The SANSIN Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

Device Description

The propose device, SANSIN Tubing Sets for Hemodialysis, is used to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The proposed devices are provided sterile and single use.

The proposed device is intended to be used with Fresenius 2008K Home Hemodialysis manufactured by Fresenius Medical Care North America, which is a hemodialysis delivery system being submitted to FDA for premarket notification (K124035).

The proposed device mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessories such as priming piece, drain bag, priming needle, fluid replacement tube, connecting tube, monitor and transducer protector.

The proposed devices are available in various specifications. Based on the different volume of air capture chamber, there are five models HDJ, HDK, HDL, HDM and HDN.

AI/ML Overview

This document describes the non-clinical performance evaluation of the SANSIN Tubing Sets for Hemodialysis for its 510(k) submission (K202796).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by a combination of internal test methods, recognized consensus standards, and specific performance attributes compared against the predicate device. The document explicitly states that the non-clinical tests were conducted to verify that the proposed device met "all design specifications" and was "Substantially Equivalent (SE) to the predicate device."

Test/Performance Characteristic	Acceptance Criteria (Derived from standards/predicate)	Reported Device Performance
Biocompatibility	Conforms to ISO 10993 Series (specifically, no cytotoxicity, no intracutaneous reactivity, no systemic toxicity, no chronic toxicity, no hemolysis, no complement activation, no significant difference in prothrombin time and partial thromboplastin time, no genotoxicity, no potential febrile reaction).	Cytotoxicity: No cytotoxicity. Intracutaneous Reactivity Test: No intracutaneous reactivity. Acute Systemic Toxicity Test: No systemic toxicity. Sub chronic Toxicity Study: No chronic toxicity. Hemolysis Study: No hemolysis. Complement Activation: No complement activation. Prothrombin Time: Not significant statistically different compared to negative control. Partial Thromboplastin Time Study: Not significant statistically different compared to negative control. Genotoxicity (Bacterial Reverse Mutation, In Vitro Mammalian Chromosome Aberration Test): No genotoxicity. Pyrogenicity: No potential febrile reaction.
Sterilization Assurance Level (SAL)	10^-6	SAL (10^-6) (Achieved via EO sterilization)
Repeated Closing Test	Ability to meet maximum closing time (Specific quantitative criteria likely defined in internal test protocol).	Demonstrated that the proposed device is able to meet the maximum closing time.
Tensile Strength Test	Any connections between components (excluding protective caps) shall withstand a static tensile force (Specific quantitative criteria likely defined in internal test protocol).	Demonstrated that any connections between the components of the transfusion set of the proposed device, excluding protective caps, shall withstand a static tensile force.
Endurance Pump Test	Ability to meet endurance requirements (Specific quantitative criteria likely defined in internal test protocol).	Demonstrated that the proposed device is able to meet the endurance requirements.
Stimulated Operation Test (Compatibility with Fresenius 2008K Home Hemodialysis System)	Good compatibility performance in hemodialysis treatment conditions.	Demonstrated good compatibility performance in hemodialysis treatment conditions with specific hemodialysis delivery system (Fresenius 2008K Home Hemodialysis System).
Pressure Leak Test	(Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics").	Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics.
Priming Volume Test	(Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics" despite differences from predicate).	Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics.
Tubing Compliance Test	(Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics").	Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics.
Mechanical Hemolysis Test	(Specific criteria defined in internal test protocol, implied by "meet the requirements of mechanical and performance characteristics").	Conducted, approved that the proposed device met the requirements of mechanical and performance characteristics.
Endurance Pump Test after Aging	Ability to maintain safety and effectiveness under -300 pressure.	Approved that the product can maintain the safety and effectiveness of the product under -300 pressure.
Blood Flow	Meet blood flow requirements (Specific quantitative criteria likely defined in internal test protocol, especially concerning differences in negative pressure and inner diameter from predicate).	Stimulated operation test conducted, approved that the proposed device meets the requirements of blood flow.
Seal Strength	ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials requirements.	Complies with ASTM F88/F88M-15.
Seal Leaks (Dye Penetration)	ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration requirements.	Complies with ASTM F1929-15.
Bacterial Endotoxins Test	USP 42-NF 37:2019 <85> Bacterial Endotoxins Test requirements.	Complies with USP 42-NF 37:2019 <85>.
Luer Lock Fittings	ISO 594-2:1998 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2 Lock fittings requirements.	Complies with ISO 594-2:1998.
Cardiovascular Implants and Extracorporeal Blood Circuit	ISO 8638:2010 Cardiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters requirements.	Complies with ISO 8638:2010.

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

The document does not explicitly state the specific sample sizes used for each non-clinical performance test. It mentions that tests were performed on "proposed device" or "relevant device configurations," implying that samples of the SANSIN Tubing Sets were used.

