(165 days)
No
The description focuses on the hydraulic and control systems for hemodialysis, with no mention of AI or ML capabilities. The optional Dialysis Dose Monitor (DDM) is mentioned as a new accessory, but its description does not indicate AI/ML.
Yes
The device is indicated for hemodialysis, which is a medical treatment that filters waste products from the blood for patients with renal failure. This direct treatment of a disease or condition classifies it as a therapeutic device.
No
The device is described as a "Hemodialysis Delivery System" used for treatment, indicating its function is therapeutic rather than diagnostic. While it has a "Dialysis Dose Monitor (DDM)" as an optional accessory, the primary purpose described for the system is to deliver hemodialysis, which is a treatment.
No
The device description clearly outlines a physical system with hydraulic units, pumps, and circuitry, indicating it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided text, the DBB-06 Hemodialysis Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for hemodialysis, a treatment for renal failure, performed on patients. This is a therapeutic procedure, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a system for delivering dialysate and managing blood flow for treatment. It describes a physical process of filtering blood, not analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a patient's condition.
While the device has a "Dialysis Dose Monitor (DDM)" as an optional accessory, the primary function and description of the DBB-06 itself are focused on the therapeutic process of hemodialysis. Even the DDM, based on the context, likely monitors aspects of the dialysis treatment itself rather than performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The DBB-06 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 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
Product codes
KDI
Device Description
The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation.
A Dialysis Dose Monitor (DDM) is a new optional accessory available with the DBB-06 (under application), which was not available in the predicate DBB-06 (K091978). The Dialysis Dose Monitor (DDM) is a measurement function which estimates the Kt/V value and Urea Reduction Ratio (URR) by optical measurement of the composition change in the spent dialysis fluid.
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
physicians, qualified operators / 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)
The Dialysis Dose Monitor (DDM) of the DBB-06 (under application) was compared to the Adimea (K083460) in terms of Kt/V accuracy.
- Correlation Coefficient (comparing Kt/V from UV absorption and measurement from blood) for DDM: 0.78
- Error (measurement error in Kt/V values obtained from UV absorption relative to measurement by using blood) for DDM: Relative Error 6.26%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Nikkiso Co., Ltd. % Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo Bunkyo-ku ,Tokyo 113-0033 Japan
Re: K152938
Trade/Device Name: DBB-06 Hemodialysis Delivery System Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: February 15, 2016 Received: February 17, 2016
Dear Fumiaki Kanai,
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. 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.
1
Page 2 - Fumiaki Kanai, Ph.D.
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DBB-06 Hemodialysis Delivery System
Indications for Use (Describe)
The DBB-06 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 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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:
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3
Section 6- 510(k) Summary
a. Company name, address
Nikkiso Co., Ltd. Medical Division 20-3, Ebisu 4-Chome, Shibuya-ku, Tokyo 150-6022, Japan
b. Contact
Seiya Raijyu General Manager Quality Assurance Office
c. Date prepared
October 1, 2015
d. Name of device
| Trade Name: | DBB-06 HEMODIALYSIS DELIVERY SYSTEM |
|---|---|
| Common Name: | High Permeability Hemodialysis System |
| Classification Name: | Dialyzer, High Permeability With or Without Sealed Dialysate System |
e. Predicate devices
The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is substantially equivalent to:
| 510(k): | K091978 |
|---|---|
| Trade name: | DBB-06 Hemodialysis Delivery System |
| Product code: | KDI |
| 510(k): | K083460 |
| Trade name: | Dialog+ Hemodialysis System with |
| Adimea Option | |
| Product code: | KDI |
f. Description of the device
The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer.
4
The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation.
A Dialysis Dose Monitor (DDM) is a new optional accessory available with the DBB-06 (under application), which was not available in the predicate DBB-06 (K091978).
g. Indications for Use
The DBB-06 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 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
h. Statement of substantial equivalence
The DBB-06 HEMODIALYSIS DELIVERY SYSTEM (under application) was modified from the DBB-06 HEMODIALYSIS DELIVERY SYSTEM (K091978). The two devices are substantially equivalent and both have:
- the same Indications for Use
- use the same Operating Principle
- incorporate the same Basic System Design ●
- incorporate the same Materials ●
New optional accessories
Dialysis Dose Monitor (DDM)
A Dialysis Dose Monitor (DDM) is a new optional accessory available with the DBB-06 (under application), which was not available in the predicate DBB-06 (K091978).
The Dialysis Dose Monitor (DDM) is a measurement function which estimates the Kt/V value and Urea Reduction Ratio (URR) by optical measurement of the composition change in the spent dialysis fluid.
- DDM is a non-invasive measurement method. DDM does not influence treatment.
- DDM is a continuous measurement method.
- DDM does not require disposable items.
- DDM measurement starts automatically. ●
- Kt/V and URR are displayed on the screen as a graph. ●
5
The Dialysis Dose Monitor (DDM) of the DBB-06 (under application) and the Adimea (K083460) are identical in function and operate under the same principle of light absorption passing through the spent dialysis fluid.
