GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
Applicant
Gambro Renal Products
Product Code
KDI · Gastroenterology, Urology
Decision Date
Oct 7, 2004
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 876.5860
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Prismaflex is indicated for the following use: - continuous solute and/or fluid removal in patients with acute renal failure or fluid overload All treatments administered by the Prismaflex must be prescribed by a physician.
Device Story
Prismaflex System is an acute renal failure treatment device; provides continuous renal replacement therapy (CRRT) including SCUF, CVVH, CVVHD, and CVVHDF. System comprises a control unit and sterile disposable cartridge (hemofilter/dialyzer). Inputs include blood from patient, anticoagulant, and sterile replacement/dialysate solutions. Device automatically loads/primes cartridge; pumps blood; delivers anticoagulant; controls fluid removal via effluent pump; manages replacement/dialysate flow rates; monitors treatment data; provides alarms (visual/audible); performs automatic/manual rinseback. Used in clinical settings by trained operators. Output consists of treated blood returned to patient and monitored treatment data recorded on removable storage media. Benefits include waste product removal, acid-base balance restoration, electrolyte correction, and fluid balance management.
Clinical Evidence
No clinical data. Bench testing only. Verification and validation performed against design specifications. Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-16, ISO 14971, and ISO/IEC 12207. Disposable sets met ISO 10993-1 (biocompatibility) and AAMI/ISO 11135 (sterilization).
Technological Characteristics
System includes control unit and disposable cartridge sets. Features multiple pumps and scales for fluid management. Connectivity via removable storage media for data recording. Sterilization of disposable sets via ethylene oxide per AAMI/ISO 11135. Software developed per ISO/IEC 12207. Electrical safety per IEC 60601 series.
Indications for Use
Indicated for patients with acute renal failure or fluid overload requiring continuous solute and/or fluid removal. Must be prescribed by a physician.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined lines that form the shape of a bird or a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2004
Mr. Thomas B. Dowell Manager Regulatory Affairs Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K041005
Trade/Device Name: Gambro Prismaflex™ System with M60 and M100 Sets Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: August 10, 2004 Received: August 11, 2004
Dear Mr. Dowell:
This letter corrects our substantially equivalent letter of October 7, 2004 regarding the incorrect product code listed for the Gambro Prismaflex™ System.
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 (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 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
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#### Page 2 - Mr. Thomas B. Dowell
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 continue 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
NancyC brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Abbreviated 510(k) Notification -Gambro Prismaflex™ System
# Indications For Use
510(k) Number (if known):
K041005
Device Name:
Prismaflex™ System Prismaflex™ M60 Set Prismaflex™ M100 Set
Indications For Use:
The Prismaflex is indicated for the following use:
- continuous solute and/or fluid removal in patients with acute renal failure or ● fluid overload
All treatments administered by the Prismaflex must be prescribed by a physician.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Horton
(Division Sign-Off)
Division of Reproductiv Abdomir and Radiological Devic 510(k) Number
Confidential
Page 1
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K041005 Page 1 of 3
Abbreviated 510(k) Notification Gambro Prismaflex™ System
OCT 7 - 2004
510(k) SUMMARY
SUBMITTER:
Gambro Renal Products 10810 West Collins Avenue Lakewood, CO 80215 USA
Thomas B. Dowell, Manager Regulatory Affairs CONTACT: Phone: (303) 231-4094 (303) 542-5138 Fax:
April 16, 2004 DATE PREPARED:
Prismaflex System DEVICE NAME: Prismaflex M60 Set Prismaflex M100 Set
Hemodialysis System COMMON/UNUSUAL NAME:
High Permeability Hemodialysis System CLASSIFICATION NAMES:
KDI PRODUCT CODE:
Gastroenterology - Urology (GU) CLASSIFICATION PANEL:
Class II per 21 CFR 876.5860 CLASSIFICATION:
K021615 Baxter Accura System PREDICATE DEVICES: K963440 B.Braun Diapact CRRT K010805 Gambro Prisma System K032431 Gambro Prisma M60/M100 Sets
### DEVICE DESCRIPTION:
The Prismaflex System is an acute renal failure treatment device for removal of waste products, restoration of acid-base balance, correction of electrolyte imbalances (eg, hyperkalemia), patient fluid balance, nutritional support, and other conditions in which flyperkalomia); pationed. The system consists of a control unit and a sterile disposable nulla removal is nouth a hemofilter/dialyzer. Prismaflex offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Ropiaosmonion Hemofiltration (CVVH), Continuous Veno-venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodiafiltration (CVVHDF).
