(165 days)
Not Found
No
The description focuses on the physical filtration mechanism and performance metrics related to bacteria reduction and flow rate, with no mention of AI or ML.
No
The device aids in infection control by filtering bacteria from water used for washing and drinking; it does not directly treat or diagnose a disease or condition in a human.
No
Explanation: The device is a filter intended to produce water suitable for cleaning and washing, primarily for infection control. It is not used to diagnose any disease or condition.
No
The device description clearly states it is a "hollow fiber microfilter," which is a physical hardware component, not software.
Based on the provided information, the S100 Point of Use Filter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter drinking water to retain bacteria for washing and drinking, and for cleaning medical equipment and washing hands. This is a physical filtration process applied to water, not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The device is described as a hollow fiber microfilter that retains bacteria from water. This aligns with a water filtration device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The S100 filter's function is to purify water, which is a different category of medical device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHV
Device Description
The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.
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
Not Found
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)
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 and Biocompatibility. The filters were found to be substantially equivalent to the predicate DSU-H and SSU-H Ultrafilters (K141731).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacteria Removal: > 10^9
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
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 Ave
River Edge, NJ 07661
Establishment Registration # 3003337893 | | Subject Device | Predicate Device | | Subject Device | Predicate Device |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------|------------------------------------|
| Contact Person | Jim Summerton, Director Product Development
41 Grand Ave
River Edge, NJ 07661
201-343-5202 (p)
201-343-5207 (f)
summerton@nephros.com | 510(k)
Number | K153084 | K141731 | Materials | | |
| Date Prepared | March 8, 2016 | Manufacturer
Name | Nephros Inc. | Nephros Inc. | Casing | ABS | ABS |
| Trade 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. | The DSU-H and SSU-H Ultrafilters
are intended to be used to filter EPA
quality drinking water. The filters
retain bacteria, viruses and
endotoxin. By providing ultrapure
water for washing and drinking, the
filters aid in infection control. The
filters produce water that is suitable
for wound cleansing, cleaning of
equipment used in medical
procedures and washing of
surgeon's hands. The filters are not
intended to provide water that can be
used as a substitute for USP sterile
water. | Filter | Polysulfone Microfiltration | Polysulfone Ultrafiltration Hollow |
| Proposed Class | Class II | Operation | | | Element(s) | Hollow Fiber | Fiber |
| Classification Name
and Number | 21 CFR Part 876.5665 Water Purification Device, General
Medical Use | Feed Water
Source | 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 | Maximum
Inlet 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 that
retains 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 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. | Endotoxin | n/a | > 105 | | | |
| Summary of the
Technological | The proposed device contains a polysulfone hollow fiber
membrane encased in an ABS housing that retains bacteria. | Reduction | | | | | |
| Characteristics | Removal of contaminants is through size exclusion. | | | | | | |
| Assessment of Non-clinical Performance
Data / Substantial
Equivalence | 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 and
Biocompatibility. The filters were found to be substantially
equivalent to the predicate DSU-H and SSU-H Ultrafilters
(K141731). | | | | | | |
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SUBJECT TO PREDCATE DEVICE COMPARISON TABLE
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