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.

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.

AI/ML Overview

The CRIT-LINE III TQA Monitor is intended to non-invasively calculate the Urea Reduction Ratio (URR) based on changes in urea nitrogen concentration in spent dialysate. The device was compared to the EktaChem DT 60 (Vitros DT60 Chemistry System), a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific statistical thresholds for R-squared or standard error for the overall URR calculation. Instead, it presents the results of the comparative studies with the predicate device as evidence of substantial equivalence.

Performance Metric	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (CLM III TQA URR Sensor)
In-vivo Relative Urea Nitrogen Concentration (mg/dL)	Not explicitly stated but compared to EktaChem DT 60 as predicate	Standard error of 5.8 mg/dL and R² of 0.84
In-vitro Urea Nitrogen Concentration (mg/dL)	Not explicitly stated but compared to EktaChem DT 60 as predicate	Standard error of 1.2 mg/dL and R² of 0.998 (range 0-83 mg/dL)

2. Sample Size and Data Provenance

Test Set:

Sample Size:
- In-vivo study: 51 data points for URR calculation. This was gathered from 36 patients.
- In-vitro study: Not explicitly stated as a number of samples, but "measurements at each urea nitrogen concentration" were performed across a range of 0-83 mg/dL.
Data Provenance: Not explicitly stated (e.g., country of origin, specific clinical sites). The date range of data collection (January 1 to May 10, 2001) is provided, indicating it was prospective data collection for the in-vivo study.

3. Number of Experts and Qualifications for Ground Truth

In-vivo study: Not applicable. The ground truth for the in-vivo study was established by the EktaChem DT 60, a laboratory analyzer.
In-vitro study: Not applicable. The ground truth for the in-vitro study was established by the Kodak EktaChem DT 60 analyzer using known concentrations of pure urea.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory analysis (EktaChem DT 60) for both in-vivo and in-vitro studies, not by human expert adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on comparing the device's measurements to a predicate laboratory device.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance assessment was done. The study directly compared the CRIT-LINE III TQA URR sensor's measurements against the EktaChem DT 60 without human intervention for the URR calculation claim.

In-vivo: The CLM III TQA's calculated URR based on relative urea nitrogen concentration in spent dialysate was compared to URR measurements calculated by the EktaChem DT 60 (based on urea nitrogen concentration measurements in both blood and spent dialysate).
In-vitro: The URR sensor measurements were compared against reference urea nitrogen concentrations measured by the Kodak EktaChem DT 60 analyzer using calibrated solutions.

7. Type of Ground Truth Used

The ground truth used was predicate device measurements / laboratory analysis:

In-vivo: The EktaChem DT 60's calculation of URR, which itself is based on urea nitrogen concentration measurements in both blood and spent dialysate.
In-vitro: Reference urea nitrogen concentrations measured by a Kodak EktaChem DT 60 analyzer with pure urea dissolved in fresh dialysate.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. The description focuses on the studies conducted to demonstrate substantial equivalence, which would be considered the validation data.

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

Not applicable, as no separate training set is described. The predicate device's measurements served as the reference for the validation studies.

Summary

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JUL 2 3 2002

510 (K) Summary (#K011741) - Updated July 22, 2002

SECTION 1-GENERAL INFORMATION

1.	Applicant/Specification Developer:	HemaMetrics695 North 900 WestKaysville, UT 84037Tel: (801) 451-9000Fax: (801) 451-9007
	Registration Number:	1721979
2.	Contact Persons:	Mr. Matthew L. HaynieDir. 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

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:

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)

Over the Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.