DBB-05 HEMODIALYSIS DELIVERY SYSTEM

K023509 · Davita Clinical Research (Trri) · KDI · Oct 30, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023509
• Device Name: DBB-05 HEMODIALYSIS DELIVERY SYSTEM
• Applicant: Davita Clinical Research (Trri)
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Oct 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.

Device Story

The DBB-05 Hemodialysis Delivery System is a clinical device used in hospitals and dialysis clinics by qualified operators to perform hemodialysis. It consists of a hydraulic unit for dialysate delivery and extracorporeal blood circuitry. The system heats and deaerates permeate, mixes it with concentrate, and delivers it to the dialyzer. A closed balancing system ensures dialysate infusion matches extraction. The device automatically controls dialyzer interior pressure via ultrafiltration (UF) rate adjustments. It supports acetate and bicarbonate dialysis, as well as single-needle and double-needle treatment modes. A heparin pump allows for continuous or one-shot anticoagulation. The system includes programmable conductivity and UF profiles, selectable cleaning/disinfection cycles, and safety monitoring systems. By managing blood and dialysate flow, the device facilitates the removal of waste products and excess fluid, benefiting patients with renal failure.

Clinical Evidence

Bench testing only. Performance tests included electrical safety, failure simulation, and software testing conducted under conditions simulating normal usage to ensure conformance with product specifications.

Technological Characteristics

Hydraulic unit for dialysate delivery; extracorporeal blood circuitry; closed balancing system; automated ultrafiltration control; heparin pump; supports acetate and bicarbonate dialysis; programmable conductivity and UF profiles; selectable cleaning/disinfection programs; safety monitoring systems.

Indications for Use

Indicated for adult and pediatric patients with acute or chronic renal failure requiring hemodialysis.

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

• Fresenius Hemodialysate System, model 2008H (K994267)

Submission Summary (Full Text)

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## OCT 3 0 2003

K023509
page 1 of 2

## SUMMARY AND CERTIFICATION SECTION 2. __

| 510(k) Summary<br>A. | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Nikkiso Co., LTD |
| | Mr. Noboru Tsuchida |
| | Manager of Quality Control |
| | Medical Devices Factor |
| | 498-1, Shizutani, Haibara-cho, Haibara-gun, Shizuoka 421-496 |
| | Japan |
| | Phone number: [phone] Medical Equipment Unit |
| Contact | Harry Alcorn, Jr. PharmD. |
| Person: | Chief Operating Officer |
| | DaVita Clinical Research (TRRI) |
| | 825 South 8th Street |
| | Minneapolis, MN 55404 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Date | October 20, 2003 |
| Prepared: | October 20, 2003 |
| Trade Name: | The DBB-05 Hemodialysis Delivery System |
| Classification | Class II |
| Name and | High Permeability Hemodialyzer |
| Number: | 21 CFR 867.5860 |
| Product | KDI |
| Code: | |
| Predicate | The subject device is substantially equivalent to the Fresenius<br>Hemodialysate System, model 2008H, (K994267) manufactured by |
| Device(s): | Fresenius Medical Care North America. |
| Device | The subject device is composed of a hydraulic unit for the delivery of |
| Description: | 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 dialyser 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 dialyser is controlled automatically by adjustment of the ultra |
| | filtration amount and UF rate by the dialyser. Heparinization of the |
| | external circulating blood can be done with the heparin pump either by |
| | continuous or one-shot injection before it is passed on to the dialyser. |
| | The subject device uses both acetate dialysis and bicarbonate dialysis. |
| | Using the various functions the device, the conductivity and UF profile |
| | can be programmed. In addition, the subject device incorporates all |
| | functions necessary for double-needle dialysis as well as single-needle |
| | dialysis treatment. The hydraulic unit is cleaned and disinfected using |
| | selectable cleaning programs and is equipped with the necessary<br>protective systems for patient safety and correct operation. |
| Intended<br>Use: | The DBB-05 Hemodialysis Delivery System is indicated for<br>hemodialysis prescribed by physicians for adult and pediatric patients<br>with acute or chronic renal failure. The DBB-05 is intended for<br>hemodialysis performed in hospitals and dialysis clinics by a qualified<br>operator. |
| Functional<br>and Safety<br>Testing: | Functional and safety testing of the DBB-05 Hemodialysis Delivery<br>System consisted of performance tests that include electrical safety,<br>failure simulation and software tests. Examination of device function<br>was performed under conditions similar to those found in normal usage<br>to ensure conformance with product specifications. The result of the<br>testing was successful. The device performed as designed and met, or<br>exceeded, all product specifications. |
| Conclusion: | The DBB-05 Hemodialysis Delivery System, manufactured by Nikkiso<br>Co., LTD, is substantially equivalent to Fresenius Hemodialysate<br>System, model 2008H, (K994267) manufactured by Fresenius Medical<br>Care North America. This conclusion is based upon the devices'<br>similarities in functional design, materials, indications for use, and<br>other device features. |

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K02.3509
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of wings and a head.

OCT 3 0 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nikkiso Co., LTD c/o Harry Alcorn, Jr., PharmD. Chief Operating Officer DaVita Clinical Research (TRRI) 825 South 8th Street MINNEAPOLIS MN 55404

Re: K023509

Trade/Device Name: DBB-05 Hemodialysis Delivery System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: August 21, 2003 Received: August 25, 2003

Dear Dr. Alcorn:

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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. I rogdon 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 Page

Device Name: The DBB-05 Hemodialysis Delivery System

## Indications for Use:

The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K023509

Prescription Use (Per 21 CFR 801.109)