(90 days)
No
The summary describes a physical filter for water used in hemodialysis and makes no mention of AI or ML.
No.
The device filters water or concentrate used in hemodialysis devices, removing contaminants. It is part of a water treatment system and does not directly provide therapy to a patient.
No
The device is a filter used to purify water or bicarbonate concentrate for hemodialysis, not to diagnose a medical condition. Its function is to remove contaminants, which is a treatment support role rather than a diagnostic one.
No
The device description clearly states it is a "hollow fiber filter" and describes physical components and performance tests related to filtration, indicating it is a hardware device.
Based on the provided text, the DSU Dual Stage Ultrafilter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter water or bicarbonate concentrate used in hemodialysis devices to remove biological contaminants. This is a water treatment function, not a diagnostic test performed on biological samples.
- Device Description: The device description confirms it's a filter for removing contaminants from water and bicarbonate concentrate.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for clinical purposes. The DSU Ultrafilter's function is to purify fluids used in a medical procedure, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The DSU Dual Stage Ultrafilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists 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 (i.e., RO, DI, etc.).
Product codes
FIP
Device Description
The DSU Dual Stage Ultrafilter is a hollow fiber filter that removes bacteria, viruses, endotoxin and particulate from water and bicarbonate concentrate used in hemodialysis.
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 DSU Dual Stage Ultra Filter has been tested for performance. The tests conducted include Flow Rate versus Pressure Drop, Bicarbonate Composition Effect, Pyrogen Removal, Virus Challenge Test, Bacteria Challenge Test and Chemical Compatibility. This filter was found to be substantially equivalent to the predicate Minntech Fiberflo Filter (K983126).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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K090885 pgs lot 2
Traditional 510(k) Premarket Notification
JUN 29 2009
| Submitter: | Nephros Inc.
41 Grand Ave
River Edge, NJ 07661
Establishment Registration # 3003337893 |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vikki M. O'Connor, Director QA/RA
41 Grand Ave
River Edge, NJ 07661
201-207-2490 (p)
201-343-5207 (f)
vhoffman@nephros.com |
| Date Prepared | March 30, 2009 |
| Trade Name | DSU Dual Stage Ultrafilter |
| Proposed Class | Class II |
| Classification Name
and Number | 21 CFR Part 876.5665 Water Purification System for
Hemodialysis |
| Product Code | FIP |
| Predicate Devices | FiberFlo™ Hollow Fiber Cartridge Water Filters - K983126 |
| Device Description | The DSU Dual Stage Ultrafilter is a hollow fiber filter that
removes bacteria, viruses, endotoxin and particulate from
water and bicarbonate concentrate used in hemodialysis. |
| Intended Use | The DSU Dual Stage Ultrafilter is intended to be used to
filter water or bicarbonate concentrate used in
hemodialysis devices. The DSU assists 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 (i.e., RO, DI, etc.). |
| Summary of the
Technological
Characteristics | The proposed device has the same technological
characteristics and is similar in design as compared to the
predicate device. |
| Assessment of
Non-clinical
Performance Data /
Substantial
Equivalence | The DSU Dual Stage Ultra Filter has been tested for
performance. The tests conducted include Flow Rate
versus Pressure Drop, Bicarbonate Composition Effect,
Pyrogen Removal, Virus Challenge Test, Bacteria
Challenge Test and Chemical Compatibility. This filter was
found to be substantially equivalent to the predicate
Minntech Fiberflo Filter (K983126). |
510(k) Summary: DSU Dual Stage Ultrafilter
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K090885 page 2 of 2
Nephros Inc. DSU Dual Stage Ultrafilter
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Traditional 510(k) Premarket Notification
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vikki M. O'Connor Director, OA/RA Nephros, Inc. 41 Grand Avenue RIVER EDGE NJ 07661
Re: K090885
Trade/Device Name: Nephros Inc. DSU Filter Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 30, 2009 Received: April 3, 2009
Dear Ms. O'Connor:
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.
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. 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
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 hitp://www.fda.gov/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation -Center for Devices and Radiological Health
Enclosure
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K09085 page lot 1
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K 090885 Device Name: Nephros Inc. DSU Filter
Indications For Use:
The DSU Dual Stage Ultrafiter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists 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 (i.e., RO, DI, etc.).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Rem
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
K990875
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