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.).

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.

AI/ML Overview

The document provided describes a 510(k) premarket notification for a medical device called the "EndoPur Endotoxin 10" Filter Flat." This device is a water purification filter for hemodialysis. The information primarily focuses on establishing substantial equivalence to a predicate device through non-clinical performance data.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly present a formal table of acceptance criteria with corresponding performance results in a structured format. However, it lists the types of tests performed and implies that the results were "acceptable" or demonstrated "substantial equivalence."

Test Category	Implied Acceptance Criteria (Based on context)	Reported Device Performance (Summary)
Flow Rate vs. Pressure Drop	Performance comparable to predicate devices.	Tested; implied to be acceptable and substantially equivalent to the predicate.
Pyrogen Removal	Effective removal of pyrogens (endotoxins).	Tested; implied to be acceptable and substantially equivalent to the predicate.
Virus Challenge Test	Effective removal/inactivation of viruses.	Tested; implied to be acceptable and substantially equivalent to the predicate.
Bacteria Challenge Test	Effective removal/inactivation of bacteria.	Tested; implied to be acceptable and substantially equivalent to the predicate.
Disinfection Compatibility	Compatible with specified disinfection processes.	Tested; implied to be acceptable and substantially equivalent to the predicate.
Biocompatibility Testing	Safe, with no significant extractables/leachables or toxicity concerns.	Exhaustive Extractable and Leach testing performed, evaluated by a toxicologist, and found to be safe.
Residual Levels (after disinfection)	Acceptable residual levels after disinfection processes on accelerated aged product, per ANSI/AAMI 13959.	All results were found to be acceptable.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not specify the sample sizes used for each of the performance tests (Flow Rate, Pyrogen Removal, Virus Challenge, Bacteria Challenge, Disinfection Compatibility, Biocompatibility).
Data Provenance: The study was conducted by Nephros, Inc. (the device manufacturer) for regulatory submission to the FDA. The country of origin of the data is implicitly the USA, as Nephros, Inc. is located in River Edge, NJ. The data is retrospective in the sense that it was generated as part of a premarket notification for an existing device design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus on clinical images) is not directly applicable here as this is a physical filter device. For the biocompatibility testing, a toxicologist was used to evaluate the exhaustive extractable and leach testing results and found them to be safe. The number of toxicologists is not specified (e.g., "a toxicologist" usually implies one unless otherwise stated).

4. Adjudication method for the test set

Not applicable. The tests performed are objective laboratory and engineering tests for device performance, not subjective assessments requiring adjudication like clinical image interpretation.

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

Not applicable. This is not an AI-powered diagnostic device, and no MRMC studies or human-in-the-loop performance evaluations were conducted or are relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. The "standalone performance" refers to the filter's ability to perform its function (e.g., removing contaminants) independently, which is what the "Assessment of Non-clinical Performance Data" describes.

7. The type of ground truth used

For the performance tests:

Pyrogen Removal, Virus Challenge, Bacteria Challenge: The "ground truth" would be established by validated laboratory assays and measurement techniques for detecting and quantifying these biological contaminants (e.g., using known concentrations of pyrogens, viruses, or bacteria and measuring the reduction after filtration).
Biocompatibility: The "ground truth" is established by standard toxicological assessment methods and guidelines (e.g., AAMI/ISO standards) which evaluate the potential for adverse biological reactions. The outcome is assessed by a toxicologist.
Residual Levels: The "ground truth" is established by chemical analytical methods to quantify residual levels against pre-defined acceptable limits (e.g., as per ANSI/AAMI 13959).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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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)
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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 AveRiver Edge, NJ 07661Establishment Registration # 3003337893
Contact Person	Hollie Johnson ; Director of Quality and Regulatory41 Grand AveRiver Edge, NJ 07661201-343-5202 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 Nameand Number	21 CFR Part 876.5665 Water Purification System forHemodialysis
Product Code	FIP
Predicate Devices	FiberFlo™ Hollow Fiber Cartridge Water Filters – K95439
Device Description	The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilterthat retains bacteria, viruses, endotoxin and particulate fromwater used in hemodialysis.
Intended Use	The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilterthat retains bacteria and endotoxin from fluid.
Indications For Use	The EndoPur Endotoxin 10" Filter Flat is intended to be used tofilter water used in hemodialysis devices. It assists in providinghemodialysis quality water. The device is not a complete watertreatment system, but serves to remove biologicalcontaminants. Therefore it must be used in conjunction with
	other water treatment equipment (Reverse Osmosis,Deionization, etc.).
	CONTRAINDICATIONS
	Heat sterilization is contraindicated for use with polypropylenehousings that are not rated for disinfection temperatures above80°C
Summary of theTechnologicalCharacteristics	The subject device has the same technological characteristicsand is similar in design as compared to the primary andreference devices; see executive summary located in section10.
Assessment of Non-clinical PerformanceData / SubstantialEquivalence	The EndoPur Endotoxin 10" Filter Flat has been tested forperformance. The tests conducted include Flow Rate versusPressure Drop, Pyrogen Removal, Virus Challenge Test,Bacteria Challenge Test and Disinfection Compatibility. Thisfilter was found to be substantially equivalent to the primarypredicate Minntech Fiberflo Filter (K954349) and referencedevice, DSU/SSU.
BiocompatibilityTesting	Exhaustive Extractable and Leach testing was performed,evaluated by a toxicologist and found to be safe. AAMI panelwas executed using ANSI/AAMI 13959 Water for Hemodialysisand Related Therapies to determine residual levels after eachdisinfection process on accelerated aged product. All resultswere found to be acceptable.
Electrical Safety andElectromagneticCompatibility (EMC)	Not Applicable; not and Active Medical Device
Software Verificationand Validation Testing	Not Applicable; No Software contained
Mechanical andAcoustic Study	Not Applicable
Animal Study	Not Applicable
Clinical Studies	Not Applicable
Conclusions	Since the predicate device is comprised of the same materialsof construction that have no adverse events while on themarket and the safety testing completed by Nephrosdemonstrates no toxicity concerns, Nephros EndoPurEndotoxin 10” filter Flat is ready for marketing for its intendeduse, which is the same as its predicate and reference devices.

510(k) Summary: EndoPur Endotoxin 10" Filter Flat

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Regulation Number and Section

§ 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.