The Gambro Dialysis Quality Monitor DQM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DQM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.

Device Description

The Gambro DOM 200 measures the urea concentration in the dialysis solution leaving the waste outlet of a dialysis machine. Measurements obtained by this device are used in the treatment of certain renal diseases for patients on hemodialysis. The purpose of the Gambro DQM 200is to act as a clinical tool aiding the physician to evaluate the dialysis dose of a treatment. The DQM 200 performs a continuous urea measurement of the spent dialysate flow from a Cobe C3 machine, A Gambro AK 10 Machine, a Gambro AK 100/200 or a Gambro AK 100/200 ULTRA machine. From this measured data together with patient and treatment data provided by the operator of the DOM 200 derives clinical parameters to help define the dialysis dose. The urea measurement is achieved by catalyzing urea with the urease enzyme, with carbon dioxide gas present into ammonium ions and bicarbonate ions. The produced ions cause an increase in the electrical conductivity in proportion to the urea concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Gambro Dialysis Quality Monitor DQM 200, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance, not a detailed scientific study report. As such, it will not contain the in-depth information typically found in a full study publication, such as detailed sample sizes, expert qualifications, or specific statistical efficacy metrics. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
In Vitro Performance: Device performs as intended and labeled.	"In Vitro testing demonstrated that the device performs as intended and labeled."
Clinical Performance: Device performs as intended and labeled.	"Clinical testing demonstrated that the device performs as intended and labeled."
Substantial Equivalence: Device is substantially equivalent to the predicate device (Baxter BioStat 1000 Urea Monitor) in composition, intended use, function, and labeling.	The FDA letter (K990039) confirms substantial equivalence to the legally marketed predicate device.

Note: The document implies the acceptance criteria are that the device performs "as intended and labeled" and is "substantially equivalent" to the predicate. Specific numerical targets for accuracy, precision, or other performance metrics are not explicitly stated in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided document. The text only states "In Vitro testing" and "Clinical testing" were performed.
Data Provenance: Not specified. It is not mentioned where the data was collected (e.g., country of origin) or if the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a device measuring urea concentration, the ground truth would likely be established through a reference laboratory method rather than expert adjudication of images or clinical outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned as part of the submission. The device is a diagnostic tool (urea monitor), not an image interpretation or decision-support AI tool that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
Effect size of human reader improvement: Not applicable, as no such study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Yes, the "In Vitro testing" and "Clinical testing" describe the performance of the device itself (the "algorithm only," if we consider the device's measurement and calculation functions as an algorithm) in laboratory and clinical settings. These tests evaluate the device's ability to accurately measure urea and derive parameters. No human "in-the-loop" performance is described in these validation aspects, though the device aids a physician.

7. Type of Ground Truth Used

Type of Ground Truth: The document does not explicitly state the specific methods used for ground truth. However, for a device measuring urea concentration, the ground truth would almost certainly be established by:
- Reference Laboratory Methods: During in-vitro and clinical testing, the DQM 200's measurements and calculated parameters would be compared against results obtained from established, highly accurate laboratory methods for urea concentration, such as enzymatic assays or isotope dilution mass spectrometry.
- Validated Formulas: The clinical parameters derived by the DQM 200 would be based on established and validated mathematical formulas (e.g., for urea kinetic modeling).

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document does not detail any "training set" in the context of machine learning model development. This device appears to be based on established chemical principles and formulas rather than a data-driven machine learning model that requires a discrete training phase with a labeled dataset. Its "training" would likely refer to calibration and optimization during its development, not a separate data training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable in the context of a machine learning training set as described above. If "training set" refers to calibration or development data, the ground truth would have been established using precise chemical standards and reference measurement techniques to ensure the device's accuracy across its operational range.

Summary

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Gambro Healthcare 141 27 ባበጠበ

JAN 27 2000Confidential	FilenameGambro DQM 200 510(k)Supplement	FDA No.K990039	DateDecember 6th, 1999
510K(k) SUMMARY
SUBMITTER:	Gambro Healthcare1185 Oak StreetLakewood, CO 80215(303) 231-4436
DATE PREPARED:	October 27th, 1998
DEVICE NAME:	Gambro Dialysis Quality Monitor DQM 200
CLASSIFICATION NAMES:	In Vitro Urea Nitrogen Test System(75LFP)
PREDICATE DEVICE:	Baxter BioStat 1000 Urea Monitor

Device Description:

The purpose of the Gambro DQM 200is to act as a clinical tool aiding the physician to evaluate the dialysis dose of a treatment. The DQM 200 performs a continuous urea measurement of the spent dialysate flow from a Cobe C3 machine, A Gambro AK 10 Machine, a Gambro AK 100/200 or a Gambro AK 100/200 ULTRA machine. From this measured data together with patient and treatment data provided by the operator of the DOM 200 derives clinical parameters to help define the dialysis dose. The urea measurement is achieved by catalyzing urea with the urease enzyme, with carbon dioxide gas present into ammonium ions and bicarbonate ions. The produced ions cause an increase in the electrical conductivity in proportion to the urea concentration.

Predicate Device:

The Gambro DQM 200 is substantially equivalent to the Baxter BioStat 1000 Urea Monitor - 510(k) Number K925581. Examination of the information pertaining to the Baxter BioStat 1000 Urea Monitor demonstrates that this device is substantially equivalent in composition, intended use, function and labeling to other urea monitors for the measurement of urea concentrations in spent dialysis solution with subsequent calculation of various urea kinetic parameters which are currently cleared for commercial distribution in the United States by the FDA.

CONFIDENTIAL INFORMATION

000074

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Confidential

Date December 6th , 1999

Indications for Use Statement:

The Gambro Dialysis Ouality Monitor DOM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DOM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.

This indication for use statement is essentially the same as the indication for use statement for the predicate device.

Technological Characteristics

Comparing the proposed device to the predicate device, both devices utilize the same methods and technique for measuring urea concentrations in spent solution exiting a hemodialysis machine. Both devices utilize software and established formulas to calculate various patient and treatment related, urea parameters. There are no significant differences.

Summary of Non-Clinical Testing:

In Vitro testing demonstrated that the device performs as intended and labeled

Clinical Testing:

Clinical testing demonstrated that the device performs as intended and labeled.

CONFIDENTIAL INFORMATION 000075

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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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight. The symbol is composed of curved lines that create a sense of movement and unity.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 27 2000

Jeffrey R. Snideman, Ph.D. Gambro Healthcare 7303 Glouchester Drive Edina, Minnesota 55435

Re: K990039

Trade Name: Dialysis Quality MonitorGambro DQM 200 Regulatory Class: II Product Code: LFP Dated: December 6, 1999 Received: December 9, 1999

Dear Dr. Snideman:

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 (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 Federal 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 (QS) 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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page L of L

510 (k) NUMBER (IF KNOWN):

DEVICE NAME: Dialysis Quality MonitorGambro DQM 200

INDICATIONS FOR USE:

Indications for Use: Gambro Dialysis Quality Monitor DQM 200

Sean Cooper
(Division Sign-Off)
K990039

. (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)

Over-The-Counter-Use_ (Optional Format 1-2-96)

Regulation Number and Section

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.