NovaLine Tubing Sets for Hemodialysis

K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · FJK · Mar 10, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K201866
• Device Name: NovaLine Tubing Sets for Hemodialysis
• Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Mar 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

Device Story

NovaLine Tubing Sets (Models BL11, BL12) serve as extracorporeal blood circuits for hemodialysis. Input: patient blood; Output: blood returned to patient via hemodialyzer. Device consists of arterial (red) and venous (blue) lines, recirculating connector, and pump line. Pump line interfaces with Baxter AK98 Hemodialysis System rotor mechanism to drive blood flow. Used in clinical hemodialysis settings by trained healthcare professionals. Physician selects appropriate tubing based on patient blood volume (total extracorporeal volume must not exceed 10% of patient blood volume). Benefits include facilitating safe, controlled extracorporeal blood transport during dialysis.

Clinical Evidence

No clinical data. Bench testing only. Verification testing confirmed compliance with ISO 8638 (cardiovascular implants/extracorporeal circuits), ISO 594-2 (luer lock fittings), ASTM D4169 (shipping), ASTM F88 (seal strength), and ASTM F1929 (leak detection).

Technological Characteristics

Sterile, single-use arterial and venous tubing sets. Materials conform to ISO 10993 biocompatibility standards. Features include color-coded components, drip chambers (BL12 only), and luer lock fittings. Sterilized via e-beam radiation (SAL 10^-6). Compatible with Baxter AK98 Hemodialysis System. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for patients undergoing hemodialysis treatment requiring an extracorporeal blood circuit to transport blood between the patient and a hemodialyzer.

Regulatory Classification

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.

Predicate Devices

• DORA Tubing Sets for Hemodialysis (K161582)

Submission Summary (Full Text)

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March 10, 2021

Bain Medical Equipment (Guangzhou) Co., Ltd. Zoe Zeng Regulatory Supervisor No.10. Juncheng Road, Eastern Area, Economic and Technological Development District Guangzhou, Guangdong 510760 CHINA

Re: K201866

Trade/Device Name: NovaLine Tubing Sets for Hemodialysis Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: February 8, 2021 Received February 9, 2021

# Dear Zoe Zeng:

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.

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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201866

Device Name

Novaline Tubing Sets for Hemodialysis

### Indications for Use (Describe)

The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

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 SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _ K201866

- 1. Date of Preparation: 3/08/2021
- Sponsor Identification 2.

Bain Medical Equipment (Guangzhou) Co., Ltd No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District, 510760, Guangdong, P.R.China

Contact Person: Mu Fangzhen Position: Management Representative Tel: [phone] ext.287 Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Bain Medical Equipment (Guangzhou) Co., Ltd No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District, 510760, Guangdong, P.R.China

Ms. Zoe Zeng (Primary Contact Person) Tel: [phone] ext.290 Fax: [phone] Email: [e-mail]

Ms. Sophia Shao (Alternative Contact Person) Tel: [phone] ext.218 Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: NovaLine Tubing Sets for Hemodialysis Common Name: Blood tubing sets Models: BL11, BL12

### Regulatory Information

Classification Name: Hemodialysis system and accessories Classification: II Product Code: FJK Regulation Number: 876.5820 Review Panel: Gastroenterology/Urology

### Indications for Use:

The NovaLine Tubing Sets for Hemodialysis - Models BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

### Device Description:

The proposed devices, NovaLine Tubing Sets for Hemodialysis, 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 accessory which is recirculating connector.

There are two models BL 11 and BL 12, The main difference between BL 11 and BL 12 is the Drip chamber on the arterial line. There is drip chamber on the arterial line of BL 12, there is no drip chamber on the arterial line of BL 11. The BL 12 has more drip chambers than the BL 11 on the whole tubing.

The choice of the proper dialyzer and blood line set is the responsibility of the physician in charge. When selecting bloodline set for a treatment, the total extracorporeal blood volume (i.e. the dialyzer, the bloodline set and any other accessories combined) shall not exceed 10% of the patient's blood volume.

The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

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- న. Identification of Predicate Device
Predicate Device 510(k) Number: K161582 Product Name: DORA Tubing Sets for Hemodialysis Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd

- 6. 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. The test results demonstrated that the proposed device complies with the following standards:

- > ISO 8638 Third Edition 2010-07-01, Cadiovascular Implants and Extracorporeal Blood Circuit for Hemodialyzers, Hemodialfilters, And Hemofilters. 9-89
- > ISO 594-2 Second Edition 1998-09-01, Conical Fittings with A 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings.
- > ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
- A ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
- > ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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#### 8. Substantially Equivalent (SE) Comparison

| Table 1 Comparison of Technology Characteristic | | | |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device | |
| | | K161582 | |
| Model | BL 11/ BL 12 | BAIN-BL-002E | |
| Device Class | II | II | |
| Product Code | FJK | FJK | |
| Reg. Number | 21CFR part 876.5820 | 21CFR part 876.5820 | |
| Indications for Use<br>(Discussion 1) | The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. | 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. | |
| Compatible<br>hemodialysis delivery<br>system<br>(Discussion 2) | The hemodialysis delivery system which is compatible with the product is AK 98 Hemodialysis System manufactured by Baxter. | The hemodialysis delivery system which is compatible with the product is Fresenius 2008K manufactured by Fresenius Medical Care North America. | |
| Feature | Pre-Pump Post-Pump<br>Color Coded component<br>Sterile<br>Non-pyrogenic<br>Single Use | Pre-Pump Post-Pump<br>Color Coded<br>component Sterile<br>Non-pyrogenic<br>Single Use | |
| | | Prescription Device | Prescription Device |
| Main Configuration | | Arterial Line | Arterial Line |
| | | Venous Line | Venous Line |
| | | Drip Chamber | Drip Chamber |
| | | Branch Lines | Branch Lines; |
| | | Female Luer Lock | Female Luer Lock |
| | | Clamps | Clamps |
| | | Filter | Filters |
| Accessory<br>(Discussion 3) | | Recirculating Connector | Recirculating Connector |
| | | / | Drain Bag |
| Small Components<br>(Discussion 4) | | Dropper | / |
| | | Elbow | |
| Physical<br>performance | Length of<br>arterial<br>line(mm) | BL 11: 2890<br>BL 12: 3290 | 3500 |
| | Length of<br>venous<br>line(mm) | BL 11: 2700<br>BL 12: 2700 | 3000 |
| | Priming<br>Volume<br>(mL) | BL 11: 127±10%<br>BL 12: 186±10% | 163±10% |
| | Positive<br>pressure<br>(mmHg) | 500 | 500 |
| | Negative<br>Pressure<br>(mmHg) | -500 | -500 |
| | Blood flow<br>rate<br>limitations | 600 | 500 |
| Performance | | Conforms to<br>ISO8638:2010<br>ISO594-2:1998 | Conforms to<br>ISO8638:2010<br>ISO594-2:1998 |
| Materials | | Various materials | Various materials |
| Biocompatibility<br>(Discussion 6) | | Conforms to<br>ISO 10993 series standards | Cytotoxicity;<br>Sensitization<br>Intracutaneous reactivity;<br>Acute systemic toxicity;<br>Hemolysis<br>Partial Thromboplastin Time<br>Complement System<br>In vitro Chromosomal Aberration<br>Bacterial Reverse Mutation<br>Mouse Bone Marrow Micronucleus |
| Sterilization | | SAL(10-6) | SAL(10-6) |
| Labeling | Direction for Use | Direction for Use | |
| | Intended Use | Intended Use | |
| | Description | Description | |
| | Warnings and Cautions | Warnings and Cautions | |

#### Table 1 Compariso of Technolo ﺭ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ toriatio

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### Discussion 1 - Indications for Use

The intended use of the proposed and predicate device are different in text, however, both of them are used to connect with a hemodialysis system and provide extracorporeal access to the patient's blood during hemodialysis. This difference will not result in any safety and effectiveness issue of the proposed device.

### Discussion 2 - Compatible hemodialysis delivery system

The compatible system of the proposed device is specified as AK 98 Hemodialysis System, which is a hemodialysis delivery system being submitted to FDA for premarket notification(K201809); the compatible system of the predicate device is Fresenius 2008K. The instructions of the proposed device have clearly stated the compatible system, which will not result in any misuse. Bench testing included in this submission support the compatibility between the proposed device and the compatible system. This difference will not result in any safety and effectiveness issue of the proposed device.

### Discussion 3- Accessory

The proposed device and predicate device have the same main configuration, meanwhile they have different components on the details. The predicate device has drain bag for waste collection, while the proposed devices don't have this accessory. No drain bag will not affect the clinical using of the proposed device, therefore, this difference will not raise new problem on the safety and effectiveness.

### Discussion 4- Small Components

The proposed device and predicate device are different in small components. The proposed have Dropper and Elbow, however, the predicate device has not the small component. Bench testing included in this submission support the performance of the device. This difference will not result in any safety and effectiveness issue of the proposed device.

### Discussion 5- Physical performance

The length of main tubes of proposed device is different to that of the predicate device. The difference on the length of main tubes leads to the difference on the priming volume. Both proposed device and predicate device comply the ISO 594-2 and ISO 8638 standards. Therefore, we think the differences on the length of main tubes and priming volume will not rain new problems on the safety and effectiveness.

### Discussion 6-Biocompatibility

The patient contact components/materials of proposed devices BL11 are covered by the BL 12, and the

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### 510(k) Summary

patient contact materials of the proposed device BL12 are covered by those of the DORA Tubing Sets for Hemodialysis, as cleared in K161582, which is also manufactured by Bain Medical Equipment(Guangzhou) Co., Ltd. Therefore, this item is considered substantially equivalent.

#### 9. Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.