(454 days)
Dialog+0 Hemodialysis System
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No
The summary describes a dialysis machine with an optional feature (Adimea) that uses UV absorption to calculate Kt/V, a measure of dialysis effectiveness. There is no mention of AI, ML, or related concepts in the description of the device's functionality or the Adimea option.
Yes
The device, a hemodialysis system, is explicitly stated to be used for "monitoring hemodialysis treatments for patients with acute or chronic kidney failure," which is a therapeutic intervention.
No
Explanation: The device description states that the Adimea option "provides an alternate means of obtaining effectiveness information on the patient's hemodialysis treatment ... by continuously measuring the UV absorption in the spent dialysate line." It also mentions "Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness." This functionality is for monitoring and evaluating the effectiveness of a treatment already being administered, rather than diagnosing a disease or condition itself.
No
The device description explicitly states that the Adimea option includes "ancillary hardware (a double-beam spectrophotometer) and electronics" in addition to controlling software. This indicates it is not a software-only medical device.
Based on the provided information, the device described is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The primary function of this device is a dialysis machine used for implementing and monitoring hemodialysis treatments. While it uses a spectrophotometer to measure UV absorption in spent dialysate (which is a fluid used in the dialysis process, not a direct sample from the patient's body for diagnostic purposes), this measurement is used to calculate treatment effectiveness (Kt/V), not to diagnose a disease or condition in the patient.
- Intended Use: The intended use is for treating patients with kidney failure through hemodialysis, not for diagnosing kidney failure or other conditions.
- Device Description: The description focuses on the mechanics of dialysis and the measurement of treatment effectiveness, not on analyzing patient samples for diagnostic information.
The Adimea option, while using a measurement technique, is focused on monitoring the effectiveness of the treatment being delivered by the dialysis machine, not on providing a diagnosis or diagnostic information about the patient's health status.
N/A
Intended Use / Indications for Use
"This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician. The following types of renal replacement therapy can be carried out with the Dialog+ System: Hemodialysis (HD) with or without phases of pure ultrafiltration - High flux hemodialysis - Low flux hemodialysis"
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
"The Adimea option to the Dialog* Hemodialysis System provides an alternate means of obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
"hospital, health center and outpatient dialysis center settings when prescribed by a physician."
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Software requirements specifications for Adimea have been met and verification and validation testing is complete. This testing demonstrates that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Dialog+0 Hemodialysis System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.”
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Premarket Notification 510(k) Dialog+ Hemodialysis System with Adimea Option November 19, 2008
K083460
Page 1 of 2
Page _________________________________________________________________________________________________________________________________________________________________________
FEB 1 8 2010
5. 510(k) Summary
APPLICANT/
SUBMITTER:
B. Braun Avitum AG Schwarzenberger Weg 73-79 Melsungen, GERMANY D-34212
CONTACT:
Bonnie J. Kincaid, RAC Manager, Regulatory Affairs B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 Phone: 610-596-2970 Fax: 610-266-4962
Dialog+0 Hemodialysis System with Adimea" Option DEVICE NAME:
COMMON OR USUAL NAME: High permeability hemodialysis system
DEVICE CLASSIFICATION:
Class II per 21 CFR §876.5860: Product Code KDI
PREDICATE DEVICE(S):
Dialog+0 Hemodialysis System
The Adimea option to the Dialog* Hemodialysis System DESCRIPTION: an alternate means of of provides obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness.
INTENDED USE: This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.
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K083460
Page 2 of 2
Premarket Notification 510(k) Dialog+ Hemodialysis System with Adimea Option November 19, 2008
Page
510(k) Summary (continued)
The following types of renal replacement therapy can be carried out with the Dialog+ System:
Hemodialysis (HD) with or without phases of pure ultrafiltration -
- · High flux hemodialysis
- · Low flux hemodialysis
SUBSTANTIAL EQUIVALENCE:
The Dialog+ System with Adimea Option has the same intended use and utilizes the same fundamental technology as the predicate Dialog+ System. The Dialog+ System with Adimea Option is also similar to the predicate device in design and materials. The optional design feature that incorporates a spectrophotometric method of measuring the UV absorption in the spent dialysate line and the software calculation of KUV does not have a significant affect upon the fundamental technology of the Dialog+ System, since it operates as a discreet component / function of the Dialog+ System. Software requirements specifications for Adimea have been met and verification and validation testing is complete. This testing demonstrates that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. To the right of the text is a symbol that resembles three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUL - 8 2010
B. Braun Avitum AG c/o Ms. Bonnie Kincaid, RAC Manager, Regulatory Affairs B. Braun Medical, Inc. 901 Marcon Boulevard ALLENTOWN PA 18109-9341
Re: K083460
Trade/Device Name: Dialog+ Hemodialysis System with Adimea Option Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 5, 2010 Received: February 12, 2010
Dear Ms. Kincaid:
This letter corrects our substantially equivalent letter of February 18, 2010.
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 (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
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Page 2 - Ms. Bonnie Kincaid
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert Hoover
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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4. Indications for Use
510(k) Number (if known):
Device Name: Dialog+® Hemodialysis System with Adimea Option
Indications for Use:
This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.
The following types of renal replacement therapy can be carried out with the Dialog+ System:
Hemodialysis (HD) with or without phases of pure ultrafiltration -
- . High flux hemodialysis
- 트 Low flux hemodialysis
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR
Over-The-Counter Use
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number