Hydrophilic Coating Guide Wire

K193653 · Suzhou Hengrui Disheng Medical Co., Ltd. · DQX · Aug 26, 2020 · Cardiovascular

Device Facts

• Record ID: K193653
• Device Name: Hydrophilic Coating Guide Wire
• Applicant: Suzhou Hengrui Disheng Medical Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.

Device Story

Hydrophilic Coating Guide Wire; manual device used by clinicians to direct catheters to specific anatomical locations within peripheral and coronary vasculature. Device consists of Nickel-Titanium alloy core wire, polyurethane jacket containing tungsten for radiopacity, and hydrophilic coating. Available in standard/stiff shaft configurations and straight/angled distal tip shapes. Provided sterile (EtO) for single use. Clinician manually manipulates wire to navigate vasculature; radiopaque tip allows visualization under fluoroscopy to confirm placement. Facilitates catheter delivery to target site; enables diagnostic or interventional procedures. Benefits patient by providing reliable, lubricious path for catheter access.

Clinical Evidence

No clinical data. Bench testing only. Performance testing conducted per FDA guidance (Coronary and Cerebrovascular Guidewire Guidance) and ISO 11070:2014, including tensile strength, torque strength, torqueability, coating integrity, particulate evaluation, lubricity, kink resistance, tip flexibility, radiopacity, fracture, and flexing. Biocompatibility testing performed per ISO 10993-1 for externally communicating, circulating blood, limited contact devices (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, hemolysis, thrombosis, PTT, PT).

Technological Characteristics

Nickel-Titanium alloy core; polyurethane jacket with tungsten for radiopacity; hydrophilic coating. Manual operation. Diameters: 0.032", 0.035", 0.038"; Lengths: 150cm, 180cm, 260cm. Sterile (EtO).

Indications for Use

Indicated for patients requiring catheter guidance in peripheral and coronary vasculature during diagnostic or interventional procedures. Not for neurovascular interventions.

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

• Acme Monaco Slidewire® (K113162)

Reference Devices

• Terumo Radifocus Guide Wire (K863138)

Submission Summary (Full Text)

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August 26, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Suzhou Hengrui Disheng Medical Co., Ltd. Ling Li Regulatory Affairs Manager No. 11 Building, No.8 Jinfeng Road Suzhou 215163, China

#### Re: K193653

Trade/Device Name: Hydrophilic Coating Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 20, 2020 Received: July 27, 2020

Dear Ling Li:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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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#### Indications for Use

510(k) Number (if known)

K193653

Device Name Hydrophilic Coating Guide Wire

Indications for Use (Describe)

The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.

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)

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# 510(k) Summary

| Submitter: | Suzhou Hengrui Disheng Medical Co., Ltd |
|-----------------------|---------------------------------------------------|
| | No. 11 Building No. 8 Jinfeng Road, Suzhou, China |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Ling Li |
| | Regulatory Affairs Manager |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Date prepared: | August 4, 2020 |
| Trade Name: | Hydrophilic Coating Guide Wire |
| Common Name: | Guide wire |
| Classification Name: | Wire, Guide, Catheter |
| Classification Panel: | Cardiovascular Devices |
| Regulation Number: | 21CFR Part 870.1330 |
| Product Code: | DQX |
| Classification: | Class II |
| Predicate device: | Acme Monaco Slidewire® (K113162) |
| Reference Device: | Terumo Radifocus Guide Wire (K863138) |

# Device Description:

The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.

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# Intended Use:

The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.

