(348 days)
Not Found
No
The description focuses on the physical components and intended use of standard hemodialysis tubing sets, with no mention of AI or ML capabilities.
No
The device is a tubing set for hemodialysis, which connects the patient to the hemodialyzer and delivery system. While it is essential for the hemodialysis treatment, it primarily facilitates the connection and flow of blood and solutions, rather than directly performing a therapeutic action itself (which is done by the hemodialyzer and the delivery system).
No
Explanation: The device is described as "single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment." This function is to facilitate treatment, not to diagnose a condition.
No
The device description clearly states it consists of physical components like tubes, an air capture chamber, and accessories, indicating it is a hardware device, not software-only.
Based on the provided information, the SANSIN Tubing Sets for Hemodialysis are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to connect the patient to the hemodialyzer and the hemodialysis delivery system for hemodialysis treatment. This is a direct connection to the patient's circulatory system for a therapeutic procedure (removing waste products from the blood), not for examining specimens in vitro (outside the body).
- Device Description: The description details tubing, connectors, and accessories used in the physical process of hemodialysis. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, or other bodily fluids.
- Detecting or measuring specific substances in biological samples.
- Providing diagnostic information based on laboratory tests.
Therefore, the SANSIN Tubing Sets for Hemodialysis are a medical device used in a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FJK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician/clinician in charge in hemodialysis treatment.
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests performed on the relevant device configurations include:
Repeated closing test: The test result demonstrated that the proposed device is able to meet the maximum closing time.
Tensile Strength Test: 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.
Endurance Pump Test: The test result demonstrated that the proposed device is able to meet the endurance requirements.
Stimulated Operation Test: The test result demonstrated that the proposed device has good compatibility performance in hemodialysis treatment conditions with specific hemodialysis delivery system.
The device also underwent biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Sub chronic Toxicity Study, Hemolysis Study, Complement Activation, Prothrombin Time, Partial Thromboplastin Time Study, Genotoxicity - Bacterial Reverse Mutation, In Vitro Mammalian Chromosome Aberration Test), and Pyrogenicity testing. All tests showed favorable results, indicating no cytotoxicity, sensitization, reactivity, systemic/chronic toxicity, hemolysis, complement activation, no significant statistical difference for prothrombin time/partial thromboplastin time, no genotoxicity, and no potential febrile reaction.
No clinical study is included in this submission.
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.
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
§ 876.5820 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K202796
Device Name SANSIN Tubing Sets for Hemodialysis
Indications for Use (Describe)
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.
| 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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3
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
-
- Date of Preparation: 08/04/2021
-
- 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
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- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)
- Designated Submission Correspondent
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
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- Identification of Proposed Device
Trade Name: SANSIN Tubing Sets for Hemodialysis Common Name: Blood Tubing Sets Models: HDJ, HDK, HDL, HDM, HDN.
- Identification of Proposed Device
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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:
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. 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.
