The Hach CM130 is an instrument that is intended for use by hemodialysis professionals to automatically monitor low levels of total chlorine (i.e. total chloramines plus free chlorine) in feed water used to prepare dialysate in hemodialysis systems.

The CM130 is a component of the complete water treatment system for hemodialysis and does not treat or alter the water used in dialysate. The CM130 instrument's automated monitoring records total chlorine values in feed water at intervals between 5 and 20 minutes.

Device Description

The Hach CM130 Chlorine Monitor is a microprocessor-controlled analyzer used to monitor the chlorine content of water which is used to prepare dialysate for hemodialysis. The monitor is mounted in the water room in a location that allows sampling of feed water between the primary (scrubbing) and secondary (polishing) carbon tanks. Water that flows into the CM130 exits the device to a drain. The water samples, once tested, are also discarded to a drain.

The monitor measures and displays total chlorine (free chlorine and combined chloramines) as Cl2, ranging from 0.03 to 0.20 mg/L.

The CM130 Chlorine Monitor employs a DPD Colorimetric Method for the detection of total chlorine. The analyzer introduces N,N-Diethyl-p-phenylenediamine (DPD) indicator with potassium iodide and a buffer to the water sample under test. The indicator and buffer are allowed to react with the chlorine and chloramines present in the water. The reaction results in a dye which forms a red color in the water sample. The intensity of the red color is proportional to the total chlorine concentration. It is measured photometrically and the results are automatically recorded and displayed.

The Remote Indicator (RI) is a subsystem that is mounted in the patient treatment area, typically near the ceiling, so that it can be easily seen. Its primary function is to communicate the status of the chlorine concentration of the feed water and the status of the analyzer to the staff while they are working in the patient treatment room.

The CM130 Chlorine Monitor and the Remote Indicator will each provide both an audible and a visual signal.

AI/ML Overview

The provided text describes the HACH CM130 Chlorine Monitor, a device intended to automatically monitor total chlorine levels in feed water for hemodialysis systems. The document is a 510(k) premarket notification summary submitted to the FDA.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

Note: This document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than outright clinical efficacy studies. Therefore, many of the typical acceptance criteria for AI/ML medical devices (such as sensitivity, specificity, PPV, NPV) and the detailed study elements like MRMC studies, large-scale ground truth establishment by multiple experts, and specific training set details, are not directly applicable or explicitly stated in this type of submission for this particular device. The focus here is on analytical performance and safety.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the analytical and safety performance of the device, rather than diagnostic accuracy in a clinical context.

Acceptance Criteria	Reported Device Performance
Bias (Accuracy)	Demonstrates the ability of the CM130 to match a known reference reading. Performance is compared to the predicate device's ability to match a known reading. Bias testing covered the entire measurement range (0.03 to 0.20 mg/L).
Repeatability (Precision - within instrument)	Demonstrates within instrument variations.
Reproducibility (Precision - between instruments)	Demonstrates between instrument variations. Comparative reproducibility testing showed less variation with the CM130 compared to the predicate.
Interference Testing	Device performs acceptably even when potentially "interfering" chemicals (e.g., iron cations, metal cations, additional inorganics) are present at limits allowed by water standards. Results are published in the instructions for use.
Electrical Safety	Evaluated against IEC61326-1 (electromagnetic compatibility) and IEC61010-1 (electrical safety).
Software Verification and Validation	Developed, verified, and validated in accordance with applicable FDA guidance documents. Results demonstrate software performs as intended.
Alarm Performance	Tested for alarm performance following CLSI EP12-A2. Positive and negative alarm performance demonstrated the device is safe and effective.
Reagent Shelf Life and Use Life	Reagents met specified shelf life and use life when stored upright in the marketing container at specified temperatures.
Human Factors Usability	Tested per ANSI/AAMI HE75:2009. Found to be safe and effective for intended users, uses, and use environments based on subjective and objective data from formative and summative (simulated and actual use) testing with representative users.

