Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on basic sensor technology, alarm systems, and self-monitoring for maintenance, with no mention of AI or ML terms or functionalities.

Therapeutic

No.
The device is described as an "auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration" in hemodialysis water treatment systems. It does not directly treat or diagnose patients, which are characteristics of therapeutic devices. Its function is to monitor water quality for the safe operation of medical procedures.

Diagnostic

Yes

The device monitors the concentration of chloramines and ammoniated free chlorine, detects when levels are above a set-point, and provides alarms (buzzers and indicators) when this condition is met. This falls under the definition of a diagnostic device as it identifies a specific condition (elevated chlorine levels) within the water treatment system.

SaMD (Software as a Medical Device)

No

The device description explicitly states it has three hardware components: a master control enclosure, a probe/tester enclosure, and a remote module. It also mentions a chlorine monitoring probe and a peristaltic pump, indicating it is a hardware-based system with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Nelson Sentinel Series Basic Chlorine Sentinel is likely considered an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The device is intended to monitor the concentration of Total chloramines plus ammoniated free chlorine in water used for hemodialysis. This water is a critical component in the preparation of dialysate, which is a solution used in hemodialysis to remove waste products from the blood. While the device doesn't directly test a patient sample, it is monitoring a substance that is directly involved in a medical procedure and has a direct impact on patient safety.
Function: The device detects dissolved chlorine using an "auxiliary meter detection technology." This involves analyzing the chemical composition of the water sample.
Regulatory Context: Devices used to monitor the quality of water used in hemodialysis are typically regulated by health authorities due to the critical nature of this water for patient safety. The fact that it is intended for use by "hemodialysis professionals" and is an "auxiliary device" for monitoring a critical parameter in the hemodialysis water treatment system further supports its classification as a medical device, and specifically one that performs an in vitro analysis of a substance used in a medical procedure.
Predicate and Reference Devices: The predicate and reference devices listed (K090338 and K162471) are also devices used for monitoring chlorine in water, and they are likely classified as IVDs or similar medical devices. This suggests that devices performing this function are generally considered within the scope of medical device regulation.
Performance Studies: The mention of performance studies like Linearity, Precision, Limit of Detection, and Method Comparison are typical types of studies conducted for IVD devices to demonstrate their analytical performance.

While the device doesn't directly analyze a human biological sample, it is analyzing a substance (water) that is directly used in a medical procedure (hemodialysis) and whose quality is critical for patient health. This type of analysis, performed to ensure the safety and efficacy of a medical treatment, falls under the scope of IVD regulation in many jurisdictions.

Therefore, based on the intended use, function, and regulatory context suggested by the predicate/reference devices and performance studies, it is highly probable that the Nelson Sentinel Series Basic Chlorine Sentinel is classified as an IVD device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total Chlorine. (i.e. total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.

Product codes (comma separated list FDA assigned to the subject device)

PSX, MSY, FIP

Device Description

The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop.

The device has three components - a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area.

A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller.

A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved.

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)

Bench Testing has been performed to verify the performance of the Nelson Sentinel Series Basic Chlorine Sentinel, which includes:

Linearity Study
Precision Study
Limit of Blank, Limit of Quantitation, Limit of Detection Study
Method Comparison Study
Peristaltic Pump and Tubing Validation
Free Chlorine Study
15 Weeks Calibration Study

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.

K090338

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.

K162471

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

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.

Summary

0

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October 29, 2020

Nelson Environmental Technologies, Inc. QuocHuy (Huy) Nguyen New Product Development Manager/Finance Manager 813 E. Fir Avenue McAllen, TX 78501

Re: K193169

Trade/Device Name: Nelson Sentinel Series Basic Chlorine Sentinel Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: PSX, MSY, FIP Dated: September 28, 2020 Received: September 29, 2020

Dear QuocHuy (Huy) Nguyen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193169

Device Name

Nelson Sentinel Series Basic Chlorine Sentinel

Indications for Use (Describe)

The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.

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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K193169 Page 6.1-1 of 6.1-20

6. 510(k) Summary

Nelson Environmental Technologies, Inc.

