(90 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, or related concepts, and the device description is not available.
Yes
The device is indicated for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload," which describes a direct medical treatment to alleviate or cure a disease or condition.
No
The PRISMA™ System is indicated for continuous solute and/or fluid removal, which is a treatment, not a diagnostic process. It does not identify or characterize a disease or condition.
No
The intended use describes a system for continuous solute and/or fluid removal, which inherently requires hardware components (e.g., pumps, filters, tubing) to perform these physical actions. The summary does not mention any software-only functionality.
Based on the provided information, the PRISMA™ System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the system as being used for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload." This is a therapeutic intervention performed directly on the patient's body (extracorporeal treatment), not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description (Not Found): While the description is missing, the intended use strongly suggests a device that interacts with the patient's blood or fluids directly, not a device that analyzes samples.
- No mention of analyzing samples: There is no indication that this device analyzes blood, urine, tissue, or any other biological sample.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The PRISMA™ System's function as described is to remove substances from the body, which is a treatment, not a diagnostic test.
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
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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
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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)
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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.
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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).
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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.”
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged vertically along the left side of the logo, and the word "SERVICES" is at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 1998
Mr., William M. Townsend Senior Regulatory Affairs Specialist GAMBRO Healthcare 1185 Oak Street Lakewood, Colorado 80215
Re: K981681
PRISMATM Continuous Fluid Management System Dated: May 11, 1998 Received: May 13, 1998 Regulatory class: III 21 CFR §876.5860/Product code: 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 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 (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 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 80) 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
1
Page 17 of 52
510(k) Number (if known): K981681
Device Name: PRISMA 74 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 | K981681 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |