(158 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is indicated for use in chronic or acute hemodialysis treatments, which is a therapeutic intervention for kidney failure.
No
Explanation: The device is indicated for hemodialysis treatments and is a delivery system, not a device used to diagnose a condition.
No
The description explicitly refers to a "Hemodialysis Delivery System," which strongly implies a physical device with hardware components for performing hemodialysis. There is no mention of the device being solely software.
Based on the provided information, the Baxter Arena™ Hemodialysis Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a system for performing hemodialysis treatments using a hollow fiber dialyzer. This is a therapeutic procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description (Not Found): While the description is missing, the intended use clearly points to a treatment delivery system.
- No mention of analyzing samples: There is no indication that the device analyzes blood, urine, or any other biological sample to provide diagnostic information.
- Focus on treatment delivery: The description emphasizes the use of a dialyzer for chronic or acute hemodialysis, which is a process of filtering blood to remove waste products and excess fluid.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Baxter Arena™ Hemodialysis Delivery System's function is to perform the treatment itself, not to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Baxter Arena™ Hemodialysis Delivery System is indicated for use when a hollow fiber dialyzer is chosen for use in chronic or acute hemodialysis treatments, including high flux hemodialysis. All therapies using the Arena Hemodialysis Delivery System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about renal replacement therapies and the treatment is performed in an in-clinic environment and supervised by trained healthcare professionals.
The Arena Hemodialysis Delivery System is not designed, sold or intended for any use except as indicated above. Furthermore, it is not intended to be used outside the device specifications or limitations.
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
physician who is familiar and well informed about renal replacement therapies and the treatment is performed in an in-clinic environment and supervised by trained healthcare professionals.
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)
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Reference Device(s)
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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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 2003
Baxter Healthcare Corporation c/o Ms. Laura Danielson TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K030099
Trade/Device Name: Baxter Arena™ Hemodialysis Delivery System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: May 30, 2003 Received: June 2, 2003
Dear Ms. Danielson:
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 application (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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
1
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
8xx. 1xxx | (301) 594-4591 |
---|---|
876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K030099(S1)
Device Name: Baxter Arena™ Hemodialysis Delivery System
Indications For Use:
The Baxter Arena™ Hemodialysis Delivery System is indicated for use when a hollow fiber dialyzer is chosen for use in chronic or acute hemodialysis treatments, including high flux hemodialysis. All therapies using the Arena Hemodialysis Delivery System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about renal replacement therapies and the treatment is performed in an in-clinic environment and supervised by trained healthcare professionals.
The Arena Hemodialysis Delivery System is not designed, sold or intended for any use except as indicated above. Furthermore, it is not intended to be used outside the device specifications or limitations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L Over-The-Counter Use (Per 21 CFR 801.109) Division Sign-Of Division of Reproductive, Abdominal, and Radiological De 510(k) Number