This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.

The following types of renal replacement therapy can be carried out with the Dialog+ System:

Hemodialysis (HD) with or without phases of pure ultrafiltration -

. High flux hemodialysis
트 Low flux hemodialysis

Device Description

The Adimea option to the Dialog* Hemodialysis System provides an alternate means of obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness.

AI/ML Overview

This document (K083460) is a 510(k) Premarket Notification for the Dialog+ Hemodialysis System with Adimea Option. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, study details, or performance data for the Adimea option's ability to measure hemodialysis effectiveness.

The document primarily focuses on establishing substantial equivalence based on the Adimea option being an "alternate means of obtaining effectiveness information" that "does not have a significant affect upon the fundamental technology" of the Dialog+ System. It mentions "Software requirements specifications for Adimea have been met and verification and validation testing is complete," but does not provide any details about these tests, the acceptance criteria used, or the results.

Therefore, based solely on the provided text, I cannot fill out the requested table and answer the study-related questions for the Adimea option's performance. The information required for those sections is typically found in a separate performance study report or verification and validation documentation, which is not included in this 510(k) summary.

Here's what I can extract from the provided text, and where I identify missing information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not provided in this document. The document states "Software requirements specifications for Adimea have been met," implying criteria existed, but they are not detailed.
Reported Device Performance: Not provided in this document. The document states "verification and validation testing is complete," but no performance results are presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not provided.
Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not provided. The Adimea option measures UV absorption for Kt/V calculation, which is a quantitative measurement, not typically relying on expert interpretation for ground truth establishment in this context. If "ground truth" refers to the accuracy of the Kt/V calculation against a gold standard, that information is missing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not provided. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data. This device performs automated measurements.

5. 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

No, an MRMC study was not described or implied. The Adimea option is described as an "alternate means of obtaining effectiveness information," implying it provides direct measurements rather than assisting human readers in interpreting clinical images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implied. The description of the Adimea option suggests it operates as a "discreet component / function" that "continuously measuring the UV absorption" and provides a "Kt/V calculation." This indicates a standalone algorithmic function. However, no performance data for this standalone operation is presented.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated, but likely a reference method for Kt/V. For a device measuring Kt/V, the "ground truth" would typically be established by a well-accepted, highly accurate reference method for measuring dialysis adequacy (e.g., blood urea nitrogen sampling and calculation, or comparison to an established device known to be accurate). This is not detailed in the document.

8. The sample size for the training set

Not applicable / Not provided. While the Adimea option includes "controlling software," it is not described as a machine learning or AI algorithm that requires a "training set" in the typical sense. It appears to be based on spectral analysis and calculation. If there was any calibration or model development data, it's not referred to as a "training set" here and its size is not provided.

9. How the ground truth for the training set was established

Not applicable / Not provided. (See point 8).

Summary

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Premarket Notification 510(k) Dialog+ Hemodialysis System with Adimea Option November 19, 2008

K083460
Page 1 of 2

Page _________________________________________________________________________________________________________________________________________________________________________

FEB 1 8 2010

5. 510(k) Summary

APPLICANT/

SUBMITTER:

B. Braun Avitum AG Schwarzenberger Weg 73-79 Melsungen, GERMANY D-34212

CONTACT:

Bonnie J. Kincaid, RAC Manager, Regulatory Affairs B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 Phone: 610-596-2970 Fax: 610-266-4962

Dialog+0 Hemodialysis System with Adimea" Option DEVICE NAME:

COMMON OR USUAL NAME: High permeability hemodialysis system

DEVICE CLASSIFICATION:

Class II per 21 CFR §876.5860: Product Code KDI

PREDICATE DEVICE(S):

Dialog+0 Hemodialysis System

The Adimea option to the Dialog* Hemodialysis System DESCRIPTION: an alternate means of of provides obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness.

INTENDED USE: This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.

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K083460
Page 2 of 2

Premarket Notification 510(k) Dialog+ Hemodialysis System with Adimea Option November 19, 2008

Page

510(k) Summary (continued)

The following types of renal replacement therapy can be carried out with the Dialog+ System:

Hemodialysis (HD) with or without phases of pure ultrafiltration -

· High flux hemodialysis
· Low flux hemodialysis

SUBSTANTIAL EQUIVALENCE:

The Dialog+ System with Adimea Option has the same intended use and utilizes the same fundamental technology as the predicate Dialog+ System. The Dialog+ System with Adimea Option is also similar to the predicate device in design and materials. The optional design feature that incorporates a spectrophotometric method of measuring the UV absorption in the spent dialysate line and the software calculation of KUV does not have a significant affect upon the fundamental technology of the Dialog+ System, since it operates as a discreet component / function of the Dialog+ System. Software requirements specifications for Adimea have been met and verification and validation testing is complete. This testing demonstrates that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. To the right of the text is a symbol that resembles three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUL - 8 2010

B. Braun Avitum AG c/o Ms. Bonnie Kincaid, RAC Manager, Regulatory Affairs B. Braun Medical, Inc. 901 Marcon Boulevard ALLENTOWN PA 18109-9341

Re: K083460

Trade/Device Name: Dialog+ Hemodialysis System with Adimea Option Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 5, 2010 Received: February 12, 2010

Dear Ms. Kincaid:

This letter corrects our substantially equivalent letter of February 18, 2010.

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 (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

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Page 2 - Ms. Bonnie Kincaid

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert Hoover

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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32

4. Indications for Use

510(k) Number (if known):

Device Name: Dialog+® Hemodialysis System with Adimea Option

Indications for Use:

The following types of renal replacement therapy can be carried out with the Dialog+ System:

Hemodialysis (HD) with or without phases of pure ultrafiltration -

. High flux hemodialysis
트 Low flux hemodialysis

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(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 and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.”