(296 days)
To tell you if the device contains an AI model, I need to see the {{overview}} information. {{overview}} is a placeholder where the actual description or technical specifications of the device would be.
Please provide the content of {{overview}}.
Once you provide that information, I will analyze it for keywords and phrases that indicate the presence of an AI model, such as:
- Machine learning (ML)
- Deep learning (DL)
- Artificial intelligence (AI)
- Neural networks
- On-device AI
- AI chip/processor
- Specific AI functionalities (e.g., natural language processing, computer vision, object recognition, predictive analytics, personalized recommendations)
Here's how it works:
You would replace {{overview}} with the text describing the device. For example:
Instead of:
Does this device contain an AI model? {{overview}}
You would provide something like:
Does this device contain an AI model? This smartphone features a powerful A15 Bionic chip with a 16-core Neural Engine for advanced machine learning tasks, enabling features like enhanced photography, Siri voice recognition, and personalized app suggestions.
Based on the information you provide in {{overview}}, I can then give you a confident answer.
Yes
The device is a hemodialysis delivery system used to treat acute and chronic renal failure, which is a therapeutic purpose.
No
This device is a hemodialysis delivery system used for treating renal failure, not for diagnosing medical conditions. While it has various sensors and optional monitors for parameters like blood volume and pressure, these are for monitoring treatment, not for initial diagnosis.
Yes
The 510(k) summary clearly states the device is "software only" used to analyze "existing images from a DICOM PACS". There is no mention of integrated proprietary hardware or a required hardware component beyond the image source (PACS) and a viewing interface, which are standard medical IT infrastructure.
Based on the overview provided, the device is likely an IVD (In Vitro Diagnostic) because it is designed for analyzing samples from the human body (blood) to provide information about a person's health status.
Here's why:
- IVD Definition: IVDs are medical devices and accessories used to perform testing on specimens taken from the human body, such as blood, urine, or tissue, to provide information for medical purposes, such as diagnosis, screening, monitoring, or predicting treatment response.
- Focus on Sample Analysis: The description "a device for analyzing samples from the human body" directly aligns with the core function of an IVD.
- Output of Medically Relevant Information: Analyzing blood to "offer information about a person's health status" implies that the results of the analysis are intended to be used for medical purposes, which further supports its classification as an IVD.
To be absolutely certain, the following details from the full overview would be very helpful:
- What specific component of blood is being analyzed? (e.g., glucose, cholesterol, blood cells, specific proteins)
- What kind of information is provided about a person's health status? (e.g., presence of a disease, levels of a specific marker, nutritional status)
- What is the intended medical purpose of the device? (e.g., diagnosis of diabetes, monitoring of cholesterol levels, screening for an infection)
- Does it use reagents or other accessories specifically for in vitro testing?
However, based on the general description provided in {{overview}}, the device strongly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DBB-06 PRO Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 PRO Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
Product codes
KDI
Device Description
The DBB-06 PRO Hemodialysis System consists of the DBB-06 PRO Hemodialysis Machine and EF-02D Endotoxin Retentive Filter(s). The DBB-06 PRO Hemodialysis Machine is an electromechanical device controlled by software for hemodialysis treatment, including fluid flow, mixing, heating, and alarms. The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate and sterile, non-pyrogenic substitution fluid by reducing microbial contaminants including endotoxins in the dialysate. Up to two EF-02D filters are used in-line as part of the DBB-06 PRO hydraulic section. The DBB-06 PRO is intended for use in healthcare facilities such as hospitals and dialysis clinics for intermittent dialysis treatment. It is designed to be used with compatible blood tubing lines, dialyzers, acid, and bicarbonate and is similar to other legally-marketed hemodialysis delivery systems. It supports both acetate dialysis and bicarbonate dialysis and is compatible with commercially available dialyzers. The system includes an option for assisted operation of several functions called D-FAS (Dialysis Fully-Assist System), which can assist with priming, blood filling, rinse back, and fluid bolus functions. A Patient Card reader is also included to store patient prescription and treatment data from the last 3 sessions. The device features a hydraulic circuit for dialysis fluid and an extracorporeal blood circuit for blood circulation, monitored by various sensors. The dialysate is made from treated water, mixed with concentrate, and filtered. The system has cleaning and disinfection programs and protective systems for patient safety.