Data provenance: Given that the manufacturer is Jiangxi Sanxin Medtec Co., Ltd. in Nanchang, Jiangxi, China, and the listed contact person is in Shanghai, China, the data provenance is China. All tests appear to be retrospective (performed on completed devices or materials) and conducted by the manufacturer or a third-party testing facility.

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

This section is not applicable as the studies described are non-clinical (bench testing) rather than clinical studies involving expert interpretation of patient data. The "ground truth" for these tests is based on objective, quantifiable measurements against established standards and design specifications.

4. Adjudication Method for the Test Set

This section is not applicable as no adjudication method is mentioned or required for non-clinical bench testing. The results are based on objective test measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The SANSIN Tubing Sets are physical medical devices used for delivering hemodialysis, and their performance is evaluated through non-clinical bench tests and compatibility assessments, not human reading studies.

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

This question is not applicable as the device is not an algorithm or AI system. It is a physical medical device. The "standalone" performance here refers to the device's ability to meet its specifications independently, which is what the non-clinical tests demonstrate.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is predominantly:

Established consensus standards: Such as various parts of ISO 10993, ISO 11135, ASTM F88, ASTM F1929, USP, ISO 594-2, and ISO 8638.
Internal design specifications: For tests like Repeated Closing, Tensile Strength, Endurance Pump, Pressure Leak, Priming Volume, Tubing Compliance, Mechanical Hemolysis, and Stimulated Operation where specific quantitative thresholds would be defined internally by the manufacturer to ensure functional performance and equivalence to the predicate.
Predicate device characteristics: For comparison of physical performance parameters (e.g., length, priming volume, negative pressure, inner diameter), although the proposed device did not always match the predicate, the testing demonstrated that the proposed device's different characteristics did not raise new safety or effectiveness concerns.

8. The Sample Size for the Training Set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

September 6, 2021

Jiangxi Sanxin Medtec Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K202796

Trade/Device Name: SANSIN Tubing Sets for Hemodialysis Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FJK Dated: August 4, 2021 Received: August 10, 2021

Dear Diana 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. 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

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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 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 (OS) 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,

Glenn B. Bell, Ph.D. 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

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Indications for Use

510(k) Number (if known) K202796

Device Name SANSIN Tubing Sets for Hemodialysis

Indications for Use (Describe)

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202796

1. Date of Preparation: 08/04/2021
1. Sponsor Identification

Jiangxi Sanxin Medtec Co., Ltd.

No. 999, Fushan Road, Xiaolan Economic Development, Nanchang, Jiangxi, 330200, China

Establishment Registration Number: 3005246939

Contact Person: Shuiqing Sun Position: RA Engineer Tel: +86-791-85950238 Fax: +86-791-85988030 Email: 1304921073@qq.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: SANSIN Tubing Sets for Hemodialysis Common Name: Blood Tubing Sets Models: HDJ, HDK, HDL, HDM, HDN.

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Regulatory Information Classification Name: Set, Tubing, Blood, With and Without Anti-Regurgitation Valve Classification: II Product Code: FJK Regulation Number: 876.5820 Review Panel: Gastroenterology/Urology

Indications for Use:

Device Description

The proposed devices are available in various specifications. Based on the different volume of air capture chamber, there are five models HDJ, HDK, HDL, HDM and HDN. For the detail information of these five models, please see the below Table 1.

Table 1
Item	HDJ	HDK	HDL	HDM	HDN
Volume of air capture chamber	Different	Different	Different	Different	Different
Diameter and Length of air capture chamber in arterial Line	Different	Different	Different	Different	Different
Diameter and Length of air capture chamber in venous Line	Different	Different	Different	Different	Different
Length of arterial Line (mm)	Different	Different	Different	Different	Different
Length of venous Line (mm)	Different	Different	Different	Different	Different

Table 1

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Diameter of arterial Line (mm)	Same	Same	Same	Same	Same
Diameter of venous Line (mm)	Same	Same	Same	Same	Same
Priming Volume (mL)	Different	Different	Different	Different	Different
Positive pressure (mmHg)	Same	Same	Same	Same	Same
Negative Pressure (mmHg)	Same	Same	Same	Same	Same
Blood Flow limits (ml/min)	Same	Same	Same	Same	Same
Length of Fluid replacement tube	Same	Same	Same	Same	Same
Diameter of Fluid replacement tube	Same	Same	Same	Same	Same

The proposed devices are provided in sterile condition, it is subject to EO sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 106.

