(349 days)
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.
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.
The provided document is a 510(k) summary for the Nelson Sentinel Series Basic Chlorine Sentinel, a device intended for continuous monitoring of total chlorine in water purification systems for hemodialysis.
However, the document does not contain the level of detail requested for acceptance criteria and the study proving the device meets these criteria in the context of an AI/ML-based medical device performance study. This document describes a hardware device for chemical measurement and its equivalence to predicate devices, not an AI/ML algorithm.
Therefore, many of the specific questions about AI/ML study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, and standalone algorithm performance, cannot be answered from the provided text.
Here's an attempt to extract what is available regarding acceptance criteria and performance, reinterpreting some points for a hardware device context where applicable, and explicitly stating where information is missing for an AI/ML context:
Acceptance Criteria and Device Performance (Based on the provided document for a hardware device)
The document primarily focuses on establishing "substantial equivalence" of the Nelson Sentinel Series Basic Chlorine Sentinel to predicate and reference devices, rather than defining explicit acceptance criteria in terms of metrics like sensitivity, specificity, or AUC as one would for an AI/ML diagnostic. The equivalence is shown through comparison of intended use, technological characteristics, and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a hardware device for chemical detection and not an AI/ML algorithm, the "acceptance criteria" are implied by performance tests to demonstrate safety and effectiveness for its intended use and similarity to established devices. The "reported device performance" refers to the results of these bench tests demonstrating the device's operational range and accuracy within its specified function.
| Acceptance Criteria (Implied for Hardware Device) | Reported Device Performance (Summary from Bench Testing) |
|---|---|
| Electrical Safety (IEC 61010-1 compliance) | Testing performed; presumed compliant (no specific results provided beyond "performed") |
| Electromagnetic Compatibility (IEC 61326-1 compliance) | Testing performed; presumed compliant (no specific results provided beyond "performed") |
| Shelf-Life of Reagent | Shelf life testing performed for ammonium sulfate reagent |
| Linearity | A Linearity Study was performed. (No specific range or R-squared provided) |
| Precision | A Precision Study was performed. (No specific CV or std. dev. provided) |
| Limit of Blank (LoB), Limit of Quantitation (LoQ), Limit of Detection (LoD) | A LoB, LoQ, LoD Study was performed. (No specific values provided) |
| Method Comparison | A Method Comparison Study was performed. (No specific comparison metrics provided) |
| Peristaltic Pump and Tubing Validation | A Validation was performed. (No specific results provided) |
| Free Chlorine Study | A Study was performed. (No specific results provided) |
| 15 Weeks Calibration Study | A Study was performed. (No specific results provided) |
| Software Validation | Software validation was performed. (No specific details of validation or metrics provided) |
| Alarm Activation (Chlorine concentration ≥ 0.10mg/L) | Device activates buzzers and red CHLORINE alarm indicators. |
| Alarm Activation (Probe failure, auxiliary input relays) | Device activates yellow MAINTENANCE needed indicators and buzzers. |
| Continuous Monitoring | Device provides continuous monitoring. |
| Operation within specified ranges (e.g., sample pressure, temperature, humidity) | The device's operating ranges are described and compared to the reference device, with stated differences not affecting safety or effectiveness. Specific test results demonstrating compliance with these ranges are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document. The document mentions various "studies" (Linearity, Precision, LoB/LoQ/LoD, Method Comparison, Free Chlorine, 15 Weeks Calibration), but does not provide details on the number of samples or measurements used in these bench tests.
- Data Provenance: The studies were performed as "Bench Testing." The origin of the water samples or the specific laboratory where tests were conducted is not specified, but it would be laboratory-based testing relevant to water purification for hemodialysis. The document does not specify if the data was retrospective or prospective in the context of an AI/ML study, as it's not an AI/ML device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the device is a chemical sensor, not an AI/ML device requiring expert interpretation for ground truth. Ground truth for chlorine concentration would be established by analytical chemistry methods (e.g., lab-grade spectrophotometry, titration).
4. Adjudication Method for the Test Set
- Not applicable for a chemical sensor device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- Not applicable. This is a hardware device for chemical detection; MRMC studies are relevant for evaluating diagnostic image interpretation by humans, often with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable as this is not an AI/ML algorithm. The "performance" refers to the device's ability to accurately measure chlorine and provide alerts.