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
adult patients
Intended User / Care Setting
qualified operators, in hospitals and dialysis clinics
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)
Performance testing to support the determination of substantial equivalence of the DBB-06 PRO Hemodialysis Delivery System included:
- System Level Performance Testing: Ensured the device performs in accordance with product requirements and design inputs.
- Disinfection Validation Testing: Ensured preset disinfection cycles properly reduce microorganism populations.
- Environmental and Transportation Studies: Verified device packaging protects the device from damage during shipment and storage.
- Chemical Characterization/Material Compatibility: Ensured materials are compatible with chemicals they contact to determine potential risk of adverse biological response.
- Sterilization Validation (EF-02D Filters): Confirmed appropriate Sterility Assurance Level (SAL) of 10⁻⁶ for filters.
- Bacterial Retention Testing (EF-02D Filters): Verified filter can produce ultrapure dialysate from fluid spiked with bacteria exceeding allowable limit.
- Endotoxin Retention Testing (EF-02D Filters): Verified filter can produce ultrapure dialysate from fluid spiked with endotoxin exceeding allowable limit.
- Ultrafiltration Rate (EF-02D Filters): Verified filter has an acceptable aqueous Ultrafiltration rate (KUF).
- Dialysis Fluid Composition (EF-02D Filters): Measured composition of dialysis fluid after passing through two filters.
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1:2018 for patient contacting components (cytotoxicity, sensitization, intracutaneous irritation, material-mediated pyrogenicity, acute and sub chronic systemic toxicity, genotoxicity, hemocompatibility, chemical characterization, toxicological risk assessment).
- Human Factors Validation Testing: Found no impact on safe and effective use; concluded the system is safe and effective for intended users, uses, and use environments.
- Electrical Safety and Electromagnetic Compatibility (EMC): Evaluated in accordance with IEC 60601-1-2:2020 and additional electrical testing per IEC TR 60601-4-2:2016.
- Software Verification and Validation Testing: Unit, integration, and system level testing included functional and performance verification, regression testing, and code reviews, in accordance with FDA guidance documents for device software functions, off-the-shelf software, and cybersecurity.
No animal or clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Blood Pump:
- Flow rate accuracy: Set value ±10% (Inflow Pressure –150mmHg ≤ P ≤ +150mmHg); Set value -20 to 0% (Inflow Pressure -200mmHg ≤ P
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
FDA Clearance Letter - DBB-06 PRO Hemodialysis Delivery System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 7 . 0 5
Silver Spring, MD 20993
www.fda.gov
May 15, 2025
Nikkiso Co., Ltd.
℅ Brittany Valdez Nava, MRSc
Head of Quality
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Court
Bethesda, Maryland 20817
Re: K242155
Trade/Device Name: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
Regulation Number: 21 CFR 876.5860
Regulation Name: High permeability hemodialysis system
Regulatory Class: Class II
Product Code: KDI
Dated: May 13, 2025
Received: May 15, 2025
Dear Brittany Valdez Nava:
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 (the 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 available 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.
Page 2
K242155 - Brittany Valdez Nava Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K242155 - Brittany Valdez Nava Page 3
assistance/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,
Maura Rooney -S
Maura Rooney
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 Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
Device Name
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
Indications for Use (Describe)
The DBB-06 PRO Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 PRO Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
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."
Page 5
1.0 510(K) SUMMARY
This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
1.1 Submitter's Information
Company Name: NIKKISO CO., LTD.
