K Number
K241581
Device Name
Hemodialysis Catheter
Date Cleared
2025-05-16

(347 days)

Product Code
Regulation Number
876.5540
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis. * It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient. * Alternate insertion sites include subclavian vein as required. * Catheters greater than 40 cm are intended for femoral vein insertion. * The curved Hemodialysis Catheter is intended for internal jugular vein insertion. * 8-10Fr Hemodialysis Catheters can be used in pediatric patients.
Device Description
The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.
More Information

Not Found

No.

The device is a hemodialysis catheter, which is a physical medical device for vascular access. The description focuses on its materials, dimensions, and operational characteristics, and there are no mentions of AI, DNN, ML, or any data processing capabilities beyond basic physical measurements.

Yes.
The device is used to attain vascular access for hemodialysis therapy and apheresis, which are medical treatments for kidney failure and certain blood disorders.

No

This device is a hemodialysis catheter, indicated for obtaining vascular access for hemodialysis and apheresis therapy. Its function is to facilitate blood flow for treatment, not to diagnose a medical condition.

No

The device description, intended use, and performance studies all confirm that this is a physical medical device (a catheter) designed for hemodialysis, not a software-only product. The tests performed are all related to the physical properties, safety, and functionality of a hardware device.

No.

The device is a hemodialysis catheter, which is an invasive device used for vascular access in hemodialysis therapy and apheresis. It does not perform in vitro examination of specimens derived from the human body.

N/A

Intended Use / Indications for Use

The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
Alternate insertion sites include subclavian vein as required.
Catheters greater than 40 cm are intended for femoral vein insertion.
The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
8-10Fr Hemodialysis Catheters can be used in pediatric patients.

Product codes (comma separated list FDA assigned to the subject device)

MSD

Device Description

The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

internal jugular vein, subclavian vein, femoral vein

Indicated Patient Age Range

pediatric patients, adult patient

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)

Non-clinical data
Performance:
According to the requirements of FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016" and ISO 10555-1:2013, we performed the following testing:

  • Visual assessment
  • Air and Liquid Leakage Testing
  • Catheter Tensile Testing
  • Repeated Clamping
  • Priming Volumes
  • Luer Connector
  • Pressure Versus Flow Rates
  • Recirculation Rate
  • Mechanical Hemolysis Testing
  • Chemical Tolerance Testing
  • Particulate Contamination Testing
  • Dimension Testing

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

Biocompatibility:
The compatibility of the patient-contacting materials in the finished product meets the requirement of Biocompatibility. The Biological Evaluation and Tests are in compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices Part 1:Evaluation and testing within a risk management process".

Sterilization:

  • ISO 11607-1:2019 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K130851, K202150, K203767

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 876.5540 Blood access device and accessories.

(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

FDA 510(k) Clearance Letter - Hemodialysis Catheter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 16, 2025

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

Re: K241581
Trade/Device Name: Hemodialysis Catheter
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood access device and accessories
Regulatory Class: Class II
Product Code: MSD
Dated: May 16, 2025
Received: May 16, 2025

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

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K241581 - Lisa Xu
Page 2

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K241581 - Lisa Xu
Page 2

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-devices/device-advice-comprehensive-regulatory-assistance/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,

Maura Rooney -S

Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K241581

Device Name
Hemodialysis Catheter

Indications for Use (Describe)

  • The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
  • 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

Traditional 510(k) Submission of Hemodialysis Catheter

Haolang Medical USA Corporation

510(K) Summary-K241581

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: May 20, 2024

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: Hemodialysis Catheter
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood access device and accessories
Regulation Class: Class II
Product Code: MSD

3. Predicate Device

Primary Predicate Device#1
510(K) number: K130851
Device Name: CASCADE™ Hemodialysis /Apheresis Catheter
Manufacturer: Health Line International Corporation
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood access device and accessories
Regulation Class: Class II
Product Code: MSD

Predicate Device#2
510(K) number: K202150
Device Name: GlidePath™ 7.5F Long-Term Hemodialysis Catheter
Manufacturer: Bard Peripheral Vascular, Inc
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood access device and accessories
Regulation Class: Class II
Product Code: MSD

Haolang Medical USA Corporation 1 / 5

Page 6

Traditional 510(k) Submission of Hemodialysis Catheter

Predicate Device#3
510(k) Number: K203767
Device Name: Pristine™ Long-Term Hemodialysis Catheter
Manufacturer: Bard Peripheral Vascular, Inc
Common or usual name: Catheter, Hemodialysis, Implanted
Regulation Number: 21 CFR 876.5540
Regulation Name: Blood access device and accessories
Regulation Class: Class II
Product Code: MSD

4. Device Description

The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.

