HEMOCLEAN

K023064 · Krd Co., Ltd. · NII · Apr 6, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K023064
• Device Name: HEMOCLEAN
• Applicant: Krd Co., Ltd.
• Product Code: NII · Gastroenterology, Urology
• Decision Date: Apr 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2

Intended Use

HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition: Hemodialysis Machine Dilution rate Contact time COBE CentrySystem 3 1:9 10 minutes. Nikkiso DBB 22B 1:34 29 minutes. Fresenius 2008K. 1:34 15 minutes. Gambro Phoenix 1:25 15 minutes.

Device Story

HEMOCLEAN® is a single-component liquid germicide for hemodialysis machine disinfection. Composition: stabilized mixture of 5.3% hydrogen peroxide and 1.7% peracetic acid. Product is clear, colorless, water-soluble; decomposes into carbon dioxide, water, and oxygen. Used full-strength with automated dilution by hemodialysis machines; requires AAMI-quality water for dilution. Packaged in 5-liter polyethylene containers. Operated by clinical staff in dialysis clinics. Disinfectant action is bactericidal, sporicidal, tuberculocidal, and pseudomonacidal. Benefits include effective machine sanitation with low-toxicity decomposition products.

Clinical Evidence

Testing performed in a dialysis clinic using hemodialysis machines. Demonstrated device functioned according to specifications as a disinfectant. No specific sensitivity/specificity metrics provided; relies on established efficacy of peracetic acid-based germicides.

Technological Characteristics

Liquid chemical germicide; stabilized mixture of hydrogen peroxide (5.3%) and peracetic acid (1.7%). Completely water-soluble. Packaged in 5L polyethylene containers with vent filter. Automated dilution via hemodialysis machine. No electronic components or software.

Indications for Use

Indicated for disinfection of hemodialysis machines. Used in clinical settings for maintenance of artificial kidney equipment.

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

• Actril® (K861730)

Submission Summary (Full Text)

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K023064

APR - 6 2004

510K Notification Supplement KRD CO., LTD. Hemoclean -K023064 March 29th *, 2004

# 510K(k) SUMMARY

| SUBMITTER: | KRD CO., LTD. |
|-----------------------|------------------------------------------------------------------------------|
| | 1529-4 Songjeong-dong, Gangseo-gu, |
| | Busan 618-270, Korea |
| DATE PREPARED: | March 29th 2004 |
| DEVICE NAME: | KRD CO., LTD. HEMOCLEAN® |
| CLASSIFICATION NAMES: | System, Dialysate Delivery, Central and Multiple- Accessory for Hemodialysis |
| PREDICATE DEVICE: | Minntech/Renal Systems Actril® (510(k) Number: K861730) |

### Device Description:

HEMOCLEAN® is a single component germicide that does not require mixing or activation. HEMOCLEAN® is a stabilized mixture of hydrogen peroxide 5.3%(<6.0%) and peracetic acid 1.7%; inert ingredients are 93%. The product is a clear colorless liquid, high acid, and completely soluble in water. HEMOCLEAN® finally breaks down to carbon dioxide, water, and oxygen. The product is used full strength with automated dilution by the hemodialysis machine for the intended use. It is packaged in five liters polyethylene containers with a vent filter on the cap and is shipped in two 5-liter containers per box. The shelf life of the concentrate is one year when properly stored.

HEMOCLEAN® is indicated for the disinfection of hemodialysis machines. To use HEMOCLEAN® in automated hemodialysis machines, the user should follow the manufacture's recommendations for dilution of peracetic acid-based disinfectants. AAMI-quality water for hemodialysis must be used for diluting HEMOCLEAN® in the hemodialysis machine.

#### Predicate Devices:

There has been a device previously cleared by the FDA in the following 510(K) Notification indicated as a disinfectant for hemodialysis machines:

| Device | 510(k)<br>Number | Document | Date Cleared | Indications |
|-----------------------------------|------------------|----------|----------------|-------------------------------------------------------------|
| Actril®<br>Minntech/Renal Systems | K861730 | | June 9th, 1987 | Artificial Kidney<br>(hemodialysis)<br>Machine Disinfection |

### CONFIDENTIAL

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K023064

510K Notification Suppleme KRD CO., LTD. Hemoclean -K02306 March 29th 6, 2004

#### Intended Use:

#### HEMOCLEAN Indications:

HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines). It should be used under the following the dilution rate and contact condition:

| Hemodialysis Machine | Dilution rate | Contact time |
|----------------------|---------------|--------------|
| COBE CentrySystem 3 | 1:9 | 10 minutes. |
| Nikkiso DBB 22B | 1:34 | 29 minutes. |
| Fresenius 2008K. | 1:34 | 15 minutes. |
| Gambro Phoenix | 1:25 | 15 minutes. |

#### Technological Characteristics:

Comparing the proposed devices to the predicate devices, they are substantially equivalent with respect to technological characteristics.

#### Summary of Non-Clinical Tests:

In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices.

#### Clinical Test Results:

Testing was performed in a dialysis clinic in hemodialysis machines to demonstrate that the device functioned according to specifications as a hemodialysis machine disinfectant.

#### Conclusions:

KRD CO., LTD. has performed testing to demonstrate that HEMOCLEAN® is safe and effective when used according to the instructions for use. Peracetic acid, which is the primary active ingredient in both Actril® and HEMOCLEAN® has been shown to be an effective biocidal agent. Peracetic acid-based chemical germicides have a long history of use in artificial kidney machines (hemodialysis machines) as disinfection agents. The actions of these germicides are bactericidal, sporicidal, tuberculocidal, psedomonacidal, and are effective against non-tuberculosis mycobacterium(NTM). The decomposition products have low or no toxicity. Efficacy and other performance characteristics are well established by extensive long-term clinical use and welldocumented in the scientific literature. The safety and effectiveness performance of HEMOCLEAN® are identical to the safety and effectiveness performance of Actril®.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 6 2004

KRD Company Limited C/O Mr. Jeffery R. Shideman International Medical Products Corporation & Anderson Consulting International 7307 Glouchester Drive Edina, Minnesota 55435

Re: K023064

Trade/Device Name: HEMOCLEAN® Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: NII Dated: January 8, 2004 Received: January 12, 2004

Dear Mr. Shideman:

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 such 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.

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Page 2 - Mr. Shideman

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 (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.

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 [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 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 vours.

fitt Waitochaser

feri

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510 (k) NUMBER (IF KNOWN): K023064 Device Name: HEMOCLEAN®

#### INDICATIONS FOR USE:

#### HEMOCLEAN® Indications:

HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis It should be used under the following the dilution rate and contact condition: machines).

| Hemodialysis Machine | Dilution rate | Contact time |
|----------------------|---------------|--------------|
| COBE CentrySystem 3 | 1:9 | 10 minutes. |
| Nikkiso DBB 22B | 1:34 | 29 minutes. |
| Fresenius 2008K | 1:34 | 15 minutes. |
| Gambro Phoenix | 1:25 | 15 minutes. |

Kein Mely for cc
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number _

## (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED.)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

> Over-The-Counter-Use (Optional Format 1-2-96)

#### CONFIDENTIAL