(413 days)
EktaChem DT60
EktaChem DT 60
No
The summary describes standard optical sensing and calculation methods, with no mention of AI or ML techniques. The performance studies focus on correlation with a predicate device and calibration, not on training or validation of an AI/ML model.
No.
The device is a monitoring and diagnostic tool that measures various physiological parameters and estimates others, but it does not directly treat or provide therapy.
Yes.
The device monitors hematocrit, oxygen saturation, percent change in blood volume, access recirculation, access blood flow, and calculates an estimated Urea Reduction Ratio. These measurements provide information about a patient's physiological state, which can be used to aid in diagnosis or guide treatment, making it a diagnostic device.
No
The device description explicitly mentions hardware components like an "optical light emitted by the URR sensor" and a "transmitted light is then detected," indicating it is not solely software.
Based on the provided information, the CRIT-LINE III TQA Monitor is partially an IVD (In Vitro Diagnostic).
Here's why:
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Core Functionality (Non-invasive measurements): The primary functions of measuring hematocrit, oxygen saturation, percent change in blood volume, access recirculation, and access blood flow are described as non-invasive. This means they are measuring parameters directly from the patient's body without requiring a sample to be taken and tested outside the body. These aspects are generally not considered IVD.
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URR Estimation (In Vitro Component): The device also calculates an estimated Urea Reduction Ratio (URR) based on relative changes in urea nitrogen concentration in the spent dialysate. The description explicitly states that the URR sensor directs optical light through the spent dialysate stream. Spent dialysate is a fluid that has been used in dialysis and is outside of the patient's body. Measuring substances in this fluid to assess a physiological parameter (urea reduction) is a characteristic of an In Vitro Diagnostic test.
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Performance Studies: The performance studies described include both "IN-VIVO UREA NITROGEN DETECTION" (comparing the device's URR calculation to a reference method using blood and spent dialysate) and "IN-VITRO UREA NITROGEN CALIBRATION" (calibrating the URR sensor with pure urea dissolved in fresh dialysate). The in-vitro study specifically involves testing the sensor with a substance outside the body.
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Predicate Device: The predicate device listed, the EktaChem DT60 (Vitros DT60 Chemistry System), is a chemistry analyzer that performs in vitro diagnostic tests on biological samples (like blood and spent dialysate, as mentioned in the performance study). This further supports the idea that the URR estimation component of the CRIT-LINE III TQA is related to IVD testing.
In summary:
While the majority of the CRIT-LINE III TQA's functions are non-invasive and not IVD, the component that estimates URR by analyzing the spent dialysate stream is performing an in vitro diagnostic function because it is analyzing a fluid that is outside of the patient's body to provide information about a physiological state (urea reduction).
Therefore, the device has both non-IVD and IVD components.
N/A
Intended Use / Indications for Use
The intended use of the CRIT-LINE III TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE III TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM III TQA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.
Product codes
78 FIL, 78 MOS
Device Description
The CRIT-LINE III TQA is an FDA cleared device that non-invasively measures Hct, O2 Sat, Percent Change in Blood Volume. The CLM III TOA also estimates Access Recirculation and Access Blood Flow. The URR sensor is an additional attachment to the CRIT-LINE III TOA. The optical light emitted by the URR sensor is directed through the spent dialysate stream and absorbed by the constituents of the spent dialysate. The transmitted light is then detected and the relative urea nitrogen concentration in the spent dialysate is calculated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical light
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Between January 1 and May 10, 2001, 51 data points were gathered in-vivo on 36 patients comparing the CLM III TQA's calculated URR based on relative urea nitrogen concentration measurements in the spent dialysate to URR measurements as calculated by the EktaChem DT 60 based on urea nitrogen concentration measurements in both blood and spent dialysate.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IN-VIVO UREA NITROGEN DETECTION: 51 data points were gathered in-vivo on 36 patients comparing the CLM III TQA's calculated URR based on relative urea nitrogen concentration measurements in the spent dialysate to URR measurements as calculated by the EktaChem DT 60 based on urea nitrogen concentration measurements in both blood and spent dialysate. The analysis yielded a standard error of 5.8 mg/dL and an R of 0.84.
IN-VITRO UREA NITROGEN CALIBRATION: The URR sensor was calibrated with pure urea dissolved in fresh dialysate solution. The URR sensor measurement at each urea nitrogen concentration was compared with the reference urea nitrogen concentration measured by a Kodak EktaChem DT 60 analyzer. In the urea nitrogen concentration range of 0 ~ 83 mg/dL, the CLM III TQA URR sensor measurements had a standard error of 1.2 mg/dL and an R2 of 0.998 when compared to the reference measurements obtained from EktaChem DT 60. These results indicate that the CLM III TQA URR sensor and the Kodak EktaChem DT 60 analyzer are substantially equivalent in the measurement of urea nitrogen concentration in an in-vitro assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Summary of Performance Studies for standard error and R/R2 values.
