(386 days)
Not Found
No
The description focuses on electrochemical measurement of urea concentration and calculation of clinical parameters based on measured data and operator input, with no mention of AI or ML techniques.
No
The device is a diagnostic tool that measures clinical parameters to aid physicians in evaluating the dialysis dose; it does not directly provide therapy.
Yes
Explanation: The device measures urea concentration to derive clinical parameters that aid the physician in evaluating the dialysis dose. This process of measuring and deriving parameters for assessment of a medical condition or treatment falls under diagnostics.
No
The device description explicitly states that the device "measures the urea concentration" and achieves this measurement through a chemical reaction involving a "urease enzyme" and measuring "electrical conductivity." This indicates the presence of physical components and a measurement process that goes beyond software alone.
Based on the provided information, the Gambro Dialysis Quality Monitor DQM 200 is an In Vitro Diagnostic (IVD) device.
Here's why:
- Measures substances in a sample from the body: The device measures urea concentration in the spent dialysate, which is a fluid that has been in contact with the patient's blood during dialysis. While not directly measuring a substance in the patient's body, it's measuring a substance from the patient's body (urea) that has been transferred into the dialysate. This falls under the scope of IVD testing, which involves examining specimens derived from the human body.
- Used to provide information for diagnosis, monitoring, or treatment: The intended use clearly states it's a "clinical tool aiding the physician to establish a dialysis dose of treatment of the patient" and helps in "evaluating the dialysis dose." This information is used by the physician to manage the patient's treatment.
- Performs a test on a sample: The device performs a chemical reaction (catalyzing urea with urease) and measures the resulting change in electrical conductivity to determine urea concentration. This is a form of in vitro testing.
- Predicate device is an IVD: The predicate device listed, the Baxter BioStat 1000 Urea Monitor (K925581), is also a device that measures urea in dialysate for similar purposes, and devices of this nature are typically classified as IVDs.
Therefore, the Gambro Dialysis Quality Monitor DQM 200 fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LFP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Clinical setting (hemodialysis)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Gambro Healthcare 141 27 ባበጠበ
| JAN 27 2000
Confidential | Filename
Gambro DQM 200 510(k)
Supplement | FDA No.
K990039 | Date
December 6th, 1999 |
|-----------------------------|------------------------------------------------------------------------------|--------------------|----------------------------|
| 510K(k) SUMMARY | | | |
| SUBMITTER: | Gambro Healthcare
1185 Oak Street
Lakewood, 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 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.
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
1
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
2
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.
3
Page 2
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
4
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
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.
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)
OR
Over-The-Counter-Use_ (Optional Format 1-2-96)