KDL Micro catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels

Device Description

The KDL Micro catheter is available in two French configurations, 2.3F (proximal)/1.6F (distal) and 2.5F (proximal) /1.8F (distal), 110cm, 130cm, 180cm of effective lengths. The proposed device consists of Hub with luer connector, strain relief, catheter shaft, a radiopaque marker and soft tip. The catheter shaft and radiopaque marker consist of 3 layers, an outer layer of Eurelon or pebax tube containing BaSO4, a middle layer of stainless steel braid mesh and an inner layer of PTFE tube, in addition, the middle layer of radiopaque marker consist of Platinoiridium. The radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The soft tip consists of 2 layers, an outer layer of pebax tube containing BaSO4, an inner layer of PTFE tube. The outer surface of the micro catheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the micro catheter into the vasculature.

The distal tip of micro catheter is offered in straight (MCS) and swan neck (MCM) configurations.

All models of the catheter are designed to accept a maximum guidewire diameter of 0.010 inch or 0.014 inch.

AI/ML Overview

The provided text is a 510(k) summary for the KDL Micro catheter. It describes the device, its intended use, comparison to predicate devices, and performance data from bench and biocompatibility testing. However, it does not contain information about an AI/ML powered device or a study involving human readers, expert ground truth adjudication, or statistical metrics like sensitivity, specificity, or AUC. Therefore, I am unable to fulfill the request based on the provided input.

The document pertains to a Class II medical device (percutaneous catheter) and its substantial equivalence determination to previously cleared predicate devices. The performance data presented are for the physical and biological characteristics of the catheter, not the performance of an AI/ML algorithm.

Summary

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July 22, 2021

Shanghai Kindly Medical Instruments Co., Ltd. Xu Jianhai RA Supervisor No. 925. Jinyuan Yi Road Shanghai, Shanghai 201803 China

Re: K201706

Trade/Device Name: KDL Micro catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 7, 2021 Received: June 22, 2021

Dear Xu Jianhai:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201706

Device Name KDL Micro catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.

510(k) Number: K201706

Date of Submission: June 17, 2021 1.

Applicant 2.

Shanghai Kindly Medical Instruments Co., Ltd. Address: 925 Jinyuan Yi Road, Shanghai, 201803, China Contact: Jianhai Xu, Regulatory Affairs Supervisor Tel.:+086-021-59140056 Email: xujianhai(@kdlchina.com

3. Proposed Device

Trade Name: KDL Micro catheter Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1250 Classification name: Percutaneous Catheter Regulation Class: Class II Product Code: DQY

4. Predicate device

510(k) Number: K190401 a. Product Name: MAMBA and MAMBA Flex Microcatheters Product Code: DQY Device Class: II Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Boston Scientific Corporation. Manufacturer:
b. 510(k) Number: K173548 Product name: Merit Pursue Microcatheter Product Code: DQY Device Class: II Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Manufacturer: Merit Medical Systems, Inc
C. 510(k) Number: K082519

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Product name: FINECROSS™MG Coronary Micro-Guide catheter Product Code: KRA Device Class: II Classification Name: Catheter, Continuous Flush Regulation Number: 21 CFR 870.1210 Manufacturer: TERUMO Corporation.

Device description 5.

The distal tip of micro catheter is offered in straight (MCS) and swan neck (MCM) configurations.

All models of the catheter are designed to accept a maximum guidewire diameter of 0.010 inch or 0.014 inch.

Intended Use Statement 6.

7. Substantially Equivalent comparison

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Item	Proposed Device	Predicate Device			Comparison
		K190401	K173548	K082519
Applicant	Shanghai Kindly MedicalInstruments Co., Ltd	Boston Scientific Corporation.	Merit Medical Systems, Inc	Terumo Corporation	/
Product code	DQY	DQY	DQY	KRA	Same toK190401and K173548
DeviceClassification	Class II,21 CFR 870.1250	Class II,21 CFR 870.1250	Class II,21 CFR 870.1250	Class II,21 CFR 870.1210	Same toK190401and K173548
Indicationsfor Use	KDL Micro catheter isused to provide support tofacilitate the placement ofguidewires in theperipheral and coronaryvasculature, and be used toexchange one guidewirefor another. Micro catheteralso intended to assist inthe delivery ofdiagnostics, embolic, ortherapeutic materials intothe peripheral andcoronary vessels.	The MAMBA and MAMBAFlex microcatheters are intendedto provide support to facilitatethe placement of guidewires inthe coronary vasculature, and beused to exchange one guidewirefor another.The microcatheters are alsointended to assist in the deliveryof contrast media into thecoronary vasculature.	The Microcatheter is intendedfor general intravascular use,including peripheral andcoronary vasculature. Oncethe subselective region hasbeen accessed, theMicrocatheter can be used forthe controlled and selectiveinfusion of diagnostics,embolic, or therapeuticmaterials into vessels. Thecatheter should not be used inthe cerebral vessels.	The product (Finecross MG) isintended to be percutaneouslyintroduced into blood vesselsand support a guide wire whileperforming PCI (percutaneouscoronary intervention). Theproduct is also intended forinjection of radiopaque contrastmedia for the purpose ofangiography	Similar
Curve shapeof the distaltip	Straight and swan neckconfigurations.	A variety of shapes.	Straight or pre-shaped 45degree and swan neckconfigurations.	Straight or pre-shaped 70degree	Similar
EffectiveLength	110cm,130cm,150cm,180cm	135cm,150cm	110cm,130cm,150cm	130cm,150cm	Different

