Microcatheter and guide-wire system by Suzhou Hengrui Disheng Medical Co.,Ltd.

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 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Micro Catheter and Guidewire System). This type of document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets a specific set of quantitative acceptance criteria through a clinical study or a study directly measuring performance against predetermined thresholds for an AI/software as a medical device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for AI/software, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details is not present in this document. This document details the physical characteristics, intended use, and bench testing for a physical medical device.

Here's why the information is not here, and what type of information is provided:

Acceptance Criteria & Reported Device Performance (Table 1): The document does not provide a table of quantitative acceptance criteria for performance in the way you'd expect for, say, an AI diagnostic tool (e.g., "sensitivity > 90%"). Instead, it lists various bench tests conducted (e.g., Catheter Sizes, Coating Integrity, Peak tensile force, etc.) and states that "The data provided demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device." This implies the device passed these bench tests, but the specific numerical acceptance criteria and measured values are not detailed in this public summary.
Sample size and data provenance for test set: Not applicable for this type of device and study. Bench testing is performed on physical samples.
Number of experts and qualifications for ground truth: Not applicable. Ground truth for physical device bench testing is based on engineering specifications and direct measurement.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This is a physical device, not an AI or imaging diagnostic tool that assists human readers.
Standalone performance: Not applicable in the context of AI performance. The document describes the standalone performance of the physical device through bench testing.
Type of ground truth used: For this device, the "ground truth" is defined by engineering specifications, material properties, and physical testing standards (e.g., ISO 10555.1, ISO 11070).
Sample size for training set & How ground truth for training set was established: Not applicable. This is not a machine learning/AI device.

What the document does provide in relation to "proving the device meets acceptance criteria":

The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary regulatory pathway for 510(k) submissions. This is achieved by:

Indications for Use: Stating that the device has the same intended use as the predicate device (infusion of contrast media, drug infusion in intra-arterial therapy, infusion of embolic materials for hemostasis into peripheral vasculature).
Technological Characteristics: Highlighting similarities in design (catheter, guidewire, accessories, provided sterile, single use, hydrophilic coating, platinum-iridium alloy radiopaque marker).
Performance Data: Listing a comprehensive set of biocompatibility tests (e.g., Cytotoxicity, Sensitization, Hemolysis study) and bench tests (e.g., Catheter Sizes, Coating Integrity, Tensile force, Burst pressure, Guidewire Fracture test, Torque strength, Simulated use). These tests demonstrate that the device performs as intended and is safe, similar to the predicate. The implication is that the results of these tests met internal acceptance criteria to support the claim of substantial equivalence.

In summary, while the document indirectly "proves the device meets acceptance criteria" by stating its substantial equivalence based on safety and performance tests, it does not provide the detailed quantitative acceptance criteria and study particulars you've asked for, as those typically relate to AI/software performance rather than a physical medical device.

Summary

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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 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.

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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 (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

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Indications for Use

510(k) Number (if known) K171665

Device Name Micro Catheter and Guidewire System

Indications for Use (Describe)

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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510(k) Summary

Submitter:	Suzhou Hengrui Disheng Medical Co., LtdNo. 11 BuildingNo. 8 Jinfeng RoadSuzhou, China215163
Contact Person:	Jingwen LiRegulatory Affairs ManagerPhone: +86- 512-6805-0607Fax: +86- 512-6680-6133Email: 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 MedicalCorporation)
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, aguidewire, and accessories. The accessories include a flushingdevice, a shaping mandrel, an insertion tool, and a torque device.The catheter is consist of a hub, a stress relief tube and a catheterbody. The catheter body 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 polyamides of different hardness mixedwith pigment. There is also a hydrophilic coating on the cathetersurface.
	The guidewire is consist of a nitinol core, a polymer jacket withhydrophilic coating over its entire surface and a radiopaquedistal marker. It has a white marker at the proximal end toindicate the length inserted into human body and its relativeposition with the catheter.
Indications for Use:	The Micro Catheter and Guidewire System is intended for theinfusion of contrast media into the peripheral vasculature. TheMicro Catheter and Guidewire system is also intended for druginfusion in intra-arterial therapy and the infusion of embolicmaterials for hemostasis.
Comparison withPredicate Device:	The Micro Catheter and Guidewire System is similar to theProgreat Micro Catheter System in following ways:Each of the devices is intended to be used for theinfusion of contrast media into all peripheral vessels,drug infusion in intra-arterial therapy and the infusion ofembolic materials for hemostasis. Each of the devices is compatible with 5Fr GuideCatheter. 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 devices has a platinum-iridium alloyradiopaque marker. The following technological differences exist between thesubject 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, catheterhub Biocompatibility TestingBiocompatibility evaluation for the Micro Catheter andGuidewire System was conducted in accordance with currentstandards and the following tests were included: Cytotoxicity

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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

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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.

Regulation Number and Section

§ 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).