The OLpür H₂H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLpūr MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPûr MD 220 Hemodiafilter is only to be used with the OLpūr H₂H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician. The OLpür H₂H Hemodiafiltration (HDF) Module works in conjunction with a qualified host (UF controlled) hemodialysis machine and it's accessories (i.e., bloodlines, dialysate, concentrates, etc.), the H₂H Module accessories (water and substitution fluid filters, infusion / rinse line, and optional blood extension line), appropriately prepared water and ultrapure dialysate for hemodialysis, and a high permeability hemodiafil- (i.e., the OLPūr MD 220 Hemodiafilter).
Device Story
H2H Hemodiafiltration Module is a programmable electro-mechanical device used in clinical settings alongside a standard UF-controlled hemodialysis machine. Device connects to clinic water supply, drain, and electricity. Primary function: generates on-line substitution fluid by ultrafiltering dialysate from the host hemodialysis machine through a reusable substitution filter. Secondary function: serves as a reprocessing machine for the substitution filter when disconnected from the hemodialysis machine. MD 220 Hemodiafilter acts as the high-permeability interface for the HDF process. System requires physician prescription and oversight of treatment parameters. Benefits include enabling on-line hemodiafiltration therapy for chronic renal failure patients using existing hemodialysis infrastructure.
Clinical Evidence
No clinical data provided in the summary; substantial equivalence is supported by bench testing and performance data as referenced in the submission sections.
Technological Characteristics
Programmable electro-mechanical module. Components include reusable substitution filters, water filters, infusion/rinse lines, and blood extension sets. Operates via ultrafiltration of dialysate. Requires connection to clinic water, drain, and power. Designed for use with UF-controlled hemodialysis machines and high-permeability hemodiafilters (MD 220).
Indications for Use
Indicated for patients with chronic renal failure requiring hemodiafiltration. Must be used with a UF-controlled hemodialysis machine providing ultrapure dialysate per ANSI/AAMI/ISO standards. Contraindicated for use without the specified H2H Module and MD 220 Hemodiafilter.
Regulatory Classification
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).
Special Controls
*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.”
Nipro Blood Tubing Set w/Transducer Protector and Priming Set (K072024)
Submission Summary (Full Text)
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510(k) Summary: Nephros OLpūr® H₂H H₂H Hemodiafiltration (HDF) Module and OLpūr MD 220 Hemodiafilter
| Submitter: | Nephros Inc.<br>41 Grand Ave, Suite 201<br>River Edge, NJ 07661<br>Establishment Registration # 3003337893 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Gregory Collins Ph.D., V.P. of R&D<br>41 Grand Ave, Suite 201<br>River Edge, NJ 07661<br>201-343-5202 (p)<br>201-343-5207 (f)<br>collins@nephros.com |
| Date Prepared | August 10, 2011 |
| Trade Name | Nephros OLpūr H2H Hemodiafiltration (HDF) Module and OLpūr<br>MD 220 Hemodiafilter |
| Proposed Class | Class II |
| Classification Name<br>and Number | 21 CFR Part 876.5665 Water Purification System for<br>Hemodialysis; 21 CFR Part 876.5860 Dialyzer, High<br>Permeability With or Without Sealed Dialysate System |
| Product Code | FIP, KDI |
| Predicate Devices | ➤ Predicate for the Nephros MD 220 Hemodiafilter -<br>Nephros OLpūr HD190 (K050603)<br>➤ Predicate for the H2H Module with qualified UF-<br>Controlled Hemodialysis Machine - Aksys PHD Personal<br>Hemodialysis System (K010131)<br>➤ Predicate for the H2H Module in the stand-alone<br>configuration - Aksys PHD Personal Hemodialysis<br>System (K010131)<br>➤ Predicates for the H2H Substitution Fluid Filter --<br>Nephros DSU Dual Stage Ultrafilter (K090885), Minntech |
