KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.

Device Description

The proposed device consists of tube hub, strain relief, catheter shaft with stainless steel braid layer, soft extension and distal tip. The catheter shaft is made of Pebax contain Barium Sulfate that is radiopaque and a middle stainless steel braid layer. Soft extension and distal tip is made of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.

The distal tip of the catheter is available in 32 kinds tip shape configurations. The outer diameter is available in 4F, 5F, 6F, 7F sizes and the length is available in 100cm except for Pig angiography catheter in length of 110cm. The side hole on distal tip is used to disperse the contrast media and balance pressure.

AI/ML Overview

The provided text is related to the FDA 510(k) premarket notification for a medical device: the KDL Angiography Catheter. This document demonstrates the substantial equivalence of the proposed device to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a study involving AI-driven performance or human reader improvements.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically in the context of AI performance, human reader studies (MRMC), or a comprehensive ground truth establishment process for a diagnostic algorithm, is not contained within the provided document.

The document primarily focuses on:

Device Description: Physical characteristics, materials, sizes, and configurations.
Intended Use Statement: Delivery of radiopaque contrast media during angiography.
Substantial Equivalence Comparison: A detailed table comparing the proposed device with predicate and reference devices across various parameters like product code, indications for use, principle of operation, design, dimensions, materials, and sterilization methods.
Performance Data (Nonclinical Bench Testing): A list of physical and chemical tests performed to ensure the device meets engineering specifications (e.g., burst pressure, flexibility, guidewire compatibility).
Biocompatibility Testing: Compliance with ISO 10993 standards, including in vitro and in vivo tests for hemolysis, toxicity, sensitization, etc.

Since the request is about AI performance, human reader studies, and related metrics for a diagnostic device, and the provided document describes an Angiography Catheter (a physical medical instrument for delivering contrast), the requested information as described (AI performance, MRMC study, ground truth for AI, training set, etc.) is not applicable to this submission.

The document is a regulatory submission for a physical device, not a diagnostic algorithm or AI product.

Summary

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May 14, 2021

Shanghai Kindly Medical Instruments Co., Ltd. Jeffery Hui Official Correspondent No. 925, Jinyuan yi Road Shanghai, Shanghai 201803 China

Re: K201929

Trade/Device Name: KDL Angiography Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: July 8, 2020 Received: July 10, 2020

Dear Jeffery Hui:

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 Interventional 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) K201929

Device Name KDL Angiography Catheter

Indications for Use (Describe)

K.DL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.

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

Reproductive Use (Per 21 CFR 201.66) Subject to Disapproval
On-Site Compounding (21 CFR 201.66)

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 510(k) guidance and 21 CFR 807.92.

510(k) Number: K201929

Date of Submission: May 13, 2021 1.

2. Applicant

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

Proposed Device 3.

Device Name: KDL Angiography Catheter Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1200 Regulation name: Diagnostic intravascular catheter. Regulation Class: Class II Product Code: DQO

4. Predicate Device

	Device Name	510(k) No.	Product Code
Predicate Device	Radifocus® Optitorque™Angiographic Catheter	K150232	DQO
Reference Device	Alvision™ InterventionalCardiology Diagnostic CatheterAlvicath™ EndovascularDiagnostic Catheter	K143604	DQO

ട. Device Description

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of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.

6. Intended Use Statement

KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.

