DBB-06 HEMODIALYSIS DELIVERY SYSTEM

K091978 · NIKKISO CO., LTD. · KDI · Mar 25, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K091978
• Device Name: DBB-06 HEMODIALYSIS DELIVERY SYSTEM
• Applicant: NIKKISO CO., LTD.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Mar 25, 2010
• 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 self-contained machine for hemodialysis treatment in hospitals and clinics. It manages extracorporeal blood circuitry and dialysate preparation; heating, deaerating, and mixing concentrate with permeate. A closed balancing system ensures dialysate volume equilibrium. The device controls ultrafiltration (UF) rates and transmembrane pressure automatically. Heparin is administered via an integrated pump. Optional accessories include a Blood Volume Monitor (BVM) for real-time hematocrit/blood volume tracking to prevent fluid removal complications, and a Non-Invasive Blood Pressure (NIBP) module (Omron Colin M2500) for patient monitoring. Operators (clinicians/technicians) program conductivity and UF profiles via an LCD interface. The system includes automated cleaning and disinfection cycles. Output data assists clinicians in adjusting fluid removal rates and monitoring treatment progress, aiming to optimize patient safety and treatment efficacy.

Clinical Evidence

No clinical trials were performed for the primary system. The Blood Volume Monitor (BVM) accessory underwent clinical testing; however, specific results are not detailed beyond the statement that it performs equivalently to the CRIT-LINE Monitor III (K972470). Bench testing, failure simulation, and comparison testing were conducted to validate the system and its optional modules against predicate specifications.

Technological Characteristics

System includes hydraulic unit, extracorporeal blood circuit, and microprocessor control (3-system, 32-bit). Features include volumetric proportioning, automated UF control, and chemical/thermo-chemical disinfection. Connectivity includes RS-232 and optional TCP/IP. Optional BVM uses light absorption (photoplethysmography principle) to measure hematocrit/blood volume. Optional NIBP (Omron M2500) uses oscillometric method. Compliant with IEC60601-2-30, EN1060-1/3, and ANSI/AAMI SP-10 standards.

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-05 Hemodialysis Delivery System (K023509)
• Modification to DBB-05 Hemodialysis Delivery System (K061519)

Reference Devices

• CRIT-LINE Monitor III (CLMIII) (K972470)
• Press-Mate Advantage (K973637)

Submission Summary (Full Text)

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NIKKISO CO., LTD

# Section 6- 510(k) Summary

MAR 2 5 2010

- a. Company name, address NIKKISO CO., LTD. Medical Equipment Unit 498-1 Shizutani, Makinohara-shi Shizuoka, 421-0496, Japan
- b. Contact Hachiro Edamura Manager of Quality Control
- Date prepared ن

June 19, 2009

# d. Name of device.

| Trade Name: | DBB-06 HEMODIALYSIS DELIVERY SYSTEM |
|----------------------|---------------------------------------------------------------------|
| Common Name: | High Permeability Hemodialyzer |
| 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): | K023509 |
|---------------|-----------------------------------------------------|
| Trade name: | DBB-05 Hemodialysis Delivery System |
| Product code: | KDI |
| 510(k): | K061519 |
| Trade name: | Modification to DBB-05 Hemodialysis Delivery System |
| Product code: | KDI |

## Description of the device ﮨﮯ

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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K091978 Page 2 of 10

NIKKISO CO., LTD

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 Blood Volume Monitor (BVM) is an optional accessory available for the DBB-06 HEMODIALYSIS DELIVERY SYSTEM, and was not available with the predicate device, the DBB-05 Hemodialysis Delivery System. The BVM monitors blood volume to assist in the prevention of excessive removal of fluid.

# g. Indications for Use

## Indication 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 is substantially equivalent to the DBB-05 Hemodialysis Delivery System (K023509) and the Modification to DBB-05 Hemodialysis Delivery System (K061519).

