(89 days)
The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafitration controller to prevent excessive loss of water from the patient's blood, an extracomoreal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard nearchardialysis treatment capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acctate mode for concentrates .
The Meridian Hemodialysis Machine is designed to operate in the chronic and acute dialysis environment.
The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.
No information is available regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size of AI improvement.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- Ground truth establishment for the training set.
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NOV 2 4 1999
Renal Division
:
Baxter Healthcare Corporation 1620 Waukegan Road
McGaw Park, II 60085-6730
847-473-6030
BAXTER
(
510(k) SUMMARY BAXTER MERIDIAN HEMODIALYSIS MACHINE
| Submitter's name, addresss, phone, fax, contact person | Baxter Healthcare CorporationRenal Division1620 Waukegan RoadMcGaw Park, IL 60085Phone: (847) 473-6335Fax: (847) 473-6952Contact: Robert Wilkinson |
|---|---|
| Date prepared | July 28, 1999 |
| Trade name of device | Baxter Meridian Hemodialysis Machine |
| Common name | Hemodialysis Machine |
| Classification name | High Permeability Hemodialysis System(per 21CFR 867.5860) |
| Substantially equivalent devices | Baxter 1550 Hemodialysis Machine and the 1550, SingleNeedle Patient System[510(k) number K883111 and K922757, respectively] |
| Description of the device | The Baxter Meridian is a single patient hemodialysisinstrument that prepares dialysis solution, circulates bloodthrough an extracorporeal circuit of blood tubing andhemodialyzer, and monitors the system for safe operatingconditions. Its features include high blood flow rates,automatic ultrafiltration control, variable sodium andbicarbonate dialysis capabilities, and patient prescriptionentry through a patient data card. Optional featuresinclude automated patient blood pressure monitoring, aheparin pump and a sodium administration button. |
| Intended use of the device | The Baxter Meridian Hemodialysis machine is part of ahigh permeability hemodialysis system which consists ofa controlled dialysate delivery system that incorporates anultrafiltration controller to prevent excessive loss of waterfrom the patient's blood, an extracorporeal blood set anda high permeability dialyzer. The standard features of theMeridian machine include high blood flow rate capacity(for shortened hemodialysis treatment time), automaticultrafiltration, standard and variable bicarbonate andsodium capabilities and automated chemical disinfection.The Meridian machine will operate in either thebicarbonate or acetate mode for concentrates. TheMeridian machine is designed to operate in the chronicand acute dialysis environment. |
| Comparison of technologicalcharacteristics between new andpredicate devices | The Baxter Meridian Hemodialysis Machine consists of a Baxter 1550'shydraulic (fluid) components repackaged in a new structural foamcabinet with a CRT user interface and repackaged electronics |
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized, and the overall appearance is clean and professional.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1999
Mr. Robert Wilkinson, RAC Director, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
Dear Mr. Wilkinson:
Re: K992894
Meridian Hemodialysis Machine, Model 5M5576 Dated: August 24, 1999 Received: August 27, 1999 Regulatory class: III 21 CFR §876.5860/Product code: 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 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 Enderal 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 (GS) 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 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) 594-4633. Also, please note the regulation entitled, "Mistranding by reference to premarket notification"(21 CFR 807.7). Other general information on your responsibilities under the Promined 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
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510(k) Number (if known):K992894
Device Name: Baxter Meridian Hemodialysis Machine_(Model SM5576)
Indications For Use:
The Baxter Meridian machine is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafitration controller to prevent excessive loss of water from the patient's blood, an extracomoreal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard nearchardialysis treatment capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acctate mode for concentrates .
The Meridian Hemodialysis Machine is designed to operate in the chronic and acute dialysis environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The Counter Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, EN and RadioIngical D 510(k) Number
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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.”