Inno-Hydrowire

K172187 · Suzhou Innomed Medical Device Co., Ltd. · DQX · Apr 11, 2018 · Cardiovascular

Device Facts

• Record ID: K172187
• Device Name: Inno-Hydrowire
• Applicant: Suzhou Innomed Medical Device Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.

Device Story

Inno-Hydrowire is a sterile, single-use guidewire used to navigate catheters through the vascular system during diagnostic or interventional procedures. It consists of a Nickel-Titanium alloy core wire, a Pebax jacket containing Barium Sulfate for radiopacity, and a hydrophilic Polyvinyl Pyrrolidon (PVP) coating. The device is operated manually by a clinician; a provided torquer attaches to the proximal end to facilitate rotation and control. It is available in various lengths and diameters with straight or angled distal tips. By providing a track for catheter advancement, the device assists in reaching target anatomical sites, potentially improving procedural efficiency and patient outcomes. It is used in clinical settings.

Clinical Evidence

Bench testing only. Performance testing conducted per FDA guidance for Coronary and Cerebrovascular Guidewires and ISO 11070:2014, including tensile strength, torque strength, tip flexibility, surface lubricity, corrosion, kink resistance, torqueability, particulate, coating integrity, dimensional verification, and radiodetectability. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous injection, acute systemic toxicity, rabbit pyrogen, hemolysis, hemocompatibility, clotting time, thrombogenicity, and complement activation. All tests met requirements.

Technological Characteristics

Nickel-Titanium alloy core; Pebax jacket with Barium Sulfate (BaSO4); hydrophilic Polyvinyl Pyrrolidon (PVP) coating. Manual operation. Diameters: 0.014"-0.038"; Lengths: 80-260cm. Sterilized via Ethylene Oxide (ISO 11135). Biocompatibility per ISO 10993. Performance testing per ISO 11070:2014.

Indications for Use

Indicated for directing catheters to desired anatomical locations within the vascular system during diagnostic or interventional procedures. Not for neurovascular or coronary use.

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

• Terumo Radifocus® Guidewire (K863138)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.

#### April 11,2018

Suzhou Innomed Medical Device Co., Ltd c/o Ms. Darlene Garner Regulatory Affairs Consultant 113 Garner Cove Georgetown, Texas 78633

#### Re: K172187

Trade/Device Name: Inno-Hydrowire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: March 13, 2018 Received: March 14, 2018

Dear Ms. Garner:

We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K172187

Device Name Inno-Hydrowire

#### Indications for Use (Describe)

The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------------|
| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

This 510(k) summary is provided per the requirements of 21 CFR Part 807.92.

| Applicant: | Suzhou Innomed Medical Device Co., LTD |
|-----------------------|-----------------------------------------------------------------------------------------------|
| | 218 Xinghu St.,#B1-404,Suzhou, Jiangsu, 215123, P.R. China |
| | Phone: [phone] |
| | Fax: [phone] |
| Applicant Contact: | Darlene Garner<br>Regulatory Affairs Consultant<br>979/864-9232<br>[e-mail] |
| Date Prepared: | April 5, 2018 |
| Trade Name: | Inno-Hydrowire |
| Common Name: | Guidewire |
| Classification Name: | Wire, Guide, Catheter |
| Regulation Name: | Catheter guide wire |
| Regulation Number: | 21CFR Part 870.1330 |
| Product Code: | DQX |
| Classification: | Class II |
| Classification Panel: | Division of Cardiovascular Devices |
| Predicate device: | Terumo Radifocus® Guidewire (K863138) |

#### Device Description

The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer

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coating (Pebax containing BaSO4 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 Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The Hydrowires are packaged within a cardboard box which contains five individual guidewires.

### Intended Use

The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.

# Principle of Operation

The Inno-Hydrowire is operated manually or by a manual process.

