(155 days)
The Baxter Meridian Hemodialysis Machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal 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 and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian 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 document is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which is a medical device. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed studies proving performance against acceptance criteria in the manner of an AI/ML medical device or diagnostic test.
The core of a 510(k) for a device like a hemodialysis machine relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical metrics.
Therefore, the requested information elements related to AI/ML performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies are not applicable to this type of device and submission.
Here's a breakdown based on the provided text, highlighting what is available and explaining why other elements are not:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantial Equivalence: Conformance to the safety and efficacy of the predicate device (Baxter Meridian Hemodialysis Machine - K992894) in terms of technological characteristics and intended use. | The submission states: "The Baxter Meridian Hemodialysis Machine is technologically the same as the predicate device." This is the core "performance" claim for a 510(k) of this nature – that it performs equivalently to the predicate and thus meets the safety and effectiveness standards already established by the predicate. |
| Functional Features: Ability to prepare dialysis solution, circulate blood, monitor safe operating conditions, provide high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis, and patient prescription entry. (These are features described as standard or optional on the device and presumably meet or exceed those of the predicate). | The device's description outlines these features: "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 implicit performance is that these features function as intended and comparably to the predicate device. The intended use statement further elaborates on the system's capabilities. |
| Intended Use Achievement: Designed for chronic and acute dialysis environments, operating in bicarbonate or acetate mode for concentrates, and preventing excessive water loss. | The intended use explicitly states: "The Baxter Meridian Hemodialysis machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood... The Meridian machine is designed to operate in the chronic and acute dialysis environment." This implies the device successfully achieves these stated functionalities within its intended environment. |
Non-Applicable Information for this 510(k) Submission:
The following information points are typically associated with performance studies for software/AI devices or clinical trials, which are not detailed in this 510(k) summary for a hemodialysis machine where substantial equivalence is based on technological characteristics.
- Sample size used for the test set and the data provenance: Not applicable. Performance is demonstrated through comparison of engineering and functional specifications to the predicate, rather than a clinical "test set" in the diagnostic sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to ground truth for diagnostic accuracy, which is not the focus here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a treatment machine, not an interpretive diagnostic tool that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would relate to engineering validation and verification that the machine performs its mechanical and electronic functions correctly and safely, rather than a diagnostic 'truth'.
- The sample size for the training set: Not applicable. There is no mention of an "algorithm" or "training set" in the context of this device.
- How the ground truth for the training set was established: Not applicable.
Summary Rationale:
The provided document is a 510(k) summary for a hemodialysis machine. This type of device is classified as a physical medical device (Class II) that performs a therapeutic function. The regulatory pathway for such a device, a 510(k), focuses heavily on demonstrating substantial equivalence to an already legally marketed predicate device. In this case, the Baxter Meridian Hemodialysis Machine is stated to be "technologically the same" as its predicate (K992894).
This means the submission relies on comparing design specifications, materials, operational principles, and intended use to the predicate. It is not an AI/ML-driven diagnostic device that would require extensive performance studies involving test sets, training sets, ground truth established by experts, or MRMC studies to evaluate algorithmic performance or human-AI interaction. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is as safe and effective as the predicate device.
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MAY 2 4 2006
Page 1 of 1 Section 5
510(k) SUMMARY BAXTER MERIDIAN HEMODIALYSIS MACHINE
| Submitter's name, addresss, phone, fax, contact person | David E. CurtinBaxter Healthcare CorporationRenal Division1620 Waukegan RoadMcGaw Park, IL 60085(847) 473-6079(847) 473-6952 (FAX) |
|---|---|
| Date prepared | |
| 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 Meridian Hemodialysis Machine - K992894 |
| Description of the device | 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. |
| Intended use of the device | The Baxter Meridian Hemodialysis machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal 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 and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian machine is designed to operate in the chronic and acute dialysis environment. |
| Comparison of technological characteristics between new and predicate devices | The Baxter Meridian Hemodialysis Machine is technologically the same as the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
MAY 2 4 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
David E. Curtin, R.A.C. Associate Director, Regulatory Affairs Baxter Healthcare Corporation Renal Division, MPGR-A2E 1620 Waukegan Road MCGAW PARK IL 60085
Re: K053539
Trade/Device Name: Meridian Hemodialysis Machine Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 25, 2006 Received: April 27, 2006
Dear Mr. Curtin:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a stylized font. Three stars are arranged in a horizontal line beneath the word "Centennial".
Protesting and Promoting Public Health
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotes notification. The FDA finding of substantial equivalence of your device to a legally prematics notification - 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 11 you don't Epocked Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology). | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, process not regaratin other general information on your responsibilities under the Act from CI I 60 : 77). I ou may overn outs getternational 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/industry/support/index.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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Meridian Hemodialysis Machine 510(k) Premarket Notification
Page 1 of 1 Section 4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K053539
Device Name: Meridian Hemodialysis Machine
The Baxter Meridian Hemodialysis Machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal 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 and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian 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
(Per 21 CFR 801.109)
OR Over-The-Counter Use
Nancy C Brogdon
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Baxter Confidential
§ 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.”