Fresenius Liberty Select Cycler

K181108 · Fresenius Medical Care Renal Therapies Group, LLC · FKX · May 24, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181108
• Device Name: Fresenius Liberty Select Cycler
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: May 24, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

Device Story

Liberty Select Cycler is a table-top electromechanical device for Automated Peritoneal Dialysis (APD) therapy; treats end-stage renal disease (ESRD). Device uses cassette and tubing sets to manage fluid flow, heating, and drainage; operates via physician-prescribed settings. Used in professional and home settings; operated by patients or clinicians. Software controls fluid delivery, heating, and alarm monitoring. Updated software (v2.8.8) implements a full stroke test for the Patient Line Check (PLC) feature to detect slow-flow or no-flow conditions during the drain phase; triggers immediate soft alarms upon detection. Benefits include improved monitoring of dialysis fluid flow, ensuring therapy efficacy and patient safety during automated treatment cycles.

Clinical Evidence

No clinical data. Evidence consists of software verification and validation testing, including unit, regression, and system-level testing performed in compliance with ANSI/AAMI/IEC 62304:2006 to confirm the functionality of the modified Patient Line Check feature.

Technological Characteristics

Electromechanical table-top cycler. Materials: plastic housing, aluminum heater tray, aluminum cassette housing. Connectivity: optional peripheral wireless modem (3G/4G LTE). Software-controlled fluid flow (45–316 mL/min inflow, 30–286 mL/min outflow) and heating (37°C ± 1°C). Volume accuracy: ± 2% fill, ± 3% drain. Software developed per ANSI/AAMI/IEC 62304:2006.

Indications for Use

Indicated for patients requiring acute or chronic peritoneal dialysis for the treatment of end-stage renal disease (ESRD).

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 Select Cycler (K171652)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 24, 2018

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs-Devices 920 Winter Street Waltham, MA 02451

Re: K181108

Trade/Device Name: Fresenius Liberty Select Cycler Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: FKX Dated: April 26, 2018 Received: April 27, 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.

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for 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

{2}------------------------------------------------

# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

# K181108

1 - 1 - 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Device Name Fresenius Liberty Select Cycler

Indications for Use (Describe)

The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.

# 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 of this 510(k) summary is provided in conformance with 21 CFR 8807.92.

## Submitter's Information 5.1.

| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|-------------------|-------------------------------------------------------------------|
| Address: | 920 Winter Street<br>Waltham, MA<br>02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann, Senior Director<br>Regulatory Affairs – Devices |
| Preparation Date: | 26 April 2018 |

### 5.2. Device Name

| Trade Name: | Fresenius Liberty Select Cycler |
|-----------------------|--------------------------------------------|
| Common Name: | Peritoneal Dialysis Cycler |
| Regulation Name: | Peritoneal Dialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | FKX |
| Classification Panel: | Gastroenterology/Urology |

# 5.3. Legally Marketed Predicate Device

The legally marketed predicate device is the Fresenius Liberty Select Cycler (K171652).

## Device Description 5.4.

#### 5.4.1. Device Identification

The Liberty Select Cycler will be available in the configuration described below.

| Product Line | Part Number | Description |
|--------------|-------------|-----------------------|
| Liberty | 180343 | Liberty Select Cycler |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the Fresenius Medical Care logo. On the left side of the logo is a blue symbol that looks like three downward-pointing arrows stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The logo is set against a white background.

#### 5.4.2. Device Characteristics

The Liberty Select Cycler is an electro-mechanical medical device. Software controls the functions of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms.

#### 5.4.3. Environment of Use

The Liberty Select Cycler is prescribed for use in both professional and home treatment settings.

#### Brief Written Description of the Device 5.4.4.

Like the predicate device, the modified Liberty Select Cycler is a software-controlled electromechanical medical device designed as a table-top unit to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription.

Also like the predicate device. the modified Liberty Select Cycler is compatible with three (3) accessories:

- Cassette and tubing set
- IQdrive
- Optional peripheral wireless modem (AT&T and Verizon 3G/4G LTE networks) ●

The software has been updated from version 2.8.8 to modify the Patient Line Check (PLC) feature to use a full stroke test to check for a slow-flow or no-flow condition in the patient line during the drain phase. The software changes also modified the soft alarm feature to sound the alarm as soon as a slow-flow or no-flow condition is detected.

#### 5.4.5. Materials of Use

There are no changes to the materials of use from the previous 510(k) submission (K171652). The Liberty Select Cycler enclosure consists of the following materials:

- Plastic housing ●
- Aluminum heater tray ●
- Aluminum cassette housing ●

#### 5.4.6. Essential Performance Characteristics

The Liberty Select Cycler has the same essential performance characteristics as the predicate device (K171652) listed in Table 1.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

| Feature | Specification |
|------------------------|-------------------------------------------|
| Inflow | 45–316 mL/min |
| Outflow | Minimum: 30 mL/min<br>Maximum: 286 mL/min |
| Temperature | 37°C ± 1°C |
| Volume Accuracy, Fill | ± 2% of the fill volume |
| Volume Accuracy, Drain | ± 3% of the drain volume |

#### Table 1: Liberty Select Cycler Essential Performance Characteristics

### ર.ર. Indications for Use

The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

# 5.6. Comparison of Technological Characteristics with the Predicate Device

There are no changes in the technological characteristics of the previously cleared Liberty Select Cycler (K171652). The modifications to the Liberty Select Cycler pertain only to software.

The following technical specifications of the Liberty Select Cycler remain the same as those of the predicate device:

- Principle of operation ●
- Environmental requirements ●
- Accessories ●
- Transportation and storage specifications
- Hardware specifications ●
- Manufacturing location ●

#### 5.7. Performance Data

Performance testing requirements were determined through the application of a risk management process, applicable FDA guidance documents, and performance standards (21 CFR §876.5630). Performance testing to support the determination of substantial equivalence included testing in compliance with ANSI/AAMI/IEC 62304:2006.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons 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.

#### 5.7.1. Software Verification and Validation Testing

Unit, software, regression (system verification), exploratory, and validation testing were performed to demonstrate the effectiveness of the software modifications and to confirm operation of the machine.

#### 5.7.2. Mechanical and Acoustic Testing

No mechanical or acoustic tests were performed.

#### Human Factors Testing 5.7.3.

The software modifications from version 2.8.7 to version 2.8.8 did not introduce any new userelated risks or create any changes in the user interface or operation of the Liberty Select Cycler. Labeling modifications involve minor administrative changes with no impact to risk. Therefore, no human factors testing was performed.

#### 5.8. Conclusion

The indications for use, materials of construction, and technological characteristics of the modified Liberty Select Cycler are the same as the predicate device. Differences between the Liberty Select Cycler and the predicate do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the modified Liberty Select Cycler is substantially equivalent to the predicate device, Liberty Select Cycler (K171652).