K Number
K102833
Device Name
DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
Date Cleared
2011-11-18

(415 days)

Product Code
Regulation Number
876.5540
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.
Device Description
Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.
More Information

Not Found

No
The device description and performance studies focus on the physical components and material properties of a standard hemodialysis catheter set, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is a hemodialysis access catheter set, which provides vascular access for hemodialysis, a medical procedure used to treat kidney failure. Hemodialysis is a therapeutic intervention, and the device facilitates this treatment.

No

Explanation: The device is a catheter set intended for vascular access for hemodialysis, which is a therapeutic treatment. It does not perform diagnostic functions like measuring physiological parameters or detecting diseases.

No

The device description explicitly lists physical components like a catheter, puncture needle, guide wire, and dilator, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "attain long or short term vascular access for hemodialysis via the internal jugular, subclavian or femoral vein." This describes a device used in vivo (within the body) for a medical procedure (hemodialysis access).
  • Device Description: The description details components like a catheter, puncture needle, guide wire, and dilator, which are all tools used for accessing blood vessels in vivo.
  • Anatomical Site: The specified anatomical sites (internal jugular, subclavian, or femoral vein) are locations within the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to facilitate a medical treatment procedure by providing access to the vascular system.

N/A

Intended Use / Indications for Use

Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.

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

MPB

Device Description

Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Internal jugular, subclavian or femoral vein.

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)

Laboratory testing was conducted to validate and verify that Disposable Hemodialysis Access Catheter Set met all design specifications and was substantially equivalent to the predicate device. These tests include:

  • Biocompatibility Tests per 150 10993-1:2009 were performed to evaluate the biocompatibility of the materials of the proposed device. The test results were determined to be acceptable;
  • Performance Tests per ISO 10555-1:1995/AMD.1:1999/AMD.2:2004(E) and ISO 10555-3:1996/AMD.1:1999 were performed to evaluate the physical performance of the proposed device, including surfaces, dimensions, mechanical strength, leakage, flow rate and fatigue. The test results demonstrated that the proposed devices comply with the performance standards:
  • Recirculation and Repeated clamp tests;
  • Sterilization Validation Study per ISO 11135-1:2006 were performed. The results demonstrated that the sterilization method and cycle of the proposed device could reach SAL of 10th-6, and the sterilant residual was acceptable;
  • Package Integrity Tests, including seal strength, internal pressure and dye penetration, were performed to evaluate the package integrity of the proposed device to demonstrate that the immediate package could maintain the sterility during its shelf life.

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.

K090102, K063355

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.

0

K102833 Page 1 of 2

OV 1 8 2011

Exhibit #2 510(k) Summary

This 510(k) Summary is prepared per the requirements of 21 CFR 807.92(k).

The assigned 510(k) Number is: K102833

Date of Preparation: 31 OCT 2011 1.

Sponsor Information 2.

Foshan Nanhai Bai He Medical Technology Co., LTD Establishment Registration Number: 3006621386 No. 5, Taoyuan West Road, Nanhai Software Tech. Park, Foshan Guangdong, 528225, China

Contact Person: Mr. Baoyou Ge, Position: Management Representative Tel: +86-757-81207300 | Fax: +86-757-81207311

  • Submission Correspondent 3.
    Ms. Diana Hong, Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 | Fax: 240-238-7587 | Email: info@mid-link.net
  1. Proposed Device Identification

Trade Name: Disposable Hemodialysis Access Catheter Set; Classification Name: Catheter, Hemodialysis, Non-implanted; Regulation Number: 21 CFR 876.5540 Review Panel: Gastroenterology/Urology

Intended Use:

Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.

Device Description:

Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the

1

K102833

Page 2 of 2

internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.

    1. Test Conclusion
      Laboratory testing was conducted to validate and verify that Disposable Hemodialysis Access Catheter Set met all design specifications and was substantially equivalent to the predicate device. These tests include:
  • Biocompatibility Tests per 150 10993-1:2009 were performed to evaluate the રા. biocompatibility of the materials of the proposed device. The test results were determined to be acceptable;

  • Performance Tests per ISO 10555-1:1995/AMD.1:1999/AMD.2:2004(E) and ISO b. 10555-3:1996/AMD.1:1999 were performed to evaluate the physical performance of the proposed device, including surfaces, dimensions, nechanical strength, leakage, flow rate and fatigue. The test results demonstrated that the proposed devices comply with the performance standards:

  • Recirculation and Repeated clamp tests; C.

  • Sterilization Validation Study per ISO 11135-1:2006 were performed. The results ਪ. demonstrated that the sterilization method and cycle of the proposed device could reach SAL of 10th, and the sterilant residual was acceptable;

  • Package Integrity Tests, including seal strength, internal pressure and dye penetration, were ୯. performed to evaluate the package integrity of the proposed device to demonstrate that the immediate package could maintain the sterility during its shelf life.

Substantially Equivalent 6.

Predicate Device 1: Niagara®, Niagara® Slim-Cath®, Brevia® Dual Lumen Catheters 510(k) Number: K090102

Predicate Device 2: Joline D-Line Catheter STfamily of catheters in kits consisting of Dual Lumen Short Term Hemodialysis Catheter Extra Flow (EF) Short Term Hemodialysis Catheter

510(k) Number: K063355

SE Claim: the proposed device, Disposable Hemodialysis Access Catheter Set, is claimed to be substantially equivalent (SE) to the predicate devices.

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Foshan Nanhai Bai He Medical Technology Co., LTD % Ms. Diana Hong General Manager MID-LINK Consulting Co., Ltd P.O. Box 237-023 SHANGHAI CHINA 200237

NOV 1 8 2011

Re: K102833 ·

Trade/Device Name: Disposable Hemodialysis Access Catheter Set Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MPB Dated: October 31, 2011 Received: November 14, 2011

· Dear Ms. Hong:

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. 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 801); medical device reporting of medical device-related

3

Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health .

Enclosure

4

Premarket Notification Traditional Section 510(k) Submission – Exhibit #1 Indication for Use statement

Exhibit #1 Indication for Use statement

510(k) Number: K 102833 Device Name:Disposable Hemodialysis Access Catheter Set

Indicationfor Use:

Disposable Hemodialysis Access Catheter Sets, including single lumen and dual lumen, are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

□OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of i

Hichard Lume

ductive, Gastro-Renal, and

EI-I