(220 days)
No
The device description and performance studies focus on the physical components and mechanical properties of the catheter and guidewire system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates the infusion of substances but does not directly provide a therapeutic effect itself beyond its delivery function.
No
The device is intended for the infusion of substances (contrast media, drugs, embolic materials) and does not inherently provide information about the diagnosis, treatment, or prevention of disease.
No
The device description clearly outlines physical components such as a catheter, guidewire, and accessories, including materials and construction details. There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of substances (contrast media, drugs, embolic materials) directly into the peripheral vasculature. This is an in vivo procedure, meaning it is performed within the living body.
- Device Description: The device is a physical system designed for delivering substances into blood vessels. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is therapeutic and interventional, not diagnostic in the IVD sense.
N/A
Intended Use / Indications for 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.
Product codes
KRA
Device Description
Micro Catheter and Guidewire System consists of a catheter, a guidewire, and accessories. The accessories include a flushing device, a shaping mandrel, an insertion tool, and a torque device.
The catheter is consist of a hub, a stress relief tube and a catheter body. The catheter body has three layers. The inner layer is a PTFE tube, the middle layer is consist of stainless steel wire reinforce and platinum-iridium alloy radiopaque distal marker, and the outer layer is polyamides of different hardness mixed with pigment. There is also a hydrophilic coating on the catheter surface.
The guidewire is consist of a nitinol core, a polymer jacket with hydrophilic coating over its entire surface and a radiopaque distal marker. It has a white marker at the proximal end to indicate the length inserted into human body and its relative position with the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, intra-arterial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing
Biocompatibility evaluation for the Micro Catheter and Guidewire System was conducted in accordance with current standards and the following tests were included:
- Cytotoxicity
- 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
- 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
Key Results: The data provided demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device which is currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033913 - Progreat™ Micro Catheter system
Reference Device(s)
K101450 - Cantata TM Microcatheter, K052841 - Mira-FlexTM 18 Micro catheter
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
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.(b)
Classification. Class II (performance standards).
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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
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3
510(k) Summary
| Submitter: | Suzhou Hengrui Disheng Medical Co., Ltd
No. 11 Building
No. 8 Jinfeng Road
Suzhou, China
215163 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jingwen Li
Regulatory Affairs Manager
Phone: +86- 512-6805-0607
Fax: +86- 512-6680-6133
Email: lijingwen@hrmedical.com.cn |
| 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
Corporation) |
| Reference Devices: | K101450 - Cantata TM Microcatheter (Cook Incorporated.)
K052841 - Mira-FlexTM 18 Micro catheter (Cook Incorporated.) |
| Device Description: | Micro Catheter and Guidewire System consists of a catheter, a
guidewire, and accessories. The accessories include a flushing
device, a shaping mandrel, an insertion tool, and a torque device.
The catheter is consist of a hub, a stress relief tube and a catheter
body. The catheter body has three layers. The inner layer is a
PTFE tube, the middle layer is consist of stainless steel wire
reinforce and platinum-iridium alloy radiopaque distal marker,
and the outer layer is polyamides of different hardness mixed
with pigment. There is also a hydrophilic coating on the catheter
surface. |
| | The guidewire is consist of a nitinol core, a polymer jacket with
hydrophilic coating over its entire surface and a radiopaque
distal marker. It has a white marker at the proximal end to
indicate the length inserted into human body and its relative
position with the catheter. |
| Indications for 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. |
| Comparison with
Predicate Device: | The Micro Catheter and Guidewire System is similar to the
Progreat Micro Catheter System in following ways:
Each of the devices is intended to be used for the
infusion of contrast media into all peripheral vessels,
drug infusion in intra-arterial therapy and the infusion of
embolic materials for hemostasis. Each of the devices is compatible with 5Fr Guide
Catheter. Each of the devices is provided with catheter, guidewire
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
radiopaque marker. The following technological differences exist between the
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
hub Biocompatibility Testing
Biocompatibility evaluation for the Micro Catheter and
Guidewire System was conducted in accordance with current
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.