(119 days)
No
The document describes a physical water filtration device and does not mention any AI or ML components or functionalities.
No
Explanation: The device is a water filter intended for infection control by providing ultrapure water for washing and drinking. It does not directly treat or prevent a disease or condition in a patient.
No
This device is an ultrafilter used to purify water for patient washing and drinking, aiding in infection control. It does not diagnose any medical conditions.
No
The device description clearly states it is a "hollow fiber ultrafilter," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the filters are used to filter drinking water for patient washing and drinking, wound cleansing, cleaning of medical equipment, and washing of surgeon's hands. These are all applications related to water purification for external use or consumption, not for analyzing samples taken from the human body to diagnose a condition.
- Device Description: The device description confirms it's a water filter.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to purify water, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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 patient 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.
Product codes
NHV
Device Description
The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate 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
Based on non-clinical performance testing, the DSU-H and SSU-H Ultrafilters have been found to be substantially equivalent to the predicate PrisMedical MainStream Filter (K012716).
Key Metrics
Bacteria Reduction: > 10^11
Virus Reduction: > 10^8
Endotoxin Reduction: > 10^5
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
Nephros Incorporated Mr. Jim Summerton Manager Product Development 41 Grand Avenue River Edge, NJ 07661
Re: K141731
Trade/Device Name: DSU-H and SSU-H Ultrafilters Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification Device, General Medical Use Regulatory Class: II Product Code: NHV Dated: September 24, 2014 Received: September 26, 2014
Dear Mr. 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.
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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. 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K141731
Device Name: DSU-H and SSU-H Ultrafilters
Indications For Use:
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 patient 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _____________
(Part 21 CFR 801 Subpart D)
(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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Attachment 3
005: 510(k) Summary
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| Submitter: | Nephros Inc.
41 Grand Ave
River Edge, NJ 07661
Establishment Registration # 3003337893 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jim Summerton, Manager Product Development
41 Grand Ave
River Edge, NJ 07661
201-343-5202 (p)
201-343-5207 (f)
summerton@nephros.com |
| Date Prepared | September 22, 2014 |
| Trade Name | DSU-H and SSU-H Ultrafilters |
| Proposed Class | Class II |
| Classification Name
and Number | 21 CFR Part 876.5665 Water Purification Device, General
Medical Use |
| Product Code | NHV |
| Predicate Device | MainStream™ Water Purification Device – K012716 |
| Reference Devices | DSU and SSU Filters – K110285 |
| Device Description | The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters
that retain bacteria, viruses, endotoxin and particulate from water
used for washing and drinking. |
| Intended Use | 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. |
510(k) Summary: DSU-H and SSU-H Ultrafilters
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| Summary of the | The proposed device contains a polysulfone hollow fiber |
|---|---|
| Technological | membrane encased in an ABS housing that retains bacteria, |
| Characteristics | viruses and endotoxin. Retention of contaminants is through size |
| exclusion. Further details of the technology can be found in | |
| Section 11 'Device Description'. | |
| Assessment of Non- | Based on non-clinical performance testing, the DSU-H and SSU- |
| clinical Performance | H Ultrafilters have been found to be substantially equivalent to |
| Data / Substantial | the predicate PrisMedical MainStream Filter (K012716). |
| Equivalence |
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SUBJECT - PREDICATE COMPARISON TABLES
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) | |||
| Number | K141731 | K012716 | K110285 |
| Manufacturer | |||
| Name | Nephros Inc. | PrisMedical | Nephros Inc. |
| Indications | |||
| for Use | 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. | To produce from EPA | ||
| grade drinking water, | |||
| sterile purified water to | |||
| be used within 24 hours | |||
| of collection that is | |||
| suitable for: |
- Cleaning and rinsing
open wounds - Infection control
(cleaning equipment
used in medical
procedures, medical
personnel's hands) - Use as a diluent for
enteral, nutritional,
oral vaccine, or oral
drug preparations - All other uses of
sterile purified water
the practitioner or
clinician deems
necessary - Not for parenteral
administration | The DSU and SSU
Filters are intended to
be used to filter water
or bicarbonate
concentrate used in
hemodialysis devices.
They assist in
providing
hemodialysis quality
water or bicarbonate
concentrate. The
device is not a
complete water
treatment system, but
serves to remove
biological
contaminants.
Therefore it must be
used in conjunction
with other water
treatment equipment
(RO, DI, etc.). |
| | Subject Device | Predicate Device | Reference Device |
| Operation | | | |
| Feed Water
Source | In-line plumbing | Gravity feed | In-line plumbing |
| Use Life | up to 3 Mo. (SSU-H)
up to 6 Mo. (DSU-H) | 3 Liters | 1 Year |
| Maximum
Inlet Pressure | 75 psi (SSU-H)
100 psi (DSU-H) | 1011 | > 107 | > 1011 |
| Virus
Reduction | > 108 | > 104 | > 108 |
| Endotoxin
Reduction | > 105 | > 104 | > 105 |
| Organic
Reduction | N/A | TOC reduced to 103 dissociable ions | N/A |
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