5. Indication for use

  • The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.
  • It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
  • Alternate insertion sites include subclavian vein as required.
  • Catheters greater than 40 cm are intended for femoral vein insertion.
  • The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
  • 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

6. Comparison to Predicate Device

The subject device has similar technological characteristics as compared to the predicate device(s). Differences, if any, are not critical to the intended use of the subject device and do not raise new questions regarding safety and effectiveness.

FeatureSubject devicePrimary Predicate Device#1Comments
Manufacturer/K#Haolang Medical USA CorporationHealth Line International Corporation/ K130851\

Haolang Medical USA Corporation 2 / 5

Page 7

Traditional 510(k) Submission of Hemodialysis Catheter

Device NameHemodialysis CatheterCASCADE™Hemodialysis/Apheresis Catheter\
Regulation Number and name,Product Code21 CFR 876.5540 Blood access device and accessories Class II MSD21 CFR 876.5540 Blood access device and accessories Class II MSDSame
Indications for use- The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis. * It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient. * Alternate insertion sites include subclavian vein as required. * Catheters greater than 40 cm are intended for femoral vein insertion. * The curved Hemodialysis Catheter is intended for internal jugular vein insertion. * 8-10Fr Hemodialysis Catheters can be used in pediatric patients.The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining Long-Term (greater than 30 days) vascular access for Hemodialysis therepy and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The curved CASCADE™ Hemodialysis/Apheresis Catheter is intended for internal jugular vein insertion.The indications for use of the two devices are basically the same, but 8-10Fr Hemodialysis Catheters of the subject device can be used in pediatric patients. The comparison performance test results with the pediatric catheter (K202150) and the toxicological risk assessment based on the weight of the children proved that the difference does not affect the safety and effectiveness of the device.
Insertion SitesInternal jugular vein, subclavian vein and femoral veinInternal jugular vein, subclavian vein and femoral veinSame
Duration of useShort-term or Long-Term (greater than 30 days)Long-Term (greater than 30 days)SE
Catheter length13cm~55cm13~55cmSame
Catheter O.D.8F~15.5F12.5FrDifferent.(01)

Haolang Medical USA Corporation 3 / 5

Page 8

Traditional 510(k) Submission of Hemodialysis Catheter

Lumen22Same
Luer connectorsConforms to ISO 80369-7:2021Conforms to ISO 80369-7:2021Same
Catheter configurationStraight catheter tubing with Straight extension legs , Straight catheter tubing with Curved extension legs , Curved catheter tubing with Straight extension legsStraight or curved catheterSE
Patient-Contacting MaterialsPU and SiliconeSiliconeDifferent.(02)
ComponentsYes,provided for catheter insertionYes,provided for catheter insertionSE
SterilizationEO sterile for single useEO sterile for single useSame
Shelf life3 years3 yearsSame

Discussions on the differences from the predicated device:

01: According to different vessel size of patients, we provided larger catheter size range, but our size range does not exceed that of the hemodialysis catheters already available in the market. For example, GlidePath™ 7.5F Long-Term Hemodialysis Catheter is cleared for marketing under K202150 and 15.5F Pristine™ Long-Term Hemodialysis Catheter is cleared for marketing under K203767. We had also performed the performance test according to the ISO 10555-1 and the FDA Guidance "Implanted Blood Access Devices for Hemodialysis". The performance data demonstrates that the difference does not affect the safety and effectiveness of the device.

02: We conducted the biocompatibility evaluation on subject device and determined the endpoint according to ISO 10993-1, which proved that the material of subject device is biocompatibility, the difference of material does not affect the safety and effectiveness of the device.

7. Performance Data

Clinical test:
Clinical testing is not required.

Non-clinical data
Performance:
According to the requirements of FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016" and ISO 10555-1:2013, we performed the following testing:

  • Visual assessment

Haolang Medical USA Corporation 4 / 5

Page 9

Traditional 510(k) Submission of Hemodialysis Catheter

  • Air and Liquid Leakage Testing
  • Catheter Tensile Testing
  • Repeated Clamping
  • Priming Volumes
  • Luer Connector
  • Pressure Versus Flow Rates
  • Recirculation Rate
  • Mechanical Hemolysis Testing
  • Chemical Tolerance Testing
  • Particulate Contamination Testing
  • Dimension Testing

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

Biocompatibility:
The compatibility of the patient-contacting materials in the finished product meets the requirement of Biocompatibility. The Biological Evaluation and Tests are in compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices Part 1:Evaluation and testing within a risk management process".

Sterilization:

  • ISO 11607-1:2019 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 subject device is substantially equivalent to the predicate device(s).

Haolang Medical USA Corporation 5 / 5