1. Identification of Predicate Device
  510(k) Number: K161582 Product Name: DORA Tubing Sets for Hemodialysis Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd
1. Substantially Equivalent (SE) Comparison

Table 2 Comparison of Technology Characteristics
ITEM	Proposed DeviceSANSIN Tubing Sets forHemodialysis	Predicate DeviceDORA Tubing Sets forHemodialysisK161582BAIN-BL-001E	Remark
Device Class	II	II	Same
Product Code	FJK	FJK	Same
RegulationNumber	21 CFR 876.5820	21 CFR 876.5820	Same
Indications forUse	The SANSIN Tubing Sets forHemodialysis are single-use sterilemedical devices intended toconnect the patient to thehemodialyzer and the hemodialysisdelivery system in hemodialysistreatment. The compatibility ofavailable configurations is theresponsibility of thephysician/clinician in charge.	The DORA Tubing Sets forHemodialysis are single-usesterile medical devicesintended to connect the patientto the hemodialyzer and thehemodialysis delivery systemin hemodialysis treatment. Thecompatibility of availableconfigurations is theresponsibility of thephysician/clinician in charge.	Same
CompatibleHemodialysisDeliverySystem	The hemodialysis delivery systemwhich is compatible with theproduct is Fresenius 2008KHome Hemodialysis Systemmanufactured by FreseniusMedical Care North America.	The hemodialysis deliverysystem which is compatiblewith the product is Fresenius2008K manufactured byFresenius Medical Care NorthAmerica.	Difference 1
Feature	Pre-PumpPost-PumpColor Coded componentSterileNon-pyrogenicSingle UsePrescription Device	Pre-PumpPost-PumpColor Coded componentSterileNon-pyrogenicSingle UsePrescription Device	Same
MainConfiguration	Arteria LineVenous LineAir capture chamberBranch Tubings;Female Luer LockClampsFilters	Arteria LineVenous LineDrip ChamberBranch Lines;Female Luer LockClampsFilters	Difference 2
Accessory	Drain BagTransducer ProtectorMonitorTubing in the Arterial linePriming connector in the Arterialand Venous linesPriming Piece, Priming Needle	Drain BagTransducer ProtectorPillowHeparin LineRecirculating Connector	Difference 3
	Fluid Replacement Tube,Connecting Tube
Sterilization	SAL (10-6)	SAL (10-6)	Same
Labeling	Direction for Use	Direction for Use	Same
	Indications for Use	Indications for Use
	Description	Description
	Warnings and Cautions	Warnings and Cautions
	PhysicalPerformance	Length ofarterial Line(mm)		HDJ:3500mmHDK:3500mmHDL:3600mmHDM:3660mmHDN:3500mm
Length ofvenous Line(mm)		HDJ:3000mmHDK:3000mmHDL:2900mmHDM:2400mmHDN:3000mm	3000
PrimingVolume(mL)		HDJ: $143\pm10%$HDK: $147\pm10%$HDL: $153\pm10%$HDM: $162\pm10%$HDN: $167\pm10%$	$163\pm10%$
Positivepressure(mmHg)		500	500
NegativePressure(mmHg)		-300	-500
Blood Flowlimits(ml/min)		500	500
	Innerdiameter ofthe venousand arteriallines(mm)	5.6	4.48	Difference 6
Materials		Various materials	Various materials	Same
Biocompatibility
Cytotoxicity		No cytotoxicity.	Conforms to ISO 10993 Series	Same

Table 2 Comparison of Technology Characteristics

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		sensitization.
	Intracutaneous Reactivity Test	No intracutaneousreactivity.
	Acute Systemic Toxicity Test	No systemictoxicity.
	Sub chronic Toxicity Study	No chronictoxicity.
	Hemolysis Study	No hemolysis.
	Complement Activation	No complementactivation.
	Prothrombin Time	The test articlecompared withthat of negativecontrol article isnot significantstatisticallydifferent.
	Partial Thromboplastin TimeStudy	The test articlecompared withthat of negativecontrol article isnot significantstatisticallydifferent.
Genotoxicity	Bacterial ReverseMutation	No genotoxicity.
	In Vitro MammalianChromosome AberrationTest	No genotoxicity.

	Pyrogenicity	No potentialfebrile reaction

Difference 1 – Compatible Hemodialysis Delivery System

The proposed device and predicate device have the different Compatible Hemodialysis Delivery System. Considering 1) Fresenius 2008K Home Hemodialysis System and Fresenius 2008K are both manufactured by Fresenius Medical Care North America. There is no huge difference. 2) They are both used by the physician in a clinical facility. 3) Stimulated Operation Testing Report demonstrated that the proposed device had good compatibility performance in hemodialysis treatment conditions with

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Fresenius 2008K Home Hemodialysis System. Therefore, this difference will not raise new problem on the safety and effectiveness.