This 510(k) Summary is in conformance with 21CFR 807.92

| Submitter: | Nelson Environmental Technologies, Inc
813 E. Fir Avenue
McAllen, TX 78501
Phone: 956-618-0375 |
|------------------|---------------------------------------------------------------------------------------------------------|
| Primary Contact: | QuocHuy (Huy) Nguyen
Email: admin@nws.bz
Phone: 956-618-0375 |

Date Prepared: August 13, 2020
Device Name and Classification

Trade Name/Device Name:	Nelson Sentinel Series Basic Chlorine Sentinel
Regulation Number:	21 CFR 876.5665
Regulation Name:	Water Purification System for Hemodialysis
Regulatory Class:	Class II
Classification Panel:	Gastroenterology/Urology
Product Code:	PSX, MSY, FIP

Fax: 956-618-4330

Predicate Device:

Trade Name	Ultra Low Total Chlorine (K100-0118) and E-Z Chek Sensitive Total Chlorine (K100-0106) Test Strips
Common Name	Total Chlorine Test Strips
510(k) Submitter / Holder	Reprocessing Products Corporation (RPC)
510(k) Number	K090338
Regulation Number	21 CFR§ 876.5665 Water purification system for hemodialysis
Classification Panel	Gastroenterology/Urology
Product Code	MSY

4

Reference Device:

Trade Name		Hach CM130 Chlorine Monitor
Common Name
510(k) Submitter / Holder		HACH Company
510(k) Number		K162471
Regulation Number		21 CFR§ 876.5665 Water Purification System For
Hemodialysis
Classification Panel		Gastroenterology/Urology
Product Code		Primary Product Code PSX
Secondary Product Code FIP

Device Description

The Nelson Sentinel Series Basic Chlorine Sentinel is a complete system that attaches to the drain of a hemodialysis water treatment system sample port. The Basic Chlorine Sentinel detects dissolved chlorine by an auxiliary meter detection technology, self-monitors for maintenance-required conditions, loss of electrical power, as well as two other system conditions such as flooding and the status of RO shutdown alarm. The device chlorine monitoring probe is preferably placed after the second carbon filter, before the RO machine or at the beginning of the patient water treatment loop.

The device has three components - a lockable master control enclosure, a lockable probe/tester enclosure, and the remote module installed in the patient area.

A chlorine concentration equal to or above the set-point (default: 0.10mg/L) will activate the buzzers and the red CHLORINE alarm indicators for as long as the condition exists. The buzzers can only be muted for 3 minutes (then automatically reset) for as long as the condition exists. The yellow AUTO-TEST OK/CL DETECTED indication will latch. The AUTO-TEST/CL DETECTED indication can be deactivated after the event by pressing the blue RESET PUSHBUTTON on the front cover of the controller.

A probe failure or the activation of one of the auxiliary input relays will activate the yellow MAINTENANCE needed indicators as well as the Buzzers which will remain activated as long as the condition exists. However, the buzzers can be muted by the key mute switch while the maintenance issue is being resolved.

Indications for Use

The Nelson Sentinel Series Basic Chlorine Sentinel is an instrument that is intended for use by hemodialysis professionals as an auxiliary device to provide continuous monitoring of Total Chlorine. (i.e. total chloramines plus ammoniated free chlorine) concentration. It is not intended to replace the primary method for monitoring total chlorine as part of the hemodialysis water

5

treatment system. It functions completely independent of the water treatment system and does not come into direct contact with feed water used to prepare dialysate.

Risk Analysis Method

Nelson Sentinel Series Basic Chlorine Sentinel was assessed to determine risks to health associated with the use of the device, a risk analysis was conducted in accordance with ISO 14971: 2007, Medical devices - Application of risk management to medical devices.

Substantial Equivalence

The table below provides a detailed comparison of Nelson Sentinel Series Basic Chlorine Sentinel to the predicate and reference devices.

