(165 days)
The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.
The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.
Here's a breakdown of the acceptance criteria and study information for the Nephros S100 Point of Use Filter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (S100 Filter) |
|---|---|---|
| Bacteria Removal | > 10^11 reduction | > 10^9 reduction |
| Flow Rate vs. Pressure Drop | 4.5 L/min at 20 psi (SSU-H) 4 L/min at 20 psi (DSU-H) | 4 L/min at 20 psi |
| Maximum Inlet Pressure | 75 psi (SSU-H) 100 psi (DSU-H) | 75 psi |
| Use Life | Up to 3 Months (SSU-H) Up to 6 Months (DSU-H) | Up to 3 months |
Note: The document directly compares the S100 filter to the DSU-H and SSU-H Ultrafilters (K141731) as predicate devices. The "Acceptance Criteria" here are derived from the performance specifications of these predicate devices as presented in the "SUBJECT TO PREDCATE DEVICE COMPARISON TABLE." The S100's performance is considered "substantially equivalent" to these predicates.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set (number of S100 filters tested for performance). It only mentions "The S100 Point of Use Filter has been tested for performance."
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described for the filter's performance (Flow Rate, Simulated Use Life, Bacteria Challenge, Biocompatibility) are typically lab-based tests with objective measurements, not requiring expert consensus for "ground truth" in the way a clinical study for diagnosis might.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the performance tests described are objective, laboratory-based measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable to this type of device. The S100 Point of Use Filter is a physical water filter, not an AI-powered diagnostic tool. The document describes performance testing for filtration capabilities.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. As mentioned, the S100 Point of Use Filter is a physical filter, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the performance testing (e.g., bacteria removal, flow rate) would be established through laboratory-based measurements and validated testing methods. For example:
- Bacteria Removal: Direct enumeration of bacteria in the influent and effluent water (e.g., colony-forming units, turbidity measurements) using standard microbiological laboratory practices.
- Flow Rate: Direct measurement of water volume passed over time at a given pressure.
- Use Life: Controlled flow and pressure conditions over an extended period, with periodic performance checks for bacteria removal and flow.
8. The Sample Size for the Training Set
This is not applicable/provided. As the S100 Point of Use Filter is a physical device and not an AI/machine learning model, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Nephros, Inc. James Summerton Director Product Development 41 Grand Ave River Edge, NJ 07661
Re: K153084
Trade/Device Name: S100 Point of Use Filter Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: NHV Dated: March 7, 2016 Received: March 10, 2016
Dear James Summerton,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K153084 Device Name: S100 Point of Use Filter
Indications For Use:
The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ____________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Submitter: | Nephros Inc.41 Grand AveRiver Edge, NJ 07661Establishment Registration # 3003337893 | Subject Device | Predicate Device | Subject Device | Predicate Device | ||
|---|---|---|---|---|---|---|---|
| Contact Person | Jim Summerton, Director Product Development41 Grand AveRiver Edge, NJ 07661201-343-5202 (p)201-343-5207 (f)summerton@nephros.com | 510(k)Number | K153084 | K141731 | Materials | ||
| Date Prepared | March 8, 2016 | ManufacturerName | Nephros Inc. | Nephros Inc. | Casing | ABS | ABS |
| Trade Name | S100 Point of Use Filter | Indicationsfor Use | The S100 Point of Use Filter isintended to be used to filter EPAquality drinking water. The filterretains bacteria. By retainingbacteria in water for washing anddrinking, the filter may aid ininfection control. The filterproduces water that is suitable forcleaning of equipment used inmedical procedures and washingof surgeon's hands. The filter isnot intended to provide water thatcan be used as a substitute forUSP sterile water. | The DSU-H and SSU-H Ultrafiltersare intended to be used to filter EPAquality drinking water. The filtersretain bacteria, viruses andendotoxin. By providing ultrapurewater for washing and drinking, thefilters aid in infection control. Thefilters produce water that is suitablefor wound cleansing, cleaning ofequipment used in medicalprocedures and washing ofsurgeon's hands. The filters are notintended to provide water that can beused as a substitute for USP sterilewater. | Filter | Polysulfone Microfiltration | Polysulfone Ultrafiltration Hollow |
| Proposed Class | Class II | Operation | Element(s) | Hollow Fiber | Fiber | ||
| Classification Nameand Number | 21 CFR Part 876.5665 Water Purification Device, GeneralMedical Use | Feed WaterSource | Municipal tap water | Municipal tap water | Removal | ||
| Product Code | NHV | Use Life | Up to 3 months | Up to 3 Months (SSU-H)Up to 6 Months (DSU-H) | Bacteria | > 109 | > 1011 |
| Predicate Device | DSU-H and SSU-H Ultrafilters – K141731 | MaximumInlet Pressure | 75 psi | 75 psi (SSU-H)100 psi (DSU-H) | Reduction | ||
| Device Description | The S100 Point of Use Filter is a hollow fiber microfilter thatretains bacteria from water used for washing and drinking. | Flow Rate vs.Pressure Drop | 4 L/min at 20 psi | 4.5 L/min at 20 psi (SSU-H)4 L/min at 20 psi (DSU-H) | Virus removal | n/a | > 108 |
| Intended Use | The S100 Point of Use Filter is intended to be used to filter EPAquality drinking water. The filter retains bacteria. By retainingbacteria in water for washing and drinking, the filter may aid ininfection control. The filter produces water that is suitable forcleaning of equipment used in medical procedures and washingof surgeon's hands. The filter is not intended to provide waterthat can be used as a substitute for USP sterile water. | Endotoxin | n/a | > 105 | |||
| Summary of theTechnological | The proposed device contains a polysulfone hollow fibermembrane encased in an ABS housing that retains bacteria. | Reduction | |||||
| Characteristics | Removal of contaminants is through size exclusion. | ||||||
| Assessment of Non-clinical PerformanceData / SubstantialEquivalence | The S100 Point of Use Filter has been tested for performance.The tests conducted include Flow Rate versus Pressure Drop,Simulated Use Life, Bacteria Challenge Test andBiocompatibility. The filters were found to be substantiallyequivalent to the predicate DSU-H and SSU-H Ultrafilters(K141731). |
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SUBJECT TO PREDCATE DEVICE COMPARISON TABLE
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§ 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.