The family of CRIT-LINE Monitors (CLM's), include the CLM II (predicate device) and the CLM III. These devices are used to noninvasively to measure hematocrit, oxygen saturation and percent charge in blood volume. Both the CLM II and the CLM III measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. In addition, the CLM II and CLM III estimate the amount of blood that is recirculated back into the dialysis circuit instead of the patients circulating volume. Based on the data that the monitors provide, the dialysis technician intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

Device Description

The CLMIII consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLMIII is used in conjunction with the In-Line Diagnostics, Inc. Blood Chamber. The Blood Chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM is connected to the Blood Chamber which reads critical blood parameters as the blood passes through the Blood Chamber.

AI/ML Overview

The provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for medical device performance studies (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the document is a 510(k) summary for the CRIT-LINE Monitor III (CLMIII), which seeks substantial equivalence to a predicate device, the CRIT-LINE II (CLMII). The basis for this equivalence is primarily technological similarity and comparison testing under simulated clinical conditions rather than a formal clinical study with defined acceptance criteria for diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance (CLMIII)	Notes
Hematocrit (HCT)	Not specified	"Operate under the principles of light absorption through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT)"	The document states equivalence in function to the predicate CLMII, which already performs this measurement. No specific numerical performance metrics (e.g., accuracy, precision) for HCT are provided for the CLMIII or the CLMII.
Oxygen Saturation (O2 SAT)	Not specified	"Operate under the principles of light absorption through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT)"	Similar to HCT, no specific numerical performance metrics are provided.
Percent Change in Blood Volume (BV)	Not specified	"Calculate the related value of Blood Volume (BV)"	Derived from HCT and O2 SAT measurements. No specific numerical performance metrics are provided.
Substantial Equivalence	To CRIT-LINE II (CLMII) in "significant features, materials, dimensions and intended use."	The CLMIII is deemed "safe and effective and performs as well as the legally marketed CLMII."	This is the primary "acceptance criterion" for 510(k) clearance, and the conclusion is that it meets this. However, this is about equivalence to an existing device, not necessarily meeting a predefined clinical performance threshold.
Safety Compliance	IEC 601-1: 1988 standard.	Tests performed and concluded that the CLMIII is safe.	This is related to device safety, not clinical performance.
EMC/ESD Compliance	FDA Guidance for Premarket Notification Submission Appendix A Sections (ii)(a) and (ii)(b) for Electrostatic Discharge and Electromagnetic Interference (EMI).	Tests performed and concluded that the CLMIII is effective from an EMC/ESD standpoint.	This is related to device safety and functionality, not clinical performance.

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

Sample size: Not explicitly stated. The document mentions "comparison testing to the predicate was performed on blood bank blood." It does not specify the number of blood samples or the volume of blood used.
Data Provenance: "Blood bank blood" used for testing. The location was "at In-Line Diagnostics, Inc." This suggests in vitro or ex vivo testing under simulated clinical conditions, not data from human patients. The testing was retrospective in the sense that existing blood bank samples were used, but not clinical data from patients.

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

Not applicable / Not stated. The testing described is a comparison to a predicate device using blood bank blood under simulated conditions. There is no mention of "ground truth" establishment by human experts for diagnostic purposes (e.g., categorizing disease states). Instead, the "ground truth" implicitly would be the measurements obtained from the predicate device and/or standard laboratory methods for hematocrit and oxygen saturation, if such methods were used for comparison (though not specified).

4. Adjudication Method for the Test Set

Not applicable / Not stated. No adjudication method is described because the testing did not involve human interpretation or subjective assessments that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not done. The device (CRIT-LINE Monitor III) is an automated monitoring device; it does not involve human readers interpreting images or data where AI assistance would be a factor. The comparison was to a predicate device's measurements, not to human performance.

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

Yes, effectively. The CRIT-LINE Monitor III is an automated device that provides real-time measurements. The testing described was a comparison of this automated device's output to that of the predicate automated device (CLMII) using blood bank blood. There is no human "in the loop" for the measurement itself, only for interpreting the output data and making clinical decisions (by a dialysis technician).