6

Detailed Comparison of the Subject and Predicate Devices

| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | The Nelson Sentinel
Series Basic Chlorine
Sentinel is an instrument
that is intended for use
by hemodialysis
professionals as an
auxiliary device to
provide continuous
monitoring of Total
Chlorine. (i.e. total
chloramines plus
ammoniated free
chlorine) concentration. It
is not intended to replace
the primary method for
monitoring total chlorine
as part of the
hemodialysis water
treatment system. It
functions completely
independent of the water
treatment system and
does not come into direct
contact with feed water
used to prepare
dialysate. | The Reprocessing
Product Corporation
(RPC) Total Chlorine
Test Strips are indicated
for detection of Free
Chlorine and Total
Chlorine in water. These
Test Strips are indicated
for testing water used to
prepare dialysate (Free
Chlorine and
Chloramines) and for
testing rinse water
following dialysis
equipment disinfection
(Free Chlorine). | N/A; Nelson Sentinel
Series Basic Chlorine
Sentinel is compared to
UltraLow Total Chlorine
and E-Z Chk Sensitive
Total Chlorine Test
Strips for Intended Use
and Indications For Use. | The Nelson Sentinel Series
Basic Chlorine Sentinel
intended use / indications
for use is identical to the
UltraLow Total Chlorine and
E-Z Chek Sensitive Total
Chlorine Test Strips
intended use and
indications for use, related
to the detection of Total
Chlorine in Water and
testing water used to
prepare dialysate. |
| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Provides Exact
Chlorine Value? | No; Intended to indicate
chlorine above set-point
only | No; Indicates an
approximate, semi-
quantitative value based
on the colorimetric
method, which can be
used to confirm if
chlorine is above a
specific value | Yes; presents an exact
chlorine value on its
display intended to be
used to make clinical
decisions | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to UltraLow Total
Chlorine and E-Z Chek
Sensitive Total Chlorine
Test Strips. |
| Detection
Chemistry/
Technology | Direct measuring
polarographic sensor
utilizing a special
polymeric membrane. | N/A | DPD Colorimetric
Method | Nelson Sentinel Series
Basic Chlorine Sentinel
uses a different detection
technology from Hach
CM130 Chlorine Monitor.
The difference in detection
technology does not affect
the intended use or the
safety of the device. |
| Chlorine Sensor
Type | Polarographic sensor | N/A | Photometric sensor | Nelson Sentinel Series
Basic Chlorine Sentinel
uses a different sensor from
Hach CM130 Chlorine
Monitor.
The difference in sensor
type does not affect the
intended use or the safety of
the device. |
| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Reagents | Ammonium sulfate | N/A | Indicator solution (DPD
indicator with potassium
iodide), buffer solution | The reagents used by
Nelson Sentinel Series
Basic Chlorine Sentinel and
Hach CM130 Chlorine
Monitor are different.
The difference in reagents
used does not affect the
intended use or safety and
effectiveness of the device. |
| Reagent
Delivery | Peristaltic pump | N/A | Peristaltic pump | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| Type of
Chlorine
Detected | Total Chlorine (free
chlorine plus total
chloramines) | N/A | Total Chlorine (free
chlorine plus total
chloramines) | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Detection
Range | 0.05 mg/L Cl2- 0.15
mg/L Cl2 | N/A | 0.03 mg/L Cl2- 0.20
mg/L Cl2 | Nelson Sentinel Series
Basic Chlorine Sentinel is
able to detect a wider range
of chlorine levels than Hach
CM130 Chlorine Monitor.
This difference in detection
range does not affect the
intended use or safety and
effectiveness of the device. |
| Allowable
Chlorine Level | 0.1 mg/L Cl2 | N/A | 0.1 mg/L Cl2 | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| Sampling | The chlorine sensor is
located on the
downstream side of a
water treatment test
sample port. The
sampled water is then
discharged down the
drain. | N/A | Feed water is sampled.
Water that flows into the
CM130 device exits the
device to a drain. The
water samples, once
tested, are also
discarded to a drain. | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor. |
| Water Sample
Conditioning
and Delivery | Automated | N/A | Automated | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Measurement
Interval | Continuous | N/A | 5 minutes | Nelson Sentinel Series
Basic Chlorine Sentinel has
a higher measurement
interval than Hach CM130
Chlorine Monitor.
This difference in
measurement interval does
not affect the safety or
effectiveness of the device. |
| Alarms/ Alerts | Controller: Three colors
(green for power
indication, and yellow
and red for alerts) and a
buzzer
Remote Module: Three
colors (green for power
indication, yellow and red
for alerts) and a buzzer | N/A | Analyzer: Two colors
(amber and red) on the
display and three
sounds for notifications.
Remote Indicator: Two
lights show the analyzer
status (blue, amber, or
red). Two lights show
the chlorine status (blue,
amber, or red). Three
different sounds:
hardware alarm,
medium-high chlorine
alert, and high chlorine
alarm. | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor.
Differences in light colors
and types of sounds do not
affect the intended use or
safety and effectiveness of
the device. |
| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Measurement
Point | After the secondary
carbon filter, before the
reverse osmosis (RO)
machine. | N/A | Between the primary
and secondary carbon
