The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve. The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment. The Arterial Catheter is provided sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arterial Catheter, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "flow rate must be > X mL/min"). Instead, it lists the types of performance tests conducted and generally states that the device "comply with" standards and that "performance is acceptable."

Acceptance Criteria Category	Reported Device Performance
Performance (General)	Complies with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" and ISO 10555-1:2013
Visual Assessment	Performed (implies satisfactory-unless stated otherwise)
Corrosion Resistance	Performed (implies satisfactory-unless stated otherwise)
Liquid Leakage Testing	Performed (implies satisfactory-unless stated otherwise)
Air Leakage Testing	Performed (implies satisfactory-unless stated otherwise)
Flow Rate Testing	Performed (implies satisfactory-unless stated otherwise)
Catheter Tensile Testing	Performed (implies satisfactory-unless stated otherwise)
Guidewire Tensile Testing	Performed (implies satisfactory-unless stated otherwise)
Dimensional Verification	Performed (implies satisfactory-unless stated otherwise)
Simulated Use and Simulated Blood Withdrawal	Performed (implies satisfactory-unless stated otherwise)
Kink Testing	Performed (implies satisfactory-unless stated otherwise)
Torque Strength Testing	Performed (implies satisfactory-unless stated otherwise)
Radiopacity Testing	Performed (implies satisfactory-unless stated otherwise)
Needle Testing (Visual assessment; Tensile strength of needle and hub; Penetration force)	Performed (implies satisfactory-unless stated otherwise)
Shelf Life	3 years (validated by accelerated aging tests, "performance is acceptable")
Biocompatibility	Meets requirements of Biocompatibility, in compliance with ISO 10993-1. Material is biocompatible.
Sterilization Packaging	Complies with ISO 11607-1:2016
Sterilization Process	Complies with ISO 11135:2014

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the non-clinical performance tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these tests, as they appear to be laboratory-based engineering performance evaluations rather than clinical data involving human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and not provided. The "ground truth" for these tests would be established by the physical and chemical properties of the device and its direct performance against defined engineering standards, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpretation of results or image assessment, not for direct engineering performance tests.

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 MRMC comparative effectiveness study was mentioned. The device is an arterial catheter, a physical medical device, not an AI-powered diagnostic tool. Therefore, human reader improvement with/without AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical medical instrument and not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical performance tests (e.g., flow rate, tensile strength, leakage) is established by adherence to recognized engineering standards (e.g., ISO 10555-1, ISO 10993-1, ISO 11607-1, ISO 11135) and the physical properties and measured performance of the device against predefined specifications derived from those standards. For biocompatibility, it's based on the material's interaction with biological systems as assessed by specific tests.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical instrument, not a learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical medical device like this catheter.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 7, 2021

Haolang Medical USA Corporation Lisa Xu RA Manager 1100 Bellevue Way NE 8A-533 Bellevue, Washington 98004

Re: K201726

Trade/Device Name: Arterial Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 1, 2020 Received: September 18, 2020

Dear Lisa Xu:

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 (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-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-regulatory-assistance/contact-usdivision-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 Lydia Glaw 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) K201726

Device Name Arterial Catheter

Indications for Use (Describe)

The Arterial Catheter permits access to the peripheral arterial circulation.

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: June 1, 2021

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	Haolang Medical USA Corporation
Address:	1100 Bellevue Way NE 8A-533, Bellevue, WA 98004 USA
Contact person:	Lisa Xu
Title:	RA Manager
E-mail:	lisa.xu@haolangmed.com
Tel:	1-425-503-6325

2. Device Identification

Trade/Device Name:	Arterial Catheter
Models:	18Ga, 20Ga, 21Ga, 22Ga, 24Ga
Regulation Number:	21 CFR 870.1250
Common Name:	Percutaneous Arterial Catheter
Regulation Class:	Class II
Product Code:	DQY

3. Predicate Device

510(K) number:	K171146
Device Name:	Arrow Seldinger Arterial Catheterization Device
Manufacturer:	Arrow International, Inc.
Regulation Number:	21 CFR 870.1250
Regulation Name:	Percutaneous Catheter
Regulation Class:	Class II
Product Code:	DQY

4. Device Description

The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of

Haolang Medical USA Corporation

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2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment.

The Arterial Catheter is provided sterile.

5. Indication for use

The Arterial Catheter permits access to the peripheral arterial circulation.

6. Comparison to Predicate Device

Compared to the predicate devices, the subject device has same intended use, similar product design, performance effectiveness as the predicate device as summarized in the following table.