7. The Type of Ground Truth Used
- For the performance testing mentioned (Linearity, Precision, etc.), the ground truth for chlorine concentration would have been established by accurate chemical analysis methods in a laboratory setting (e.g., using reference standards and validated analytical techniques). It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
Summary of Document Relevance to AI/ML Device Analysis:
This document is a regulatory submission for a physical medical device (a chlorine monitor) demonstrating its substantial equivalence to pre-existing devices. It details the device's functional characteristics, intended use, and bench testing performed to ensure safety and effectiveness. It does not provide information related to the development, validation, or performance of an AI/ML algorithm, which would require a significantly different set of acceptance criteria and study designs focusing on model performance metrics, data sets, and human-AI interaction.
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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
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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
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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, Inc813 E. Fir AvenueMcAllen, TX 78501Phone: 956-618-0375 |
|---|---|
| Primary Contact: | QuocHuy (Huy) NguyenEmail: admin@nws.bzPhone: 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 |
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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 ForHemodialysis | |
| Classification Panel | Gastroenterology/Urology | |
| Product Code | Primary Product Code PSXSecondary 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
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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.
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Detailed Comparison of the Subject and Predicate Devices
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
|---|---|---|---|---|
| IntendedUse/Indicationsfor Use | The Nelson SentinelSeries Basic ChlorineSentinel is an instrumentthat is intended for useby hemodialysisprofessionals as anauxiliary device toprovide continuousmonitoring of TotalChlorine. (i.e. totalchloramines plusammoniated freechlorine) concentration. Itis not intended to replacethe primary method formonitoring total chlorineas part of thehemodialysis watertreatment system. Itfunctions completelyindependent of the watertreatment system anddoes not come into directcontact with feed waterused to preparedialysate. | The ReprocessingProduct Corporation(RPC) Total ChlorineTest Strips are indicatedfor detection of FreeChlorine and TotalChlorine in water. TheseTest Strips are indicatedfor testing water used toprepare dialysate (FreeChlorine andChloramines) and fortesting rinse waterfollowing dialysisequipment disinfection(Free Chlorine). | N/A; Nelson SentinelSeries Basic ChlorineSentinel is compared toUltraLow Total Chlorineand E-Z Chk SensitiveTotal Chlorine TestStrips for Intended Useand Indications For Use. | The Nelson Sentinel SeriesBasic Chlorine Sentinelintended use / indicationsfor use is identical to theUltraLow Total Chlorine andE-Z Chek Sensitive TotalChlorine Test Stripsintended use andindications for use, relatedto the detection of TotalChlorine in Water andtesting water used toprepare dialysate. |
| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| Provides ExactChlorine Value? | No; Intended to indicatechlorine above set-pointonly | No; Indicates anapproximate, semi-quantitative value basedon the colorimetricmethod, which can beused to confirm ifchlorine is above aspecific value | Yes; presents an exactchlorine value on itsdisplay intended to beused to make clinicaldecisions | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to UltraLow TotalChlorine and E-Z ChekSensitive Total ChlorineTest Strips. |
| DetectionChemistry/Technology | Direct measuringpolarographic sensorutilizing a specialpolymeric membrane. | N/A | DPD ColorimetricMethod | Nelson Sentinel SeriesBasic Chlorine Sentineluses a different detectiontechnology from HachCM130 Chlorine Monitor.The difference in detectiontechnology does not affectthe intended use or thesafety of the device. |
| Chlorine SensorType | Polarographic sensor | N/A | Photometric sensor | Nelson Sentinel SeriesBasic Chlorine Sentineluses a different sensor fromHach CM130 ChlorineMonitor.The difference in sensortype does not affect theintended use or the safety ofthe device. |
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| Reagents | Ammonium sulfate | N/A | Indicator solution (DPDindicator with potassiumiodide), buffer solution | The reagents used byNelson Sentinel SeriesBasic Chlorine Sentinel andHach CM130 ChlorineMonitor are different.The difference in reagentsused does not affect theintended use or safety andeffectiveness of the device. |