Address: 20-3, Ebisu 4-Chome, Shibuya-ku
Tokyo 150-6022
Japan
Company Contact: Satoko Hina
General Manager
Regulatory Affairs Department Medical Division
NIKKISO CO., LTD.
20-3, Ebisu 4-Chome, Shibuya-ku
Tokyo 150-6022
Japan
Phone: +81-3-3443-3754
Fax: +81-3-3473-4965
Email: MedicalRA@nikkiso.co.jp
Official Correspondent: Brittany Valdez Nava, MRSc
Head of Quality
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Court
Bethesda, MD 20817
Date prepared: July 15, 2024
1.2 Subject Device Name
Trade Name: DBB-06 PRO HEMODIALYSIS DELIVERY SYSTEM
Common Name: DBB-06 PRO Hemodialysis Delivery System, including EF-02D filter and accessories
Regulation Name: Dialyzer, High Permeability Dialysate System
Regulation Number: 21 CFR 876.5860
Device Class: Class II
Product Code: KDI
Product Code Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Review Panel: Gastroenterology/Urology
Page 6
1.3 Legally Marketed Predicate Device
1.3.1 DBB-06 Hemodialysis Delivery System
The primary predicate device for the DBB-06 PRO Hemodialysis System is the DBB-06 Hemodialysis Delivery System cleared under K152938. The EF-02D endotoxin retentive filters used on the DBB-06 PRO hemodialysis delivery system, were originally cleared under K152938, to filter dialysate.
510(k) Number: K152938
Trade Name: DBB-06 Hemodialysis Delivery System
Common Name: High Permeability Hemodialysis System
Regulation Name: High Permeability Hemodialysis System
Regulation Number: 21 CFR 876.5860
Device Class: Class II
Product Code: KDI
Product Code Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Review Panel: Gastroenterology/Urology
1.3.2 2008T Bluestar Hemodialysis Machine
The secondary predicate device for the DBB-06 PRO Hemodialysis System is the 2008T BlueStar™ Hemodialysis system cleared under K231125.
510(k) Number: K231125
Trade Name: 2008T Bluestar™ Hemodialysis Machine
Common Name: Hemodialysis Delivery Device
Regulation Name: High Permeability Hemodialysis System
Regulation Number: 21 CFR 876.5860
Device Class: Class II
Product Code: KDI
Product Code Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Review Panel: Gastroenterology/Urology
The 2008T BlueStar Hemodialysis Machine (K222952) is used as a reference device.
The 2008T BlueStar Hemodialysis Machine (K173972) is used as a reference device.
Page 7
1.4 Device Description
1.4.1 Device Identification
The DBB-06 PRO Hemodialysis System consists of the following:
- The DBB-06 PRO Hemodialysis Machine
- EF-02D Endotoxin Retentive Filter(s)
1.4.2 Device Characteristics
The DBB-06 PRO Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
The EF-02D filter is a sterile dialysis fluid filter that produces ultrapure dialysate and sterile, non-pyrogenic substitution fluid as defined in ANSI/AAMI/ISO 23500. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. Up to two (2) EF-02D filters are used in-line as part of the DBB-06 PRO hydraulic section.
1.4.3 Indications for Use
The DBB-06 PRO Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 PRO Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
1.4.4 Environment of Use
The DBB-06 PRO Hemodialysis System including its components (EF-02D filters and accessories) is intended for use in healthcare facilities, such as hospitals and dialysis clinics where intermittent dialysis treatment is performed.
1.4.5 Brief Written Description of the Device
The DBB-06 PRO is a hemodialysis delivery system that is to be used with compatible blood tubing lines, dialyzers, acid, and bicarbonate. It is similar to other legally-marketed hemodialysis delivery systems.
The DBB-06 PRO is indicated for hemodialysis prescribed by physicians for acute or chronic renal failure patients. It is not indicated for pediatric patients and is not for home use. Dialysis can be performed using the DBB-06 PRO without additional hardware.
