CROSSLEAD Peripheral Guide Wire

K213315 · Asahi Intecc Co., Ltd. · DQX · Jul 1, 2022 · Cardiovascular

Device Facts

• Record ID: K213315
• Device Name: CROSSLEAD Peripheral Guide Wire
• Applicant: Asahi Intecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

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

Device Story

CROSSLEAD is a steerable peripheral guide wire (0.035" diameter; 200cm/300cm lengths) used to navigate catheters through peripheral vasculature. Device consists of a Ni-Ti alloy core wire and stainless steel coil, joined by Ag-Sn solder. Distal portion features hydrophilic coating; proximal portion features hydrophobic coating. Operated by physicians in clinical settings during diagnostic or interventional procedures. Radiopaque coil provides visibility under fluoroscopy. Shaping needle accessory facilitates distal end contouring. Device functions as a mechanical guide to facilitate catheter placement; no electronic or software components.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance 'Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling' (2018). Tests included tensile strength, torque strength/ability, tip flexibility, coating integrity, catheter compatibility, corrosion resistance, kink resistance, and radiodetectability. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and dog thrombogenicity study). All acceptance criteria met.

Technological Characteristics

Ni-Ti alloy core wire; stainless steel outer coil; Ag-Sn solder. Distal hydrophilic coating; proximal hydrophobic coating. 0.035" (0.89mm) diameter. Sterilized via Ethylene Oxide to SAL 10^-6. Mechanical device; no energy source or software.

Indications for Use

Indicated for directing catheters to desired anatomical locations in the peripheral vasculature during diagnostic or interventional procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Radifocus Glidewire Advantage (K063372)

Reference Devices

• ASAHI Silverway (K183062)
• ASAHI Regalia XS 1.0 (K083146)
• Emerald guidewire (K935170)
• MINAMO (K190176)

Submission Summary (Full Text)

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July 1, 2022

Image /page/0/Picture/1 description: The image shows the logo for 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 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, Regulatory Affair Asahi Intecc USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780

Re: K213315

Trade/Device Name: CROSSLEAD Peripheral Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: May 20, 2022 Received: May 24, 2022

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

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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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

510(k) Number (if known)

#### K213315

Device Name CROSSLEAD 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)

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 21CFR § 807.92(c)]

# ЛЅЛНІ ІNTECC CO.,LTD.

Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : [phone] FAX : [phone] http://www.asahi-intecc.co.jp/

## CROSSLEAD Peripheral Guide Wire

510(K) __K_ __________________________________________________________________________________________________________________________________________________________________

| DATE PREPARED: | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | ASAHI INTECC CO., LTD.<br>3-100 Akatsuki-cho, Seto<br>Aichi 489-0071, Japan |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela<br>Director, Regulatory Affairs<br>ASAHI INTECC USA, INC.<br>3002 Dow Avenue, Suite 212<br>Tustin, California 92780<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| ALTERNATE CONTACT: | Mr. Yoshi Terai<br>President, CEO<br>ASAHI INTECC USA, INC.<br>Tustin, CA 92780 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| TRADE NAME: | CROSSLEAD Peripheral Guide Wire |
| DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 |
| CLASSIFICATION NAME: | Catheter Guide Wire |
| PRODUCT CODE: | DQX |
| PREDICATE DEVICE(S): | Radifocus Glidewire Advantage (K063372) |
| REFERENCE DEVICE(S): | ASAHI Silverway (K183062)<br>ASAHI Regalia XS 1.0 (K083146)<br>Emerald guidewire (K935170)<br>ΜΙΝΑΜΟ (K190176) |

### 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:

The CROSSLEAD Peripheral Guide Wire (hereafter "CROSSLEAD") is a steerable guide wire with a maximum diameter of 0.035 inches (0.89mm) and available in 200cm and 300cm length. The guide wire is constructed from a Ni-Ti alloy core wire with a stainless steel coil. The 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 coating of the CROSSLEAD are unchanged from that previously described in the predicate Radifocus Glidewire Advantage (K063372) and reference ASAHI Silverway (K183062) and ASAHI Regalia XS 1.0 (K083146)

# Accessory

The CROSSLEAD is packaged with a shaping needle.

The shaping needle can be used to facilitate shaping of the guide wire distal end. The shaping needle consists of a stainless-steel needle, a polypropylene hub and polyethylene cover.

| Predicate | Device Name | 510(K) Number |
|-------------------|-------------------------------|---------------|
| Primary Predicate | Radifocus Glidewire Advantage | K063372 |
| Reference Device | ASAHI Silverway | K183062 |
| Reference Device | ASAHI Regalia XS 1.0 | K083146 |
| Reference Device | Emerald guidewire | K935170 |
| Reference Device | MINAMO | K190176 |

