The HDF Assist Module is indicated for use, with the Fresenius 2008K2, and 2008T dialysis machines, for treatment of adult patients with acute or chronic renal failure or whenever hemodiafiltration is physician.

The HDF Assist Module works in conjunction with a qualified host high permeability (UF controlled) hemodialysis machine and its accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HDF Assist Module accessories (HDF Infusion Set and Substitution Filter), appropriately purified water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPür™ MD 220 Hemodiafilter).

Device Description

The HDF Assist Module is a software controlled; electro-mechanical medical device designed to work in combination with a sterile single use HDF Infusion Set (an accessory included in this submission) and a qualified host high permeability (UF controlled) hemodialysis machine, which produces ultrapure dialysis fluid. Upon installation the HDF Assist Module is connected to the host dialysis machine's IV Pole and plugged into a Standard 120VAC electrical mains power source.

To perform a hemodiafiltration treatment with the HDF Assist Module, the device is used in unison with the accessory sterile, single-use HDF Infusion Set to generate and control the online substitution fluid for hemodiafiltration from the ultrapure dialysis fluid of the host dialysis machine. The sterile HDF Infusion Set consists of an 0.25 m² ultrafilter, tubing including a peristatic pump segment, pressure sensor pods, and check valves.

The HDF Infusion Set is primed prior to treatment to remove air from the Set. The HDF Infusion Set is placed on the unit in preparation for each HDF treatment. A peristatic pump in the HDF Assist Module pumps a preset amount of ultrapure dialysis fluid produced by the host dialysis machine via the peristatic pump segment in the HDF Infusion Set. The dialysis fluid is drawn from an input dialysate Hansen T-connector and pumped through a sterile single use 0.25 m² ultrafilter in the HDF Infusion Set. The rest of the dialysis fluid flows outside of the fiber in the OLPūr™ MD 220 Hemodiafilter as in conventional hemodialysis.

During priming and treatment, the ultrafilter in the HDF Infusion Set removes bacteria and endotoxins from the ultrapure dialysis fluid, thereby generating an injectable quality substitution (replacement) fluid of correct electrolyte composition. The ultrafiltered substitution fluid flows through tubing connected to the extracorporeal circuit where it is infused as part of the hemodiafiltration treatment at the MD220 Mid-Dilution port. The ultrafilter is 100% tested in a production integrity check during manufacture.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Nephros, Inc. HDF Assist Module, HDF Infusion Set, and Substitution Filter. The acceptance criteria and the study that proves the device meets them are primarily described within the "Assessment of Non-Clinical Performance Data/Substantial Equivalence" section.

Here's an analysis based on the provided text:

Key Takeaway: This 510(k) submission is for modifications to an existing cleared device (K112314, OLPūr™ H2H Hemodiafiltration Module). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the modified device remains substantially equivalent (safe and effective) to the predicate device, rather than proving a de novo device's initial safety and effectiveness. No clinical studies were performed for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification submission, the "acceptance criteria" are generally compliance with relevant standards and demonstration of continued substantial equivalence. The "reported device performance" refers to the successful completion of various tests.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit from text)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and FDA Guidance "Use of International Standard ISO 10993-1" for Externally Communicating Device; Blood Path, indirect; Prolonged (Category B).	"Testing was performed according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 and FDA Guidance..." (Implies successful completion and meeting of criteria).
Electrical Safety	Compliance with AAMI ES60601-1:2005 +A1, CSA C22.2#60601-1:2014 Ed.3, IEC 60601-1-8, and IEC 60601-2-16:2018 (Applicable Clauses).	"The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for Electrical Safety and other applicable standards by an independent ANSI Certified Testing Service company Interek Testing Services N.A. Inc." (Implies successful compliance).
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 ed 4.0 (2014-02) (with EMC deviations per IEC 60601-2-16:2018).	"The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for EMC Compatibility by an independent ANSI Certified Testing Service company (Interek Testing Services N.A. Inc.)" (Implies successful compliance).
Microbiological Quality of Substitution Fluid	Conformance with ANSI AAMI ISO 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies. Specifically, generation of injectable quality substitution fluid through a multistage redundant system:	"The microbiological quality... is in conformance with ANSI AAMI ISO 23500:2014 Guidance..." (Explicitly states conformance). The multistage system (water treatment, Diasafe filters, and 0.25 m² ultrafilter in HDF Infusion Set) assures this quality. The mention of Log10 reduction for endotoxins and bacteria indicates performance metrics for the filter.
	- Output from water treatment system: <100 CFU/ml and <0.25 EU/ml (action limit <50 CFU/ml and <0.125 EU/ml).
	- Output from Diasafe®/Diasafe®plus Filters: <0.1 CFU/ml and <0.03 EU/ml.
	- Ultrafilter (0.25 m²): Capable of a Log 10^9 reduction endotoxins and a Log 10^11 reduction of bacteria. 100% integrity tested.
Software Verification and Validation	Compliance with ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes.	"system level software verification testing... demonstrated that the HDF Assist Module meets functional and performance software requirements per ANSI AAMI IEC 62304:2006/A1:2016..." (Explicitly states successful demonstration).
System Performance	Verification of design inputs specific to HDF Assist Module and HDF Infusion Set for specified areas (e.g., Ultrafilter Disinfection and Reprocessing System Removal, Internal Pump Removal, Software Modification, Module Modification, Stand Removal, Filter and Cap Modification, Infusion Set and Substitution Filter Modification, Sensor and Regulator Modification).	"Performance Testing included verification of design inputs specific to HDF Assist Module including HDF Infusion Set in the following areas:..." (Implies successful verification for the listed areas).
Usability	Compliance with IEC 60601-1-6-Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard Usability [IEC 60601-1-6:2010 Ed. 3 +A1].	"The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for Usability (IEC 60601-1-6)..." (Implies successful evaluation and compliance).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify sample sizes for the non-clinical performance tests (e.g., how many units were tested for electrical safety, how many filters for integrity, etc.). The testing mentioned is primarily laboratory-based engineering and microbiological testing, not human subject testing.
Data Provenance: The data provenance is generally from laboratory testing (e.g., independent ANSI Certified Testing Services like Interek Testing Services N.A. Inc.). There is no mention of specific countries of origin for the data or whether the data was retrospective or prospective in the context of clinical studies, as no clinical studies were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For non-clinical (engineering, software, microbiology) testing, "ground truth" is typically established by compliance with industry standards and validated test methods, rather than expert consensus on a dataset.

