Microcatheter and guide-wire system

K171665 · Suzhou Hengrui Disheng Medical Co., Ltd. · KRA · Jan 11, 2018 · Cardiovascular

Device Facts

• Record ID: K171665
• Device Name: Microcatheter and guide-wire system
• Applicant: Suzhou Hengrui Disheng Medical Co., Ltd.
• Product Code: KRA · Cardiovascular
• Decision Date: Jan 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vasculature. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis.

Device Story

Micro Catheter and Guidewire System consists of catheter, guidewire, and accessories (flushing device, shaping mandrel, insertion tool, torque device). Catheter features three-layer body (PTFE inner, stainless steel wire-reinforced middle, polyamide outer) with hydrophilic coating and platinum-iridium radiopaque marker. Guidewire features nitinol core, polymer jacket with hydrophilic coating, and radiopaque distal marker. Used by clinicians in peripheral vascular procedures. Device facilitates targeted delivery of contrast media, therapeutic drugs, or embolic agents. Clinician navigates system through vasculature to target site; output is delivery of therapeutic or diagnostic agents. Benefits include precise, minimally invasive access to peripheral vessels for therapy or imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility evaluation. Bench testing included mechanical performance (tensile force, torque strength, burst pressure, kink resistance, coating integrity) per ISO 10555.1 and ISO 11070. Biocompatibility testing included cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, pyrogenicity, hemolysis, in-vivo thrombosis, and complement activation.

Technological Characteristics

Catheter: PTFE inner layer, stainless steel wire reinforcement, platinum-iridium radiopaque marker, polyamide outer layer, hydrophilic coating. Guidewire: Nitinol core, polymer jacket, hydrophilic coating, radiopaque marker. Accessories: Flushing device, shaping mandrel, insertion tool, torque device. Standards: ISO 10555.1, ISO 11070. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for patients requiring infusion of contrast media into peripheral vasculature, drug infusion in intra-arterial therapy, or infusion of embolic materials for hemostasis.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Progreat™ Micro Catheter system (K033913)

Reference Devices

• Cantata TM Microcatheter (K101450)
• Mira-FlexTM 18 Micro catheter (K052841)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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, 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.

January 11, 2018

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

Re: K171665

Trade/Device Name: Micro Catheter and Guidewire System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: December 8, 2017 Received: December 13, 2017

Dear Jingwen 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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

K171665

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 medical devices and radiation-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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K171665

Device Name Micro Catheter and Guidewire System

Indications for Use (Describe)

The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vasculature. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis.

| 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 [e-mail]

"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."

