminal
coronary
angioplasty
(PTCA) and
percutaneous
transluminal
angioplasty
(PTA). The
ASAHI PTCA
Guide Wires are
not to be used 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.	The 110cm V-18
Control Wire is
intended for
general
intravascular use
including the
placement of PTA
balloon catheters
requiring an 0.018"
guide wire in
hemodialysis AV
access
procedures. The
wire can be
torqued to facilitate
placement of
diagnostic or
therapeutic
catheters. This
device is intended
for peripheral
vascular use only.
A torque device is
included with each
wire to facilitate
directional
manipulation of the
guide wire.
Device name	Subject	Predicate	Reference
	CROSSLOOP	Astato 30	CROSSLEAD
Penetration	SION blue	Astato XS 40	V-18 Control
Wire
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	Austenitic
Stainless Steel
Pt-Ni alloy	Pt-Ni alloy	unknown
Tapered Core
Wire	Austenitic
Stainless Steel	Austenitic
Stainless Steel	Austenitic
Stainless Steel	Austenitic
Stainless Steel	Austenitic
Stainless Steel	Stainless Steel
Tip Shape	Straight, Pre-
shape	Straight	Straight, Pre-
shape	Straight, J-shape,
Pre-shape	Straight	Straight
Distal Tip
Structure	Round	Round	Micro-corn	Round	Round	Round
Coating	Hydrophilic
PTFE
Silicone	Hydrophilic
PTFE	Hydrophilic
PTFE	Hydrophilic
PTFE
Silicone	Hydrophilic
PTFE	Hydrophilic
PTFE
Solder	Ag-Sn
Au-Sn	Ag-Sn
Au-Sn	Au-Sn	Ag-Sn
Au-Sn	Ag-Sn
Au-Sn	unknown
Sterilization	Ethylene oxide
SAL 10-6	Ethylene oxide
SAL 10-6	Ethylene oxide
SAL 10-6	Ethylene oxide
SAL 10-6	Ethylene oxide
SAL 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.