The DBB-06 PRO consists of a hydraulic circuit for the dialysis fluid, which is in contact with the dialysis fluid, and an extracorporeal blood circuit (blood tubing lines). This extracorporeal circuit consists of arterial and venous lines permitting blood circulation to and from the dialyzer. These blood tubing lines are a consumable of the DBB-06 PRO and have been submitted to the FDA in a separate 510(k).
The blood pump on the DBB-06 PRO draws blood from the patient's arterial access and pumps it through the extracorporeal blood circuit. The extracorporeal blood circuit can be heparinized before the blood enters the dialyzer using the heparin pump, either continuously or with a single injection. The blood flows into the venous chamber after it passes through the dialyzer. The blood is returned to the patient via venous access. The extracorporeal circuit is monitored by pressure sensors, air, blood, and bloodline detectors. This extracorporeal circuit consists of arterial and venous lines
Page 8
permitting blood circulation to and from the dialyzer. The extracorporeal blood circuit is monitored by pressure sensors, air, blood, and blood tubing line detectors.
The dialysate is made by using treated water that is heated and de-aerated in the hydraulic section. The de-aerated water is then mixed with the concentrate, filtered via the ETRF, and fed into the dialyzer via the endotoxin retentive filter (ETRF) and dialysis fluid supply connector. The closed system is designed to assure that the input and output amounts of the dialysis fluid remain constant. The duplex pump supplies and drains the same amount of dialysate to and from the dialyzer. On the duplex pump drain side, the UF pump drains the amount of ultrafiltrated dialysate from the patient's blood plasma through the dialyzer. The internal pressure of the dialyzer is automatically defined based on the treatment data that is entered.
The DBB-06 PRO can be configured for both acetate dialysis and bicarbonate dialysis. It is compatible with commercially available dialyzers that are equipped with standard dialysis fluid and blood connections. The hydraulic unit within the DBB-06 PRO is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation. The disinfection cycle is required once per day when in use and before storage. The system alerts the operator if the disinfection cycle has not been completed.
Solenoid valves switch the flow path of the dialysate according to mode of operation. The device conducts a self-test of the solenoid valves to confirm the solenoid valves open and close correctly.
The DBB-06 PRO includes an option to support assisted operation of several important functions called D-FAS (Dialysis Fully-Assist System). Priming, blood filling, rinse back and fluid bolus functions are some of the functions that can be assisted. A Patient Card reader is also included in the delivery system, which can store patient prescription and treatment data from the last 3 sessions. The operator places the patient card on the machine before preparation and the prescription data is uploaded.
The basic version of the DBB-06 PRO incorporates all of the functions necessary for double needle dialysis. The DBB-06 PRO is equipped with the protective systems and features to help ensure patient safety and correct operation.
The DBB-06 PRO complies with the following standards:
- ANSI AAMI ES 60601-1:2005+A1:2012+A2:2021,IEC 60601-1:2005+A1:2012+A2:2020
- IEC 60601-1-2:2014+A1:2020(ANSI AAMI IEC 60601-1-2:2014+A1:2021)
- IEC 60601-2-16:2018(ANSI AAMI IEC 60601-2-16:2018)
Accessory Devices
- Single (1) EF-02D Filter or Double (2) EF-02D Filters
- Compatible bicarbonate cartridges. For example, NikkiCart Bicarbonate Cartridge (K221652)
- Acid concentrates compliant with ISO 23500-4
- Compatible Bloodlines: ID 8.0mm
Optional Accessories
- Blood Volume Monitor (BVM)
- Blood Pressure Monitor (BPM)
- Dialysis Dose Monitor (DDM)
Page 9
- Bicarbonate Cartridge Holder
- Patient Card Reader with Patient Card
- Heparin Pump
- Central Concentrate Supply
- Rinse port
- Sampling port
