(205 days)
No
The description focuses on a DPD Colorimetric Method and microprocessor control for automated monitoring and display of chlorine levels. There is no mention of AI or ML algorithms for data analysis, pattern recognition, or decision-making beyond basic measurement and alarming.
No
The device monitors chlorine levels in water used for hemodialysis but does not treat or alter the water, and therefore does not have a therapeutic effect on a patient.
No
Explanation: The device monitors the quality of water used to prepare dialysate for hemodialysis, not directly diagnose a patient's medical condition. It is a component of a water treatment system, verifying the suitability of an input material (water) for a medical procedure, rather than providing a medical diagnosis.
No
The device description clearly states it is a "microprocessor-controlled analyzer" that uses a "DPD Colorimetric Method" and measures color intensity photometrically. It also mentions a "Remote Indicator (RI)" subsystem. These are all hardware components, not solely software.
Based on the provided information, the Hach CM130 is not an In Vitro Diagnostic (IVD) device. Here's why:
- Intended Use: The device is intended to monitor the quality of feed water used to prepare dialysate. It does not analyze a biological specimen (like blood, urine, or tissue) from a human body.
- Device Description: The device analyzes water samples using a chemical reaction (DPD Colorimetric Method) to measure chlorine levels. The water samples are discarded after testing.
- Lack of Biological Specimen Analysis: The core function of an IVD is to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. The CM130 does not perform this function.
While the device is used in a healthcare setting (hemodialysis) and its function is critical for patient safety by ensuring the quality of the water used in dialysate, it falls under the category of a water quality monitoring device rather than an IVD. The predicates listed also support this, as they are related to water treatment systems, infusion pumps, and other devices used in the hemodialysis process, but not typically classified as IVDs themselves.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PSX, FIP
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-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.
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.
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
hemodialysis professionals
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 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.
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.
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.
Key Results:
CM130 Bias Verification: Demonstrates the ability of the CM130 to match a known reference reading (Accuracy) and compares performance to the Predicate Devices ability to match a known reading.
CM130 Repeatability - Reproducibility Verification: Demonstrates within instrument and between instrument variations.
CM130 Reproducibility of the Predicate: Comparative reproducibility demonstrates there is less variation with the CM130.
Effects of Iron Cations on Total Chlorine Measurements: Interference Testing - Interferences are tested to limits allowed in water by standards. The testing demonstrates the device performs acceptably even when potentially "interfering" chemicals are present. The results are published in the instructions for use.
Effects of Metal Cations on Total Chlorine Measurements: Not specified.
Effects of Additional Inorganics on Total Chlorine Measurements: Not specified.
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.
K974899, K082182, K093244, K100237, K121022
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the 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 human profiles facing to the right, with flowing lines beneath them.
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.
1
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
2
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.
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.
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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3
Section 6:
510 (k) SUMMARY
| 1. Submitted by: | Hach Company
100 Dayton Avenue
Ames
Iowa, 50010 USA | Phone: | (714) 516 - 7659 |
|-----------------------------------------|---------------------------------------------------------------------------------------|--------|-------------------------|
| | | Fax: | (714) 516 - 7474 |
| | Contact: Jeff Ryberg, VP RA/QA | | jeff.ryberg@danaher.com |
| 2. Date
Prepared: | March 30, 2017 | | |
| 3. Device Name: | Water Purification System for Hemodialysis
Auxiliary Component | | |
| Classification
of Device: | Class II
21 CFR 876.5665
Primary Product Code PSX
Secondary Product Code FIP | | |
| 4. Trade Name of
Proposed
Device: | Hach CM130 Chlorine Monitor | | |
6. Predicate Device:
| Sub-System | Predicate Device Name | Description | 510(k)
Number |
|------------|--------------------------------------|--------------------------|------------------|
| Chemistry | SteriChek®
Total Chlorine DPD Kit | Chlorine
Measurements | K983997 |
7. Reference Devices:
| Sub-System | Reference Device
Name | Description | 510(k)
Number |
|----------------------------------------------|---------------------------------------------------------------|--------------------------------------------|------------------|
| Water Sample
Conditioning and
Delivery | Gambro Central
Water Treatment
System, CWP 100
WRO H | Water Flow Control | K974899 |
| Reagent Delivery | AP 34 Multi-Therapy
Infusion Pump | Fluid movement using a
Peristaltic pump | K082182 |
4
| Sub-System | Reference Device
Name | Description | 510(k)
Number |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------|
| Measurement
Chamber | DensiChek Plus Fully
Automated Short
Term Incubation
Cycle Antimicrobial
Susceptibility Device | Provides measurements
based on the optical
density of a
microorganism
suspension | K093244 |
| Electronic Hardware
Software Controls
with Enclosure | Dialysate Meter,
Model D-6 | Microprocessor
controlled automation
in a water room | K100237 |
| Remote Indicator | AmeriWater Alarm | Remotely mounted
device “state” indicator | K121022 |
8. Proposed 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.
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
5
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.
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.
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.
6
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:
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.
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:
-
- Automated water sample conditioning and delivery
-
- Automated reagent delivery
-
- Automated measurements
-
- Electronic hardware and software used to control device operation
-
- A Remote Indicator (RI) to allow individuals in the patient treatment area, to monitor the status of equipment in the water room
-
- An Enclosure to protect electronics from incidental splashing or spills
7
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 a |
| known reference reading (Accuracy) and | |
| compares performance to the Predicate Devices | |
| ability to match a known reading. | |
| CM130 Repeatability - | |
| Reproducibility | |
| Verification | Demonstrates within instrument and between |
| instrument variations. | |
| CM130 Reproducibility | |
| of the Predicate | Comparative reproducibility demonstrates there is |
| less variation with the CM130 | |
| Effects of Iron Cations | |
| on Total Chlorine | |
| Measurements | |
| Note: Minerals are | |
| grouped see intro to | |
| each protocol | Interference Testing |
| Interferences are tested to limits allowed in water | |
| by standards. The testing demonstrates the device | |
| performs acceptably even when potentially | |
| "interfering" chemicals are present. | |
| The results are published in the instructions for | |
| use | |
| Effects of Metal Cations | |
| on Total Chlorine | |
| Measurements | |
| Effects of Additional | |
| Inorganics on Total | |
| Chlorine 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.
8
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
9
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.