Study Details Proving Device Meets Acceptance Criteria

The studies conducted are primarily non-clinical performance, analytical, and safety validations.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of a specific number of samples for each test (e.g., how many water samples for bias, how many for repeatability). The document mentions "same solutions and test setups" were used for the CM130 and the predicate device.
- Data Provenance: The studies were "Non-clinical testing" conducted by Hach Company. The location of the testing or the origin of the solutions is not specified, but it implies laboratory-based or simulated environment testing rather than clinical patient data. The nature is prospective in the sense that the device was actively tested under controlled conditions.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable in the typical sense for this device. The "ground truth" for chemical measurements (total chlorine) was established by a reference method for independent verification of "true" measurement values, not by human expert interpretation like in image analysis. Humans were involved in establishing the "ground truth" for human factors testing (representative users), but their qualifications are not specified beyond being "representative users" in target groups (hemodialysis professionals).
Adjudication Method for the Test Set:
- Not applicable as the primary tests are quantitative measurements against a reference method or engineering standards, not subjective interpretations. Human factors testing involved observation and subjective/objective data collection, but no explicit adjudication method (e.g., 2+1 consensus) is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic performance. The CM130 Chlorine Monitor is a chemical monitoring device, not an imaging diagnostic device.
Standalone (Algorithm-Only) Performance:
- Yes, the core of the performance testing (bias, repeatability, reproducibility, interference) assessed the standalone analytical performance of the CM130 Chlorine Monitor. The "algorithm" here refers to the instrument's measurement and display capabilities. The comparison was made against a "reference method" and the predicate device.
Type of Ground Truth Used:
- Reference Method: For accuracy (bias) testing, a "reference method used to independently verify the 'true' measurement" of total chlorine was utilized. This is equivalent to a highly accurate laboratory standard or gold standard measurement.
- Engineering Standards: For electrical safety, software validation, and alarm testing, the ground truth was defined by compliance with specific, recognized engineering and performance standards (e.g., IEC61326-1, IEC61010-1, CLSI EP12-A2).
- Usability Objectives: For human factors testing, the "ground truth" was the ability of representative users to safely and effectively use the device, as assessed against predefined usability objectives and observed performance.
Sample Size for the Training Set:
- Not Applicable / Not Explicitly Stated. The CM130 is not described as an AI/ML device that requires a "training set" in the sense of supervised learning from data. It's a deterministic chemical analyzer. Its "calibration" or internal parameters would be set through engineering and testing, not by training on a large dataset in the AI sense. Software verification and validation refer to traditional software engineering processes, not machine learning model training.
How the Ground Truth for the Training Set Was Established:
- Not Applicable. Since there isn't a "training set" for an AI/ML model as described in the typical context, this question does not apply. The device's operational parameters would be established through manufacturer specifications, calibration procedures, and adherence to design control processes.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 30, 2017

HACH Company Jeff Ryberg Vice President RA /OA 100 Dayton Avenue Ames, IA 50010

Re: K162471

Trade/Device Name: CCM130 Chlorine Monitor Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: II Product Code: PSX, FIP Dated: February 24, 2017 Received: February 27, 2017

Dear Jeff Ryberg:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162471

Device Name CM130 Chlorine Monitor

Indications for Use (Describe)

The Hach CM130 is an instrument that is intended for use by hemodialysis professionals to automatically monitor low levels of total chlorine (i.e. total chlorine) in feed water used to prepare dialysate in hemodialysis systems.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 6:

510 (k) SUMMARY

1. Submitted by:	Hach Company100 Dayton AvenueAmesIowa, 50010 USA	Phone:	(714) 516 - 7659
		Fax:	(714) 516 - 7474
	Contact: Jeff Ryberg, VP RA/QA		jeff.ryberg@danaher.com
2. DatePrepared:	March 30, 2017
3. Device Name:	Water Purification System for HemodialysisAuxiliary Component
Classificationof Device:	Class II21 CFR 876.5665Primary Product Code PSXSecondary Product Code FIP
4. Trade Name ofProposedDevice:	Hach CM130 Chlorine Monitor