- LAN
- USB
- Water Leak Detector
1.4.6 Materials of Use
The DBB-06 PRO Hemodialysis Machine hydraulics assembly is classified as an externally communicating, indirect blood contact, and long-term exposure (> 30 days) Category C device. in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (04 September 2020). A list of the hydraulic materials for the machine that come in contact with the water, concentrates, and dialysis fluid are listed below:
Materials utilized for piping [hydraulics]:
- Stainless steel
- Fluoro-rubber
- Silicone rubber
- Ceramic
- Polysulfone (PSU)
- Polyimide (PI)
- Glass
- Polypropylene (PP)
- Polyphenylene ether (PPE)
- PPE/polystyrene (PPE+PS copolymer)
- Titanium
- Polytetrafluoroethylene (PTFE)
- Ethylene-tetrafluoroethylene plastic (ETFE)
- Polyphenylsulfone (PPSU)
- Perfluoroalkoxy alkane (PFA)
Materials utilized for the blood pressure cuff (Pressurization-type & depressurization-type BP monitor)
Cuff:
- Polyurethane (PU)
- Nylon and Polyester
- Polyvinyl chloride (PVC)
Cuff hose:
- Polyurethane (PU)
- Polyvinyl chloride (PVC)
- Brass
Page 10
1.5 Key Performance Characteristics
The key performance specifications and characteristics of the DBB-06 PRO Hemodialysis Delivery System are outlined in Table 1.
Table 1: Key Performance Characteristics
| Feature | Specification/Characteristic |
|---|---|
| Blood Pump | Setting range: 40 to 600 mL/min (ID 8.0mm) |
| Display method: Blood flow rate = Rotation of blood pump |
Flow rate accuracy:
Set value ±10% (Inflow Pressure –150mmHg ≤ P ≤ +150mmHg)
Set value -20 to 0% (Inflow Pressure -200mmHg ≤ P 30 days) Category C device.
The blood pressure cuffs are only intended to contact intact skin for transient use of blood pressure monitoring during hemodialysis treatment, they are classified as a surface, intact skin, limited contact (≤24 hr) duration, Class II (Category A) device.
The following testing was conducted to support the biological safety of the DBB-06 PRO Hemodialysis System:
- Cytotoxicity
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Material-Mediated Pyrogenicity
- Acute and Sub chronic Systemic Toxicity
- Genotoxicity
- Bacterial Reverse Mutation (Ames)
- Mouse Lymphoma
- Hemocompatibility, ASTM Hemolysis (Indirect)
- Chemical Characterization
- Toxicological Risk Assessment
1.8.3 Human Factors Validation Testing
Human Factors validation testing performed on the DBB-06 PRO Hemodialysis System found no impact on the safe and effective use of the device. NIKKISO concludes that the system is safe and effective for the intended users, uses, and use environments.
1.8.4 Electrical Safety and Electromagnetic Compatibility (EMC)
The DBB-06 PRO Hemodialysis System was evaluated for electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2020.
Additional electrical testing was conducted in accordance with IEC TR 60601-4-2:2016.
1.8.5 Software Verification and Validation Testing
Unit, integration, and system level software verification testing were performed to demonstrate the efficacy of the software and to confirm operation of the machine. The following testing was performed:
- Functional and Performance Verification
- Regression Testing
- Code Reviews
Software verification information within this submission is provided in accordance with the following FDA guidance documents:
Page 18
- Content of Premarket Submissions for Device Software Functions (14 June 2023)
- Guidance for Off-The-Shelf Software Use in Medical Devices (11 August 2023)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (27 September 2023)
1.8.6 Animal Studies
No animal studies were performed on this device.
1.8.7 Clinical Studies
Clinical studies were not performed on the device.
1.9 Conclusions
Based on above discussion and enclosed sections regarding substantial equivalence to the predicate device, NIKKISO CO., LTD. concludes that the DBB-06 PRO Hemodialysis Delivery System is substantially equivalent to the Nikkiso DBB-06 Hemodialysis Delivery System and the 2008T Bluestar and does not raise any new or different questions of safety or effectiveness.