{3}------------------------------------------------

## 510(k) Summary

| Submitter: | Suzhou Hengrui Disheng Medical Co., Ltd<br>No. 11 Building<br>No. 8 Jinfeng Road<br>Suzhou, China<br>215163 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jingwen Li<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | May 22nd, 2017 |
| Trade Name: | Micro Catheter and Guidewire System |
| Common Name: | Continuous flush catheter |
| Classification: | Class II, 21 CFR Part 870.1210 |
| Product Code: | KRA |
| Predicate Device: | K033913 - Progreat™ Micro Catheter system (Terumo Medical<br>Corporation) |
| Reference Devices: | K101450 - Cantata TM Microcatheter (Cook Incorporated.)<br>K052841 - Mira-FlexTM 18 Micro catheter (Cook Incorporated.) |
| Device Description: | Micro Catheter and Guidewire System consists of a catheter, a<br>guidewire, and accessories. The accessories include a flushing<br>device, a shaping mandrel, an insertion tool, and a torque device.<br>The catheter is consist of a hub, a stress relief tube and a catheter<br>body. The catheter body has three layers. The inner layer is a<br>PTFE tube, the middle layer is consist of stainless steel wire<br>reinforce and platinum-iridium alloy radiopaque distal marker,<br>and the outer layer is polyamides of different hardness mixed<br>with pigment. There is also a hydrophilic coating on the catheter<br>surface. |
| | The guidewire is consist of a nitinol core, a polymer jacket with<br>hydrophilic coating over its entire surface and a radiopaque<br>distal marker. It has a white marker at the proximal end to<br>indicate the length inserted into human body and its relative<br>position with the catheter. |
| Indications for Use: | The Micro Catheter and Guidewire System is intended for the<br>infusion of contrast media into the peripheral vasculature. The<br>Micro Catheter and Guidewire system is also intended for drug<br>infusion in intra-arterial therapy and the infusion of embolic<br>materials for hemostasis. |
| Comparison with<br>Predicate Device: | The Micro Catheter and Guidewire System is similar to the<br>Progreat Micro Catheter System in following ways:<br>Each of the devices is intended to be used for the<br>infusion of contrast media into all peripheral vessels,<br>drug infusion in intra-arterial therapy and the infusion of<br>embolic materials for hemostasis. Each of the devices is compatible with 5Fr Guide<br>Catheter. Each of the devices is provided with catheter, guidewire<br>and accessories. Each of the devices is provided sterile. Each of the devices is intended to be single use. Each of the devices has a hydrophilic coating. Each of the devices has a platinum-iridium alloy<br>radiopaque marker. The following technological differences exist between the<br>subject and predicate devices: |
| Performance Data: | Effective length Available outer/inner diameter of the catheter Accessories Guidewire Hub Proximal marker of guidewire Materials of Hydrophilic coating, catheter body, catheter<br>hub Biocompatibility Testing<br>Biocompatibility evaluation for the Micro Catheter and<br>Guidewire System was conducted in accordance with current<br>standards and the following tests were included: Cytotoxicity |

{4}------------------------------------------------

{5}------------------------------------------------

- Sensitization ●
- Irritation/Intracutaneous Reactivity ●
- Systemic Toxicity ●
- Pyrogenicity ●
- Hemolysis study
- In-vivo thromboses study
- Complement Activiation .

## Bench Testing

Mechanical testing was performed per ISO 10555.1 and ISO 11070. The tests included the following:

- Catheter Sizes
- Catheter Surface
- Catheter Hub ●
- Coating Integrity/Adherence of catheter ●
- Peak tensile force of catheter ●
- Freedom from leakage
- Distal tip of catheter ●
- Torque Strength of catheter ●
- Kink resistant of catheter
- Radio-detectability of catheter .
- Hydration judgment of catheter ●
- Burst pressure under static conditions ●
- Guidewire Sizes ●
- Guidewire surface .
- Coating Integrity/Adherence of guidewire ●
- . Fracture test of guidewire
- Flexing test of guidewire ●
- Bending force of guidewire ●
- Peak tensile force of guidewire ●
- Torque strength testing of guidewire .
- Tip rigidity of guidewire ●
- Radio-detectability of guidewire ●
- . Surface of flushing device
- Finger grips of flushing device ●
- Piston of flushing device .
- Nozzle of flushing device ●
- Limits for extractable metals

{6}------------------------------------------------

- Limits for acidity or alkalinity ●
- Reducing substances ●
- Size of torque device ●
- . Surface of torque device
- Use performance of torque device ●
- . Lock adapter of the torque device
- Sizes of insertion tool
- Surface of insertion tool ●
- Connection strength of the needle and hub of insertion ● tool
- Corrosion resistance of the insertion tool
- Size of shaping mandrel ●
- Surface of shaping mandrel ●
- Corrosion resistance of shaping mandrel .
- Push and withdrawal ability of the system ●
- Simulated use of the system ●
- Torsion transmissibility of the system ●
- EO and ECH residual
- Sterile ●
- Bacterial endotoxin ●
- Dye leakage test of the inner pouch ●
- . Sealing-strength of the inner pouch

The data provided demonstrate that the Micro Catheter and Conclusion: Guidewire System is substantially equivalent to the predicate device which is currently marketed for the same intended use.