K173718 · Fresenius Medical Care Renal Therapies Group, LLC · FKX · May 1, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K173718
Device Name
Liberty Cycler Set
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product Code
FKX · Gastroenterology, Urology
Decision Date
May 1, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5630
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.
Device Story
Single-use, sterile, nonpyrogenic disposable set for peritoneal dialysis; used with Liberty Cycler. Comprises rigid plastic cassette with flexible film membrane, fluid channels, valve domes, pumping chambers, and seven fluid lines (drain, patient, and dialysate solution lines). Operates by interaction between cycler and cassette to direct dialysate flow to/from patient peritoneal cavity. Used in healthcare and home environments. Provides sterile fluid path with secure connectors (stay safe-Lock, Luer lock). Benefits patient by enabling automated peritoneal dialysis therapy.
Clinical Evidence
No clinical studies were performed. Substantial equivalence supported by bench testing, including fill/drain accuracy, tubing clamp load, connector push force, cassette port break-force, structural integrity (leak, tensile, seal endurance), shipping/packaging tests, and biocompatibility (cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility).
Indicated for patients requiring acute or chronic peritoneal dialysis using the Liberty Cycler system.
Regulatory Classification
Identification
(1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments. (3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles. (4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
Special Controls
*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.
Predicate Devices
Fresenius Liberty Cycler and Disposable Cycler Sets (K043363)
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May 1, 2018
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K173718
Trade/Device Name: Liberty Cycler Set Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: FKX Dated: March 29, 2018 Received: March 30, 2018
Dear Denise 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 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 statutes and regulations administered by other Federal agencies.
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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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K173718
Device Name Liberty Cycler Set
Indications for Use (Describe)
The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.
Type of Use (Select one or both, as applicable)
X 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/0 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol consisting of three downward-pointing chevron shapes stacked vertically. To the right of the symbol are the words "FRESENIUS" and "MEDICAL CARE" stacked on top of each other, also in blue. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
#### 510(K) SUMMARY 5.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) Summary is provided in conformance with 21 CFR §807.92.
#### 5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|-------------------|---------------------------------------------------|
| Address: | 920 Winter Street |
| | Waltham, MA |
| | 02451-1457 |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann |
| | Senior Director Regulatory Affairs – Devices |
| Preparation Date: | December 4, 2017 |
#### 5.2. Device Name
| Trade Name: | Liberty Cycler Set |
|-----------------------|--------------------------------------------|
| Common Name: | Cycler Set |
| Regulation Name: | Peritoneal dialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | FKX |
| Product Code Name: | System, Peritoneal, Automatic Delivery |
| Classification Panel: | Gastroenterology/Urology |
#### 5.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Fresenius Liberty Cycler and Disposable Cycler Sets (K043363). This device has not been subject to a design related recall.
The Liberty PDx Cycler Set (K141145) is used as a reference device.
#### 5.4. Device Description
#### 5.4.1. Device Identification
The Liberty Cycler Set (hereinafter referred to as "Cycler Set") is available in three (3) configurations. The sets differ only in the length of the patient and drain lines or in the number of patient connectors (Table 1).
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Image /page/4/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".
| Cycler Set Product Codes | Product Name |
|--------------------------|------------------------------------------------------------------------------------|
| 050-87212 | Liberty Cycler Set, Two patient connectors |
| 050-87215 | Liberty Cycler Set, One patient connector |
| 050-87216 | Liberty Cycler Set, One patient connector with<br>extended patient and drain lines |
#### Table 1: Liberty Cycler Sets
#### 5.4.2. Device Characteristics
The Cycler Sets are single-use Class II devices designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis. The Cycler Sets are provided sterile and nonpyrogenic. The Cycler Sets are sterilized using ethylene oxide (EO).
#### 5.4.3. Environment of Use
The Cycler Sets are used in both healthcare and home environments.