tanks (filters). | Nelson Sentinel Series
Basic Chlorine Sentinel is
different from Hach CM130
Chlorine Monitor.
This difference in
measurement point does
not affect the intended use
or the safety and
effectiveness of the device. |
| Device
Location | Remote Module is
located in the nurse's
station: all other
components are located
in the water room | N/A | Remote indicator is
located in the patient
room; all other
components are located
in the water room | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor. |
| Remote
Indicator | Yes | N/A | Yes | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| Enclosure to
protect
electronics
from splashing
or spills | Yes | N/A | Yes | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Water
Treatment? | No | N/A | No | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| Device
Components | Controller, Probe/Tester,
Remote Module | N/A | Analyzer, Remote
Indicator | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor.
This difference in device
components does not affect
the intended use or safety
and effectiveness of the
device. |
| Control
Mechanism | Microcontroller | N/A | Microcontroller | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |
| Maintenance | Quarterly | N/A | Monthly | Nelson Sentinel Series
Basic Chlorine Sentinel
requires less frequent
maintenance than Hach CM
130 Chlorine Monitor. The
difference in maintenance
interval does not affect the
intended use or safety and
effectiveness of the device. |
| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Data Logger | No data logger. | N/A | 3000 measurements
maximum | Data logging features are
not available for Nelson
Sentinel Series Basic
Chlorine Sentinel. This
difference does not affect
the intended use or safety
and effectiveness of the
device. |
| Status Outputs | Five water treatment
status outputs:
(1) Continuous
auxiliary monitoring of
Total Chlorine (i.e. total
chloramines plus
ammoniated free
chlorine) concentration
(this is not to be
confused with primary
or secondary testing
for chlorine. The
device display is for
calibration function
only and is not to be
used for accurate
chlorine concentration
readings. The device | N/A | High chlorine | Nelson Sentinel Series
Basic Chlorine Sentinel
provides additional status
outputs from the Hach
CM130 Chlorine Monitor.
This difference does not
affect the intended use or
safety and effectiveness of
the device. |
| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| | does not record usable
chlorine concentration
values, it only
compares the actual
concentration to the
set-point). When the
concentration equals
or exceeds the pre-set
set-point, the
notification output is
activated. Notification
closes Output Relay
#1;
(2) Loss of system or
facility mains electrical
power. Default Output
Relay #2;
(3) Aux#1 Input
(recommended for the
status of flood
detection monitors), (it
does not control any
equipment).
Notification closes
Output Relay #3;
(4) Aux #2 Input
(recommended for the | | | |
| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| | status of flood
detection monitors), (it
does not control any
equipment) Notification
closes Output Relay #4
(5) Self-diagnostic
system failures or
maintenance required. | | | |
| Display | Backlit LCD: 1.91 cm
(0.75 in.)high 4-digit
main display, 0.76 cm
(0.3 in.) 5x7 dot matrix
12-digit secondary
display | N/A | 10.9 cm (4.3 in.) color
display, backlit LCD
WQVGA | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor, with the
only difference being that
Nelson Sentinel Series
Basic Chlorine has a
smaller screen than Hach
CM130 Chlorine Monitor.
This difference in screen
size does not affect safety
or effectiveness of the
device. |
| Power
Requirement | 110 – 240 VAC line
power | N/A | 100 - 240 VAC, 50/60
Hz, 1 A max | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor. |
| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Dimensions | Controller: 38.0 x 46.0
x 16.5 cm (15 x 18 x
6.5 in.)
Probe/Tester: 22.5 x
31.0 x 18.5 cm (8.875
x 12.125 x 7.5 in.)
Remote Module: 20.0
x 14.5 x 10.0 cm (4.5 x
6.5 x 1.75 in.) | N/A | Analyzer: 37.0 x 53.8 x
22.6 cm (14.6 x 21.2 x
8.9 in.)
Remote indicator: 12.3 x
19.4 x 10.7 cm (4.8 x
11.6 x 4.2 in.) | The dimensions of Nelson
Sentinel Series Basic
Chlorine Sentinel
components are different
from the dimensions of
Hach CM130 Chlorine
Monitor components.
This difference in
dimensions does not affect
the intended use or safety
and effectiveness of the
device. |
| Weight | Controller: 6.5 kg
(14.3 lbs.)
Probe/Tester: 3 kg
(6.6 lbs.)
Remote Module: 0.25
kg (0.5 lbs.) | N/A | Analyzer: 8.9 kg (19.6
lbs.)
Remote Indicator: 1.1 kg
(2.5 lbs.) | The weights of the Nelson
Sentinel Series Basic
Chlorine Sentinel
components are different
from the weights of the
Hach CM130 Chlorine
Monitor components.
This weight difference does
not affect the intended use
or safety and effectiveness
of the device. |
| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
| Materials | Controller: PVC and
stainless steel monitor,
ABS plastic enclosure
Probe/Tester: ABS
plastic enclosure
Remote Module: ABS
plastic enclosure | N/A | Analyzer:
polycarbonate/ABS
plastic case,
polycarbonate door,
polycarbonate hinges
and latches, 316 SST
(stainless steel)
hardware
Remote indicator:
polycarbonate/ABS
plastic | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor. |
| Sample Flow
Rate | 250 mL/min minimum | N/A | 250 mL/min minimum | Nelson Sentinel Series
Basic Chlorine Sentinel is
identical to Hach CM130
Chlorine Monitor. |

