Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Applicant
Baxter Healthcare Corporation
Product Code
KDI · Gastroenterology, Urology
Decision Date
Apr 1, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5860
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane. The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). All treatments administered via the Prismaflex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment. If patients suffer from acute kidney injury and / or volume overload, the Prismaflex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as: - Slow Continuous UltraFiltration (SCUF) - Continuous Veno-Venous Hemofiltration (CVVH) - Continuous Veno-Venous HemoDialysis (CVVHD) - Continuous Veno-Venous HemoDiaFiltration (CVVHDF) to perform fluid management and reduction of uremic toxins. The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
Device Story
Disposable extracorporeal circuit; includes AN69 ST hollow fiber hemofilter/dialyzer and tubing. Used with PrismaFlex or PrisMax control units for CRRT (SCUF, CVVH, CVVHD, CVVHDF). Operates by circulating patient blood through semipermeable membrane for fluid management and uremic toxin reduction. Operated by clinicians in clinical settings. Output consists of purified blood returned to patient; fluid management data processed by control unit. Benefits include stabilization of fluid balance and removal of metabolic waste in acute kidney injury patients.
Clinical Evidence
Bench testing only. Performance evaluated per ISO 8637-1 and ISO 8638. Testing confirmed structural/blood compartment integrity, solute clearances, sieving coefficients, ultrafiltration rates, and pressure drops. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis).
Technological Characteristics
AN69 ST hollow fiber membrane; disposable extracorporeal tubing circuit. Sterilized via ethylene oxide (EO). Complies with ISO 8637-1 and ISO 8638. Biocompatibility per ISO 10993-1. Standalone disposable set for use with external control unit.
Indications for Use
Indicated for patients with acute kidney injury and/or volume overload requiring continuous renal replacement therapies (CRRT) including SCUF, CVVH, CVVHD, and CVVHDF. ST100/ST150 sets for patients ≥30 kg; ST60 set for patients >11 kg.
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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April 1, 2022
Baxter Healthcare Corporation % Maud Humbert Senior Manager, Global Regulatory Affairs Gambro Industries 7 Avenue Lionel Terray, BP 126 Meyzieu. F-69883 FRANCE
Re: K212216
Trade/Device Name: Prismaflex ST set (ST60/ST100/ST150 sets) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 18, 2022 Received: March 3, 2022
Dear Maud Humbert:
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
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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); 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 (QS) 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
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### Indications for Use
510(k) Number (if known) K212216
Device Name Prismaflex ST set
Indications for Use (Describe)
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.
The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- · Slow Continuous UltraFiltration (SCUF)
- · Continuous Veno-Venous Hemofiltration (CVVH)
- · Continuous Veno-Venous HemoDialysis (CVVHD)
- Continuous Veno-Venous HemoDiaFiltration (CVVHDF)
to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif and the letters are evenly spaced.
### 510(k) Summary
### OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
### CONTACT PERSON:
Fortunato Aldape Sr. Director, Global Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015
Telephone: T +1.224.948.4867 / M +1.224.358.8599
Date of Preparation: February 15, 2022
# IDENTIFICATION OF THE DEVICE:
Common Name: High Permeability Hemodialyzer
Trade/Device Name: Prismaflex ST Set
Classification Panel: Gastroenterology/Urology
Regulation Number: 21 CFR 876.5860
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II
#### Product Code: KDI
### Table 1. Code Numbers for Prismaflex ST set
| Code Number | Name |
|-------------|----------------------|
| 107643US | Prismaflex ST60 set |
| 107636US | Prismaflex ST100 set |
| 107640US | Prismaflex ST150 set |
#### PREDICATE DEVICE:
### Table 2. Predicate Device(s)
| Device | Company | Predicate 510(k) | Clearance Date |
|---------|---------------------------|------------------------------|----------------|
| K041005 | Gambro Industries, France | Prismaflex M60 and M100 sets | 10/18/2004 |
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| Baxter |
|--------|
| |
| Device | Company | Predicate 510(k) | Clearance Date |
|---------|---------------------------|---------------------------------------------------------------------------------|----------------|
| K080519 | Gambro Industries, France | Prismaflex M150 set | 06/13/2008 |
| K190910 | Gambro Industries, France | Prismaflex M60, M100 and M150<br>sets (intended for use with Prismax<br>system) | 07/25/2019 |
Table 2. Predicate Device(s)
## DESCRIPTION OF THE DEVICE:
The Prismaflex ST60/ST100/ST150 set is a disposable, extracorporeal circuit for use with the PrismaFlex system, or with the PrisMax system. The Prismaflex ST60/ST100/ST150 set consists of an AN69 ST hollow fiber haemofilter/dialyser and tubing system.