### Substantial Equivalence

The Inno-Hydrowire was found to be substantially equivalent to the Terumo Radifocus® Guidewire, Premarket Notification K863138. A comparison of the technological characteristics is summarized in the table below:

| Comparison<br>Feature | Inno-Hydrowire<br>Guidewire | Radifocus® Guidewire |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | Manual | Manual |
| Indications for<br>use | Intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular. | Intended to direct a catheter to the desired anatomical location during diagnostic or interventional procedures. |
| Core Wire | Nickel Titanium | Nickel Titanium |
| Jacket | Pebax | Polyurethane |
| Radiopaque<br>Material | Barium Sulfate (BaSO4) | Tungsten |

| Comparison of the Inno-Hydrowire and Predicate Device | | | |
|-------------------------------------------------------|--|--|--|
| | | | |

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| Comparison<br>Feature | Inno-Hydrowire<br>Guidewire | Radifocus® Guidewire |
|------------------------------|--------------------------------------------------|--------------------------------------------------------------|
| Hydrophilic<br>Coating | Polyvinyl Pyrrolidon (PVP) | Half-ester methyl vinyl<br>ether-maleic anhydride copolymer |
| Adhesive<br>(Core/Jacket) | Extrusion | Extrusion |
| Distal Tip<br>Configurations | Straight, Angle, | Straight, Angle, and J shape |
| Lengths | 80cm, 150cm, 180cm and 260cm | 120cm, 150cm, 180cm, 220cm,<br>260cm, 300cm, 400cm and 450cm |
| Diameters | 0.014",0.018",0.025",0.032"<br>0.035" and 0.038" | 0.018",0.025",0.032",<br>0.035" and 0.038" |
| Sterility | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | Two Years | Two Years |

The Inno-Hydrowire does not have the exact intended use as the predicate Radifocus Guidewire in that the Inno-Hydrowire is specific to the vasculatory system.

The Inno-Hydrowire is substantially equivalent to the Radifocus Guidewire in technology / principal of operation, and is similar in the material and design. The main differences between the Inno-Hydrowire device and the predicate device are the sizes and the material. These differences do not affect the intended use or performance of the Inno-Hydrowire. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended.

### Non-Clinical Performance Testing

Performance testing has been conducted in accordance with FDA guidance document Coronary and Cerebrovascular Guidewire Guidance, January 1995, ISO 11070:2014, Sterile single-use intravascular catheter introducers. The results of the following performance tests have demonstrated substantial equivalence to the predicate device.

- Tensile Strength ●
- Torque Strength ●
- Tip Flexibility ●
- Surface Lubricity ●
- Corrosion ●
- Kink Resistance ●
- Torqueability ●
- Particulate .
- Coating Adherence/Integrity ●
- Dimensional Verification ●
- Radiodetectability .

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### 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 Inno-Hydrowire is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (<24h).

The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Inno-Hydrowire:

| • | Cytotoxicity | ISO 10993-5 |
|---|--------------------------------------|---------------------------|
| • | Sensitization (Kligman Maximization) | ISO 10993-10 |
| • | Intracutaneous Injection | ISO 10993-10 |
| • | Acute Systemic Toxicity | SO 10993-11 |
| • | Rabbit Pyrogen | SO 10993-11 |
| • | Hemolysis | ASTM F756-08 /ISO 10993-4 |
| • | In Vitro Hemocompatibility | ISO 10993-4 |
| • | Lee & White Clotting Time | ISO 10993-4 |
| • | Dog Thrombogenicity | ISO 10993-4 |
| • | Complement Activation Assay(C3a) | ISO 10993-4 |
| • | Complement Activation Assay(Sc5b-9) | ISO 10993-4 |

Test results for all biocompatibility testing met the applicable test requirements.

#### Sterilization

Sterilization conditions have been validated in accordance with ISO 11135, Sterilization of health - care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. The device is sterilized to a Sterility Assurance Level (SAL) of 10th. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on ISO 10993-7, Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals.

#### Pyrogenicity

The Inno-Hydrowire has been evaluated for non-endotoxin related factors. The rabbit pyrogen test as described in ANSI/AAMI/ISO 10993-11. The results concluded that the Inno-Hydrowire does not elicit a material mediated pyrogenic response.

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## Conclusion

The Inno-Hydrowire was found to be substantially equivalent in its design, intended use, technology, principal of operation, and performance to the predicate device. There are no significant differences between the Inno-Hydrowire and the predicate device.

Suzhou Innomed has demonstrated that the proposed Inno-Hydrowire Guidewire is substantially equivalent to the predicate device (Terumo Radifocus Guidewire).