K113427 · Fresenius Medical Care North America · KDI · Dec 21, 2011 · Gastroenterology, Urology
Device Facts
Record ID
K113427
Device Name
FRESENIUS 2008T HEMODIALYSIS MACHINE
Applicant
Fresenius Medical Care North America
Product Code
KDI · Gastroenterology, Urology
Decision Date
Dec 21, 2011
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.5860
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
Device Story
The Fresenius 2008T Hemodialysis Machine is a high-permeability hemodialysis system for acute and chronic dialysis, hemofiltration, and hemoconcentration. It monitors extracorporeal blood circuits (venous/arterial pressures, air/blood detection) and manages dialysate circuits (mixing concentrates, heating, degassing, volumetric balancing). The machine features a touchscreen, keyboard, and touchpad for parameter setting and monitoring. An optional CDX PC module, housed within the cabinet, allows access to third-party medical information software but operates independently of the dialysis control system. The device is operated by clinicians in clinical settings. Modifications include the option to remove the CDX PC module and the addition of a 'Fn Lock' feature to the keyboard, which uses a high-tear-resistant elastomer. The device ensures patient safety by controlling ultrafiltration and monitoring treatment parameters, providing therapy for patients with renal failure, fluid overload, or toxemia.
Clinical Evidence
Bench testing only. No clinical data was required or provided. Performance was evaluated through software verification and validation (functional, regression, safety systems, simulated dialysis), EMC testing, and physical testing of the new keyboard elastomer (life cycle and shelf life). Results demonstrated that the device met all pre-determined acceptance criteria.
Technological Characteristics
High permeability hemodialysis system. Components include extracorporeal blood circuit monitors, dialysate mixing/balancing modules, and a user interface (touchscreen/keyboard). Connectivity includes an optional integrated CDX PC (Windows/Linux). Keyboard uses high-tear-resistant elastomer. Software/firmware modifications support the 'No CDX' configuration and 'Fn Lock' functionality. Sterilization and manufacturing processes remain unchanged from the predicate.
Indications for Use
Indicated for acute and chronic dialysis therapy in patients with acute or chronic failure, fluid overload, or toxemic conditions.
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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DEC 2 1 2011
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2008T Hemodialysis Machine Special 510(k) Notification
#### Section 5 510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92
## A. Submitter's Information
| Name: | Fresenius Medical Care North America |
|----------------------|--------------------------------------------|
| Address: | 920 Winter Street Waltham, MA 02451-1457 . |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| | Denise Oppermann, Senior Director |
| Contact Person: | Regulatory Affairs - Devices |
| | Renal Therapies Group |
| Date of Preparation: | 18 November 2011 |
| Name: | Fresenius Medical Care North America |
| Address: | 920 Winter Street Waltham, MA 02451-1457 |
- B. Device Name
| Trade Name: | Fresenius 2008T Hemodialysis Machine |
|------------------------------------|---------------------------------------|
| Common Name: | High Permeability Hemodialysis System |
| Product Code/Classification Panel: | 78 KDI/Gastroenterology/Urology Panel |
| Classification Name: | Class II per § 876.5860 |
- C. Legally Marketed Predicate Device (Unmodified Device) Fresenius 2008T Hemodialysis Machine (K111639).
#### D. Device Description
The Fresenius 2008T Hemodialysis Machine (K111639) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by
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K113427
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## 2008T Hemodialysis Machine Special 510(k) Notification
controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, the blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.
In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient.
The front of the machine, with three main sections, contains all of the controls the operator needs access to during a hemodialysis treatment.
The top section of the 2008T Hemodialysis Machine contains the control panel and houses the computer, which runs the treatment program and the separate CDX PC board, which provides the platform for users to utilize medical information software of their choice. The CDX PC is physically located in the 2008T machine's cabinet, but operates independently of the 2008T machine with no capacity to either control the operation of the 2008T hemodialysis machine or influence its programming.
The control panel includes the touchscreen display, fold-down keyboard, touchpad and keypad which allow the operator/user to control the operation of machine by aiding the setting of treatment parameters, monitoring treatment and patient status during dialysis.
The center section contains the modules used for the safe transfer of blood to and from the dialyzer. Dialysate management occurs in the bottom section of the 2008T hemodialysis machine, where the acid and bicarbonate concentrates used to make up the dialysate are mixed and pumped to the dialyzer.
Modifications to the previously cleared 2008T Hemodialysis Machine (K111639) include:
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: K113427
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2008T Hemodialysis Machine Special 510(k) Notification
#### CDX as an Optional Feature 1.
The existing CDX PC allows the user the convenience of a PC, running a Windows or Linux operating system and a compatible MDDS, within the same cabinet as the 2008T machine. The modifications are made to make the 2008T Hemodialysis Machine configuration without the CDX feature similar to a previous configuration of the 2008T (TUI; K080964) which did not contain the additional PC board. The CDX PC hardware module is removed from the 2008T user interface board to implement this configuration. Software modifications are made to the functional and user interface board to support the proposed machine configuration ("No CDX" option). The CDX feature will be made available as an upgrade with the supporting hardware and software upon customer request. The 2008T Hemodialysis Machine without CDX configuration performs identically to the unmodified device (K111639), except that users will be unable to access the third party MIS systems.