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- Identification of Predicate Device
510(k) Number: K161582 Product Name: DORA Tubing Sets for Hemodialysis Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd
- Identification of Predicate Device
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- Substantially Equivalent (SE) Comparison
| Table 2 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| ITEM | Proposed Device | |||
| SANSIN Tubing Sets for | ||||
| Hemodialysis | Predicate Device | |||
| DORA Tubing Sets for | ||||
| Hemodialysis | ||||
| K161582 | ||||
| BAIN-BL-001E | Remark | |||
| Device Class | II | II | Same | |
| Product Code | FJK | FJK | Same | |
| Regulation | ||||
| Number | 21 CFR 876.5820 | 21 CFR 876.5820 | Same | |
| Indications for | ||||
| Use | 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. | The DORA 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. | Same | |||
| Compatible | ||||
| Hemodialysis | ||||
| Delivery | ||||
| System | The hemodialysis delivery system | |||
| which is compatible with the | ||||
| product is Fresenius 2008K | ||||
| Home Hemodialysis System | ||||
| manufactured by Fresenius | ||||
| Medical Care North America. | The hemodialysis delivery | |||
| system which is compatible | ||||
| with the product is Fresenius | ||||
| 2008K manufactured by | ||||
| Fresenius Medical Care North | ||||
| America. | Difference 1 | |||
| Feature | Pre-Pump | |||
| Post-Pump | ||||
| Color Coded component | ||||
| Sterile | ||||
| Non-pyrogenic | ||||
| Single Use | ||||
| Prescription Device | Pre-Pump | |||
| Post-Pump | ||||
| Color Coded component | ||||
| Sterile | ||||
| Non-pyrogenic | ||||
| Single Use | ||||
| Prescription Device | Same | |||
| Main | ||||
| Configuration | Arteria Line | |||
| Venous Line | ||||
| Air capture chamber | ||||
| Branch Tubings; | ||||
| Female Luer Lock | ||||
| Clamps | ||||
| Filters | Arteria Line | |||
| Venous Line | ||||
| Drip Chamber | ||||
| Branch Lines; | ||||
| Female Luer Lock | ||||
| Clamps | ||||
| Filters | Difference 2 | |||
| Accessory | Drain Bag | |||
| Transducer Protector | ||||
| Monitor | ||||
| Tubing in the Arterial line | ||||
| Priming connector in the Arterial | ||||
| and Venous lines | ||||
| Priming Piece, Priming Needle | Drain Bag | |||
| Transducer Protector | ||||
| Pillow | ||||
| Heparin Line | ||||
| Recirculating 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 | |||
| Physical | ||||
| Performance | Length of | |||
| arterial Line | ||||
| (mm) | HDJ:3500mm | |||
| HDK:3500mm | ||||
| HDL:3600mm | ||||
| HDM:3660mm | ||||
| HDN:3500mm | ||||
| Length of | ||||
| venous Line | ||||
| (mm) | HDJ:3000mm | |||
| HDK:3000mm | ||||
| HDL:2900mm | ||||
| HDM:2400mm | ||||
| HDN:3000mm | 3000 | |||
| Priming | ||||
| Volume | ||||
| (mL) | HDJ: $143\pm10%$ | |||
| HDK: $147\pm10%$ | ||||
| HDL: $153\pm10%$ | ||||
| HDM: $162\pm10%$ | ||||
| HDN: $167\pm10%$ | $163\pm10%$ | |||
| Positive | ||||
| pressure | ||||
| (mmHg) | 500 | 500 | ||
| Negative | ||||
| Pressure | ||||
| (mmHg) | -300 | -500 | ||
| Blood Flow | ||||
| limits(ml/min) | 500 | 500 | ||
| Inner | ||||
| diameter of | ||||
| the venous | ||||
| and arterial | ||||
| lines(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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Page 4 of 10
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| sensitization. | ||
|---|---|---|
| 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 | The test article | |
| compared with | ||
| that of negative | ||
| control article is | ||
| not significant | ||
| statistically | ||
| different. | ||
| Partial Thromboplastin Time | ||
| Study | The test article | |
| compared with | ||
| that of negative | ||
| control article is | ||
| not significant | ||
| statistically | ||
| different. | ||
| Genotoxicity | Bacterial Reverse | |
| Mutation | No genotoxicity. | |
| In Vitro Mammalian | ||
| Chromosome Aberration | ||
| Test | No genotoxicity. | |
| Pyrogenicity | No potential | |
| febrile 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
11
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:
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ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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ISO 10993-4:2017 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood
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ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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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)]
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ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
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ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
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ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
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USP 42-NF 37:2019 Bacterial Endotoxins Test
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USP 42-NF 37:2019 Pyrogen Test (USP Rabbit Test)
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ISO 594-2:1998 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2 Lock fittings
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ISO 8638:2010 Cadiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters
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- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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- 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.
- Substantially Equivalent (SE) Conclusion