(247 days)
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No
The description focuses on automated control functions and monitoring, which are typical for medical devices but do not inherently indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is indicated for patients with acute or chronic renal failure and performs hemodialysis therapy, which is a medical treatment.
No
The text describes a hemodialysis control unit and related tubing set, which is a therapeutic device used to treat renal failure. It does not involve diagnosing medical conditions.
No
The device description clearly states it is a "totally self contained machine" that performs physical functions like pumping blood and preparing dialysate, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device 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 prevention of disease.
- Device Function: The description clearly states that the Centrysystem® 3 +plus™ Dialysis Control Unit is a machine that performs hemodialysis therapy. Its functions involve controlling the extracorporeal blood circuit, preparing dialysate, pumping fluids, controlling fluid removal from the patient, and cleaning/disinfecting the system.
- Lack of Specimen Analysis: The device does not analyze specimens taken from the patient's body to provide diagnostic information. It is a therapeutic device that directly interacts with the patient's blood outside the body for treatment purposes.
Therefore, the Centrysystem® 3 +plus™ Dialysis Control Unit and its accessory blood tubing set are therapeutic devices used for hemodialysis, not IVDs.
N/A
Intended Use / Indications for Use
The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including:
- automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set);
- prepares dialysate;
- monitors machine subsystems for proper performance and unsafe conditions;
- pumps blood, dialysate and anticoagulant at predetermined rates;
- controls fluid removal from the patient; and
- automatically cleans, disinfects and rinses dialysate flow path.
The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized symbol that resembles an eagle or a bird with outstretched wings. The image is in black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Benita Bourque, RAC Director of Regulatory Affairs GAMBRO Healthcare 1185 Oak Street Lakewood, Colorado 80215
SEP 2 6 1997
Re: K970253 Centrysystem® 3 plus™ Dialysis Control Unit Dated: June 27, 1997 Received: June 30, 1997 Regulatory class: III 21 CFR §876.5860/Product code: 78 KDI
Dear Ms. Bourque:
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 eaclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordinace with the provisions of the Federal Food, Drug, and Comments of the device, 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 problementing and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premacket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Featural 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP resulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Resister. Please note: this response to your premarket notification does not affect any obligation vou might have under sections 531 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 310(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (2) 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/cdrb/dsmamain.html".
Sincerely vours.
Sincerely yours,
William Yin, Ph.D.
Lilian 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
510(k)Number: K970253
Device Name: Centrysystem® 3 +plus™ Dialysis Control Unit
Indications For Use:
The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self contained machine that provides the necessary control functions for hemodialysis therapy, including:
- automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); ●
- . prepares dialysate;
- monitors machine subsystems for proper performance and unsafe conditions; .
- pumps blood, dialysate and anticoagulant at predetermined rates; ●
- controls fluid removal from the patient; and .
- automatically cleans, disinfects and rinses dialysate flow path. .
The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.
Dolar R. Satting
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 11 970253 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use_