(246 days)
Not Found
No
The 510(k) summary describes a physical medical device (tubing sets) and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a hemodialysis system, which is a therapeutic treatment. The blood lines are essential for transporting blood to and from the patient, enabling the hemodialysis process to remove waste products from the blood, thus providing therapy.
No
The device is a tubing set for hemodialysis, which serves as an extracorporeal blood circuit to transport blood during hemodialysis treatment. It is a therapy device component, not a diagnostic device.
No
The device description clearly states it consists of physical components (tubes, connectors, drip chambers) and is subject to sterilization, indicating it is a hardware medical device.
Based on the provided information, the NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to transport blood from the patient through a hemodialyzer and back to the patient during hemodialysis treatment. This is a direct interaction with the patient's blood outside the body for treatment purposes, not for diagnostic testing of the blood itself.
- Device Description: The description details the physical components of the tubing set used to create an extracorporeal blood circuit. There is no mention of reagents, assays, or any components designed to analyze or test the blood.
- Lack of Diagnostic Function: The device's function is purely mechanical – to facilitate the flow of blood through the hemodialysis system. It does not perform any diagnostic tests on the blood to provide information about a patient's health status.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The NovaLine Tubing Sets do not perform this function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FJK
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 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.
- 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.
- 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
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
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
-
- 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: +86-20-66856868 ext.287 Fax: +86 20 3206 7500 Email: mufangzhen@baingz.com
-
- 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
- Designated Submission Correspondent
Ms. Zoe Zeng (Primary Contact Person) Tel: +86-20-66856868 ext.290 Fax: +86 20 3206 7500 Email: zoe@baingz.com
Ms. Sophia Shao (Alternative Contact Person) Tel: +86-20-66856868 ext.218 Fax: +86 20 3206 7500 Email: sophia@baingz.com
4
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.
5
-
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 -
- 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:
- Non-Clinical Test Conclusion
-
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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
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 | |||
| (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 | |||
| hemodialysis delivery | |||
| system | |||
| (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 | ||
| Color Coded component | |||
| Sterile | |||
| Non-pyrogenic | |||
| Single Use | Pre-Pump Post-Pump | ||
| Color Coded | |||
| component Sterile | |||
| Non-pyrogenic | |||
| 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 | |||
| (Discussion 3) | Recirculating Connector | Recirculating Connector | |
| / | Drain Bag | ||
| Small Components | |||
| (Discussion 4) | Dropper | / | |
| Elbow | |||
| Physical | |||
| performance | Length of | ||
| arterial | |||
| line(mm) | BL 11: 2890 | ||
| BL 12: 3290 | 3500 | ||
| Length of | |||
| venous | |||
| line(mm) | BL 11: 2700 | ||
| BL 12: 2700 | 3000 | ||
| Priming | |||
| Volume | |||
| (mL) | BL 11: 127±10% | ||
| BL 12: 186±10% | 163±10% | ||
| Positive | |||
| pressure | |||
| (mmHg) | 500 | 500 | |
| Negative | |||
| Pressure | |||
| (mmHg) | -500 | -500 | |
| Blood flow | |||
| rate | |||
| limitations | 600 | 500 | |
| Performance | Conforms to | ||
| ISO8638:2010 | |||
| ISO594-2:1998 | Conforms to | ||
| ISO8638:2010 | |||
| ISO594-2:1998 | |||
| Materials | Various materials | Various materials | |
| Biocompatibility | |||
| (Discussion 6) | Conforms to | ||
| ISO 10993 series standards | Cytotoxicity; | ||
| Sensitization | |||
| Intracutaneous reactivity; | |||
| Acute systemic toxicity; | |||
| Hemolysis | |||
| Partial Thromboplastin Time | |||
| Complement System | |||
| In vitro Chromosomal Aberration | |||
| Bacterial Reverse Mutation | |||
| 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
7
8
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
9
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.