(227 days)
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.
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.
The provided text is a 510(k) summary for the "Micro Catheter and Guidewire System" and predominantly focuses on the regulatory submission process, device description, and a comparison to a predicate device. It briefly mentions performance testing but does not provide the detailed acceptance criteria or the specific results required to fill out a table of acceptance criteria vs. reported device performance.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer most of the questions about the study design, sample sizes, expert involvement, or ground truth establishment.
The document states that "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." This indicates that the study was primarily a nonclinical (bench) testing and biocompatibility evaluation to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy.
Here's what can be inferred or stated as "not provided" based on the text:
1. Table of acceptance criteria and the reported device performance:
- Not provided in the document. The document lists types of tests (e.g., "Peak tensile force of catheter," "Coating test of guidewire," "Burst pressure under static conditions") under "Bench Testing", but it does not specify the quantitative acceptance criteria for these tests nor the numerical results achieved by the device.
2. Sample sized used for the test set and the data provenance:
- Sample size: Not provided. The document states that "Biocompatibility evaluation... was conducted in accordance with current standards" and lists various bench tests, but the number of units/samples tested for each is not specified.
- Data provenance: The tests are "Nonclinical tests," likely performed at Suzhou Hengrui Hongyuan Medical Co., Ltd. or a contracted lab in China, given the submitter's location. There is no mention of human subject data, so "retrospective or prospective" is not applicable in the typical sense of clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a micro catheter and guidewire system, not a diagnostic AI device requiring expert interpretation for ground truth. The "ground truth" for this type of device would be established engineering specifications and material properties, against which the device's performance is measured in bench tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to studies where human reviewers assess data, often clinical images. For bench testing of a micro catheter and guidewire, "adjudication" methods are not relevant. Test results are typically objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device, not an AI/CADe/CADx system for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its physical properties and design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to ISO standards (e.g., ISO 10993 series).
- For bench testing: Engineering specifications, industry standards, and predicate device performance. These would serve as the "ground truth" or acceptance criteria for mechanical and physical properties.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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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
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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., LtdBuilding B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou,Jiangsu, China |
| Contact Person: | Wang peipeiRegulatory Affairs ManagerPhone: +86-512-6835-6665Email: wangpeipei@hrmedical.com.cn |
| Date Prepared: | August 18th, 2021 |
| Trade Name: | Micro Catheter and Guidewire System |
| Common or UsualName: | Continuous flush catheter |
| Classification: | Class II, 21 CFR Part 870.1210 |
| Product Code: | KRA |
| Predicate Device: | K171665-Micro Catheter and Guidewire System (SuzhouHengrui Disheng Medical Co., Ltd) |
| Reference Devices: | K033913- Progreat™ Angiographic Catheter (Terumo MedicalCorporation )K172081- Maestro Micro catheter (Merit Medical Systems)K080863- Traxcess 0.014" Hydrophilic Guidewire (MicroVention, Inc)K993672-Rebar™ Micro Catheter (Micro Therapeutics, Inc.) |
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| Device Description: | Micro Catheter and Guidewire System consists of a catheter, aguidewire, and accessories. The accessories include a flushingdevice, a shaping mandrel, an insertion tool, a torque device anda peel-able tube.The catheter is consist of a hub, a stress relief tube and a cathetershaft. The catheter shaft has three layers. The inner layer is aPTFE tube, the middle layer is consist of stainless steel wirereinforce and platinum-iridium alloy radiopaque distal marker.And the outer layer is polyamide. There is also a hydrophiliccoating on the catheter surface.The guidewire is consist of a nitinol core, a polymer jacket withPVP hydrophilic coating over its entire surface, and a spring coilat distal. It has a white marker at the proximal to indicate thelength inserted into human body and its relative position with thecatheter. |
|---|---|
| Indications for Use: | The Micro Catheter and Guidewire System is intended for theinfusion of contrast media into the peripheral vessels. The MicroCatheter and Guidewire system is also intended for druginfusion in intra-arterial therapy and the infusion of embolicmaterials for hemostasis. The system should not be used incerebral vessels. |
| Comparison withPredicate Device: | The Micro Catheter and Guidewire System is similar to theMicro Catheter and Guidewire System in following ways:Each of the devices is intended to be used for the infusionof contrast media into all peripheral vessels, drug infusionin intra-arterial therapy and the infusion of embolicmaterials for hemostasis. Each of the devices is provided with catheter, guidewireand 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 alloyradiopaque 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 thesubject and predicate devices: Catheter outer diameter Catheter effective length |
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- 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.
§ 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).