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 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.

AI/ML Overview

The provided text describes the device HEMOCLEAN®, a germicide for hemodialysis machines, and references non-clinical and clinical tests performed during its 510(k) submission. However, the document does not contain specific acceptance criteria with numerical targets or detailed results that demonstrate how the device "meets" those criteria in a quantitative sense as typically seen for AI/ML device performance.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (Minntech/Renal Systems Actril®) by demonstrating similar technological characteristics and performance for its intended use as a hemodialysis machine disinfectant. The "acceptance criteria" appear to be implicit in demonstrating safety and effectiveness comparable to the predicate device.

Here's an analysis based on the information provided, attempting to fit it into the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Primary Active Ingredient: Contain peracetic acid as the primary active ingredient.	HEMOCLEAN® is a stabilized mixture of hydrogen peroxide 5.3%(<6.0%) and peracetic acid 1.7%. Peracetic acid is the primary active ingredient.
Biocidal Efficacy: Effective as a broad-spectrum biocidal agent (bactericidal, sporicidal, tuberculocidal, pseudomonacidal, effective against non-tuberculosis mycobacterium).	"Peracetic acid... has been shown to be an effective biocidal agent. Peracetic acid-based chemical germicides have a long history of use... The actions of these germicides are bactericidal, sporicidal, tuberculocidal, pseudomonacidal, and are effective against non-tuberculosis mycobacterium (NTM)." (This refers to peracetic acid in general, not explicitly HEMOCLEAN®'s performance from specific testing in this document).
Decomposition Products: Decomposition products should have low or no toxicity.	"The decomposition products have low or no toxicity."
Dilution and Contact Conditions: Effective under specific dilution rates and contact times for identified hemodialysis machines.	COBE CentrySystem 3: Dilution rate 1:9, Contact time 10 minutes. Nikkiso DBB 22B: Dilution rate 1:34, Contact time 29 minutes. Fresenius 2008K: Dilution rate 1:34, Contact time 15 minutes. Gambro Phoenix: Dilution rate 1:25, Contact time 15 minutes.
Safety and Effectiveness: Demonstrate safety and effectiveness comparable to the predicate device (Actril®).	"The safety and effectiveness performance of HEMOCLEAN® are identical to the safety and effectiveness performance of Actril®." "KRD CO., LTD. has performed testing to demonstrate that HEMOCLEAN® is safe and effective when used according to the instructions for use."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "In vitro performance testing" and "Testing was performed in a dialysis clinic in hemodialysis machines," but does not provide details on the number of runs, machines, or specific samples tested for these assessments.
Data Provenance: The "clinical test results" were from "a dialysis clinic." The country of origin for the data is not specified, but the submitter (KRD CO., LTD.) is based in Korea. The submission date is March 29th, 2004, indicating retrospective data collection relative to the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The concept of "ground truth established by experts" is more common for diagnostic imaging or AI/ML evaluations. For a chemical germicide, performance is typically assessed through standardized microbiological testing and chemical analysis, rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiologist reads) to establish a consensus ground truth. This is not described for the testing of HEMOCLEAN®.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided and is not applicable to this type of device. MRMC studies evaluate the performance of human readers, sometimes with and without AI assistance, for diagnostic tasks. HEMOCLEAN® is a chemical disinfectant, not a diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as HEMOCLEAN® is a chemical germicide, not an algorithm or AI/ML device. Its performance is chemical and biological efficacy.

7. The Type of Ground Truth Used

The "ground truth" for a chemical disinfectant would typically be established through:

Microbiological assays: Demonstrating specified log reductions of various microorganisms (bacteria, spores, fungi, viruses) under defined conditions.
Chemical analysis: Confirming the breakdown of the disinfectant into non-toxic components and verifying residual levels are within safe limits.
Predicate device comparison: Using the established performance characteristics and safety profile of the legally marketed predicate device (Actril®) as a benchmark.

The document indicates "In vitro performance testing" and "Testing was performed in a dialysis clinic in hemodialysis machines," which would likely involve these types of ground truth assessments, though specific metrics are not detailed.

8. The Sample Size for the Training Set

This information is not applicable as HEMOCLEAN® is a chemical germicide, not an AI/ML device that undergoes "training."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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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:

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)Number	Document	Date Cleared	Indications
Actril®Minntech/Renal Systems	K861730		June 9th, 1987	Artificial Kidney(hemodialysis)Machine Disinfection

CONFIDENTIAL

{1}------------------------------------------------

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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.)

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

Regulation Number and Section

§ 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.”