These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed :
- SCUF: Slow Continuous Ultrafiltration
- CVVH: Continuous Veno-Venous Hemofiltration
- CVVHD: Continuous Veno-Venous Hemodialysis
- CVVHDF: Continuous Veno-Venous Hemodiafiltration
The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).
The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.
# INDICATIONS FOR USE:
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.
The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical
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condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismaflex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- Slow Continuous UltraFiltration (SCUF)
- Continuous Veno-Venous Hemofiltration (CVVH)
- Continuous Veno-Venous HemoDialysis (CVVHD)
- . Continuous Veno-Venous HemoDiaFiltration (CVVHDF) to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Prismaflex ST set has the same intended use and the same technological characteristics compared to its predicate, the Prismaflex M set, in term of design, material, chemical composition, function and operation.
The safety and performance of Prismaflex ST set was evaluated through non-clinical testing. The bench and pre-clinical testing assessed the following aspects of the device:
- Structural integrity
- Membrane integrity
- Ultrafiltration rate
- Clearances
- Sieving coefficients
- Blood pressure drop
- Total volume of blood in the set
- Priming efficacy
- Shelf life
- Sterilization validation
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- . Pvrogenicitv / LAL
- . EO residuals
- . Biocompatibility
## DISCUSSION OF NONCLINICAL TESTS:
## Performance Data:
Performance testing was conducted on the Prismaflex ST set to evaluate the functional performance of the device. In summary, the Prismaflex ST set has successfully implemented performance requirements and subsequent outputs verifying and validating:
- . The Prismaflex ST set design validation meets the user needs and intended use and is substantially equivalent to the predicate.
- . The device complies with the standard ISO 8637-1 First edition 2017-11, Extracorporeal systems for blood purification - Part 1:Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The testing specifically confirms the device meets the requirements for the mechanical characteristics (structural and blood compartment integrity), and the performance characteristics (solute clearances, sieving coefficients, ultrafiltration coefficient, volume and pressure drop of blood compartment, expiry date) according to this particular standard. The standard also includes requirements for biological safety, sterility and non pyrogenicity.
- . The device also complies with the standard ISO 8638 Third edition 2010-07-01, Cadiovascular implants and extracorporeal blood circuit for hemodialyzers hemodialfilters and hemofilters. The standard includes requirements for biological safety, sterility, non pyrogenicity, mechanical characteristics, expiry date and tubing compliance.
- . The labeling has been successfully implemented and meets the requirements of the above-mentioned standards.
- . Risk Assessment and control measures: The risk analysis confirms the device is approprietly designed and performs as expected and in a safe manner.
# Biocompatibility:
The biocompatibility evaluation for this device was conducted in accordance with ISO-10993-1 Fifth edition 2018-08, "Biological evaluation of medical devices Part 1:
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Evaluation and testing within a risk management process," as recognized by FDA and FDA guidance document Use of International Standard ISO-10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- . Cytotoxicity (per ISO 10993-5)
- Sensitization (per ISO 10993-10)
- Intracutaneous (Irritation) Reactivity (per ISO 10993-10) .
- Acute Systemic Toxicity (per ISO 10993-11) ●
- Material Mediated Pyrogen (per ISO 10993-11)
- Subacute/Subchronic Toxicity (per ISO 10993-11)
- Hemolysis (per ISO 10993-4)
## CONCLUSION:
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the Prismaflex ST set is as safe, as effective, and performs as well as the predicate device.
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is currently marketed for the same intended use.
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.