6. Predicate Device:

Sub-System	Predicate Device Name	Description	510(k)Number
Chemistry	SteriChek®Total Chlorine DPD Kit	ChlorineMeasurements	K983997

7. Reference Devices:

Sub-System	Reference DeviceName	Description	510(k)Number
Water SampleConditioning andDelivery	Gambro CentralWater TreatmentSystem, CWP 100WRO H	Water Flow Control	K974899
Reagent Delivery	AP 34 Multi-TherapyInfusion Pump	Fluid movement using aPeristaltic pump	K082182

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Sub-System	Reference DeviceName	Description	510(k)Number
MeasurementChamber	DensiChek Plus FullyAutomated ShortTerm IncubationCycle AntimicrobialSusceptibility Device	Provides measurementsbased on the opticaldensity of amicroorganismsuspension	K093244
Electronic HardwareSoftware Controlswith Enclosure	Dialysate Meter,Model D-6	Microprocessorcontrolled automationin a water room	K100237
Remote Indicator	AmeriWater Alarm	Remotely mounteddevice “state” indicator	K121022

8. Proposed Device Description:

The monitor measures and displays total chlorine (free chlorine and combined chloramines) as Cl2, ranging from 0.03 to 0.20 mg/L.

Image /page/4/Picture/6 description: The image shows a HACH CM130 instrument. The instrument has a digital display that reads "0.05 mg/L". The instrument is enclosed in a gray box with a blue frame and has two white bottles inside.

Section 6 – Figure 1: CM130 Chlorine Monitor

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CM130 Chlorine Monitor 510 (k) March 30, 2017

The CM130 Chlorine Monitor employs a DPD Colorimetric Method for the detection of total chlorine. The analyzer introduces N,N-Diethyl-pphenylenediamine (DPD) indicator with potassium iodide and a buffer to the water sample under test. The indicator and buffer are allowed to react with the chlorine and chloramines present in the water. The reaction results in a dye which forms a red color in the water sample. The intensity of the red color is proportional to the total chlorine concentration. It is measured photometrically and the results are automatically recorded and displayed.

Image /page/5/Figure/4 description: The image shows a device with visual and audible signals. There are two blue water drop icons at the top, indicating the state of the device. Below the water drop icons are two yellow squares with a curved line inside, which are also visual signals. At the bottom of the device, there is an arrow pointing to the audible signal.

Section 6: Figure 2: CM130's Remote Indicator (RI)

The CM130 Chlorine Monitor and the Remote Indicator will each provide both an audible and a visual signal.

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Alert

An alert is a signal to inform staff that total chlorine measurements indicate concentrations have increased (medium – high), but are still acceptable. This predefined "alert" level is greater than .07 mg/L but less than 0.1 mg/L Cl2. Notification at this point with an amber illumination and alert tone, allows staff to address maintenance of the water system at a time that is relatively convenient.

Alarm

The analyzer and the Remote Indicator each provide both an audible and a visual "Alarm" signal when the total Chlorine exceeds the standard allowable level of 0.1 mg/L Cl2.

9. Indications for Use:

10. Summary of Technological Characteristics of New Device Compared to Predicate and Reference Devices

The proposed CM130 Chlorine Monitor uses the same chlorine detection technology (DPD color reaction) as the predicate. Both products are used to monitor feed water used to prepare dialysate.

However, providing automatic measurements, the CM130 Chlorine Monitor adds technological features not found in the predicate device. These technological features include:

1. Automated water sample conditioning and delivery
1. Automated reagent delivery
1. Automated measurements
1. Electronic hardware and software used to control device operation
1. A Remote Indicator (RI) to allow individuals in the patient treatment area, to monitor the status of equipment in the water room
1. An Enclosure to protect electronics from incidental splashing or spills

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11. Summary of Performance Testing Supporting Substantial Equivalence System Performance Testing

Non-clinical testing was conducted on the CM130 Chlorine Monitor. Performance verification and validation testing demonstrate that the CM-130 Chlorine Monitor system and subsystems are safe and effective for their intended use.