Table 1 below compares the DBB-06 HEMODIALYSIS DELIVERY SYSTEM to the DBB-05 Hemodialysis Delivery System (K023509) and the Modification to DBB-05 Hemodialysis Delivery System (K061519). All three devices are totally self-contained machines and include:

- · the same Indication for Use
- · use the same Operating Principle
- · incorporate the same Basic System Design
- · automatic priming of the extracorporeal circuit
- · prepare dialysate
- · monitors for the dialysate and blood
- · pumps for blood and anticoagulant (heparin) at predetermined rates
- · controls fluid removal
- · automatically cleans, disinfects, and rinses the dialysate flow path
- · incorporate the same materials

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NIKKISO CO., LTD

esponse to fda letter dated september 4, 200

Table 1. Comparison table of DBB-05 and DBB-06 Device Characteris

| | Device Characteristics | PREDICATES | | | PROPOSED |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------|--|------------------------------------------------|
| | | Nikkiso DBB-05<br>Hemodialysis Delivery System<br>(K023509) | Modification to<br>Nikkiso DBB-05<br>Hemodialysis Delivery System<br>(K061519) | | Nikkiso DBB-06<br>Hemodialysis Delivery System |
| Product Code | KDI | Same | Same | | Same |
| Indications for Use | The DBB-05 Hemodialysis<br>Delivery System is indicated<br>for hemodialysis prescribed by<br>physicians for adult and<br>pediatric patients with acute or<br>chronic renal failure. The<br>DBB-05 is intended for<br>hemodialysis performed in<br>hospitals and dialysis clinics<br>by a qualified operator. | Same | Same | | Same adult indication for<br>use |
| Proportioning system | Continuous volumetric dilution<br>with duplex pump | Same | Same | | Same |
| Temperature control (°C) | 34 to 40 | Same | Same | | Same |
| Temperature alarm limit (°C) | Fixed: 33, 41<br>Auto: ±1 from set value¹ | Same | Same | | Same |
| Bicarbonate conductivity range<br>(mS/cm) | 2.30 to 7.00 | Same | Same | | Same |
| Total conductivity range (mS/cm) | 12.5 to 15.5 | Same | Same | | Same |
| Flow (mL/min) | 0, 300 to 800 | Same | Same | | Same |
| Transmembrane pressure (mmHg) | -100 to +500 | Same | Same | | Same |
| Sodium therapy | Yes, Profiled | Same | Same | | Same |
| Ultrafiltration removal rate (L/h) | 0.00; 0.10 to 4.00, Profiled UF | Same | Same | | Same |
| pH monitor | None | Same | Same | | Same |

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# K091978
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# ACHMENT QUESTION 1, 2, and 3

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DBB-06 HEMODIALYSIS DELIVERY SYSTEI
(K091978)

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| (<br>t |
|---------------------------------------|
| A State Base<br>1<br>Call of Children |

| Device Characteristics | PREDICATES<br>Nikkiso DBB-05<br>Hemodialysis Delivery System<br>(K023509) | Modification to<br>Nikkiso DBB-05<br>Hemodialysis Delivery<br>System<br>(K061519) | PROPOSED<br>Nikkiso DBB-06-<br>Hemodialysis Delivery<br>System |
|--------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------|
| BYPASS INDICATOR | Visual | Same | Same |
| BLOOD CIRCUIT | | | |
| Arterial pressure (mmHg) | -300 to +300 | Same | Same |
| Venous pressure (mmHg) | -200 to +500 | Same | Same |
| Blood pump range (mL/min) | 40 to 600 | Same | Same |
| Heparin pump range (mL/h) | 0.0 to 9.9 (10, 20, 30 mL syringe) | Same | Same |
| DISINFECTION | Chemical, thermo-chemical, hot rinse | Same | Same |
| DISPLAY TYPE | LCD, 12.1" color, SVGA | Same | Same |
| DISPLAY PARAMETERS | | | |
| Dialysate pressure | Yes | Same | Same |
| Transmembrane pressure | Yes | Same | Same |
| Bicarbonate conductivity | Yes2 | Same | Same |
| Total conductivity | Yes | Same | Same |
| Flow rate | Yes | Same | Same |
| Elapsed time | Yes | Same | Same |
| Remaining time | Yes | Same | Same |
| Complete time | Yes | Same | Same |
| Kt/V ratio calculation display | No | Yes | Yes |
| Blood pressure value history | Numeric | Numeric or Graphical | Numeric or Graphical |
| Blood volume | No | No | Yes |
| MICROPROCESSOR | | | |
| Type | 3 microprocessor system, TX1941AF Toshiba, 32bit. | Same | Same |
| Storage | Treatment data | Same | Same |

# DBB-06 HEMODIALYSIS DELIVERY SYSTER
(K091978)

# ACHMENT QUESTION 1, 2, and

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6-5 OF 6-11

Page 4 of 10

1. 1

esponse to fda letter dated september 4, 200

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| | RESPONSE TO FDA LETTER DATED SEPTEMBER 4, 2009 |
|--|------------------------------------------------|
|--|------------------------------------------------|