SCUF - Provides fluid removal by ultrafiltration.
CVVH - Provides convective solute clearance by hemofiltration. Can provide net fluid removal if desired.
nula formoval if docure solute clearance by hemodialysis. Can provide net fluid removal if desired.
CVVHDF - Provides solute clearance by both convection and diffusion. Can provide net fluid removal if desired.
### Confidential
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K041005 Page 2 of 3
Abbreviated 510(k) Notification Gambro Prismaflex™ System
The Prismaflex performs the following functions related to the administration of supported therapies:
- Automatically loads the Gambro Cartridge blood tubing/hemofilter set. .
- Primes the Gambro Cartridge set. Automatic or Manual priming may be done. . Frithes the Gambro Cartridge-specific settings for UFR, priming volume Automatic priming asso proces, sal priming allows the operator to manually select and control these priming parameters.
- Pumps blood through the blood flowpath of the Gambro Cartridge and delivers . Fullips blood through the blood flowpath. Anticoagulant may be delivered continuously anticoagulant mo the blood frompatulant-filled syringe loaded into the syringe pump or via infusion using the Pre-Blood Pump infusion pump.
- Controls fluid removal from the patient. Calculates and controls the effluent pump . oontrold from varieve the current patient Fluid Removal Rate set by the operator rate required to acon the dialysate and/or replacement pump flow(s).
- Delivers sterile replacement solution from pre-prepared bags. .
- Pumps dialysate solution from pre-prepared bags. .
- Monitors, displays, and charts treatment data. .
- Monitors the system and alerts the operator to abnormal situations through alarms. . An alarm is indicated by the alarm name and appropriate control buttons appearing on the machine display; by a red or yellow alarm light; and by an audible alarm (beeping sound).
- Provides automatic rinseback of blood in the Gambro Cartridge, if desired. If . enabled, Auto Rinseback controls the blood pump rate and saline volume pumped, according to preset values. Manual Rinseback can also return blood, where the operator controls the blood pump and saline volume.
- Records patient prescription data on a removable storage media. .
#### INDICATIONS FOR USE:
The Prismaflex is indicated for the following use:
- Continuous solute and/or fluid removal in patients with acute renal failure or fluid . overload
All treatments administered by the Prismaflex must be prescribed by a physician.
### TECHNOLOGICAL CHARACTERISTICS:
The Prismaflex is similar to the cited predicate devices in the ranges for fluid flow rates, patient fluid balance rates, operating pressures, and anticoagulation. Operation of the device and the cited predicates is similar. The number of scales and pumps included in the design varies from device to device, but the resulting performance capabilities are
#### Confidential
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K041005 Page 3 of 3
Abbreviated 510(k) Notification Gambro Prismaflex™ System
similar. With respect to the original Prisma, Prismaflex incorporates an additional scale similar. With respect to the orginal Priomer, replacement solution flexibility.
## SUMMARY OF NON-CLINICAL TESTS and CONCLUSION:
The Prismaflex was verified & validated by thorough testing to the design specifications. The results of the testing demonstrate that Prismaflex meets the requirements. The results of the testing domonatiate that . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . party assessments:
- IEC 60601-1 (+ amendments 1 & 2) .
- IEC 60601-1-1 .
- IEC 60601-1-2 .
- IEC 60601-1-4 .
- IEC 60601-2-16 .
- IEC 14971:2000 .
- ISO/IEC 12207 .
The Prismaflex M60/M100 disposable cartridge sets were tested to and met the requirements of ISO 10993-1 Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. Further, the sets were tested to and met the AAMI/ISO 1135 Evaluation and Routine Control of Ethylene Oxide Sterilization. Results of these tests and in-vitro performance tests for the system demonstrate suitability for the intended use.
## SUMMARY OF CLINICAL TESTS and CONCLUSION:
Not applicable
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.