#### 5.4.4. Brief Written Description of the Device
The Cycler Sets are sterile, single-use devices designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis. Each Cycler Set contains a cassette portion and seven (7) fluid lines. The cassette is composed of a rigid molded plastic body covered with a flexible film (membrane). The cassette contains molded features, such as fluid channels, valve domes, and pumping chambers. There are 7 fluid lines connected to the cassette body:
- One (1) drain line (yellow clamp) -
- One (1) patient connection line with two (2) stay •safe® patient connectors (blue clamp)
- -Five (5) Dialysate Solution Lines (with Safe-Lock® connectors):
- One (1) heater bag (red clamp) -
- One (1) last dialysate bag/'last fill option' (green clamp) ।
- -Three (3) additional solution bags (white clamps)
The flow of peritoneal dialysate solution to and from the patient's peritoneal cavity is directed by interaction between the Liberty Cycler and the cassette.
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Image /page/5/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
#### 5.4.5. Materials of Use
The Cycler Sets are classified as externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days) duration. Class II (Category B) devices in accordance with FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (16 June 2016).
The 3 Cycler Sets designed for use with the Liberty Cycler are constructed from materials identical to the predicate device with the exception of the new film.
Materials used in the manufacture of the Cycler Sets include:
- . Polypropylene (PP)
- . Polyvinyl chloride (PVC)
- Polycarbonate (PC)
- . High-density polyethylene (HDPE)
- . Acrylic polymer
- . Silicone
- Thermoplastic elastomer copolymer
#### Key Performance Characteristics 5.4.6.
The Cycler Sets are used as accessories to the Liberty Cycler. When used in conjunction with the Liberty Cycler, they provide a sterile fluid path with secure connections (stay safe-Lock®, and Luer lock) to alternately draw the prescribed dialysate solution to and from the patient's peritoneal cavity.
#### 5.5. Intended Use
The Liberty Cycler Sets are intended to be used with the Liberty Cycler.
#### 5.6. Indications for Use
The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.
### 5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Cycler Sets are equivalent to the predicate Liberty Cycler Set (K043363).
- . Intended use
- Principle of operation ●
- Design characteristics
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Image /page/6/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
- Sterilization method, packaging, and sterility label claims
#### 5.8. Performance Data
Testing was either conducted or leveraged to support the determination of substantial equivalence.
- . Performance
- Cycler Set fill and drain accuracy ।
- Load to close tubing clamps test |
- Load to push the stay safe patient connector test |
- -Compression tests to evaluate the break-force on the cassette ports
- Structural integrity ●
- । Abrasion test
- Positive and negative pressure leak test for the Cycler Set ।
- Bond strength testing (Tensile test) -
- -Positive pressure leak test for stay•safe patient connector and tubing clamps
- Film seal integrity test (Endurance test) -
- Shipping and packaging test -
- Biological safety (Biocompatibility) ●
- Maintenance of sterility
- Human Factors (HF) validation
#### 5.8.1. Biocompatibility Testing
Testing was conducted to support the biological safety of the Cycler Sets.
- Simulated use Leachables
- Cytotoxicity, ISO Elution Method with MEM ●
- . Sensitization, Guinea Pig Maximization
- . Intracutaneous Irritation
- Material-Mediated Pyrogenicity ●
- Hemocompatibility, ASTM Hemolysis (Indirect) Extract ●
A toxicological risk assessment was also performed.
#### 5.8.2. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The Cycler Sets do not contain electrical components.
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Image /page/7/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.
#### 5.8.3. Software Verification and Validation Testing
Not applicable. The Cycler Sets do not contain software.
#### 5.8.4. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
#### Animal Studies 5.8.5.
No animal studies were performed.
#### Clinical Studies 5.8.6.
No clinical studies were performed.
#### 5.9. Conclusion
The intended use, principle of operation, design characteristics, and sterilization method of the Liberty Cycler Sets are the same as those of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Liberty Cycler Sets are safe and effective for their 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.