4. Adjudication Method for the Test Set

This is not applicable to the type of non-clinical testing described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document explicitly states: "Clinical Studies: Not applicable. No clinical studies were performed in support of the modifications." This means there's no comparison of human readers with or without AI assistance. The device is a physical medical device (hemodiafiltration module), not an AI/software-as-a-medical-device (SaMD) that assists human interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable/done in this context. The device is not an algorithm that performs a diagnostic or interpretive function without human intervention. Its performance is evaluated through its physical and functional specifications (e.g., safety, fluid quality, software function). The "standalone" performance here refers to the device's ability to meet its design specifications independently, which is covered by the system performance testing and compliance with various standards.

7. The Type of Ground Truth Used

For the non-clinical performance tests, "ground truth" is defined by:
- Validated test methods and established engineering specifications/standards: For electrical safety, EMC, software V&V, and system performance. These are objective measurements against predefined limits.
- International standards and guidance documents: For biocompatibility (ISO 10993 series) and microbiological quality (ANSI AAMI ISO 23500:2014). The "truth" is the device's ability to meet the defined limits and requirements within these standards.
- Predicate device characteristics: The ultimate "ground truth" for this 510(k) submission is showing substantial equivalence to the OLPūr™ H2H Hemodiafiltration (HDF) Module (K112314), meaning the modified device performs comparably and remains safe and effective for its intended use.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device and its modifications, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set was used (see point 8).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 13, 2022

Nephros, Inc. Vashone R. Thomas VP of QA/RA 380 Lackawanna Place South Orange, New Jersey 07079

Re: K210575

Trade/Device Name: HDF Assist Mudule, HDF Infusion Set and Substitution Filter Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 7, 2022 Received: April 13, 2022

Dear Vashone Thomas:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210575

Device Name HDF Assist Module HDF Infusion Set & Substitution Filter

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "nephros" in a dark blue font. To the right of the word is a blue water droplet with a white outline. Below the water droplet are three curved lines that look like ripples in the water.

SECTION 05: 510(K) SUMMARY 5.

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) Summary is provided in conformance with 21 CFR Part 807.92.

Submitter's Information:

Submitter' Name & Company Address:	Nephros Inc.380 Lackawanna PlaceSouth Orange, NJ 07079Establishment Registration # 3003337893
Contact Person:	Vashone R. Thomas; Vice President of Quality and Regulatory Affairs380 Lackawanna PlaceSouth Orange, NJ 07079
Phone:	201-345-0829
Facsimile:	201-343-5207
Email:	vashone@nephros.com
Date Prepared:	May 13, 2022

Device Information:

Trade Name:	HDF Assist Module, HDF Infusion Set& Substitution Filter
Regulation Name:	High Permeability HemodialysisSystem
Classification Number:	Class II per 21 CFR Part 876.5860
Product Code	KDI
Classification Panel	Gastroenterology/Urology

Predicate Information:

The predicate device for the HDF Assist Module is the OLPur™ H2H Hemodiafiltration Module, K112314, granted 04/27/2012.

