(23 days)
No
The description focuses on a hardware modification (extension line for a blood warmer) and explicitly states no modifications were made to the control unit. There is no mention of AI/ML terms or functionalities.
Yes
The device is indicated for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload," which describes a therapeutic action.
No
Explanation: The device description states its purpose is for "continuous solute and/or fluid removal" and "gentle warming of the treated blood," indicating a treatment function rather than a diagnostic one.
No
The device description clearly outlines physical modifications to tubing sets and the introduction of an accessory sterile extension line, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. This is a therapeutic treatment, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details a system for continuous renal replacement therapy, including blood warming. This is a life support and treatment system, not a device used to diagnose conditions by analyzing samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PRISMA System, as described, is a therapeutic device used to treat patients directly.
N/A
Intended Use / Indications for Use
The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.
Product codes
78 KDI
Device Description
In accordance with Section 510(k) of the Food, Drug and Cosmetics Act, Gambro Renal Care Products intends to introduce a modification of the Prisma Continuous Fluid Management System into commercial distribution. The modification creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer manufactured by Stihler Electronic GmbH (K991159) to be used with the Prisma system during continuous renal replacement therapy. The integration of the Blood Warmer into the Prisma System will provide gentle warming of the treated blood, prior to its return to the patient. No modifications of the Prisma Dialysis Control Unit were made as part of this change. A modification is made to the Prisma Blood Tubing Set that places two luer fittings into the tubing set return line proximal to the air detector. When using the optional Blood Warmer, the user separates the new luer fittings and attaches the new warmer Extension Line. New labeling is created for the Extension Line and the Blood Tubing Set.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
OCT 6 1999
510(k) Summary of Safety and Effectiveness Information in Accordance with SMDA 1990
| Gambro Renal Care Products
1185 Oak Street
Lakewood, CO 80215
| (800) 525-2623 | DATE: 9 September, 1999 | ||
|---|---|---|---|
| OFFICIAL CONTACT: | William M. Townsend, Sr. Regulatory Specialist | ||
| PRODUCT NAME: | PRISMA CFM System Modification to Use an Accessory | ||
| Blood Warmer | |||
| PREVIOUS DEVICE CLEARANCE(s): | K942679 Date: 2/10/97 (Original) | ||
| K981681 Date: 8/11/98 (CVVHDF Mode) | |||
| TRADE NAME: | Dialyzer, High Permeability With or Without Sealed | ||
| Dialysate System | |||
| CLASSIFICATION NAME: | Gastroenterology and Urology | ||
| Class III, 78 KDI | |||
| 21 CFR 876.5860 |
SUBSTANTIAL EQUIVALENCE TO:
| 510(k) Number | Applicant | Device |
|---|---|---|
| K970253 | Gambro Healthcare | COBE Model Centrysystem 3+ Dialysis |
| Delivery Device | ||
| K982760 | Gambro Healthcare | COBE Model Cx Hemodialysis Delivery |
| System | ||
| K970446 | Althin Medical | Drake Wilock System 1000 Dialysis |
| Delivery System |
DEVICE DESCRIPTION:
In accordance with Section 510(k) of the Food, Drug and Cosmetics Act, Gambro Renal Care Products intends to introduce a modification of the Prisma Continuous Fluid Management System into commercial distribution. The modification creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer manufactured by Stihler Electronic GmbH (K991159) to be used with the Prisma system during continuous renal replacement therapy. The integration of the Blood Warmer into the Prisma System will provide gentle warming of the treated blood, prior to its return to the patient. No modifications of the Prisma Dialysis Control Unit were made as part of this change. A modification is made to the Prisma Blood Tubing Set that places two luer fittings into the tubing set return line proximal to the air detector. When using the optional Blood Warmer, the user separates the new luer fittings and attaches the new warmer Extension Line. New labeling is created for the Extension Line and the Blood Tubing Set.
1
Image /page/1/Picture/0 description: The image shows the text "510(k) #: K 993064 Page 2 of 2". The text indicates that this is a page from a 510(k) premarket submission to the FDA. The number 993064 is the specific 510(k) number for this submission. The page number indicates that this is page 2 of 2.
SUBSTANTIAL EQUIVALENCE:
In our notification, we demonstrate substantial equivalence to the identified predicate devices by demonstrating that the predicate devices provide solution heating through the use of heaters to warm either the dialysis water or dialysate prior to the solution passing through the dialyzer. The heat exchanger characteristics of the dialyzers cause heating of the patient's blood in the dialyzer. We demonstrated that the modified Prisma system uses similar design, technology and safety systems as the predicate devices to perform heating of the patient blood in the return line. There were no significant new safety and effectiveness issues identified by this modification to the Prisma CFM System.
INDICATIONS FOR USE:
"The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician." The device indications for use do not change as a result of this modification.
SAFETY AND EFFECTIVENESS:
We demonstrate and certify in the notification that a Design Control System is in place that is in compliance with the requirements listed in 21CFR Part 820.30. We further demonstrate that the design control system addresses hazards identified through both information searches and our own Risk Analysis program. A list of all system level verification and validation protocols completed with acceptable, pre-determined results is provided in the notification.
A search of the FDA's MAUDE database and the MEDLINE database were conducted for information on known manufacturer or user problems with the use of solution warmers with dialysis. In most cases, the hazards identified are recognized in the manufacture and use of dialysis therapy devices. We demonstrate in the notification that the new hazards are considered in the design of the modifications to the Prisma System. and that they do not represent significant new issues of safety and effectiveness.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1999 OCT
Mr. William M. Townsend Senior Regulatory Affairs Specialist Gambro Renal Care Products 1185 Oak Street Lakewood, CO 80215-4498
Re: K993064 PRISMA™ Continuous Fluid Management System Dated: September 9, 1999 Received: September 13, 1999 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI
Dear Mr. Townsend:
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 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. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. 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 regult 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 9.0
510(k) Number (if known): K993064
Device Name: PRISMA™ Continuous Fluid Management System
Indications For Use:
"The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K993064
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_ (Optional Format 1-2-96)