Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.

Therapeutic

No.
The device facilitates the placement of guidewires and assists in the delivery of materials, but it does not perform a therapeutic action itself.

Diagnostic

No
The device is a microcatheter used to deliver diagnostic, embolic, or therapeutic materials. It is not fundamentally a diagnostic device itself, but rather a tool for delivery.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with various material layers, a hub, strain relief, and a soft tip, all of which are hardware components. The performance studies also focus on bench and non-clinical testing of these physical attributes.

IVD (In Vitro Diagnostic)

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 about a person's health. This testing is done outside of the body.
KDL Micro catheter Function: The KDL Micro catheter is a medical device used inside the body (in the peripheral and coronary vasculature) to facilitate procedures like guidewire placement and delivery of materials. It is an interventional device, not a diagnostic one that analyzes samples.
Intended Use: The intended use clearly describes its function within the circulatory system for procedural support and delivery, not for analyzing biological samples.
Device Description: The description details the physical components and materials of a catheter designed for insertion into blood vessels.
Performance Studies: The performance studies focus on the physical and mechanical properties of the catheter and its biocompatibility for use within the body.

The device is used in vivo (within the living body) for procedural purposes, not in vitro (in glass, referring to laboratory testing of samples).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DQY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and coronary vasculature, peripheral and coronary 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)

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

Biocompatibility Testing Summary, with the following tests conducted in compliance with ISO 10993-1 for externally communicating devices with limited exposure (

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

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

1

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)

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

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

4

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 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.

Intended Use Statement 6.

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.

7. Substantially Equivalent comparison

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Item	Proposed Device	Predicate Device			Comparison
		K190401	K173548	K082519
Applicant	Shanghai Kindly Medical
Instruments Co., Ltd	Boston Scientific Corporation.	Merit Medical Systems, Inc	Terumo Corporation	/
Product code	DQY	DQY	DQY	KRA	Same to
K190401
and K173548
Device
Classification	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 to
K190401
and K173548
Indications
for Use	KDL Micro catheter is
used to provide support to
facilitate the placement of
guidewires in the
peripheral and coronary
vasculature, and be used to
exchange one guidewire
for another. Micro catheter
also intended to assist in
the delivery of
diagnostics, embolic, or
therapeutic materials into
the peripheral and
coronary vessels.	The MAMBA and MAMBA
Flex microcatheters are intended
to provide support to facilitate
the placement of guidewires in
the coronary vasculature, and be
used to exchange one guidewire
for another.
The microcatheters are also
intended to assist in the delivery
of contrast media into the
coronary vasculature.	The Microcatheter is intended
for general intravascular use,
including peripheral and
coronary vasculature. Once
the subselective region has
been accessed, the
Microcatheter can be used for
the controlled and selective
infusion of diagnostics,
embolic, or therapeutic
materials into vessels. The
catheter should not be used in
the cerebral vessels.	The product (Finecross MG) is
intended to be percutaneously
introduced into blood vessels
and support a guide wire while
performing PCI (percutaneous
coronary intervention). The
product is also intended for
injection of radiopaque contrast
media for the purpose of
angiography	Similar
Curve shape
of the distal
tip	Straight and swan neck
configurations.	A variety of shapes.	Straight or pre-shaped 45
degree and swan neck
configurations.	Straight or pre-shaped 70
degree	Similar
Effective
Length	110cm,130cm,150cm,
180cm	135cm,150cm	110cm,130cm,150cm	130cm,150cm	Different

Device
Configuration	Proximal luer hub, strain
relief, catheter shaft,
radiopaque marker, distal
tip, hydrophilic coating.	Proximal luer hub, strain relief,
catheter shaft (consist of coil),
radiopaque marker, distal tip,
hydrophilic coating.	Proximal winged hub, a
tapered strain relief, catheter
shaft, radiopaque marker,
distal tip, hydrophilic coating.	Proximal hub, a tapered strain
relief, catheter shaft,
radiopaque marker, distal tip,
hydrophilic coating.	Same
Material	Pebax (BaSO4) or Eurelon
(outer layer), stainless
steel, PTFE (inner layer),
TPU, PC, Platinoiridium,
Hydrophilic coating.	Hydrophilic coating, catheter
shaft consist of coil. Other
materials are not known.	Nylon ribbon braiding,
Platinum marker,Hydrophilic
coating, Other materials are
not known.	Pebax, Eurelon (outer layer),
PTFE (inner layer), Nylon,
Platinoiridium, Tungsten,
Hydrophilic polymer.	Different
Principle of
Operation	Manually tracked over a
guidewire to access
vasculature	Manually tracked over a
guidewire to access vasculature	Manually tracked over a
guidewire to access
vasculature	Manually tracked over a
guidewire to access vasculature	Same
Proximal and
Distal OD	2.3F/1.6F ; 2.5F/1.8F	Not known, the inner lumen
permits the use of 0.014 in or
smaller guidewires	2.8F/1.7F ; 2.9F /2.0F	2.6F/1.8F	Different
Coating	Hydrophilic coating	Hydrophilic coating	Hydrophilic coating	Hydrophilic polymer	Same
Sterile
package	Tyvek Pouch	Tyvek Pouch	Tyvek Pouch	Unknown	Same
Guidewire
compatibility	≤0.014 in	≤ 0.014 in	≤ 0.018 in	≤ 0.014 in	Same as
K190401 and
K082519
Marker	A radiopaque marker	A radiopaque marker	A radiopaque marker	A radiopaque marker	Same
Method of
supply	Sterile and single use	Sterile and single use	Sterile and single use	Sterile and single use	Same
Sterilization
Method	EO	EO	EO	EO	Same
Sterility
Assurance
Level	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

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.