(568 days)
Not Found
No
The device description and intended use clearly define HEMOCLEAN® as a chemical disinfectant solution with specific dilution and contact time requirements for different hemodialysis machines. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on in vitro testing and functional testing as a disinfectant, not on algorithmic performance.
No.
HEMOCLEAN® is intended for the disinfection of artificial kidney machines (hemodialysis machines), not for direct therapeutic use on patients.
No
The device, HEMOCLEAN®, is intended for the disinfection of artificial kidney machines (hemodialysis machines), not for diagnosing conditions in patients.
No
The device is a liquid germicide intended for disinfecting hemodialysis machines, not a software application.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of HEMOCLEAN® is explicitly stated as the "disinfection of artificial kidney machines (hemodialysis machines)." This is a cleaning and disinfection function for medical equipment, not a diagnostic test performed on biological samples.
- Device Description: The description details the chemical composition and physical properties of a germicide. It does not describe a device designed to analyze biological specimens to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples, detecting biomarkers, or providing any information related to a patient's health status or disease.
- Performance Studies: The performance studies described focus on the efficacy of the device as a disinfectant ("in vitro performance testing was performed to establish and compare performance characteristics to the predicate devices") and its function within hemodialysis machines ("Testing was performed in a dialysis clinic in hemodialysis machines to demonstrate that the device functioned according to specifications as a hemodialysis machine disinfectant"). These are not studies evaluating diagnostic accuracy.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. HEMOCLEAN® does not fit this definition.
N/A
Intended Use / Indications for 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. |
Product codes
NII
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%(
§ 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.”
0
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%( Over-The-Counter-Use (Optional Format 1-2-96)