Feature	Subject device	Predicate device	Comments
Manufacturer/K#	Haolang Medical USACorporation	Arrow International, Inc.K171146	--
Trade nameand model	Arterial Catheter	Arrow Seldinger ArterialCatheterization Device	--
Classificationsname andRegulationName	21 CFR 870.1250Percutaneous CatheterClass IIDQY	21 CFR 870.1250Percutaneous CatheterClass IIDQY	Same
Indications foruse	The Arterial Catheterpermits access to theperipheral arterialcirculation.	The Arrow SeldingerArterial CatheterizationDevices permit access tothe peripheral arterialcirculation or to othersmall vessels	Same
CatheterGauge Sizes	18 ga, 20 ga, 21 ga, 22 gaand 24 ga	18 ga, 20 ga, 22 ga and 24ga	We have one moresize than predicatedevice, but we haveperformed theperformance test,the difference doesnot raise the newrisk.
CatheterUsable Length	2.5 cm to 23 cm	5cm - 23cm	According todifferent usagerequirements, ourcatheter lengthrange is larger, butwe have alsoperformed theperformance test onwhich is smallerthan the range ofpredicate device, thedifference does notraise the new risk.
Introducerneedle size	18Ga, 20Ga, 21Ga,22Ga,23Ga, 24Ga, 26Ga	18 ga.: 18 ga X 5cm-7cm (2"-2 $\frac{3}{4}$ ")20 ga : 20 ga X 4cm-	Different, Thecoverage of theIntroducer needle
7cm (1 ½"- 2 ¾")22 ga.: 22 ga. X 4cm (11 ½")	size is more thanthat of the predicatedevice. We used athinner needle andundergoing theperformance testaccording to the ISO10555-1 and ISO11070. Thedifference does notaffect the safety andperformance of thedevice.
Spring WireGuide Size	0.012", 0.015", 0.015",0.018", 0.021", 0.025"	18 ga.: 0.64mm diameter X33.5cm-60cm (13"-23")20 ga.: 0.533mm diameter X35cm-50cm (13 ¾"-20")22 ga.: 0.533mmdiameter X 35cm (13 ¾")24 ga.: 0.46mm diameterX 25cm (9 ¾")	Different, The sizecoverage of springWire Guide Size ismore than that of thepredicate device.We are undergoing theperformance testaccording to the ISO10555-1 and ISO11070. Thedifference does notaffect the safety andperformance of thedevice.
Spring WireGuide Tip	Straight	Straight and J-tip	Same
Spring WireGuide DepthMarkings	Yes	Yes, etched on straightspring wire guides. Not on J-tip spring wire guides	Same
IntroducerMethod	Introducer needle andintroducer catheter-over-needle	Introducer needle andintroducer catheter-over-needle	Same
SterilizationMethod	EO	EO	Same
Shelf life	3 years	2 years	Different, we haveconducted the shelflife validation basedon the 3 years, theperformance isacceptable, thedifference does notaffect the safety andperformance of thedevice.
Packaging	PET/LDPE film matedwith Tyvek	PET/LDPE film matedwith Tyvek	Same

Material	1. Introducer Needle: SUS 3042. Tubing, Catheter Huband Luer: PU3. Needle Hub: ABS4. Spring guide wire: Niti&Stainless Steel5. Flex tube: PVC6. Guide wire slide: HDPE7. Catheter protector tube:LDPE	1. Introducer Needle: SUS 3042. Tubing, Catheter Hub andLuer: Polyether urethane3. Needle Hub: ABS4. Spring guide wire: SUS 3045. Flex tube: Not specified6. Guide wire slide: Notspecified7. Catheter protector tube:Not specified	Different, Theintroducer needleand the catheterbody are made ofthe same material,but the productionprocess andchemicalcharacterizationinformation of thematerial is unknown,so it is impossible toprove that itsbiocompatibility isequivalent. Weconducted thebiocompatibilityevaluation onsubject device anddetermined theendpoint accordingto ISO 10993-1,which prove that thematerial of subjectdevice isbiocompatibility, thedifference ofmaterial does notaffect the safety andperformance of thedevice.

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Traditional 510(k) Submission of Arterial Catheter

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7. Performance Data

Clinical test:

Clinical testing is not required.

Non-clinical data

Arterial Catheter comply with:

Performance:

According to the requirements of FDA guidance<Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions> ISO 10555-1:2013 we performed the following testing:

Visual assessment -
-Corrosion Resistance
Liquid Leakage Testing -
Air Leakage Testing -
Flow Rate Testing Report -
Catheter Tensile Testing -
Guidewire Tensile Testing -

Haolang Medical USA Corporation

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Dimensional verification -
Simulated use and Simulated Blood Withdrawal -
-Kink Testing
-Torque Strength Testing
Radiopacity Testing -
Needle testing: Visual assessment; Tensile strength testing of needle and hub; Penetration force

Shelf Life:

Accelerated aging tests were conducted to confirm the validity of the 3 years shelf life.

Biocompatibility:

The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices".

Sterilization:

-ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
-ISO 11135: 2014 Sterilization of health care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices

9. Conclusion

Based on the results of above testing, the Arterial Catheter is substantially equivalent to the predicate device Arrow Seldinger Arterial Catheterization Device (K171146).

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).