(442 days)
No
The device description focuses on hardware modifications and software that calculates clearance based on conductivity changes, without mentioning any AI/ML techniques. The performance studies compare the conductivity-based method to urea measurements, not to an AI/ML model's output.
No.
The device is a monitor that determines dialyzer clearance efficiency, providing information to the operator; it does not directly treat or prevent a disease.
Yes
Explanation: The device determines dialyzer clearance efficiency, which is a measurement of a physiological parameter (dialyzer performance) to assess the effectiveness of a medical treatment (dialysis).
No
The device description explicitly states that the OLC consists of "hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software." This indicates the device includes both hardware and software components.
Based on the provided information, the Fresenius On Line Clearance Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or monitoring of a disease or condition.
- Device Function: The Fresenius On Line Clearance Monitor measures dialyzer clearance efficiency by analyzing the conductivity of the dialysate solution, which is a fluid used in the dialysis process, not a specimen taken from the patient's body.
- Method of Measurement: It uses changes in dialysate conductivity as a surrogate marker for urea clearance, but the measurement itself is performed on the dialysate fluid circuit within the hemodialysis machine.
- Non-Invasive: The description explicitly states the use is "non invasive" and "performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator." This further supports that it's not interacting with or analyzing patient specimens.
While the device provides information relevant to the dialysis treatment (monitoring dialyzer performance), it does so by analyzing the dialysate fluid, not a biological specimen from the patient. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution.
The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.
Product codes
78 KDI
Device Description
The Fresenius On Line Clearance Monitor (OLC) is a module that is incorporated into the Fresenius 2008H hemodialysis equipment. The OLC consists of hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software. The dialyzer clearance determination is made using changes in dialysate conductivity (Sodium concentration). The software either increases or decreases the dialysate conductivity. This change in conductivity causes a sodium concentration gradient to be formed between the blood and dialysate sides of the dialyzer. Sodium is then either diffused into the blood or out of the blood depending whether the dialysate conductivity is high or low. Accurate conductivity readings of the inlet and outlet dialysate solution can be used to calculate the flux of sodium (or change in conductivity because of changes in sodium concentration) in the dialysate. This value can then be used to calculate the dialyzer clearance of sodium. The clearance of sodium has been used as a surrogate dialyzer performance solute since the beginning of dialysis since urea and Sodium (from NaCl) pass through the dialysis membrane at essentially the same rate.
The use of the On Line Clearance Monitor is non invasive and is performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator and minimizes the need for blood based urea analysis and dialyzer performance determination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Testing: The use of Sodium (conductivity) as a clearance marker was compared to urea using a number of different dialyzer membranes and found that there was statistically significant correlation that the clearance values obtained were the same.
Clinical Testing: A modified 2008H hemodialysis machine was used clinically to evaluate dialyzer performance during dialysis comparing clearance performance from the OLC to identical blood side urea measurements. The results of the testing indicated that there was no difference in the clearance determinations between the two methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Fresenius USA, Inc. 2637 Shadelands Drive Valnut Creek, CA 94598 10) 295-0200 1) 988-1900 (Fax)
Image /page/0/Picture/1 description: The image shows the Fresenius USA logo, which is a stylized letter F. Above the logo, there is handwritten text that reads "K961465" and "pg. 1 of 3". The logo is in black and white and is positioned on the left side of the image. The handwritten text is in the upper right corner.
510 (k) Summary of Safety and Effectiveness Information for the Fresenius On Line Clearance Monitor
JUL - 3 1997
1. Applicant:
Fresenius USA, Inc 2637 Shadelands Drive Walnut Creek, CA 94598
| Contact Person: | Thomas I. Folden
Director, Product Development |
|------------------------|---------------------------------------------------|
| Telephone: | 1-510-295-0200
1-510 988-1958 (Fax) |
| Date Summary Prepared: | April 15, 1996 |
- Fresenius On Line Clearance Monitor 2. Device Name:
3. Predicate Devices
Fresenius USA, Inc. claims that the On Line Clearance Monitor is substantially equivalent to equipment adaptors for determination of dialyzer performance using conductivity that were made commercially available and found substantially equivalent under premarket notifications K830190 and K841153. Fresenius also claims substantial equivalence to manual invasive blood urea determinations of dialyzer performance.