Predicate Device(s)
EktaChem DT60 (Vitros DT60 Chemistry System)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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JUL 2 3 2002
510 (K) Summary (#K011741) - Updated July 22, 2002
SECTION 1-GENERAL INFORMATION
| 1. | Applicant/Specification Developer: | HemaMetrics
695 North 900 West
Kaysville, UT 84037
Tel: (801) 451-9000
Fax: (801) 451-9007 |
|----|------------------------------------|--------------------------------------------------------------------------------------------------------|
| | Registration Number: | 1721979 |
| 2. | Contact Persons: | Mr. Matthew L. Haynie
Dir. of Quality Assurance/Reg. Affairs |
3. Administrative Information:
- a. Trade/Proprietary Name Including Model Number of Devices:
CRIT-LINE III TQA Monitor (CLM III TQA)
b. Common Name or Classification Name (21 CFR Part 807.87) of Device:
Non-invasive Hematocrit, Blood Volume, Oxygen Saturation, Recirculation and Access Blood Flow Monitor
c. Address of Manufacturing Facility/Sterilization Sites:
HemaMetrics 695 North 900 West Kaysville, UT 84037
Contract Manufacturers:
None
The CLM III TQA is a non-sterile product.
d. Class in which Device has been placed:
Class II
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e. Reason for Pre-market Notification
The reason for this pre-market notification is to claim that the CLM III TQA can non-invasively measure the Urea Reduction Ratio based on detected changes in the urea nitrogen concentration in the spent dialysate. The URR is a key indicator as to the efficiency of a hemodialysis treatment. It indicates the extent of toxin urea removal from the patient's body as a result of the blood flowing across one side of the dialyzer with continuous counter-flow of dialysate on the opposite side of the dialyzer membrane.
NOTE: The CLM III TOA is already cleared for the non-invasive measurement of Hct, O2 Sat, and Percent Change in Blood Volume. In addition, the CLM III TOA estimates access recirculation and transcutaneously estimates Access Blood Flow. URR is an additional claim for this already cleared device.
f. Identification of Legally Marketed Device Which We Claim Substantial Equivalency
The predicate method which was used to compare the urea nitrogen concentration measurements of the CLM III TQA includes the following:
EktaChem DT60 (Vitros DT60 Chemistry System):
The DT60 is a Vitros DT slide analyzer that performs a number of discrete clinical tests on serum, plasma, or whole blood using optical density techniques. Each Vitros DT slide, therefore contains analyte-specific reaction reagents whose resulting product is a molecule with a given color. The amount of colored product or the optical density is therefore directly dependent on the original analyte concentration delivered onto the Vitros DT slide. Optical density measurements are performed with a fiber optic-based excitation and detection scheme employing one of three LED's (red. green. yellow) and one photodetector.
Vitros DT Slide Characteristics Specific for BUN/UREA:
The BUN/ UREA DT slide is a multilayered dry film contained within a plastic support. All reagents specific to urea are self-contained within the slide. Color development results from the hydrolysis of urea to ammonia and carbon dioxide by the urease enzyme. The resulting ammonia subsequently reacts with an indicator to produce a highly colored dye.
Compliance with Requirements of the Federal FD&C Act: g.
The Gastrointestinal and Restorative Device (DGRD) Panel has classified this device as Class II, 21 CFR Part 876.5820
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SECTION 2 - INTENDED USE
The intended use of the CRIT-LINE III TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE III TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM III TOA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.
SECTION 3 - DEVICE DESCRIPTION
The CRIT-LINE III TQA is an FDA cleared device that non-invasively measures Hct, O2 Sat, Percent Change in Blood Volume. The CLM III TOA also estimates Access Recirculation and Access Blood Flow. The URR sensor is an additional attachment to the CRIT-LINE III TOA. The optical light emitted by the URR sensor is directed through the spent dialysate stream and absorbed by the constituents of the spent dialysate. The transmitted light is then detected and the relative urea nitrogen concentration in the spent dialysate is calculated.
SECTION 4-COMPARATIVE INFORMATION
a. Comparative Performance Evaluation:
IN-VIVO UREA NITROGEN DETECTION
Between January 1 and May 10, 2001, 51 data points were gathered in-vivo on 36 patients comparing the CLM III TQA's calculated URR based on relative urea nitrogen concentration measurements in the spent dialysate to URR measurements as calculated by the EktaChem DT 60 based on urea nitrogen concentration measurements in both blood and spent dialysate.
Once the data was gathered, an analysis of the data was performed. Relative urea nitrogen concentrations measured by the CLM III TQA URR sensor were first compared with that measured by the EktaChem DT 60. The analysis vielded a standard error of 5.8 mg/dL and an R of 0.84. Since each patient run has its own characteristics which can be cancelled through the ratio during the URR calculation, the accuracy of this comparison is not affecting the accuracy of calculated URR.
IN-VITRO UREA NITROGEN CALIBRATION:
In addition to the in-vivo data that was gathered from the patients in a clinical setting, the same optical-based CLM III TQA URR sensor as mentioned above was calibrated with pure urea dissolved in fresh dialysate solution. The URR sensor measurement at each urea nitrogen concentration was compared with the
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reference urea nitrogen concentration measured by a Kodak EktaChem DT 60 analyzer.
In the urea nitrogen concentration range of 0 ~ 83 mg/dL, the CLM III TQA URR sensor measurements had a standard error of 1.2 mg/dL and an R2 of 0.998 when compared to the reference measurements obtained from EktaChem DT 60. These results indicate that the CLM III TQA URR sensor and the Kodak EktaChem DT 60 analyzer are substantially equivalent in the measurement of urea nitrogen concentration in an in-vitro assay.
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Image /page/4/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Mr. Matthew L. Haynie Director of Quality Assurance/ Regulatory Affairs HemaMetrics™ 695 North. 900 West KAYSVILLE UT 84037
Re: K011741 Trade/Device Name: CRIT-LINE III TQA URR Monitor Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIL and 78 MOS Dated: April 20, 2002 Received: April 24, 2002
Dear Mr. Haynie:
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 (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 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 (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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers. International 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/dsma/dsmamain.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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510(k) Number: K011741
Device Name: CRIT-LINE III TQA MONITOR
Indications for Use:
The intended use of the CRIT-LINE III TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE III TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM III TQA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.
JaneyC Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011741
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription for Use (Per 21 CFR 801.109)
OR
Over the Counter Use
(Optional Format 1-2-96)