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| Device Description | Renaguard Dialysate Filter (K945136), Gambro Diaclear<br>Ultrafilter (K003957), Fresenius Citric Acid Dialyzer<br>Reprocessing (K974090)<br><br>➤ Predicates for the H₂H Water Filter - Nephros DSU Dual<br>Stage Ultrafilter (K090885), Minntech FiberFlo Hollow<br>Fiber Capsule Water Filter (K983126)<br><br>➤ Predicates for the Disposable H₂H Infusion Line and<br>Blood Tubing Extension Set - Codan IV Administration<br>Sets (K033301), Nipro Blood Tubing Set w/Transducer<br>Protector and Priming Set (K072024) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The H₂H™ Hemodiafiltration Module is a programmable electro-<br>mechanical medical device designed to work in conjunction with<br>and in close proximity to a hemodialysis machine during patient<br>treatments. Upon installation, the H₂H Module is placed next to<br>the hemodialysis machine (which can be on either side<br>depending upon type and model of the hemodialysis machine)<br>and is connected to the clinic's water supply, drain, and<br>electricity.<br><br>The H₂H Hemodiafiltration Module serves two basic functions.<br>The Module's primary function is to generate on-line substitution<br>fluid for hemodiafiltration. The H₂H Module does this by<br>ultrafiltering dialysate, provided by the hemodialysis machine,<br>through a reusable substitution filter. The secondary function of<br>the H₂H Hemodiafiltration Module is to serve as a substitution<br>filter reprocessing machine. These steps are performed when<br>the H₂H Hemodiafiltration Module is not connected to the<br>hemodialysis machine. More detailed descriptions of the device,<br>its accessories and how the system functions can be found in<br>Section 11 (Device Description) of this submission. | |
| Intended Use | The OLpür H₂H Hemodiafiltration (HDF) Module is indicated for<br>use, with a UF controlled hemodialysis machine that provides<br>ultrapure dialysate in accordance with current ANSI/AAMI/ISO<br>standards, for treatment of patients with chronic renal failure as<br>prescribed by a physician. The OLpūr MD 220 Hemodiafilter is<br>indicated for use for hemodiafiltration of patients with chronic<br>renal failure. The OLPûr MD 220 Hemodiafilter is only to be<br>used with the OLpūr H₂H Hemodiafiltration Module. Selection of<br>patients, as well as treatment operating parameters, are a<br>medical decision and the responsibility of the prescribing<br>physician.<br><br>The OLpür H₂H Hemodiafiltration (HDF) Module works in<br>conjunction with a qualified host (UF controlled) hemodialysis<br>machine and it's accessories (i.e., bloodlines, dialysate,<br>concentrates, etc.), the H₂H Module accessories (water and<br>substitution fluid filters, infusion / rinse line, and optional blood<br>extension line), appropriately prepared water and ultrapure<br>dialysate for hemodialysis, and a high permeability hemodiafil-<br>(i.e., the OLPūr MD 220 Hemodiafilter). |
| Summary of the<br>Technological<br>Characteristics | The proposed device has the same technological characteristics<br>and is similar in design as compared to the predicate devices<br>and already approved kidney dialysis therapy. |
| Assessment of Non-<br>clinical Performance<br>Data / Substantial | Refer to Section 18 of this application for Bench Analyses<br>performed on the subject devices. Refer to Section 20 of this<br>application for clinical data supporting substantial equivalence of |
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 27 2012
Greg Collins, Ph.D. V.P. of R&D Nephros, Inc. 41 Grand Ave. RIVER EDGE NJ 07661
. Re: K112314
Trade/Device Name: Nephros OLPur® H2H Hemodiafiltration (HDF) Module and OLPūr MD 220 Hemodiafilter
Regulation Number: 21 CFR& 876.5860
Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 26, 2012 Received: April 27, 2012
Dear Dr. Collins:
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 that I Drines intess and regulations administered by other Federal agencies. You must of any I ederal statuated and regurements, including, but not limited to: registration and listing Compry will an the 100 b ag (21 CFR Part 801); medical device reporting (reporting of medical
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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
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,
Benjamin K. Erhke
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): K 112314
Device Name: Nephros OLPuro HzH Hemodiafiltration (HDF) Module and OLPūr MD 220 Hemodiafilter
### Indications For Use:
The OLPur H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLPur MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPur MD 220 Hemodiafilter is only to be used with the OLpur H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.
The OLPur H2H Hemodiafiltration (HDF) Module works in conjunction with a qualified host (UF controlled) hemodialysis machine and it's accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HzH Module accessories (water and substitution fluid filters, infusion / rinse line, and optional blood extension line), appropriately prepared water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPur MD 220 Hemodiafilter).
Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Beijana R. Ruter
for Sign-Off n of Reproductive, Gastro-Renal, and
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
