(296 days)
K954349, K95439
No
The summary describes a physical filter for water purification and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a filter for water used in hemodialysis devices, removing biological contaminants from the water itself, rather than treating a patient directly. It serves to provide hemodialysis quality water and is not a complete water treatment system or a medical device applied to the patient.
No
The device is a filter for water used in hemodialysis devices, removing biological contaminants. It does not diagnose any medical condition or disease.
No
The device description clearly states it is a "hollow fiber ultrafilter," which is a physical hardware component used for filtration. The performance studies also focus on physical properties and filtration capabilities.
Based on the provided information, the EndoPur Endotoxin 10" Filter Flat is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to filter water used in hemodialysis devices to remove biological contaminants. This is a water treatment function, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is described as a hollow fiber ultrafilter that retains contaminants from water. This aligns with a filtration device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on the analysis of biological samples.
- Reagents or assays used to detect specific substances in biological samples.
The device's function is to improve the quality of water used in a medical procedure (hemodialysis), which is a supportive function for the procedure itself, not a diagnostic test.
N/A
Intended Use / Indications for Use
The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. 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 (Reverse Osmosis, Deionization, etc.).
Product codes
FIP
Device Description
The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter that retains bacteria, viruses, endotoxin and particulate from water 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 EndoPur Endotoxin 10" Filter Flat has been tested for performance. The tests conducted include Flow Rate versus Pressure Drop, Pyrogen Removal, Virus Challenge Test, Bacteria Challenge Test and Disinfection Compatibility. This filter was found to be substantially equivalent to the primary predicate Minntech Fiberflo Filter (K954349) and reference device, DSU/SSU.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FiberFlo™ Hollow Fiber Cartridge Water Filters – K95439
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Nephros, Inc. Hollie Johnson Director Quality and Requlatory 41 Grand Ave River Edge, NJ 07661
Re: K161304
Trade/Device Name: EndoPur Endotoxin 10" Filter Flat Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: II Product Code: FIP Dated: December 23, 2016 Received: December 27, 2016
Dear Hollie Johnson:
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,
Benjamin R. Fisher -S
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) K161304
Device Name EndoPur Endotoxin 10" Filter Flat
Indications for Use (Describe)
INDICATIONS FOR USE
Indications for Use: The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. 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 (Reverse Osmosis, Deionization, etc.).
CONTRAINDICATIONS
Heat sterilization is contraindicated for use with polypropylene housings that are not rated for disinfection temperatures above 80°C
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter: | Nephros Inc.
41 Grand Ave
River Edge, NJ 07661
Establishment Registration # 3003337893 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Hollie Johnson ; Director of Quality and Regulatory
41 Grand Ave
River Edge, NJ 07661
201-343-5202 x101(p)
201-343-5207 (f)
hollie@nephros.com |
| Date Prepared | December 28, 2016 |
| Trade Name | EndoPur Endotoxin 10" Filter Flat |
| 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 – K95439 |
| Device Description | The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter
that retains bacteria, viruses, endotoxin and particulate from
water used in hemodialysis. |
| Intended Use | The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter
that retains bacteria and endotoxin from fluid. |
| Indications For Use | The EndoPur Endotoxin 10" Filter Flat is intended to be used to
filter water used in hemodialysis devices. It assists in providing
hemodialysis quality water. 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 (Reverse Osmosis,
Deionization, etc.). |
| | CONTRAINDICATIONS |
| | Heat sterilization is contraindicated for use with polypropylene
housings that are not rated for disinfection temperatures above
80°C |
| Summary of the
Technological
Characteristics | The subject device has the same technological characteristics
and is similar in design as compared to the primary and
reference devices; see executive summary located in section
10. |
| Assessment of Non-
clinical Performance
Data / Substantial
Equivalence | The EndoPur Endotoxin 10" Filter Flat has been tested for
performance. The tests conducted include Flow Rate versus
Pressure Drop, Pyrogen Removal, Virus Challenge Test,
Bacteria Challenge Test and Disinfection Compatibility. This
filter was found to be substantially equivalent to the primary
predicate Minntech Fiberflo Filter (K954349) and reference
device, DSU/SSU. |
| Biocompatibility
Testing | Exhaustive Extractable and Leach testing was performed,
evaluated by a toxicologist and found to be safe. AAMI panel
was executed using ANSI/AAMI 13959 Water for Hemodialysis
and Related Therapies to determine residual levels after each
disinfection process on accelerated aged product. All results
were found to be acceptable. |
| Electrical Safety and
Electromagnetic
Compatibility (EMC) | Not Applicable; not and Active Medical Device |
| Software Verification
and Validation Testing | Not Applicable; No Software contained |
| Mechanical and
Acoustic Study | Not Applicable |
| Animal Study | Not Applicable |
| Clinical Studies | Not Applicable |
| Conclusions | Since the predicate device is comprised of the same materials
of construction that have no adverse events while on the
market and the safety testing completed by Nephros
demonstrates no toxicity concerns, Nephros EndoPur
Endotoxin 10” filter Flat is ready for marketing for its intended
use, which is the same as its predicate and reference devices. |
510(k) Summary: EndoPur Endotoxin 10" Filter Flat
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