DBB-06 Hemodialysis Delivery System

K152938 · NIKKISO CO., LTD. · KDI · Mar 18, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K152938
• Device Name: DBB-06 Hemodialysis Delivery System
• Applicant: NIKKISO CO., LTD.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Mar 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The DBB-06 Hemodialysis Delivery System is a clinical device for hemodialysis in hospitals and clinics. It manages extracorporeal blood circuitry and dialysate delivery; heats and deaerates permeate; mixes with concentrate; and uses a closed balancing system to ensure dialysate volume equilibrium. The device automatically controls dialyzer pressure via ultrafiltration (UF) rate adjustments and provides heparinization via a pump. It supports acetate and bicarbonate dialysis, single or double-needle procedures, and programmable conductivity/UF profiles. The new optional Dialysis Dose Monitor (DDM) uses optical light absorption in spent dialysis fluid to non-invasively and continuously estimate Kt/V and Urea Reduction Ratio (URR), displaying results as graphs. Operators (clinicians) use the device to perform dialysis; the DDM provides real-time treatment monitoring to assist in assessing dialysis adequacy.

Clinical Evidence

No new clinical trials were conducted for the base system. Performance of the DDM accessory was evaluated via comparison to the Adimea (K083460) and blood-based measurements. The DDM demonstrated a correlation coefficient of 0.78 and a relative error of 6.26% in Kt/V estimation compared to blood-based measurements.

Technological Characteristics

Hydraulic unit with duplex pump for volumetric dilution; 12.1" SVGA color LCD; 32-bit Toshiba TX1941AF microprocessor system. Connectivity includes built-in RS-232 and optional TCP/IP. DDM accessory uses optical light absorption sensors for spent dialysate analysis. Disinfection via chemical, thermo-chemical, or hot rinse. Temperature control 34-40°C.

Indications for Use

Indicated for adult patients with acute and chronic renal failure requiring hemodialysis. Not indicated for pediatric patients. Not for home use.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• DBB-06 Hemodialysis Delivery System (K091978)
• Dialog+ Hemodialysis System with Adimea Option (K083460)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

K152938

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)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 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<br>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.

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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. ●

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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.

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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<br>Nikkiso DBB-06<br>Hemodialysis Delivery System<br>(K091978) | PROPOSED<br>Nikkiso DBB-06<br>Hemodialysis Delivery System<br>(under application) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Code | KDI | Same |
| Indications for Use | The DBB-06 Hemodialysis<br>Delivery System is indicated for<br>hemodialysis prescribed by<br>physicians for adult patients with<br>acute and chronic renal failure,<br>treated in hospitals and dialysis<br>clinics by qualified operators. The<br>DBB-06 Hemodialysis Delivery<br>System is not indicated for<br>pediatric patients. It is not for<br>home use. | Same |
| Proportioning system | Continuous volumetric dilution<br>with duplex pump | Same |
| Temperature control (°C) | 34 to 40 | Same |
| Temperature alarm limit (°C) | Fixed: 33, 41<br>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 |

|--|

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| 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,<br>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,<br>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<br>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.

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#### 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).