The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.
Device Story
Hemodialyzers/hemofilters for acute/chronic renal failure, intoxications, and fluid overload. Device uses polyarylethersulfone (PES) hollow fibers housed in polycarbonate. Blood enters inlet port, traverses inside of hollow fibers; dialysate flows counter-current in compartment. Solutes/plasma water removed via diffusion and convection across membrane driven by hydrostatic/transmembrane pressure. Used in clinical settings under physician supervision. Output is filtered blood returned to patient; dialysate/filtrate exits via outlet port. Benefits include removal of uremic toxins and waste products.
Clinical Evidence
No clinical data. Bench testing only. In vitro testing evaluated blood/dialysate side priming volumes, flow resistance, ultrafiltration coefficient, and urea/vitamin B12 clearances.
Indicated for patients requiring acute or chronic hemodialysis or hemofiltration, including treatment of renal failure, certain intoxications, and acute fluid overload.
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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| 6/99 | | K98241<br>Page<br>510K Notification<br>Gambro Polyflux 11S, 14S, 17S and 21S<br>July 7th, 1998 |
|-----------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510K(k) SUMMARY | | |
| SUBMITTER: | Gambro Healthcare<br>1185 Oak Street<br>Lakewood, CO 80215<br>(303) 231-4436 | |
| DATE PREPARED: | June 1st, 1998 | |
| DEVICE NAME: | Gambro Polyflux 11S, 14S, 17S, & 21S<br>Hemodialyzers/filters | |
| CLASSIFICATION NAMES: | High Permeability Hemodialyzer / Hemofilter | |
| PREDICATE DEVICE: | Cobe Centrysystem 14 PES Hemodialyzer | |
| Device Description: | | |
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# Gambro Polyflux 11S, 14S, 17S, and 21S, Hemodialyzers/Filters
The Gambro Polyflux 11S, 14S, & 21S Hemodialyzers/Hemofiters are identical in construction in function to other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis and hemofiltration for the treatment of acute and chronic renal failure and for certain types of intoxications. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylether sulfone (polyethersulfone) (PES) which is identical to the membrane utilized in the Cobe Centrysystem 14 PES hemodialyzer which has been previously approved for marketing in the United States under a 510K Notification (K95-5592). A copy of this approval letter is included in Part D. of Section XIV of this Notification.
Blood enters a blood inlet port where it is distributed to polyarylethersulfone hollow fibers. Each hollow fiber has an inner diameter of approximately 215 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. The number of polyarylethersulfone hollow fibers in each hemodialyzer / hemofilter are 8000 for the 11S. 10000 for the 14S, 10000 for the 17S, and 12500 for the 21S. These dialyzers have effective membrane lengths of either 210mm (11S & 14S) or 250 mm (17S & 21S). The effective membrane surface areas are 1.1 m2 for the 11S, 1.4 m2 for the 14S, 1.7 m2 for the 17S, and 2.1 m2 for the 21S. The housing of this hemodialyzer is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Cobe Centrysystem 14 PES (K95 5592) (please refer to Parts A., B. C. and D. of Section XIV. of this Notification for information on the Cobe Centrysystem 14 PES Hemodialyzer). The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the polyarylethersulfone membrane,
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K982414
plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through polyarylethersulfone membrane and into the counter current flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
#### Predicate Devices:
The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/filters are substantially equivalent in construction, design, intended use, function and materials to other high 11S 14C 17S and 215 1 115, 14S, 17S, and 21S hemodialyzers/filter are substantially equivalent in function, design, composition, materials, and operation, to the Cobe Centrysystem 14 PES hemodialyzer (K95 5592) which is currently in commercial distribution in the United States.
#### Intended Use:
The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers can be used whenever hemodialysis and hemofiltration is indicated. This can be used for acute or chronic hemodialysis and hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician.
This indication statement is essentially the same as the indication statement for the predicate device.
## Technological Characteristics:
Comparing the proposed device to the predicate device, some similarities and differences are noted in the design employed to accomplish the same intended use. Both the proposed and predicate devices use the same polyarylethersulfone, hollow fiber membrane. Both the proposed and predicate devices use polycerbonate for the housing and header material and polyurethane for the membrane potting material. The predicate device is different from the proposed device in that it uses a different membrane surface areas and has different blood side priming volumes and performance parameters (i.e. clear and "
### Summary of Non-Clinical Tests:
In vitro testing was performed on the Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers/hemofilter to determine the following: blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafitration coefficient, urea, that the proposed douise and vitamin B12, clearances. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters.
## Clinical Test Results:
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K 982414
Page 3 of 3
510K Notification Gambro Polyflux 11S, 14S, 17S and 21S July 7th , 1998
Clinical testing was not performed
# Conclusions:
Testing performed on the Gambro Polyflux 11S, 14S, 17S, and 21S indicates that they are
safe, effective, and perform as well as the predicate device, when used in accordance the instructions for use.
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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is written in a bold, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 1999
Jeffrey R. Shideman, Ph.D. Gambro Healthcare 7307 Glouchester Drive Edina, MN 55435
Re: K982414
Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/Hemofilters Dated: January 31, 1999 Received: February 3, 1999 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI
Dear Dr. Shideman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Medical Detroo Annoneneric Act (Act). You may, therefore, market the device, subject to the general controls roder Pool, Drag, and e octors of the Act include requirements for annual registration, listing of provisions of the Not - 110 g practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may ir your do to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Ourient Ooo manationing the CFR Part 820) and that, through periodic QS inspections, the Food and Medial Donolar of Ochoral royalerify such assumptions. Failure to comply with the GMP regulation may result in Drug Nammondon (r Dri) mill rom) butlish further announcements concerning your device in the Federal regarder. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA This reter will and you to begin marked 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 and additionally 809.10 for in if you desire tipeonic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, the promote the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other please note rogalation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerety vours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of
510 (k) NUMBER (IF KNOWN) : K982414 DEVICE NAME: Gambro Polyflux 11S, 14S, 17S, and 21S Hemodialyzers/ Filters INDICATIONS FOR USE:
The Gambro Polyflux 11S, 14S, 17S, and 21S hemodialyzers / filters can be used whenever hemodialysis or hemofiltration is indicated. These can be used for acute or chronic hemodialysis or hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration and clotting times should be performed under the supervision / direction of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De
510(k) Number
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.
