K082414 · Fresenius Medical Care North America · KDI · Oct 28, 2008 · Gastroenterology, Urology
Device Facts
Record ID
K082414
Device Name
OPTIFLUX F250NR, MODEL 0500325E
Applicant
Fresenius Medical Care North America
Product Code
KDI · Gastroenterology, Urology
Decision Date
Oct 28, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5860
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Optiflux F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
Device Story
The Fresenius Optiflux F250NR is a high-permeability dialyzer used for hemodialysis. It functions as an extracorporeal blood treatment device to remove waste products and excess fluid from the blood of patients with renal failure. The device is used in clinical settings by trained healthcare professionals. It operates by circulating blood through a semi-permeable membrane against a dialysate solution, facilitating the diffusion of solutes and ultrafiltration of fluid. The output is the treated blood returned to the patient, which helps manage renal failure symptoms and maintain homeostasis. It is a prescription-only device.
Clinical Evidence
Bench testing only.
Technological Characteristics
High-permeability hemodialysis system. Construction, design, and materials are equivalent to predicate dialyzers. No specific material standards or software algorithms are described.
Indications for Use
Indicated for patients with acute or chronic renal failure when conservative therapy is inadequate.
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.”
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K082414 page 1 of 4
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OCT 2 8 2008
## Confidentialresenius Medical C Fresenius Optiflux® F250NR Dialyzer 510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
#### A. Submitter's Information:
| Name: | Fresenius Medical Care North America | |
|----------------------|---------------------------------------------|--|
| Address: | 920 Winter Street<br>Waltham, MA 02451-1457 | |
| Phone: | 1-781-699-4475 | |
| Fax: | (781) 699-9635 | |
| Contact Person: | Janet C. Kay RAC Regulatory Affairs Manager | |
| Date of Preparation: | January 23, 2007 | |
#### B. Device Name:
Proprietary Name:
Common Name:
Optiflux® F250NR dialyzer
Dialyzer, High Permeability with or without Sealed Dialysate System
Product Code/Classification Panel:
78KDI/Gastroenterology-Urology
Classification:
Class II per §876.5860
53
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X0824/4 pgx 2014
Image /page/1/Picture/1 description: The image shows a document with the word "Confidential" on the left side. To the right of "Confidential" is the text "Fresenius Medical Care". Below that is the text "Fresenius Optiflux® F250NR Dialyzer" and "510(k) Summary".
#### C. Predicate Devices
The Optiflux F250NR dialyzer is substantially equivalent to the Baxter Xenium 210 dialyzer and the Rexeed 25S dialyzer.
#### Baxter Xenium Dialyzer Model 210
- K062079 (10/19/2006) �
#### Asahi Kasei Rexeed Dialyzer Model 25S
- . K051187 (6/8/05)
#### D. Indications for Use/Intended Use:
The Optiflux F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
#### E. Substantial Equivalence:
#### 5. Is the product a device?
YES - The Fresenius Optiflux F250NR dialyzer is a device pursuant to 21 CFR §201 [321] (h).
#### 6. Does the new device have the same intended use?
YES - The intended use for the Fresenius Optiflux F250NR dialyzer is equivalent to the Baxter Xenium dialyzer model 210 and Asahi Rexeed model 25S
#### Fresenius Optiflux F250NR dialyzer - Intended Use
Optiflux F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
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Ko 824/4 page 304
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#### Baxter Xenium dialyzer model 210 - Intended Use
Hemodialysis with Xenium dialyzers is indicated for patients with renal failure with conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
#### Asahi Rexeed dialyzer model 25S - Intended Use
Asahi Rexeed dialyzers are intended for use in hemodialysis treatments in patients who have chronic or acute renal failure.
#### 7. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The technological characteristics of the Fresenius Optiflux F250NR dialyzer is equivalent to that of the Baxter Xenium model 210 dialyzer and Asahi Rexeed 25S and raises no new types of safety or effectiveness questions.
#### 8. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Fresenius Optiflux F250NR and that the performance characteristics and other information supplied demonstrate that it is substantially equivalent to the Baxter Xenium dialyzer and Ashai Rexeed 25S.
#### F. Safety Summary
The Fresenius Optiflux® F250NR dialyzer is substantially equivalent in construction, design, materials, and intended use to the commercially available Baxter Xenium 210 and Asahi Rexeed 25S dialyzer. In addition, testing of the Fresenius Optiflux F250NR dialyzer indicates that it is safe and effective for its intended use.
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K08244 page 4 of 4
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### G. General Safety and Effectiveness Concerns
The device labeling contains a package insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the Fresenius F250NR dialyzer.
Jarch ckay
Janet C. Kay RAC, Regulatory Affairs Manager
19-Aug-2008
Date
RQ
8-20-08
55 6 126
56
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## OCT 2 8 2008
Janet C. Kay, RAC Regulatory Affairs Manager Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K082414
Trade/Device Name: Fresenius Optiflux® F250NR Dialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 20, 2008 Received: August 21, 2008
Dear Ms. Kay:
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 such 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Jorgu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K00-0414 page 1 of 1
# Confidential
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# Fresenius Optiflux® F250NR Dialyzer
Device Name:
Fresenius Optiflux® F250NR Dialyzer
#### Indications for Use:
The Fresenius Optiflux® F250NR dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K082414
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Fresenius Medical Care North America
Corporate Headquarters: 920 Winter Street Waltham, MA 02451-1457 781-699-9000
58
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.