Device Description:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "nephros" in a dark blue font. To the right of the word is a blue water droplet with a white swirl inside. Below the water droplet are three curved lines, which give the impression of ripples in the water.

single use 0.25 m² ultrafilter in the HDF Infusion Set. The rest of the dialysis fluid flows outside of the fiber in the OLPūr™ MD 220 Hemodiafilter as in conventional hemodialysis.

Indications for Use:

	Predicate	Modified Device
	OLPūr™ H2H Hemodiafiltration (HDF) Module	HDF Assist Module, HDF Infusion Set &Substitution Filter
Indications forUse:	The OLPūr™ H2H Hemodiafiltration (HDF) Moduleis indicated for use, with an approveddialysis machine, for treatment of patients withacute or chronic renal failure or wheneverhemodiafiltration is prescribed by a physician.	The HDF Assist Module is indicated for use,with the Fresenius 2008K, 2008K2, and 2008Tdialysis machines, for treatment of adultpatients with acute or chronic renal failure orwhenever hemodiafiltration is prescribed by aphysician.
	The OLPūr™ H2H Hemodiafiltration (HDF) Moduleworks in conjunction with a qualifiedhost high permeability (UF controlled)hemodialysis machine and it's accessories (i.e.,bloodlines, dialysate, concentrates, etc.), the H2HModule accessories (water andsubstitution fluid filters infusion / rinse line, andoptional blood extension line),appropriately purified water for hemodialysis, anda high permeability hemodialyzer /hemodiafilter (i.e., the OLPūr™ MD 220Hemodiafilter).	The HDF Assist Module works in conjunctionwith a qualified host high permeability (UFcontrolled) hemodialysis machine and itsaccessories (i.e., bloodlines, dialysate,concentrates, etc.), the HDF Assist Moduleaccessories (HDF Infusion Set and SubstitutionFilter), appropriately purified water andultrapure dialysate for hemodialysis, and ahigh permeability hemodialyzer /hemodiafilter (i.e., the OLPūr™ MD 220Hemodiafilter).

Summary and Comparison of Technological Characteristics with Predicate Device:

The proposed HDF Assist Module and the predicate device (K112314) are substantially equivalent in the following technological characteristics:

Design Features
Electrical Safety
. Electromagnetic Compatibility (EMC)
Material Biocompatibility (Patient and Non-Patient Contact)
Microbiological Quality (maximum allowable levels for total viable microbial count and endotoxins in the substitution fluid)
Principle of Operation
Software
Standards (Electrical and electromagnetic safety, Water Purification and Hemodialysis Standards)

The performance testing completed on the proposed device to support the determination of substantial equivalence is summarized below and has been developed in accordance with appropriate FDA guidance

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "nephros" in a bold, sans-serif font. The word is in a dark blue color. To the right of the word is a stylized water droplet in a lighter blue color. Below the water droplet are three curved lines, suggesting ripples in the water.

documents and relevant standards. The HDF Assist Module has been modified to simplify the design and optimize performance.

The complete list of changes implemented and included in the HDF Assist Module are included in the summary of Non-clinical Performance data below.

Assessment of Non-Clinical Performance Data/Substantial Equivalence:

Safety and Effectiveness

To assess the effects of the modified characteristics of the modified device and to demonstrate substantial equivalence with the predicate device, the following data assessed by scientific methods, performance and clinical data are provided.

Biocompatibility Testing

Design updates to the module, infusion set, and substitution filter have been made to the predicate device and biocompatibility has been evaluated. Testing was performed according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1", under the category of Externally Communicating Device; Blood Path, indirect; Prolonged (Category B).

Electrical Safety

The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for Electrical Safety and other applicable standards by an independent ANSI Certified Testing Service company Interek Testing Services N.A. Inc. The applicable standards include:

AAMI ES60601-1:2005 +A1 – Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
. CSA C22.2#60601-1:2014 Ed.3 – Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
IEC 60601-1-8 Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems [IEC 60601-1-8:2003 Ed.1+A1]
. IEC 60601-2-16:2018 - Medical electrical equipment Part 2-16: Particular requirements for the safety and essential performance of haemodiafiltration and haemofiltration equipment (Applicable Clauses)

Electromagnetic Compatibility (EMC)

The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for EMC Compatibility by an independent ANSI Certified Testing Service company (Interek Testing Services N.A. Inc.) The applicable standards include:

IEC 60601-1-2 ed 4.0 (2014-02) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests (with EMC deviations per IEC 60601-2-16:2018)

Microbiological Quality

The microbiological quality of the substitution fluid as determined by the maximum allowable levels for total viable microbial count and endotoxins is in conformance with ANSI AAMI ISO 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies. The microbiological

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "nephros" in a bold, sans-serif font. The word is in dark blue, and to the right of the word is a blue water droplet. Below the water droplet are three curved lines, which give the impression of ripples in the water.

quality of the substitution fluid produced by the HDF Assist Module is assured by a multistage redundant system.