NIKKISO CO., LTD

| Device Characteristics | PREDICATES<br>Nikkiso DBB-05<br>Hemodialysis Delivery System<br>(K023509) | Modification to<br>Nikkiso DBB-05<br>Hemodialysis Delivery System<br>(K061519) | PROPOSED<br>Nikkiso DBB-06<br>Hemodialysis Delivery<br>System |
|------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------|
| Interface | Built-in RS-232 for technician,<br>Optional TCP/IP for network<br>system. | Same | Same |
| LOSS-OF-WATER ALARM | Yes | Same | Same |
| OTHER SPECIFICATION | Yes | Same | Same |
| Single needle Click-Clack | No | Yes | Yes |
| Arterial clamp for use during Single<br>needle Click-Clack | Liquid | Liquid or Dry Powder | Liquid or Dry Powder |
| Bicarbonate concentrate type | Yes | Same | Same |
| Built in BP monitoring | Yes | Same | Same |
| Isolation UF | Yes, Continuously3 | Same | Same |
| Online UF control test | No | Same | Same |
| Built in Blood Volume Monitor (BVM) | Notes: | | |

- The dialysate temperature alam limit is set to ±1°C from the temperature target value automatically. The alam wind
#1°C can be changed from 0 to ±3°C.
The maximum concentrate "I ನ ಗ
- -

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# New optional accessories

# Blood Volume Monitor (BVM)

A Blood Volume Monitor (BVM) is a new optional accessory available with the DBB-06 HEMODIALYSIS DELIVERY SYSTEM, which was not available in the predicate devices; the DBB-05 Hemodialysis Delivery System (K023509) and the Modification to DBB-05 Hemodialysis Delivery System (K061519).

The predicate device used to determine substantial equivalence to the Blood Volume Monitor (BVM) was the CRIT-LINE Monitor III (CLMII) (K972470). Both the Blood Volume Monitor (BVM) and the CRIT-LINE Monitor III (CLMIII) (K972470) are identical in function and operate under the same principle of light absorption passing through the blood under test, to measure hematocrit and calculate the related value of blood volume.

Following is comparison table for the Blood Volume Monitor of DBB-06 and the CRIT-LINE Monitor III (K972470);

| Table 2 BVM Comparison Table | | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Predicate Device:<br>CRIT-LINE Monitor III (K972470) | DBB-06 Blood Volume Monitor |
| Intended Use | Used for non-invasive hematocrit, oxygen saturation and blood volume monitoring. Percent change in blood volume in real time application in the treatment of dialysis patients with intended purpose of providing a more effective treatment for the dialysis patient. Based on the data that the monitors provide, the dialysis technician increases or decreases the rate at which fluid is removed from the blood in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting. | Used for non-invasive blood volume monitoring. This monitoring provides the percent change in blood volume in real time. The healthcare provider may increase or decrease the rate at which fluid is removed from the blood based on the data that blood volume monitor provides. |
| Technological<br>Characteristics | | |
| Principle of blood<br>volume monitoring | The device functions and operates under the principles of light absorption through the blood to calculate the relative value of Blood Volume (BV). | The device functions and operates under the principles of light absorption through the blood to calculate the relative value of Blood Volume (BV). |
| Microprocessor<br>control | Yes | Yes |

# Table 2 BVM Comparison Table

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RESPONSE TO FDA LETTER DATED SEPTEMBER 4, 2009

# K091978

NIKKISO CO., LTD

| The measurement is accomplished by calibrated Analog to Digital Converters (ADC). | Yes | Yes |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Accuracy | Approximately +/-2% and compare well with other methods such as centrifuge. | Approximately +/-2% and compare well with other methods such as centrifuge. |
| Clinical testing | No clinical testing was performed. Comparison testing was performed on blood bank blood under simulated conditions. | Clinical Test was performed |

Based on the technical characteristics, performance and failure simulation testing of the Blood Volume Monitor (BVM), NIKKISO CO., LTD. concludes that the Blood Volume Monitor (BVM) performed as well as and is substantially equivalent to the CRIT-LINE Monitor III (CLMIII) (K972470) and does not raise any new questions regarding safety or effectiveness.

Non-Invasive Blood Pressure (NIBP) measurement module

A Non-Invasive Blood Pressure (NIBP) measurement module is an optional accessory used to monitor the patient's blood pressure during hemodialysis treatment. The DBB-05 Hemodialysis Delivery System (K023509) and the Modification to DBB-05 Hemodialysis Delivery System (K061519) both use the Omron Colin Model M2100 NIBP. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses a newer model, the Omron Colin Model M2500 NIBP. The manufacturer for both models is Omron Colin Co., Ltd., 1-12-14 Koishikawa, Bunkyo-ku, Tokyo Japan.