DeviceConfiguration	Proximal luer hub, strainrelief, catheter shaft,radiopaque marker, distaltip, hydrophilic coating.	Proximal luer hub, strain relief,catheter shaft (consist of coil),radiopaque marker, distal tip,hydrophilic coating.	Proximal winged hub, atapered strain relief, cathetershaft, radiopaque marker,distal tip, hydrophilic coating.	Proximal hub, a tapered strainrelief, catheter shaft,radiopaque marker, distal tip,hydrophilic coating.	Same
Material	Pebax (BaSO4) or Eurelon(outer layer), stainlesssteel, PTFE (inner layer),TPU, PC, Platinoiridium,Hydrophilic coating.	Hydrophilic coating, cathetershaft consist of coil. Othermaterials are not known.	Nylon ribbon braiding,Platinum marker,Hydrophiliccoating, Other materials arenot known.	Pebax, Eurelon (outer layer),PTFE (inner layer), Nylon,Platinoiridium, Tungsten,Hydrophilic polymer.	Different
Principle ofOperation	Manually tracked over aguidewire to accessvasculature	Manually tracked over aguidewire to access vasculature	Manually tracked over aguidewire to accessvasculature	Manually tracked over aguidewire to access vasculature	Same
Proximal andDistal OD	2.3F/1.6F ; 2.5F/1.8F	Not known, the inner lumenpermits the use of 0.014 in orsmaller guidewires	2.8F/1.7F ; 2.9F /2.0F	2.6F/1.8F	Different
Coating	Hydrophilic coating	Hydrophilic coating	Hydrophilic coating	Hydrophilic polymer	Same
Sterilepackage	Tyvek Pouch	Tyvek Pouch	Tyvek Pouch	Unknown	Same
Guidewirecompatibility	≤0.014 in	≤ 0.014 in	≤ 0.018 in	≤ 0.014 in	Same asK190401 andK082519
Marker	A radiopaque marker	A radiopaque marker	A radiopaque marker	A radiopaque marker	Same
Method ofsupply	Sterile and single use	Sterile and single use	Sterile and single use	Sterile and single use	Same
SterilizationMethod	EO	EO	EO	EO	Same
SterilityAssuranceLevel	10-6	10-6	10-6	10-6	Same

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8. The results of the comparison

The indication for use, design and materials used in KDL Micro Catheter are similar to the predicated device, MAMBA and MAMBA Flex Microcatheters, Merit Pursue Microcatheter and FINECROSS™M MG Coronary Micro-Guide catheter.

Performance data 9.

Both bench and non-clinical testing was conducted on KDL Micro catheter to support a determination of substantial equivalence to the predicate devices.

The non-clinical, bench testing included:

1. Appearance
1. Length
1. Out diameter
1. Hub
1. Corrosion resistance
1. Liquid leakage
1. Air leakage
1. Bond strength
1. Burst pressure
1. Power injection flowrate
1. Flexibility and Kink Test
1. Torque resistance
1. Catheter insertion/retraction force
1. Particulate
1. Guidewire compatibility
1. Radio-detectability
1. EO residuals
1. ECH residuals
1. Sterility
1. Bacterial endotoxin

10. Biocompatibility Testing Summary

The following biocompatibility tests were conducted in compliance with ISO 10993-1 for externally communicating devices with limited exposure (<24 hours) to circulating blood.

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Table 10-1 Biocompatibility tests
Items	Standards	Conclusion
In Vitro hemolytic	ASTM F756-17	Met the requirement
Acute System Toxicity	ISO 10993-11:2017	Met the requirement
In Vitro Cytotoxicity	ISO 10993-5:2009	Met the requirement
Skin Sensitization	ISO 10993-10:2010	Met the requirement
Intracutaneous reactivity	ISO 10993-10:2010	Met the requirement
Pyrogenicity	ISO 10993-11:2017	Met the requirement
In vivo thrombogenicity	ISO 10993-4:2017	Met the requirement
Complement activation	ISO 10993-4:2017	Met the requirement

ohlo 10.1 Diacompatibilit

The rests showed that subject device, KDL Micro catheter is biocompatible based on ISO 10993-1 standards.

11. Conclusion

Based on the indication for use, technological characteristics, and performance testing results, KDL Micro catheters are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).