1. As required for standard hemodialysis, there must be a properly maintained dialysis water treatment system with reverse osmosis and other required components as determined by water analysis and the ISO 23500 standard. This produces maximum allowable levels for total viable microbial count and endotoxins in the water input to the dialysis machine of <100 CFU/ml and <0.25 EU/ml, with an action limit half the maximum value (<50 CFU/ml and <0.125 EU/ml).
1. The qualified host Fresenius 2008 K, 2008K2, and 2008T Dialysis Machines must be equipped with the Diasafe® (K944767) or Diasafe®plus Options (K182367) which, provide ultrapure dialysis fluid in conformance with ISO 23500:2014 of <0.1 CFU/ml and <0.03 EU/ml. Note the qualified Fresenius machines with Diasafe®/Diasafe®plus are indicated to provide this maximum level of bacteria and endotoxins, when presented with input dialysis solution with a bacterial two times the maximum level and an endotoxins level of 8 times the maximum level per ISO 23500 standard for dialysis water.
- In addition, the integrity of the Diasafe®/Diasafe®plus filters are tested after each chemical a. disinfection by the Fresenius 2008 K, 2008K2, and 2008T Dialysis Machine.
- ﻓ The sterile single use Nephros HDF Infusion set contains an additional filtration step using a 0.25 m² ultrafilter as required by the ISO 23500 Standard and FDA Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems. Both the membrane and filter integrity are 100% tested in the production process and the filter is capable of a Log 10° reduction endotoxins and a Log 1011 reduction of bacteria. Since this redundant filtration step is a single use disposable, there is no potential for biofilm formation in quiescent periods in between treatments. Note the integrity of the D150/U filter is 100% checked during the production process, in an identical process to dialyzer integrity process.

Software Verification and Validation Testing

For all software development and modifications, system level software verification testing per ANSI AAM IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)] demonstrated that the HDF Assist Module meets functional and performance software requirements per ANSI AAMI IEC 62304:2006/A1:2016 Medical device software life cycle processes [Including Amendment 1 (2016)]

System Performance Testing

Performance Testing included verification of design inputs specific to HDF Assist Module including HDF Infusion Set in the following areas:

. Ultrafilter Disinfection and Reprocessing System Removal
Internal Pump Removal
Software Modification
Module Modification
Stand Removal
Filter and Cap Modification
Infusion Set and Substitution Filter Modification
Sensor and Regulator Modification

Usability Testing

The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for Usability

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "nephros" in a bold, sans-serif font. The word is in a dark blue color. To the right of the word is a stylized water droplet in a lighter blue color. Below the water droplet are three curved lines, suggesting ripples in the water.

IEC 60601-1-6-Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard Usability [IEC 60601-1-6:2010 Ed. 3 +A1]

Animal Studies

Not applicable. No animal studies were performed in support of the modifications.

Clinical Studies

Not applicable. No clinical studies were performed in support of the modifications.

Comparison of Substantial Equivalence

The predicate device, OLPūr™ H2H Hemodiafiltration (HDF) Module (K112314) was used for modification to the HDF Assist Module. The modified device has a substantially equivalent indication for use as the cleared and marketed predicate device. HDF Assist Device modifications are due to the removal of the secondary function of the predicate, as a reprocessing machine, that disinfects the H2H Substitution Filter. The HDF Infusion set including 0.25 m² ultrafilter is a sterile, single use medical device, so there is no need for an ultrafilter reprocessing capability. The 0.25 m² ultrafilter in the HDF Infusion set uses the same membrane and has similar technological characteristics of bacteria and endotoxins removal to the predicate device. These modified characteristics are achieved by a validated process that demonstrates safety and effectiveness of the modified device.

Conclusion

The successful non-clinical testing indicated above demonstrates the safety and effectiveness of the HDF Assist Module when used for the defined indications for use and intended use. The information and data provided in this Special 510(k) Premarket Notification establishes that the modified HDF Assist Module is substantially equivalent in the intended use, indications for use, design, principle of operation, technology, materials, specifications, and performance to the original referenced OLpūr™ H2H Hemodiafiltration (HDF) Module.

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”