7. The Type of Ground Truth Used

The "ground truth" for the comparison testing was likely measurements from the predicate device (CRIT-LINE II) and/or established laboratory methods for hematocrit and oxygen saturation. The document explicitly states "Comparison testing to the predicate was performed on blood bank blood." It does not specify if external laboratory gold standards were simultaneously used to verify either device's accuracy beyond the comparison to the predicate.

8. The Sample Size for the Training Set

Not applicable / Not stated. The CRIT-LINE Monitor III seems to be based on physical principles of light absorption rather than a machine learning model that requires a "training set." Therefore, a training set in the AI/ML sense is not relevant here. The device hardware and software are "state-of-the-art microprocessor[s]" designed to implement existing algorithms for light absorption measurement and calculation.

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

Not applicable. As noted above, there is no mention or indication of a "training set" for a machine learning model.

Summary

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K972470

DEC | | 1997

EXHIBIT #1 510(k) SUMMARY Page 1 of 3

510(k) SUMMARY

1. Submitter's Information:

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Matthew Haynie In-Line Diagnostics 4646 S. 1500 W., Suite 160 Riverdale, UT 84405 Tel: (801) 394-8669 Fax: (801) 394-8037

510(k) Summary Prepared by:

Thomas J. Bouchard mdi CONSULTANTS, INC. 55 Northern Blvd. Great Neck, NY 11021 Tel: (516) 482-9001

June 27, 1997 Date 510(k) Summary Prepared: 2.
1. Name of the Device

Trade or Proprietary Name:

Common Name:

CRIT-LINE Monitor III (CLMII)

Non-invasive hematocrit, blood volume and oxygen saturation monitor

Classification Name:

Hemodialysis system monitor accessory

Identification of legally marketed device which the submitter claims equivalence. 4.
The CRIT-LINE III (CLMII) is substantially equivalent to the CRIT-LINE II (CLMI) currently marketed by In-Line Diagnostics in significant features, materials, dimensions and intended use ..

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Description of the Subject Devices: ડ.

Intended Use of the Subject Devices: ર.

The CLMIII and the predicate CLMII are used as non-invasive hematocrit, oxygen saturation and blood volume monitors. Both measure hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for the dialysis patient. Based on the data that the monitors provide, the dialysis technician increases or decreases the rate at which fluid is removed from the blood in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

Technological Characteristics of the Subject Devices. 7.

Both the predicate CLMII and the CLMIII are identical in function and operate under the principles of light absorption through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT) and to calculate the related value of Blood Volume (BV).

The CLMIII uses a Motorola 61332A microprocessor which is also a member of the Motorola 68000 family of microprocessors used in the CLMII, but is more up-to-date and has incorporated within it all of the chip select logic, serial communications, timing and watchdog circuits. The code was consolidated into a more modular version to parallel the hardware layout. The measurements in both the CLMI and the CLMIII are accomplished by calibrated Analog to Digital Converters (ADC). The CLMII uses a multiplexer to switch between two circuits, whereas the CLMIII contains completely separate circuits.

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8. Discussion of Clinical Tests Performed:

No Clinical testing was performed. Comparison testing to the predicate was performed on blood bank blood under simulated clinical conditions at In-Line Diagnostics, Inc.

9. Conclusions:

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In summary, based on comparison with the legally marketed CLMII and tests of this device to IEC 601-1: 1988 and to the FDA Guidance for Premarket Notification Submission Appendix A Sections (ii) (a) and (ii) (b) for Electrostatic Discharge and Electromagetic Interference (EMI), the subject CLMIII is safe and effective and performs as well as the legally marketed CLMII.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its head facing to the right and its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1997

Mr. Matthew L. Haynie Director of Quality Assurance In-Line Diagnostics Corporation 4646 South 1500 West Suite 160 Riverdale, Utah 84405

K972470 In-Line Diagnostics CRIT-LINE Monitor III (for Hemodialysis Applications) Dated: October 8, 1997 Received: October 10, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 MQS

Dear Mr. Haynie:

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.

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) 594-4613. 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/dsmamain.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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EXHIBIT A

Page 1 of 1

510(k) Number (if known): K972470

Device Name: CRIT-LINE Monitor III (CLM III)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Robert R. Silling/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K972470

Prescription Use
(PER21 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.