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Nelson Sentinel Series Basic Chlorine Sentinel Traditional 510(k)

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| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
|--------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample
Pressure | 270 kPa - 530 kPa (40
psi - 80 psi) | N/A | 2.76 bar – 6.89 bar (40
psi - 100 psi) nominal;
pressure spikes 8.27 bar
(120 psi) or less | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor.
The upper limit of the
sample pressure of Nelson
Sentinel Series Basic
Chlorine Sentinel is lower
than that of Hach CM130
Chlorine Monitor. This
difference in sample
pressure does not affect the
intended use or safety and
effectiveness of the device. |

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| ltem | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
|-----------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample
Temperature | 15 - 40°C (60 - 105°F) | N/A | 15 - 30°C (60 - 85°F) | Nelson Sentinel Series
Basic Chlorine Sentinelis
equivalent to Hach CM130
Chlorine Monitor.
The upper limit of the
sample temperature
ofNelson Sentinel Series
Basic Chlorine Sentinel is
higher than that of Hach
CM130 Chlorine Monitor.
This difference in sample
temperature does not affect
the intended use or safety
and effectiveness of the
device. |

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| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
|--------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Temperature | 15 – 40°C (60 – 105°F) | N/A | 15 – 30°C (60 – 85°F) | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor.
The upper limit of the
operating temperature of
Nelson Sentinel Series
Basic Chlorine Sentinel is
higher than that of Hach
CM130 Chlorine Monitor.
This operating temperature
difference does not affect
the intended use or safety
and effectiveness of the
device. |

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| Item | Subject Device
Nelson Sentinel Series
Basic Chlorine Sentinel | Predicate Device
UltraLow Total Chlorine
and E-Z Chek Sensitive
Total Chlorine Test
Strips | Reference Device
Hach CM130 Chlorine
Monitor | Comparison |
|-----------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Humidity | 35 - 85% RH | N/A | 5 – 90% non-condensing
at 30°C (85°F) maximum | Nelson Sentinel Series
Basic Chlorine Sentinel is
equivalent to Hach CM130
Chlorine Monitor.
Hach CM130 Chlorine
Monitor has a wider
humidity range than Nelson
Sentinel Series Basic
Chlorine Sentinel. This
difference in operating
humidity has no impact on
the intended use or the
safety and effectiveness of
the device. |

22

Testing

The following testing has been performed for Nelson Sentinel Series Basic Chlorine Sentinel:

Electrical Safety / Electromagnetic Compatibility

Testing was performed in accordance with the following standards:

IEC 61010-1 Safety Requirements for Electrical Equipment for Measurement. Control. . and Laboratory Use - Part 1: General Requirements
IEC 61326-1 Electrical Equipment for Measurement, Control, and Laboratory Use -● EMC Requirements - Part 1: General Requirements

Shelf-Life

Shelf life testing has been performed for the ammonium sulfate reagent used in the device.

Performance - Bench

Bench Testing has been performed to verify the performance of the Nelson Sentinel Series Basic Chlorine Sentinel, which includes:

Linearity Study
. Precision Study
Limit of Blank, Limit of Quantitation, Limit of Detection Study ●
. Method Comparison Study
Peristaltic Pump and Tubing Validation ●
Free Chlorine Study .
. 15 Weeks Calibration Study

Software

Software validation has been performed for the software component of the Nelson Sentinel Series Basic Chlorine Sentinel.

Substantial Equivalence Conclusions

In conclusion, the Nelson Sentinel Series Basic Chlorine Sentinel has the same intended use as the predicate device as they both can be used to monitor the level of total chlorine (free chlorine/chloramines) and do not come into direct contact with feed water used to prepare dialysate. The proposed device is intended as an auxiliary monitoring system while the UltraLow Total Chlorine and E-Z Chek Sensitive Total Chlorine Test strips are intended as primary chlorine detection technological characteristics where compared to the Hach CM130 Chlorine Monitor reference device and performance testing demonstrates that the proposed device is safe and effective despite differences in technology. The proposed Nelson Sentinel Series Basic Chlorine Sentinel is substantially equivalent to Ultra Low Total Chlorine and E-Z Chek Sensitive Total Chlorine Test Strips.

Conclusion

The 510(k) Pre-market Notification for Nelson Sentinel Series Basic Chlorine Sentinel contains adequate information and data to determine that Nelson Sentinel Series Basic Chlorine Sentinel as safe and effective as the legally marketed predicate device.