(665 days)
Not Found
No
The document describes a standard dialysis machine with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is used for the treatment of renal failure or toxic conditions, which directly addresses a medical condition to restore health.
No
The device is described as an "artificial kidney system" used for the "treatment of renal failure or toxic Conditions" and "High-Flux Hemodialysis." It separates substances via a semipermeable membrane and allows for ultrafiltration and heparin infusion. These are treatment functions, not diagnostic ones.
No
The device description clearly states it is a "Dialog Dialysis Machine" and describes physical components like an "extracorporeal blood system" and a "blood pump," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Volume controlled ultrafiltration and infusion of heparin through a blood pump for the treatment of renal failure or toxic Conditions" and "High Flux Hemodialysis." These are therapeutic procedures performed on the patient's body, not tests performed on samples taken from the body.
- Device Description: The description details an "artificial kidney system" with an "extracorporeal blood system" and a "semipermeable membrane" for separating substances. This describes a device that directly interacts with the patient's blood flow to perform a treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.) to provide diagnostic information. The device is used for treatment, not diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the device is for Volume controlled ultrafiltration and infusion of heparin through a blood pump for the treatment of renal failure or toxic Conditions. This device may be used for High. Flux Hemodialysis.
Product codes (comma separated list FDA assigned to the subject device)
78 FKP, 78 KDI
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Dialog Dialysis Machine. The Dialog Dialysis Machine is an artificial kidney system used for the treatment of patients with renal failure or toxic conditions. The device consists of an extracorporeal blood system for the separation of substances in solutions via a semipermeable membrane. The system allows for volume controlled ultfiltration and/or infusion of heparin through a blood pump by utilizing a standard double needle or optional single needle dialysis procedure. The components and materials used for the Dialog Dialysis Machine do not come into direct patient contact.
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)
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K854367, K850569 Modified, K880459
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.
Not Found
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).
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
JUN 26 1998
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
August 29, 1996
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem. PA 18018 (610)691-5400
Mark S. Alsberge, Regulatory Affairs Manager CONTACT:
Dialog Dialysis Machine PRODUCT NAME:
Single Patient Dialysate Delivery System TRADE NAME:
CLASSIFICATION NAME:
Gastroenterology & Urology Class II, 78 FKP, Single Patient Dialysate Delivery System 21 CFR 876.5820
SUBSTANTIAL EQUIVALENCE TO:
| 510 (k) Number | Applicant | Description |
|---|---|---|
| K854367, K850569 Modified | Organon Teknika | HD Secura Dialysis Unit |
| K880459 | CD Medical | 480 High-Flow Ultrafiltration Control |
| Dialysate |
DEVICE DESCRIPTION:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Dialog Dialysis Machine. The Dialog Dialysis Machine is an artificial kidney system used for the treatment of patients with renal failure or toxic conditions. The device consists of an extracorporeal blood system for the separation of substances in solutions via a semipermeable membrane. The system allows for volume controlled ultfiltration and/or infusion of heparin through a blood pump by utilizing a standard double needle or optional single needle dialysis procedure.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product technology used to manufacture the product.
1
K963440
p. 2/2
The components and materials used for the Dialog Dialysis Machine do not come into direct patient contact.
SUBSTANTIAL EQUIVALENCE:
The Dialog Dialysis Machine is identical in materials, form, and intended use to the HD Secura Dialysis Unit currently marketed by Organon Teknika and the 480 High-Flow Ultrafiltration Control Dialysate marketed by CD Medical. There are no new issues of safety or effectiveness raised by Dialog Dialysis Machine.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
5
2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health and Human Services. The logo is a stylized eagle with three lines extending from its head. The word "DEPARTMENT" is written vertically along the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1998
Mr. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018-0027
Dear Mr. Alsberge:
Re: K963440 Dialog Dialysis Machine Dated: May 27, 1998 Received: June 5, 1998 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI
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 indications for use stated in the enclosure) to 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). 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 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 requirements, as set forth in the Quality System Regulation (QS) 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 542 of the Act for devices under the Electronic Product 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 questions on the promotion 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/cdrh/dsmaldsmamain.html".
Sincerely yours.
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
3
510(k) Number (if known):
Device Name: Dialog Dialysis Machine
Indications For Use:
The intended use of the device is for
Volume controlled ultrafiltration and infusion
of heparin through a blood pump for the
treatment of renal failure or toxic Conditions.
This device may be used for High. Flux
Hemodialysis.
(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)
OR
Over-The-C ter Use
(Optional Format 1-2-9G)