Description	Performance Test Comment
CM130 Bias Verification	Demonstrates the ability of the CM130 to match aknown reference reading (Accuracy) andcompares performance to the Predicate Devicesability to match a known reading.
CM130 Repeatability -ReproducibilityVerification	Demonstrates within instrument and betweeninstrument variations.
CM130 Reproducibilityof the Predicate	Comparative reproducibility demonstrates there isless variation with the CM130
Effects of Iron Cationson Total ChlorineMeasurementsNote: Minerals aregrouped see intro toeach protocol	Interference TestingInterferences are tested to limits allowed in waterby standards. The testing demonstrates the deviceperforms acceptably even when potentially"interfering" chemicals are present.The results are published in the instructions foruse
Effects of Metal Cationson Total ChlorineMeasurements
Effects of AdditionalInorganics on TotalChlorine Measurements

Performance testing was conducted on the CM130 Chlorine Monitor and on the predicate device using the same solutions and test setups with modifications as appropriate for the differences between manual and automated testing. The CM130 Chlorine Monitor is designed to test automatically, generating a measurement of a new sample of water every 5 minutes during use. The predicate is a manual process that takes an unspecified amount of time to collect and process each water sample.

The devices have similar measurement capability in that the predicate scale is manually read to the nearest .02 mg/L and is interpolated to .01 mg/L while the CM130 Chlorine Monitor measures to .01mg/L Cl2.

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CM130 Chlorine Monitor 510 (k) March 30, 2017

Accuracy (Bias) and Precision (Repeatability) verifications were conducted under CLSI-EP Standards. These protocols address equivalency testing with the CM130 Chlorine Monitor results compared to the predicate.

Bias testing covered the entire measurement range of the CM130 Chlorine Monitor. Test measurements for each device are compared to a reference method used to independently verify the "true" measurement.

Electrical Safety Testing

The CM-130 Chlorine Monitor has been evaluated against the requirements for electromagnetic compatibility and electrical safety in accordance with IEC61326-1 and IEC61010-1.

Software Verification and Validation Testing

The CM-130 Chlorine Monitor software was developed, verified and validated in accordance with the applicable FDA guidance documents. The results of the verification and validation activities demonstrate the software performs as intended.

Alarm Testing

The CM130 system was tested for alarm performance following CLSI EP12-A2. The positive and negative alarm performance demonstrate the device is safe and effective for intended use.

Reagent Shelf Life and Use Life Testing

The CM130 reagents were tested to confirm that they met the specified shelf life and use life. The reagents meet all specifications when stored upright in the marketing container at the specified temperatures. The results of the shelf life and use life testing demonstrate the device is safe and effective for intended use.

Human Factors Testing

The CM130 was tested for human factors usability per ANSI/AAMI HE75:2009. The CM130 has been found to be safe and effective for the intended users, uses and use environments as demonstrated in summative simulated and actual use testing of the user interfaces with representative users. The Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative user testing and summative user testing. Formative and summative user testing included simulated use and actual use tasks for both user groups. Based on subjective and objective data it can be concluded that all users can safely and effectively use the device.

12. Conclusion

CM-130 Chlorine Monitor non-clinical performance, electrical safety, software verification and validation, alarm testing, reagent and use life testing and

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CM130 Chlorine Monitor 510 (k) March 30, 2017

human factors testing demonstrate the device is safe and effective for its intended use.

The proposed device uses the same active chemistry, has the same intended use, and has labeling similar to the predicate device. The CM130 Chlorine Monitor is also similar to the reference devices in specific technological features.

The predicate and subject devices were tested to plan with passing results, therefore demonstrating substantial equivalence.

Regulation Number and Section

§ 876.5665 Water purification system for hemodialysis.

(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.