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 | Radifocus Glidewire<br>Advantage | ASAHI Silverway | ASAHI Regalia XS 1.0 | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Subject | Predicate | Reference | Reference | |
| 510(k) | TBD | K063372 | K183062 | K083146 | |
| Manufacturer | ASAHI INTECC | TERUMO | ASAHI INTECC | ASAHI INTECC | |
| Classification Regulation | 21 CFR 830.1330, Cardiovascular | | | | |
| Common Name | Catheter Guide Wire | | | | |
| Product Code | DQX | | | | |
| Class | | II | | | |
| Intended Use | | | Guide wire for percutaneous intervention | | |
| Indications for Use | This product is designed to<br>direct a catheter to the<br>desired anatomical location<br>in the peripheral<br>vasculature during<br>diagnostic or interventional<br>procedures. | The Radifocus Glidewire<br>Advantage is designed to<br>direct catheter to the desired<br>anatomical location during<br>diagnostic or interventional<br>procedures. | This product is intended to be<br>used for the adjustment of the<br>position of interventional<br>devices in a blood vessel and<br>as an aid in moving the<br>catheter. It is not for use in<br>coronary arteries or<br>intracranial vessels. | This product is intended to<br>facilitate the placement and<br>exchange of diagnostic and<br>therapeutic devices during<br>intravascular procedures. This<br>device is intended for<br>peripheral vascular use only. | |
| Nominal OD | 0.89mm (0.035inch) | 0.36mm (0.014inch)<br>0.45mm (0.018inch)<br>0.89mm (0.035inch) | 0.89mm (0.035inch) | 0.36mm (0.014inch) | |
| Overall Length | 200cm, 300cm | 180cm, 260cm, 300cm | 150cm, 180cm, 200cm<br>220cm, 260cm, 300cm | 180cm, 300cm | |
| Outer Coil | SUS | Gold | SUS | Pt-Ni and SUS | |
| Core Wire | Ni-Ti alloy | Nitinol alloy | SUS | SUS | |
| Tip Shape | Straight, Angled | 45°Angle | Angled, J-Shape (1.5mm),<br>J-Shape (3.0mm) | Straight | |
| Coating | <Distal> Hydrophilic<br><Proximal> Hydrophobic | <Distal> Hydrophilic<br><Proximal> Hydrophobic | <Distal, Proximal><br>Hydrophobic<br><Middle> Hydrophilic | <Distal> Hydrophilic<br><Proximal> Hydrophobic | |
| Sterilization | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | Provided sterile via Ethylene<br>Oxide to SAL 10-6 | |

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# Non Clinical Testing / Performance Data:

The substantial equivalence of the CROSSLEAD 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 Adhesion / Integrity ●
- . Catheter Compatibility
- Appearance and Cleanliness ●
- Corrosion Resistance ●
- Kink Resistance ●
- Radio - detectability
- . Dimensional Verification

The in vitro bench tests demonstrated that the CROSSLEAD 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 was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed:

| Test | Test Summary | Conclusion |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Cytotoxicity - ISO 10993-5<br>L929 cells/MEM Elution Test | The test system is considered suitable if no<br>signs of cellular reactivity (Grade 0) are noted<br>for both the negative control article and the<br>medium control. | Non-cytotoxic |
| Sensitization - ISO 10993-10<br>KLIGMAN Maximization Test | The extracts should show no evidence of<br>causing delayed dermal contact sensitization<br>in the guinea pig. | Non-sensitizing |
| Irritation - ISO 10993-10<br>Intracutaneous Injection Test | The test extract and the negative control must<br>exhibit similar edema and erythema scores. | Non-irritant |
| Systemic Toxicity - ISO 10993-11<br>Acute System Toxicity Test | The test article must not show significantly<br>greater biological activity than the control. | No Systemic<br>Toxicity |
| Systemic Toxicity - ISO 10993-11<br>Rabbit Pyrogen Test (material<br>mediated) | The test article should not increase the rectal<br>temperature of any of the animals by more<br>than 0.5 degrees Celsius. | Non-pyrogenic |
| Hemocompatibility - ISO 10993-4<br>Rabbit Blood Hemolysis Test | Test article in direct contact with blood and<br>test article extract must be non-hemolytic. | Non-hemolytic |
| Hemocompatibility - ISO 10993-4<br>Unactivated Partial Thromboplastin<br>Time Test | The UPTT of the plasma exposed to test<br>article extract should not significantly<br>decreased when compared to untreated and<br>negative controls. | Not an activator |
| Hemocompatibility - ISO 10993-4<br>Complement Activation Assay<br>(SC5b-9) | The plasma exposed to test article must<br>exhibit no significant increase in SC5b-9 when<br>compared to activated NHS and negative<br>control after 60 minutes exposure. | Not an Activator |
| Hemocompatibility - ISO 10993-4<br>Thrombogenicity Study in Dogs | Compare results of test article to predicate<br>control for Thrombogenici response.<br>Determine acceptability of results as part of<br>risk management. | Comparable<br>thromboresistance<br>with control |

# Biocompatibility Results (brief)

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### CONCLUSION:

The CROSSLEAD 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 is substantially equivalent to the predicate device.