This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

Device Description

The CROSSLEAD Penetration Peripheral Guide Wire (hereafter "CROSSLEAD Penetration") is steerable guide wire with a maximum diameter of 0.014" (0.36 mm) and 0.018" (0.46 mm) and available in 200 cm, 235 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a Pt-Ni-Au alloy coil. The coil is soldered to the core wire with Au-Sn solder. The coil has radio - detectability to achieve visibility and can be made to bend 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 coating of the CROSSLEAD Penetration are similar to that previously described in the predicate ASAHI Peripheral Guide Wire ASAHI Astato XS 40 (K153443) (hereafter "ASAHI Astato XS 40") and reference CROSSLEAD Peripheral Guide Wire (K213315) (hereafter "CROSSLEAD").and ASAHI Peripheral Guide Wire ASAHI Halberd (K150445) (hereafter "ASAHI Halberd")..

AI/ML Overview

The provided document describes the FDA's 510(k) clearance for the CROSSLEAD Penetration Peripheral Guide Wire. This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract information related to its non-clinical testing and acceptance criteria as provided.

1. A table of acceptance criteria and the reported device performance

The document states that the CROSSLEAD Penetration met all acceptance criteria in its bench testing. Specific acceptance criteria are not detailed in the summary, but the categories of tests performed are listed. The reported performance is generally stated as "performed similarly to the predicate devices" and "functions as intended."

Acceptance Criteria Category (Test Type)	Reported Device Performance
Tensile Strength	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Torque Strength	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Torqueability	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Tip Flexibility	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Coating Integrity	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Catheter Compatibility	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Appearance and Cleanliness	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Corrosion Resistance	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Kink Resistance	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Radio - detectability	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Dimensional Verification	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Coating Integrity/Particulate Evaluation	Met all acceptance criteria; performed similarly to predicate devices; functions as intended.
Cytotoxicity - ISO 10993-5	Non-cytotoxic
Sensitization - ISO 10993-10	Non-sensitizer
Irritation - ISO 10993-23	Non-irritant
Systemic Toxicity - ISO 10993-11 (Acute)	Non-toxic
Systemic Toxicity - ISO 10993-11 (Pyrogen)	Non-pyrogenic
Hemocompatibility - ISO 10993-4 (Hemolysis)	Non-hemolytic
Hemocompatibility - ISO 10993-4 (UPTT)	Not an activator (meaning it did not significantly decrease UPTT)
Hemocompatibility - ISO 10993-4 (Complement Activation)	Not an activator (meaning no significant increase in SC5b-9)
Hemocompatibility - ISO 10993-4 (Thrombogenicity Study in Dogs)	Thromboresistant

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical bench testing and biocompatibility testing. It generally refers to "bench testing" and "in vitro bench tests." There is no mention of a "test set" in the context of patient data, as this is a device clearance for a physical medical guide wire, not a diagnostic or prognostic algorithm. Therefore, information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided in this document.

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)

Not applicable. This is a physical medical device. "Ground truth" in the context of expert consensus on data is not relevant here. The "ground truth" for the performance of the device is established by meeting specified physical and biological performance criteria during bench and biological compatibility testing, per established international standards (e.g., ISO 10993).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of a test set based on expert opinion.

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

Not applicable. This is a physical medical device, not an AI/ML device, and therefore no MRMC study or AI assistance assessment was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this medical device is established through compliance with recognized performance standards and validated test methods for physical characteristics and biocompatibility. This includes:

Compliance with FDA guidance document: "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018."
Compliance with ISO 10993 series for biocompatibility: This involves specific laboratory tests with predefined acceptance criteria. For example, for cytotoxicity, the ground truth is established by observing no signs of cellular reactivity (Grade 0) for controls. For sensitization, no evidence of delayed dermal contact sensitization in guinea pigs. For pyrogenicity, no increase in rectal temperature by more than 0.5 degrees Celsius.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Summary

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July 20, 2023

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, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ASAHI INTECC Co., Ltd. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue. Suite 212 Tustin, California 92780

Re: K230377

Trade/Device Name: CROSSLEAD Penetration Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 3, 2023 Received: July 3, 2023

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K230377

Device Name

CROSSLEAD Penetration Peripheral Guide Wire

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740

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510(k) Summary

[as required by 21CFR § 807.92(c)]

ΛՏΛΗΙ 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/

CROSSLEAD Penetration Peripheral Guide Wire

510(k)

DATE PREPARED:	16FEB2023
APPLICANT:	ASAHI INTECC CO., LTD.3-100 Akatsuki-cho, SetoAichi 489-0071, Japan
PRIMARY CONTACT:	Mrs. Cynthia ValenzuelaDirector, Quality System, Regulatory Affairs & Regulatory ComplianceASAHI INTECC USA, INC.3002 Dow Avenue, Suite 212Tustin, California 92780Phone: (714) 442 0575Mobile: (949) 745 1617Email: cynthiav@asahi-intecc-us.com
ALTERNATE CONTACT:	Mr. Hiroshi ObaraManager, Regulatory AffairsASAHI INTECC CO., INC.3-100 Akatsuki-choSeto, Aichi, Japan 489-0071Email: hiroshi.obara@asahi-intecc.com
TRADE NAME:	CROSSLEAD Penetration Peripheral Guide Wire
DEVICE CLASSIFICATION:	Class II, 21CFR § 870.1330
CLASSIFICATION NAME:	Catheter Guide Wire
PRODUCT CODE:	DQX
PREDICATE DEVICE(S):	ASAHI Peripheral Guide Wire ASAHI Astato XS 40(K153443)
REFERENCE DEVICE(S):	ASAHI Peripheral Guide Wire ASAHI Halberd (K150445)CROSSLEAD Peripheral Guide Wire (K213315)

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.