| ReagentDelivery | Peristaltic pump | N/A | Peristaltic pump | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| Type ofChlorineDetected | Total Chlorine (freechlorine plus totalchloramines) | N/A | Total Chlorine (freechlorine plus totalchloramines) | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| DetectionRange | 0.05 mg/L Cl2- 0.15mg/L Cl2 | N/A | 0.03 mg/L Cl2- 0.20mg/L Cl2 | Nelson Sentinel SeriesBasic Chlorine Sentinel isable to detect a wider rangeof chlorine levels than HachCM130 Chlorine Monitor.This difference in detectionrange does not affect theintended use or safety andeffectiveness of the device. |
| AllowableChlorine Level | 0.1 mg/L Cl2 | N/A | 0.1 mg/L Cl2 | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| Sampling | The chlorine sensor islocated on thedownstream side of awater treatment testsample port. Thesampled water is thendischarged down thedrain. | N/A | Feed water is sampled.Water that flows into theCM130 device exits thedevice to a drain. Thewater samples, oncetested, are alsodiscarded to a drain. | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor. |
| Water SampleConditioningand Delivery | Automated | N/A | Automated | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| MeasurementInterval | Continuous | N/A | 5 minutes | Nelson Sentinel SeriesBasic Chlorine Sentinel hasa higher measurementinterval than Hach CM130Chlorine Monitor.This difference inmeasurement interval doesnot affect the safety oreffectiveness of the device. |
| Alarms/ Alerts | Controller: Three colors(green for powerindication, and yellowand red for alerts) and abuzzerRemote Module: Threecolors (green for powerindication, yellow and redfor alerts) and a buzzer | N/A | Analyzer: Two colors(amber and red) on thedisplay and threesounds for notifications.Remote Indicator: Twolights show the analyzerstatus (blue, amber, orred). Two lights showthe chlorine status (blue,amber, or red). Threedifferent sounds:hardware alarm,medium-high chlorinealert, and high chlorinealarm. | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor.Differences in light colorsand types of sounds do notaffect the intended use orsafety and effectiveness ofthe device. |
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| MeasurementPoint | After the secondarycarbon filter, before thereverse osmosis (RO)machine. | N/A | Between the primaryand secondary carbontanks (filters). | Nelson Sentinel SeriesBasic Chlorine Sentinel isdifferent from Hach CM130Chlorine Monitor.This difference inmeasurement point doesnot affect the intended useor the safety andeffectiveness of the device. |
| DeviceLocation | Remote Module islocated in the nurse'sstation: all othercomponents are locatedin the water room | N/A | Remote indicator islocated in the patientroom; all othercomponents are locatedin the water room | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor. |
| RemoteIndicator | Yes | N/A | Yes | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| Enclosure toprotectelectronicsfrom splashingor spills | Yes | N/A | Yes | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| WaterTreatment? | No | N/A | No | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| DeviceComponents | Controller, Probe/Tester,Remote Module | N/A | Analyzer, RemoteIndicator | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor.This difference in devicecomponents does not affectthe intended use or safetyand effectiveness of thedevice. |
| ControlMechanism | Microcontroller | N/A | Microcontroller | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
| Maintenance | Quarterly | N/A | Monthly | Nelson Sentinel SeriesBasic Chlorine Sentinelrequires less frequentmaintenance than Hach CM130 Chlorine Monitor. Thedifference in maintenanceinterval does not affect theintended use or safety andeffectiveness of the device. |
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| Data Logger | No data logger. | N/A | 3000 measurementsmaximum | Data logging features arenot available for NelsonSentinel Series BasicChlorine Sentinel. Thisdifference does not affectthe intended use or safetyand effectiveness of thedevice. |
| Status Outputs | Five water treatmentstatus outputs:(1) Continuousauxiliary monitoring ofTotal Chlorine (i.e. totalchloramines plusammoniated freechlorine) concentration(this is not to beconfused with primaryor secondary testingfor chlorine. Thedevice display is forcalibration functiononly and is not to beused for accuratechlorine concentrationreadings. The device | N/A | High chlorine | Nelson Sentinel SeriesBasic Chlorine Sentinelprovides additional statusoutputs from the HachCM130 Chlorine Monitor.This difference does notaffect the intended use orsafety and effectiveness ofthe device. |
| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| does not record usablechlorine concentrationvalues, it onlycompares the actualconcentration to theset-point). When theconcentration equalsor exceeds the pre-setset-point, thenotification output isactivated. Notificationcloses Output Relay#1;(2) Loss of system orfacility mains electricalpower. Default OutputRelay #2;(3) Aux#1 Input(recommended for thestatus of flooddetection monitors), (itdoes not control anyequipment).Notification closesOutput Relay #3;(4) Aux #2 Input(recommended for the | ||||
| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| status of flooddetection monitors), (itdoes not control anyequipment) Notificationcloses Output Relay #4(5) Self-diagnosticsystem failures ormaintenance required. | ||||
| Display | Backlit LCD: 1.91 cm(0.75 in.)high 4-digitmain display, 0.76 cm(0.3 in.) 5x7 dot matrix12-digit secondarydisplay | N/A | 10.9 cm (4.3 in.) colordisplay, backlit LCDWQVGA | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor, with theonly difference being thatNelson Sentinel SeriesBasic Chlorine has asmaller screen than HachCM130 Chlorine Monitor.This difference in screensize does not affect safetyor effectiveness of thedevice. |
| PowerRequirement | 110 – 240 VAC linepower | N/A | 100 - 240 VAC, 50/60Hz, 1 A max | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor. |
| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| Dimensions | Controller: 38.0 x 46.0x 16.5 cm (15 x 18 x6.5 in.)Probe/Tester: 22.5 x31.0 x 18.5 cm (8.875x 12.125 x 7.5 in.)Remote Module: 20.0x 14.5 x 10.0 cm (4.5 x6.5 x 1.75 in.) | N/A | Analyzer: 37.0 x 53.8 x22.6 cm (14.6 x 21.2 x8.9 in.)Remote indicator: 12.3 x19.4 x 10.7 cm (4.8 x11.6 x 4.2 in.) | The dimensions of NelsonSentinel Series BasicChlorine Sentinelcomponents are differentfrom the dimensions ofHach CM130 ChlorineMonitor components.This difference indimensions does not affectthe intended use or safetyand effectiveness of thedevice. |
| Weight | Controller: 6.5 kg(14.3 lbs.)Probe/Tester: 3 kg(6.6 lbs.)Remote Module: 0.25kg (0.5 lbs.) | N/A | Analyzer: 8.9 kg (19.6lbs.)Remote Indicator: 1.1 kg(2.5 lbs.) | The weights of the NelsonSentinel Series BasicChlorine Sentinelcomponents are differentfrom the weights of theHach CM130 ChlorineMonitor components.This weight difference doesnot affect the intended useor safety and effectivenessof the device. |
| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
| Materials | Controller: PVC andstainless steel monitor,ABS plastic enclosureProbe/Tester: ABSplastic enclosureRemote Module: ABSplastic enclosure | N/A | Analyzer:polycarbonate/ABSplastic case,polycarbonate door,polycarbonate hingesand latches, 316 SST(stainless steel)hardwareRemote indicator:polycarbonate/ABSplastic | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor. |
| Sample FlowRate | 250 mL/min minimum | N/A | 250 mL/min minimum | Nelson Sentinel SeriesBasic Chlorine Sentinel isidentical to Hach CM130Chlorine Monitor. |
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Nelson Sentinel Series Basic Chlorine Sentinel Traditional 510(k)
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| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
|---|---|---|---|---|
| SamplePressure | 270 kPa - 530 kPa (40psi - 80 psi) | N/A | 2.76 bar – 6.89 bar (40psi - 100 psi) nominal;pressure spikes 8.27 bar(120 psi) or less | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor.The upper limit of thesample pressure of NelsonSentinel Series BasicChlorine Sentinel is lowerthan that of Hach CM130Chlorine Monitor. Thisdifference in samplepressure does not affect theintended use or safety andeffectiveness of the device. |
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| ltem | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
|---|---|---|---|---|
| SampleTemperature | 15 - 40°C (60 - 105°F) | N/A | 15 - 30°C (60 - 85°F) | Nelson Sentinel SeriesBasic Chlorine Sentinelisequivalent to Hach CM130Chlorine Monitor.The upper limit of thesample temperatureofNelson Sentinel SeriesBasic Chlorine Sentinel ishigher than that of HachCM130 Chlorine Monitor.This difference in sampletemperature does not affectthe intended use or safetyand effectiveness of thedevice. |
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| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
|---|---|---|---|---|
| OperatingTemperature | 15 – 40°C (60 – 105°F) | N/A | 15 – 30°C (60 – 85°F) | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor.The upper limit of theoperating temperature ofNelson Sentinel SeriesBasic Chlorine Sentinel ishigher than that of HachCM130 Chlorine Monitor.This operating temperaturedifference does not affectthe intended use or safetyand effectiveness of thedevice. |
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| Item | Subject DeviceNelson Sentinel SeriesBasic Chlorine Sentinel | Predicate DeviceUltraLow Total Chlorineand E-Z Chek SensitiveTotal Chlorine TestStrips | Reference DeviceHach CM130 ChlorineMonitor | Comparison |
|---|---|---|---|---|
| OperatingHumidity | 35 - 85% RH | N/A | 5 – 90% non-condensingat 30°C (85°F) maximum | Nelson Sentinel SeriesBasic Chlorine Sentinel isequivalent to Hach CM130Chlorine Monitor.Hach CM130 ChlorineMonitor has a widerhumidity range than NelsonSentinel Series BasicChlorine Sentinel. Thisdifference in operatinghumidity has no impact onthe intended use or thesafety and effectiveness ofthe device. |
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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.
§ 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.