# Substantial Equivalence Comparison:

The Hydrophilic Coating Guide Wire was found to be substantially equivalent to the predicate device Acme Monaco Slidewire® (K113162) and reference device Terumo Radifocus Guide Wire (K863138). A comparison of the technological characteristics is summarized on the table below:

| Description | Subject Device:<br>Hydrophilic Coating<br>Guide Wire Guide Wire | Predicate Device:<br>Acme Monaco<br>Slidewire | Reference Device:<br>Radifocus Guide Wire | Remark |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 510(k)<br>Number | K193653 | K113162 | K863138 | N/A |
| Manufacturer | Suzhou Hengrui Disheng<br>Medical Co., Ltd | Acme Monaco<br>Corporation | Terumo Medical<br>Corporation | N/A |
| Classification | II | II | II | Same |
| Product Code | DQX | DQX | DQX | Same |
| Regulation | 21 CFR Part 870.1330 | 21 CFR Part 870.1330 | 21 CFR Part 870.1330 | Same |
| Indications<br>for use | Designed to direct a<br>catheter to the desired<br>anatomical location in<br>the peripheral and<br>coronary vasculature<br>during diagnostic or<br>interventional<br>procedures.<br>This device is not<br>intended for<br>neurovascular<br>interventions. | Intended for use in<br>diagnostic or<br>interventional<br>procedures to assist in<br>directing a catheter to<br>the desired anatomical<br>location in the<br>coronary or peripheral<br>vasculature. | Designed to direct a<br>catheter to the desired<br>anatomical location<br>during diagnostic or<br>interventional<br>procedures. | Same with<br>predicate<br>device |
| Operation<br>Principle | Manual | Manual | Manual | Same |
| Core wire | Nickel Titanium | Nickel Titanium | Nickel Titanium | Same |
| Jacket | Polyurethane | Polyurethane | Polyurethane | Same |
| Radiopaque | Tungsten | Tungsten | Tungsten | Same |

#### Table 1 Summary of Comparative Information

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| Description | Subject Device:<br>Hydrophilic Coating<br>Guide Wire Guide Wire | Predicate Device:<br>Acme Monaco<br>Slidewire | Reference Device:<br>Radifocus Guide Wire | Remark |
|---------------|-------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|
| Coating | Hydrophilic Caoting | Hydrophilic Caoting | Hydrophilic Caoting | Same |
| Specification | Diameter:<br>0.032",0.035",0.038"<br><br>Length:<br>150cm, 180cm, 260cm | Diameter:<br>0.014"- 0.052"<br><br>Length:<br>30cm - 300cm | Diameter:<br>0.018"- 0.052"<br><br>Length:<br>30cm - 300cm | Within the<br>range of<br>predicted<br>device<br>specification |
| | Usability | Single use | Single use | Single use |

## Biocompatibility Testing:

Biocompatibility testing was performed to ensure the material safety in accordance with the tests recommended in the International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part-I: Evaluation and testing within a risk management process." The wire is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24h). The following biocompatibility tests were completed and the biocompatibility was acceptable:

- Cytotoxicity ●
- Sensitization (Kligman Maximization) ●
- Irritation / Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Pyrogen ●
- Hemolysis test(extract method) ●
- Thrombosis test ●
- Partial Thromboplastin Time (PTT) test ●
- Prothrombin time (PT) test ●

## Non-Clinical Performance Testing:

Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995; Coronary, Peripheral, and Neurovascular Guidewire-Performance Tests and Recommended Labeling, Draft Guidance for Industry and Food and Drug Administration Staff, June 15, 2018; ISO 11070:2014, Sterile Single-use Intravascular Introducers, Dilators And Guidewires. The tests included the following:

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- Size and Surface
- Tensile Strength ●
- Torque Strength ●
- Torqueability ●
- Coating Integrity ●
- Particulate Evaluation ●
- Lubricity ●
- Kink Resistance ●
- Tip Flexibility ●
- Radiopacity ●
- Fracture test ●
- Flexing test ●
- EO and ECH residual ●
- Sterile Bacterial endotoxin ●
- Visual Inspection of the inner pouch ●
- Dye leakage test of the inner pouch ●
- Sealing-strength of the inner pouch ●

#### Conclusion:

The Hydrophilic Coating Guide Wire was found to be substantially equivalent in its design, intended use, technology, principal of operation, and performance to the predicate device. There are not significant differences between the Hydrophilic Coating Guide Wire and the predicate device that raise new issues of safety and effectiveness.