#### 2. Proposed maintenance changes
The following modifications were implemented following a regulatory assessment that the changes did not affect the fundamental scientific technology or intended use of the device. Based on FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", FMCNA determined that these modifications did not necessitate a 510(k) submission:
# Fn Lock Keyboard
The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K111639) is located directly below the display screen. The keyboard folds down to allow the operator to enter treatment parameter values, chart with CDX or make selections inside the treatment screen and folds up again to prevent unintentional changes.
For added user convenience while navigating their MIS systems, FMCNA added function lock capability to the current 2008T's keyboard. The modification includes repurposing the "Fn" key to a "Fn Lock" key and adding a function lock indicator light to the immediate right of the Caps Lock indicator light. Software and hardware modifications were made to implement this feature is only available in 2008T Hemodialysis Machines with activation of the CDX option. In dialysis mode, the Fn Lock LED will be off and the function lock feature will be off. In addition, the keyboard is now equipped with a new elastomer material with high tear resistant
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properties as compared to the standard silicon elastomer of the existing keyboard in the unmodified device (K111639).
Treatment modalities for the modified Fresenius 2008T hemodialysis machine remain identical to those for the unmodified 2008T (K111639):
The 2008T is a high permeability hemodialysis system used for the treatment of patients with acute or chronic failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.
#### E. Indications for Use
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
#### F. Technological Characteristics
There are no changes in the technological characteristics of the previously cleared Fresenius 2008T Hemodialysis Machine (K111639). The modified Fresenius 2008T hemodialysis machine incorporates changes pertaining only to "Software or Firmware" and reliability for the user interface. All water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device.
The following technical specifications of the modified device remain the same as the unmodified device:
- . Safety system
- . System performance
- . Environmental Requirements
- . Transportation and Storage condition
- . User Interface (except for the Fn Lock feature)
- . Hardware and therapy settings
- . Accessories
- . Environmental Design
- . Alarms
- . Accuracy and Controls
- . Protection against Mechanical Hazard
- . Identification, marketing and documentation due to changes
- . Protection against Electrical Hazard
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# 2008T Hemodialysis Machine Special 510(k) Notification
- . Protection against excessive temperature or other hazards
- . Manufacturing location
- . Manufacturing process (assembly, testing, shipping, installation, and service)
A Risk Analysis has been completed and potential hazards associated with the modifications have been identified and mitigated. Performance and safety testing were conducted to ensure the safety and effectiveness of the device after the proposed modifications. All potential risks were deemed acceptable after mitigation. Mitigations have been verified wherever applicable.
#### G. Performance Testing
The performance of the 2008T machine with CDX as an optional feature (and all other modifications discussed in the scope of this submission) was evaluated according to existing FMCNA procedures protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820). Design verification and validation testing were conducted to ensure that the modifications described in this submission will not impact the essential performance of the device and the device functions as intended.
The following tests were conducted:
#### 1. Software Verification and Validation Testing
- Software Verification (Functional Tests) .
- . Regression
- Safety Systems Verification
- Simulated Dialysis Treatment
- . Production Test Procedure
- . Unstructured and Static Code Verification
#### Safety Testing 2.
- � EMC Testing (ESD immunity, emissions)
- 3. Unit Testing (Fn Lock Keyboard)
- 4. Physical Testing (Fn Lock Keyboard)
- High Tear Elastomer: Use Life (Shelf Life) .
- . High Tear Elastomer: Life cycle
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# 2008T Hemodialysis Machine Special 510(k) Notification
#### H. Conclusion
The test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria. Results of functional and software validation, performance testing, risk analysis, and usability evaluation indicate that the modified Fresenius 2008T Hemodialysis Machine is substantially equivalent to the named predicate device and remains safe and effective for its intended use.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Denise Oppermann Senior Director, Regulatory Affairs Devices Fresenius Medical Care, North America 920 Winter Street WALTHAM MA. 02451
DEC 2 1 2011
Re: K113427
Trade/Device Name: Fresenius 2008T Hemodialysis Machine Regulation Number: 21 CFR8 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: November 18, 2011 Received: November 21, 2011
Dear Ms. Oppermann:
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 regustration, 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 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
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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm142694.htm
Sincerely yours,
Huchard Leuner MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 Indications for Use Statement
510(k) Number (if known): KI13427
Device Name:
Fresenius 2008T Hemodialysis Machine
Indications for Use:
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
X Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113427
Vol 1/Page 109
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.