Difference 2 – Main Configuration

The air capture chamber and branch tubing of proposed device is same with the drip chamber and branch lines of predicate device. They are only difference in the name of components. Names of components will not affect the clinical using of the proposed device, this difference will not raise new problem on the safety and effectiveness.

Difference 3 - Accessory

The predicate device has the accessory of Heparin Line, while the proposed device doesn't have this accessory. However, the component (15 tubing) has been included in the Arterial line of the proposed device. The Heparin Line of predicate device and component (15 tubing) of proposed device are both the path for heparin injection. Therefore, this difference will not raise new problem on the safety and effectiveness.

Fig.1 Assembly Drawing of SANSIN Tubing Sets for Hemodialysis (Arterial line)

Image /page/9/Figure/7 description: The image shows a diagram of a medical device with several labeled parts. The top part of the device has labels 1 through 7, while the bottom part has label 24. The device appears to be a type of tubing or connector used in medical procedures. The diagram provides a visual representation of the device's components and their arrangement.

The proposed device and predicate device have the same main configuration. The predicate device has the accessory of recirculating connector, while the proposed device doesn't have this accessory. However, the component (Priming connector) has been included in the Arterial and Venous lines of the proposed device. The Recirculating Connector of predicate device and component (Priming connector) of proposed device are both for reducing the amount of normal saline for priming. Therefore, this difference will not raise new problem on the safety and effectiveness.

The proposed device has Priming Needle, Fluid Replacement Tube and Connecting Tube, while the predicate device doesn't have these accessories. The clinicians will choose these accessories based on the clinical conditions. Having these accessories will not affect the Indications for Use of the proposed device, therefore, this difference will not raise new problem on the safety and effectiveness.

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Difference 4- Physical performance (Length of arterial line & venous Line, Priming Volume)

The length of arterial and venous tubes of proposed device is different to that of the predicate device. The difference on the length of arterial and venous tubes leads to the difference on the priming volume. Differences in the tubing length and priming volume can impact the mechanical and performance characteristics of device. The bench tests such as stimulated operation test, pressure leak test, priming volume test, tubing compliance test, mechanical hemolysis test, Tensile Strength Test, Repeated Closing Test and Endurance Pump Test were conducted to approve that the proposed device meet the requirements of mechanical and performance characteristics. Therefore, the differences in length of arterial line & venous line, priming volume will not lead to new safety and effectiveness problems.

Difference 5- Physical performance (Negative Pressure)

The negative pressure limitation of the proposed device is smaller than that of the predicate device. The negative pressure has been tested in the Endurance Pump Test and Endurance Pump Test after Aging. The test result approved that the product can maintain the safety and effectiveness of the product under -300 pressure. The negative pressure will affect the blood flow. The stimulated operation test was conducted to approve that the proposed device meets the requirements of blood flow.

In additional, this negative pressure is included in the user will set the negative pressure based on the user manual and will therefore be limited to hemodialysis with a negative pressure up to -300 mmHg as opposed to -500 mmHg for the predicate. Therefore, the difference in negative pressure will not lead to new safety and effectiveness problems.

Difference 6- Physical performance (Inner diameter of the venous and arterial lines)

The inner diameter of the venous and arterial lines for the predicate device is 4.48 mm. The inner diameter of the venous and arterial lines for the proposed device is 5.6 mm. The inner diameter of the venous and arterial lines will affect the blood flow. The stimulated operation test was conducted to approve that the proposed device meets the requirements of blood flow. Therefore, the differences in the inner diameter of the venous and arterial lines will not lead to new safety and effectiveness problems.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. For full titles of the standards and guidances used, see below. The tests performed on the relevant device configurations include:

Repeated closing test

The repeated closing test was performed on proposed device. The test result demonstrated that the

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proposed device is able to meet the maximum closing time. This test is an internal test.

Tensile Strength Test

The tensile strength test was performed on proposed device. The test result demonstrated that any connections between the components of the transfusion set of the proposed device, excluding protective caps, shall withstand a static tensile force. This test is an internal test.

Endurance Pump Test

The endurance pump test was performed on proposed device. The test result demonstrated that the proposed device is able to meet the endurance requirements. This test is an internal test.

Stimulated Operation Test

The stimulated operation test was performed on proposed device. The test result demonstrated that the proposed device has good compatibility performance in hemodialysis treatment conditions with specific hemodialysis delivery system. This test is an internal test.

The test results demonstrated that the proposed device complies with the following standards and guidance. The following tests were conducted as applicable to the subject devices:

ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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 [Including: Amendment 1 (2018)]
ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
USP 42-NF 37:2019 <85> Bacterial Endotoxins Test
USP 42-NF 37:2019 <151> Pyrogen Test (USP Rabbit Test)
ISO 594-2:1998 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2 Lock fittings
ISO 8638:2010 Cadiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters

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1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.