The following is a comparison table between the Dialysis Dose Monitor (DDM) of the DBB-06 (under application) and the Adimea (K083460):
| Item | Dialog+ Hemodialysis System with Adimea Option (K083460) | Dialysis Dose Monitor (DDM) DBB-06 (under application) |
|---|---|---|
| Intended Use | It is used for estimating the Kt/V value and Urea Reduction Ratio (URR) by optical measurement of the composition change in the spent dialysis fluid. | Same |
| Technological Characteristics | ||
| Principle of Kt/V and URR | The accessory functions and operates under the principles of light absorption through the spent dialysis fluid to calculate Kt/V and URR. | Same |
| Microprocessor control | Yes | Yes |
| Kt/V Accuracy | ||
| Correlation Coefficient*1 | 0.93, 0.80 | 0.78 |
| Error*2 | Nonsystematic error 7% | Relative Error 6.26% |
Table 1 DDM Comparison Table
Note:
11 Correlation Coefficient was obtained by comparing Kt/V from UV absorption and measurement from blood. For Adimea two correlation coefficients were obtained for Study 1 and 2. See Section 22 Performance Testing-Clinical for details.
" Measurement error in Kt/V values obtained from UV absorption relative to measurement by using blood. See Section 22 Performance Testing-Clinical for details.
6
Based on the technical characteristics, performance and failure simulation testing of the Dialysis Dose Monitor (DDM) of the DBB-06 (under application), NIKKISO CO., LTD. concluded that the Dialysis Dose Monitor (DDM) of the DBB-06 (under application) performed as well as and is substantially equivalent to the Adimea (K083460) and does not raise any new questions regarding safety or effectiveness.
i. Comparison table
Table 2 below compares the DBB-06 (under application) and the predicate DBB-06 (K091978). The two devices have the same Indications for Use, proportioning system, temperature control, alarm limits, bicarbonate and total conductivity range, flow rates, pressure monitoring and other relevant characteristics.
| Device Characteristics | PREDICATE
Nikkiso DBB-06
Hemodialysis Delivery System
(K091978) | PROPOSED
Nikkiso DBB-06
Hemodialysis Delivery System
(under application) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Code | KDI | Same |
| Indications for Use | The DBB-06 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 Hemodialysis Delivery
System is not indicated for
pediatric patients. It is not for
home use. | Same |
| Proportioning system | Continuous volumetric dilution
with duplex pump | Same |
| Temperature control (°C) | 34 to 40 | Same |
| Temperature alarm limit (°C) | Fixed: 33, 41
Auto: ±1 from set value*1 | Same |
| Bicarbonate conductivity range (mS/cm) | 2.30 to 7.00 | Same |
| Total conductivity range (mS/cm) | 12.5 to 15.5 | Same |
| Flow (mL/min) | 0, 300 to 800 | Same |
| Transmembrane pressure (mmHg) | -100 to +500 | Same |
| Sodium therapy | Yes, Profiled | Same |
| Ultrafiltration removal rate (L/h) | 0.00; 0.10 to 4.00, Profiled UF | Same |
| PH monitor | None | Same |
| Bypass indicator | Visual | Same |
|--|
7
| Table 2. Comparison table between the DBB-06 (under application) and the predicate DBB-06 (K091978) | |||||
|---|---|---|---|---|---|
| (continued) |
| Device Characteristics | PREDICATE | PROPOSED |
|---|---|---|
| Nikkiso DBB-06 | Nikkiso DBB-06 | |
| Hemodialysis Delivery System | Hemodialysis Delivery System | |
| (K091978) | (under application) | |
| BLOOD CIRCUIT | ||
| Arterial pressure (mmHg) | -300 to +300 | Same |
| Venous pressure (mmHg) | -200 to +500 | Same |
| Blood pump range (mL/min) | 40 to 600 | Same |
| Heparin pump range (mL/h) | 0.0 to 9.9 (10, 20, 30 mL syringe) | Same |
| Disinfection | Chemical, thermo-chemical, | |
| hot rinse | Same | |
| Display type | LCD, 12.1" color, SVGA | Same |
| DISPLAY PARAMETERS | ||
| Dialysate pressure | Yes | Same |
| Transmembrane pressure | Yes | Same |
| Bicarbonate conductivity | Yes*2 | Same |
| Total conductivity | Yes | Same |
| Flow rate | Yes | Same |
| Elapsed time | Yes | Same |
| Remaining time | Yes | Same |
| Complete time | Yes | Same |
| Kt/V ratio calculation display | Yes | Same |
| Dialysis Dose Monitor (DDM) | No | Yes |
| Blood pressure value history | Numeric or Graphical | Same |
| Blood volume | Yes | Same |
| MICROPROCESSOR | ||
| Type | 3 microprocessor system, | Same |
| TX1941AF Toshiba, 32 bit | ||
| Storage | Treatment data | Same |
| Interface | Built-in RS-232 for technician, | |
| Optional TCP/IP for network | Same | |
| Loss of water alarm | Yes | Same |
| OTHER SPECIFICATIONS | ||
| Single needle Click-Clack | Yes | Same |
| Arterial clamp for use during Single | ||
| needle Click-Clack | Yes | Same |
| Bicarbonate concentrate type | Liquid or Dry Powder | Same |
| Built in BP monitoring | Yes | Same |
| Isolation UF | Yes | Same |
| Online UF control test | Yes, Continuously*3 | Same |
| Built in Blood Volume Monitor (BVM) | Yes | Same |
Note:
Note:
- The dialysate temperature alarm limit is set to ±1°C from the temperature target value automatically. The alarm window ±1℃ can be changed from 0 to ±5℃.
*2 The maximum concentrate deviation alarm limit is set at ±3%.
*3 Specification of online UF control test.
8
j. Conclusion
Based on the above discussion, enclosed sections regarding substantial equivalence to the predicate devices, and the substantial equivalence of Dialysis Dose Monitor (DDM) of the DBB-06 (under application) to the Adimea (K083460), NIKKISO CO., LTD. concludes that the DBB-06 (under application) is substantially equivalent to the predicate DBB-06 (K091978).