The M2500 is integrated into a variety of patient monitors worldwide and is used to measure patient blood pressure using the oscillometric method with a standard blood pressure cuff wrapped on the patient's upper arm. The M2500 consists of the following four major hardware and software blocks:

- · Cuff pressure control hardware block
- · Cuff pressure detection and pulse detection hardware block
- · Cuff pressure and pulse amplitude data set generation block
- · Blood pressure determination block

The M2100 was developed using similar technology of the predicate device, the Press-Mate Advantage (K973637). All three (3) NIBPs, the M2500, M2100 and the Press-Mate Advantage are manufactured by Colin Corporation, which merged with Omron Group creating the new company Omron Colin Co., Ltd.

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RESPONSE TO FDA LETTER DATED SEPTEMBER 4, 2009

Following is comparison table of the M2500, M2100 and the Press-Mate Advantage.

Table 3 comparison table of the M2500, M2100 and the Press-Mate Advantage.

| No. | Item | M2500<br>NIBP for DBB-06<br>(K091978) under<br>application | M2100<br>NIBP for DBB-05<br>(K023509) and<br>modified DBB-05<br>(K061519) | Press-Mate Advantage<br>(K973637) |
|-----|-----------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------|
| 1 | Cuff<br>(Arm circumference<br>range) | 12~40cm | Same | 10~66cm |
| 2 | Cuff Biocompatibility | Compliant | Compliant | Compliant |
| 3 | IEC60601-2-30:1999 | Compliant | Compliant | IEC60601-2-30:1995 |
| 4 | EN1060-1:1995 | Compliant | Compliant | Compliant |
| 5 | EN1060-3:1997 | Compliant | Compliant | Compliant |
| 6 | ANSI/AAMI SP-10<br>for NIBP Measurement | Compliant | Compliant | Compliant |
| 7 | Measuring range and<br>Accuracy | 0 to 300mmH<br>Within +/-3mmHg | 0 to 300mmH<br>Within +/-3mmHg | 0 to 300mmH<br>Within +/-3mmHg |
| 8 | Power supply | DC 12 V | DC 12 V | * |
| 9 | Pin assigns | 3 Signal Pins and 7<br>Power supply pins | 3 Signal Pins and 7<br>Power supply pins | -* |
| 10 | Technical Alarms | 12 types of alarms<br>(C11-21) | 12 types of alarms<br>(C11-21) | 12 types of alarms<br>(C11-21) |
| 11 | Fatal Alarms | 4 types of alarms(E03,<br>E07, E08,E09) | 4 types of alarms(E03,<br>E07, E08,E09) | 4 types of alarms(E03,<br>E07, E08,E09) |
| 12 | Software algorithms | Same | Same | Same |

*: Device is an all-in-one vital signs monitor with NIBP, and is not connected to another device.

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RESPONSE TO FDA LETTER DATED SEPTEMBER 4, 2009

NIKKISO CO., LTD

As shown in the above comparison table as well as in the performance test in those blood pressure monitors, it is demonstrated that M2500 is substantially equivalent to the M2100 used in the predicate devices, the DBB-05 Hemodialysis Delivery System (K023509) and the Modification to DBB-05 Hemodialysis Delivery System (K061519) and to Press-Mate Advantage, and does not raise any new questions regarding safety or effectiveness.

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NIKKISO CO., LTD

# i. Conclusion

Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices, NIKKISO CO., LTD. concludes that the DBB-06 HEMODIALYSIS DELIVERY SYSTEM is substantially equivalent to the DBB-05 Hemodialysis Delivery System (k023509) and the Modification to DBB-05 Hemodialysis Delivery System (k061519), and does not raise any new questions regarding safety or effectiveness.

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Image /page/10/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Nikkiso Co., Ltd. % Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo Bunkyo-ku Tokyo, 113-0035 JAPAN

MAR 2 5 2010

Re: K091978

Trade/Device Name: DBB-06 Hemodialysis Delivery System Regulation Number: 21 CFR \$876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Codes: KDI Dated: March 19, 2010 Received: March 22, 2010

Dear Dr. 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. 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

1091978 510(k) Number (If known):

Device Name: DBB-06 HEMODIALYSIS SYSTEM

# Indication 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.

| Prescription Use | X |
|----------------------------|---|
| (Per 21 CFR 801 Subpart D) | |

AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Ott) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number