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Description:

Accessory

There are no accessories packed with CORSSLEAD Penetration.

Predicate	Device Name	510(K) Number
Primary Predicate	ASAHI Astato XS 40	K153443
Reference Device	CROSSLEAD	K213315
Reference Device	ASAHI Halberd	K150445

Comparison with Predicate Device and Reference Device:

The subject device has the following similarities to those which previously received 510(k) clearance.

Have the similar intended use and indications for use ●
Use the same operating principle; ●
. Incorporate the same basic designs; and
. Incorporate the same materials

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Comparison with Predicate Device and Reference Device

Name of Devices	CROSSLEAD Penetration	ASAHI Astato XS 40	CROSSLEAD	ASAHI Halberd
	Subject	Predicate	Reference	Reference
510(k)	TBD	K153443	K213315	K150445
Manufacturer	ASAHI INTECC	ASAHI INTECC	ASAHI INTECC	ASAHI INTECC
Classification	21 CFR 830.1330, Cardiovascular
Regulation.
Common Name	Catheter Guide Wire
Product Code	DQX
Class	II
Intended Use		Guide wire for percutaneous intervention
Indications for Use	This product is designed todirect a catheter to thedesired anatomical locationin the peripheral vasculatureduring diagnostic orinterventional procedures.	This product is intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures.This device is intended forperipheral vascular use only.	This product is designed todirect a catheter to thedesired anatomical locationin the peripheral vasculatureduring diagnostic orinterventional procedures.	This product is intended tofacilitate the placement andexchange of diagnostic andtherapeutic devices duringintravascular procedures.This device is intended forperipheral vascular use only.
Nominal OD(Maximum)	0.36 mm (0.014")0.46 mm (0.018")	0.36 mm (0.014")	0.89 mm (0.035")	0.36 mm (0.014")0.45 mm (0.018")
Overall Length	200 cm, 235 cm, 300 cm	200 cm, 300 cm	200 cm, 300 cm	200 cm, 235 cm, 300 cm
Coil	Pt-Ni-Au	Pt-Ni	SUS	Pt-Ni
Core Wire	SUS	SUS	Ni-Ti alloy	SUS
Solder	Au-Sn	Ag-SnAu-Sn	Ag-SnAu-Sn	Ag-Sn
Tip Shape	Straight, Pre-shape	Straight	Straight, Angled	Straight, Pre-shape
Coating	Hydrophilic Hydrophobic	Hydrophilic Hydrophobic	Hydrophilic Hydrophobic	Hydrophilic Hydrophobic
Sterilization	Provided sterile via EthyleneOxide to SAL 10-6	Provided sterile via EthyleneOxide to SAL 10-6	Provided sterile via EthyleneOxide to SAL 10-6	Provided sterile via EthyleneOxide to SAL 10-6

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Non Clinical Testing / Performance Data:

The substantial equivalence of the CROSSLEAD Penetration was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018.

Tensile Strength
Torque Strength ●
Torqueability ●
Tip Flexibility ●
Coating Integrity ●
Catheter Compatibility
Appearance and Cleanliness ●
Corrosion Resistance ●
Kink Resistance
Radio - detectability
Dimensional Verification ●
Coating Integrity/Particulate Evaluation in a clinically relevant mode ●

The in vitro bench tests demonstrated that the CROSSLEAD Penetration met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device.

BIOCOMPATIBILITY:

The CROSSLEAD Penetration was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed:

Test	Test Summary	Conclusion
Cytotoxicity - ISO 10993-5L929 cells/MEM Elution Test	The test system is considered suitable if nosigns of cellular reactivity (Grade 0) are notedfor both the negative control article and themedium control.	Non-cytotoxic
Sensitization - ISO 10993-10KLIGMAN Maximization Test	The extracts should show no evidence ofcausing delayed dermal contact sensitizationin the guinea pig.	Non-sensitizer
Irritation - ISO 10993-23Intracutaneous Injection Test	The test extract and the negative control mustexhibit similar edema and erythema scores.	Non-irritant
Systemic Toxicity - ISO 10993-11Acute System Toxicity Test	The test article must not show significantlygreater biological activity than the control.	Non-toxic
Systemic Toxicity - ISO 10993-11Rabbit Pyrogen Test (materialmediated)	The test article should not increase the rectaltemperature of any of the animals by morethan 0.5 degrees Celsius.	Non-pyrogenic
Hemocompatibility - ISO 10993-4Rabbit Blood Hemolysis Test	Test article in direct contact with blood andtest article extract must be non-hemolytic.	Non-hemolytic
Hemocompatibility - ISO 10993-4Unactivated Partial ThromboplastinTime Test	The UPTT of the plasma exposed to testarticle extract should not significantlydecreased when compared to untreated andnegative controls.	Not an activator
Hemocompatibility - ISO 10993-4Complement Activation Assay(SC5b-9)	The plasma exposed to test article mustexhibit no significant increase in SC5b-9 whencompared to activated NHS and negativecontrol after 60 minutes exposure.	Not an activator
Hemocompatibility - ISO 10993-4Thrombogenicity Study in Dogs	Compare results of test article to predicatecontrol for Thrombogenic response.Determine acceptability of results as part ofrisk management.	Thromboresistant

Biocompatibility Results (brief)

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CONCLUSION:

The CROSSLEAD Penetration has similar 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 device. Performance data demonstrates that the device functions as intended.

Therefore, the CROSSLEAD Penetration is substantially equivalent to the predicate device.

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.