(227 days)
No
The summary describes a purely mechanical device (catheter and guidewire system) and makes no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies are focused on biocompatibility and bench testing of physical properties.
Yes
The "Intended Use / Indications for Use" states that the system is used for "intra-arterial therapy and the infusion of embolic materials for hemostasis," which are therapeutic applications.
No
The device is intended for the infusion of contrast media and therapeutic materials, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a catheter, guidewire, and accessories, all of which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "Micro Catheter and Guidewire System" intended for the infusion of substances (contrast media, intra-arterial therapy, embolic materials) directly into the peripheral vessels of a patient.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. Its function is to deliver substances into the body.
Therefore, based on the intended use and device description, this is an invasive medical device used for therapeutic and diagnostic procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vessels. The Micro Catheter and Guidewire system is also infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.
Product codes (comma separated list FDA assigned to the subject device)
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, a torque device and a peel-able tube.
The catheter is consist of a hub, a stress relief tube and a catheter shaft. The catheter shaft 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 polyamide. There is also a hydrophilic coating on the catheter surface.
The guidewire is consist of a nitinol core, a polymer jacket with PVP hydrophilic coating over its entire surface, and a spring coil at distal. It has a white marker at the proximal 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 vessels
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 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
- Acute systemic Toxicity
- Pyrogenicity
- Hemolysis study
- Partial Thromboplastin time
- Complement Activiation
- Thrombogenicity
Bench Testing:
The tests included the following:
- Catheter Sizes
- Catheter Surface
- Catheter Hub
- Peak tensile force of catheter
- Coating test of catheter
- Freedom from leakage
- Distal tip of catheter
- Torque Strength of catheter
- Kink resistant of catheter
- Radiopacity of catheter
- Hydration judgment of catheter
- Burst pressure under static conditions
- Guidewire Sizes
- Guidewire surface
- Coating test of guidewire
- Peak tensile force of guidewire
- Torque strength testing of guidewire
- Torqueability test of guidewire
- Kink resistance of guidewire
- Simulated Use
- Tip flexibility of guidewire
- Radio-detectability of guidewire
- Sterile
- Bacterial endotoxin
- Particulate test
Conclusion: The data provided of the Micro Catheter and Guidewire System and the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions. Nonclinical tests 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K033913, K172081, K080863, K993672
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image shows 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.
April 11, 2022
Suzhou Hengrui Hongyuan Medical Co., Ltd Wang Peipei Regulatory Affairs Manager Building B9 Unit 201, No. 218 Xinghu Road, SIP Suzhou, Jiangsu 215126 China
Re: K212719
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: March 3, 2022 Received: March 14, 2022
Dear Wang Peipei:
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
1
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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212719
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 vessels. The Micro Catheter and Guidewire system is also infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
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 | |
|---|---|
| Micro Catheter and Guidewire System | |
| (per 21 CFR 807.92) | |
| Submitter: | Suzhou Hengrui Hongyuan Medical Co., Ltd |
| Building B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou, | |
| Jiangsu, China | |
| Contact Person: | Wang peipei |
| Regulatory Affairs Manager | |
| Phone: +86-512-6835-6665 | |
| Email: wangpeipei@hrmedical.com.cn | |
| Date Prepared: | August 18th, 2021 |
| Trade Name: | Micro Catheter and Guidewire System |
| Common or Usual | |
| Name: | Continuous flush catheter |
| Classification: | Class II, 21 CFR Part 870.1210 |
| Product Code: | KRA |
| Predicate Device: | K171665-Micro Catheter and Guidewire System (Suzhou |
| Hengrui Disheng Medical Co., Ltd) | |
| Reference Devices: | K033913- Progreat™ Angiographic Catheter (Terumo Medical |
| Corporation ) | |
| K172081- Maestro Micro catheter (Merit Medical Systems) | |
| K080863- Traxcess 0.014" Hydrophilic Guidewire (Micro | |
| Vention, Inc) | |
| K993672-Rebar™ Micro Catheter (Micro Therapeutics, Inc.) |
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| 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, a torque device and
a peel-able tube.
The catheter is consist of a hub, a stress relief tube and a catheter
shaft. The catheter shaft 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 polyamide. There is also a hydrophilic
coating on the catheter surface.
The guidewire is consist of a nitinol core, a polymer jacket with
PVP hydrophilic coating over its entire surface, and a spring coil
at distal. It has a white marker at the proximal 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 vessels. The Micro
Catheter and Guidewire system is also intended for drug
infusion in intra-arterial therapy and the infusion of embolic
materials for hemostasis. The system should not be used in
cerebral vessels. |
| Comparison with
Predicate Device: | The Micro Catheter and Guidewire System is similar to the
Micro Catheter and Guidewire 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 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 catheter has a platinum-iridium alloy
radiopaque marker. Each of the catheter has the same raw materials. Each of the guidewire has the same structure. Each of the guidewire has the same raw materials. The following technological differences exist between the
subject and predicate devices: Catheter outer diameter Catheter effective length |
5
- Guidewire effective length ●
- . Accessories
Biocompatibility Testing Performance Data:
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 ●
- Acute systemic Toxicity ●
- Pyrogenicity ●
- Hemolysis study
- Partial Thromboplastin time ●
- Complement Activiation ●
- . Thrombogenicity
Bench Testing
The tests included the following:
- Catheter Sizes
- Catheter Surface
- Catheter Hub .
- Peak tensile force of catheter
- . Coating test of catheter
- Freedom from leakage ●
- . Distal tip of catheter
- Torque Strength of catheter ●
- Kink resistant of catheter .
- Radiopacity of catheter .
- Hydration judgment of catheter
- Burst pressure under static conditions ●
- Guidewire Sizes .
- Guidewire surface ●
- Coating test of guidewire ●
- Peak tensile force of guidewire ●
- . Torque strength testing of guidewire
- Torqueability test of guidewire ●
- Kink resistance of guidewire ●
- Simulated Use ●
- Tip flexibility of guidewire .
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- Radio-detectability of guidewire .
- Sterile
- Bacterial endotoxin ●
- . Particulate test
- The data provided of the Micro Catheter and Guidewire System Conclusion: and the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions. Nonclinical tests demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device which is currently marketed for the same intended use.