7. Substantially Equivalent comparison

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	Proposed Device	Predicate Device	Reference Device	Note
Item	K201929	K150232	K143604
Product code	DQO	DQO	DQO	Same
Indication for use	KDL AngiographyCatheter are intended fordelivery of radiopaquecontrast media to selectedsites in the angiographyprocedure of the peripheraland coronary vascularsystem.	The Radifocus OptitorqueAngiographic Catheter is indicatedfor use in cardiac and vascularprocedures. It is designed todeliver radiopaque media, guidewires, catheters, and therapeuticagents to selected sites in thevascular system. The differentshapes are designed to selectivelyengage arteries from access sitessuch as the femoral, radial, andbrachial artery.	Alvision™ InterventionalCardiology Diagnostic Cathetersare intended for use in the deliveryof radio-opaque media to selectedsites in the coronary vascularsystem.Alvicath™ EndovascularDiagnostic Catheters are intendedfor use in the delivery ofradio-opaque media to selectedsites in the peripheral vascularsystem.	Same
Principle ofOperation	The proposed device isintroduced into the bloodvessel by the guide wire.	The predict device is introducedinto the blood vessel by the guidewire.	The predict device is introducedinto the blood vessel by the guidewire.	Same
DesignDescription	KDL AngiographyCatheter consist of tubehub, strain relief, cathetershaft with stainless steelbraid layer, catheter softextension.	The Radifocus OptitorqueAngiographic Catheter consist ofcatheter shaft, the soft tip, softtube, tube hub and strain relief.	Alvision™ and Alvicath™ aresterile, nonpyrogenic, single lumencatheters with a soft distal tip and aproximal strain relief and luer hub.	Same
Distal shape	32 distal shapeconfigurations	A variety of distal shapeconfigurations	A variety of distal shapeconfigurations	Similar
Catheter size	4F, 5F, 6F, 7F	4F, 5F, 6F	4F, 5F, 6F, 7F	Same asK143604
EffectiveLength(cm)	100 cm,110 cm.	65cm, 80 cm, 90 cm, 100 cm, 110cm.	45 cm, 60 cm, 65 cm, 80 cm,100cm,110 cm	Similar
Side holes	Yes	Yes	Yes	Same
Sterile package	Yes	Yes	Yes	Same
Guidewirecompatibility	Accept a maximumguidewire diameter of0.038"	Accept a maximum guidewirediameter of 0.038"	Accept a maximum guidewirediameter of 0.038"	Same
Method ofsupply	Sterile and single use	Sterile and single use	Sterile and single use	Same
Material	Pebax, Barium Sulfate,stainless steel,Thermoplasticpolyurethane (TPU),Polycarbonate (PC).	Pebax, Barium Sulfate, 316stainless steel, Bismuth Oxide,Nylon, Barium Sulfate,Polyurethane elastomer,Polyamide elastomer, Polyamide,Polyethylene	Stainless steel wire, Nylon 12,Barium Sulfate, Pebax.	Different
MaximumPressure	1200 psi	4 Fr: 750 psi5 Fr and 6 Fr: 1000 psi	1200 psi	Same asK143604
Shelf life	Three years	Three years	Three years	Same
SterilizationMethod	EO	EO	EO	Same
SterilityAssurance Level	10-6	10-6	10-6	Same

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8. The results of the comparison

The indication for use, design and materials were used to determine equivalent performance in KDL angiography catheter, Radifocus Optitorque Angiographic Catheter and Alvision™, Alvicath™ Diagnostic Catheters.

9. Performance data

The following nonclinical bench testing was conducted on KDL angiography catheter to support to determine the performance proposed device is substantially equivalent to the predicate device.

1. Appearance
1. Length
1. Out diameter
1. Hub
1. Side holes
1. Corrosion resistance
1. Liquid leakage
1. Air leakage
1. Burst pressure
1. Dynamic flow rate and pressure
1. Bond strength
1. Tip pull test
1. Kink and flexibility test
1. Torque resistance
1. Catheter insertion/retraction force
1. Guidewire compatibility
1. Particulate
1. Radio-detectability
1. EO residuals
1. Sterility
1. Bacterial endotoxin

10. Biocompatibility Testing Summary

Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (<24 hours) to circulating blood, and included the following tests:

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Items	Standard	Conclusion
In Vitro hemolytic	ASTM F756-17	The test result showed the test article had no influence on hemolytic properties
Acute System Toxicity	ISO 10993-5:2009	Under the conditions of this study, there was no evidence of systemic toxicity from the extract, the test article extract met the requirements of this study.
In Vitro Cytotoxiciy	ISO 10993-10:2010	Under the conditions of this study, the test article extract did not show potential toxicity to L-929 cells.
Skin Sensitization	ISO 10993-10:2010	No evidence of causing skin sensitization
IntracutaneousReactivity	ISO 10993-11:2017	The test results showed that the polar and non-polar test article extracts did not induce intracutaneous reactivity in rabbit under the test condition
Pyrogenicity	ISO 10993-11:2006	No rabbit an individual rise in temperature of 0.5°C or more
In vivoThrombogenicity	ISO 10993-4:2017	Met the requirement of in vivo thrombogenicity test
Complement Activation	ISO 10993-4:2017	No influence on complement activity

Biocompatibility tests results

In accordance with ISO 10993-1, the testing results demonstrated that KDL angiography catheter is biocompatible.

10. Conclusion

Based on the indication for use, technological characteristics and performance testing results, KDL angiography catheter is substantially equivalent to Radifocus Optitorque Angiographic Catheter and Alvision™, Alvicath™ Diagnostic Catheters.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).