4. Intended Use
ﻟﻤﺴﺘﻘ く
The Fresenius On Line Clearance Monitor is a module that is incorporated into the Fresenius 2008H hemodialysis equipment to be used during a dialysis treatment to determine dialyzer clearance efficiency using changes in conductivity of the dialysate solution.
K961465 - 1/3
1
K961465
pg. 2 of 3
Device Description 5.
The Fresenius On Line Clearance Monitor (OLC) is a module that is incorporated into the Fresenius 2008H hemodialysis equipment. The OLC consists of hardware modifications to the 2008H dialysate fluid circuit which includes a second conductivity probe in the effluent dialysate line and software. The dialyzer clearance determination is made using changes in dialysate conductivity (Sodium concentration). The software either increases or decreases the dialysate conductivity. This change in conductivity causes a sodium concentration gradient to be formed between the blood and dialysate sides of the dialyzer. Sodium is then either diffused into the blood or out of the blood depending whether the dialysate conductivity is high or low. Accurate conductivity readings of the inlet and outlet dialysate solution can be used to calculate the flux of sodium (or change in conductivity because of changes in sodium concentration) in the dialysate. This value can then be used to calculate the dialyzer clearance of sodium. The clearance of sodium has been used as a surrogate dialyzer performance solute since the beginning of dialysis since urea and Sodium (from NaCl) pass through the dialysis membrane at essentially the same rate.
The use of the On Line Clearance Monitor is non invasive and is performed automatically by the hemodialysis equipment with no effect to the patient or action of the operator and minimizes the need for blood based urea analysis and dialyzer performance determination.
Comparison of Technological Characteristics and Statement of 6. Substantial Equivalence
The Fresenius On Line Clearance Monitor utilizes conductivity as a marker to determine dialyzer performance in the same manner as the Colorado Medical equipment adaptor previously found substantially equivalent under premarket notifications K 830190 and K841153 by monitoring the inlet and outlet dialysate conductivities with standard conductivity probes and calculating a clearance value for the dialyzer. The OLC also is equivalent to blood urea clearance determinations currently used clinically to rate dialyzer efficiency.
Testing:
Non Clinical Testing: The use of Sodium (conductivity) as a clearance marker was compared to urea using a number of different dialyzer membranes and found that there was statistically significant correlation that the clearance values obtained were the same.
K961465 - 2/3
2
K961465
pg. 3 of 3
Clinical Testing: A modified 2008H hemodialysis machine was used clinically to evaluate dialyzer performance during dialysis comparing clearance performance from the OLC to identical blood side urea measurements. The results of the testing indicated that there was no difference in the clearance determinations between the two methods.
K961465 - 3/3
3
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Folden Director, Product Development Fresenius USA 2637 Shadelands Drive Walnut Creek, California 94598
JUL - 3 1997
Re: K961465 2008H On Line Clearance Monitor Dated: April 2, 1997 Received: April 4, 1997 Regulatory class: III 21 CFR §876.5860/Product code: 78 KDI
Dear Mr. Folden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the inclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 vour device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/odrh/dsmamain.html"
Sincerely vours
H.J.Liau Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K961465
Device Name: . Fresenius 2008H On Line Clearance Monitor . . . . . . . . . . .
Indications for Use:
The Fresenius On Line Clearance Monitor is intended to be used as a module with the Fresenius 2008H hemodialysis machine for determination of dialysis treatment urea clearance efficiency using Sodium conductivity as the surrogate solute marker.
Robert R. Ratliff/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K961465 510(k) Number_
L Prescription Use _ (Per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________