LIBERTY PDX CYCLER

K141145 · Fresenius Medical Care Renal Therapies Group, LLC · FKX · Jul 30, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141145
• Device Name: LIBERTY PDX CYCLER
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: Jul 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Liberty PDx™ Cycler is intended for Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD) in clinical and home settings. The supported peritoneal dialysis therapy types include: Continuous Cycling Peritoneal Dialysis (CCPD), Intermittent Peritoneal Dialysis (IPD), Peritoneal Dialysis Plus™ Therapy (PD+), and Tidal Peritoneal Dialysis (TPD).

Device Story

Liberty PDx Cycler is a software-controlled electromechanical device for Automated Peritoneal Dialysis (APD). Used in clinical or home settings by patients or clinicians. System inputs include programmed treatment parameters (infusion volume, dwell time). Device heats dialysate solution, uses mushroom-head piston pump module to linearly displace fluid through a single-use disposable cassette, and monitors drained volume. Cassette features fluid channels and valve domes to direct flow between solution bags, patient, and drain. Output includes automated fluid delivery and treatment data stored on IQdrive (USB) or transmitted via optional cellular modem to FTP server. Healthcare providers use data to monitor therapy. Benefits include automated, precise management of peritoneal dialysis therapy for ESRD patients.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing included electrical safety (ES 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and mechanical performance (IEC 60601-2-39). Biocompatibility of disposable sets verified per ISO 10993-1, ISO 10993-7, and ISO 11135-1.

Technological Characteristics

Software-controlled electromechanical pumping system. Components: touchscreen control panel, mushroom-head piston pump module, cassette compartment. Disposable set: polypropylene cassette with flexible film, PVC tubing, Safe-Lock connectors. Sterilization: Ethylene oxide (fluid path). Standards: IEC 60601-2-39:2007, ES 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, ISO 10993-1:2009, ISO 10993-7:2008, ISO 11135-1:2007.

Indications for Use

Indicated for acute and chronic peritoneal dialysis in patients with 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 Cycler (K123630)

Submission Summary (Full Text)

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#### 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 § 807.92.

#### Submitter's Information 5.1.

| Name: | Fresenius Medical Care Renal Therapies Group, LLC<br>(FMC-RTG) |
|----------------------|--------------------------------------------------------------------|
| Address: | 920 Winter Street<br>Waltham, MA 02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann,<br>Senior Director, Regulatory Affairs - Devices |
| Date of Preparation: | 01 May 2014 |

#### 5.2. Device Name

| Trade Name: | Liberty PDx™ Cycler |
|------------------------------------|--------------------------------------------|
| Common Name: | System, Peritoneal, Automatic Delivery |
| Classification Name: | Peritoneal dialysis system and accessories |
| Classification Number: | Class II per 21 CFR §876.5630 |
| Product Code/Classification Panel: | FKX/Gastroenterology/Urology |

#### 5.3. Legally Marketed Predicate Device

Fresenius Liberty Cycler (K123630)

#### 5.4. Device Description

The Liberty PDx Cycler is a software-controlled electromechanical device designed for use in Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty PDx Cycler is designed as a table-top unit for use with single-use, dedicated disposable set (referred to as Liberty PDx Cycler sets). The Liberty PDx Cycler may be prescribed for either clinical or home treatment settings, as the predicate Liberty Cycler. Treatment settings, such as the amount of solution to be infused and the length of time the solution remains in the peritoneal cavity, are programmed into the cycler. During treatment, the Liberty PDx Cycler heats the

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peritoneal dialysis solution prior to patient infusion, measures and delivers a predetermined amount of fluid to the patient, and monitors the drained volume.

The Liberty PDx Cycler system consists of a Control Panel (user interface), Pump Module, Cassette Compartment, a disposable Cycler set (single-use), IOdrive, and an optional peripheral cellular modem. The control panel consists of a touchscreen display and front panel keys which provide a user interface. The pump module consists of mushroom-head piston(s) that are linearly displaced to alternately draw the dialysate solution to and from the patient's peritoneal cavity. The cassette compartment provides the interface for the disposable cycler set with the pump module's mushroom-head pistons. The cycler set is connected to a number of tubes which, in turn, connect to the dialysate solution bags, the patient, or a drain and provide a flow path between the cycler and the patient. At the end of each treatment, data generated by the Liberty PDx Cycler and stored in battery-backed memory are read and written to a treatment data set on the IQdrive (USB memory stick). Additionally, an optional peripheral cellular modem can also be used with the Liberty PDx Cycler to transmit treatment data files to an FTP server at the end of each treatment.

The Liberty PDx Cycler set is loaded into the cassette compartment of the Liberty PDx Cycler at the initiation of treatment. The cassette is composed of a ridged molded plastic (polypropylene) body covered with a flexible film/membrane. The cassette contains molded features, such as fluid channels, flexible valve domes and two (2) pumping chambers that are acted upon by the cycler to direct the flow of the peritoneal dialysate to and from the patient's peritoneal cavity.

There are seven (7) fluid lines connected to the cassette:

- . One (1) drain line
- . One (1) patient connection line (with one (1) or two (2) stay safe® patient connectors depending on the model)
- . Five (5) Dialysate Solution Lines (with Safe-Lock® connector):
- One (1) heater bag
- One (1) last dialysate bag/'last bag option' ।
- Three (3) additional solution bags -

The three Liberty PDx Cycler sets designed for use with the Liberty PDx Cycler are constructed from identical materials. The sets differ only in the length of lines or in the number of patient connectors, as described in Table 1.

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| Cycler Set<br>Product Codes | Features |
|-----------------------------|------------------------------------------------------------------------------------|
| 050-87220 | • Dual Patient Connector<br>• Patient Line - 10 feet<br>• Drain Line - 28 inches |
| 050-87221 | • Single Patient Connector<br>• Patient Line - 10 feet<br>• Drain Line - 28 inches |
| 050-87222 | • Single Patient Connector<br>• Patient Line - 20 feet<br>• Drain Line - 20 feet |

#### Liberty PDx Disposable Cycler Sets Table 1:

#### 5.5. Indications for Use

The Liberty PDx™ Cycler is indicated for acute and chronic peritoneal dialysis.

#### 5.6. Intended Use

The Liberty PDx™ Cycler is intended for Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD) in clinical and home settings. The supported peritoneal dialysis therapy types include: Continuous Cycling Peritoneal Dialysis (CCPD), Intermittent Peritoneal Dialysis (IPD), Peritoneal Dialysis Plus™ Therapy (PD+), and Tidal Peritoneal Dialysis (TPD).

#### Technological Characteristics 5.7.

The Liberty PDx Cycler system and the predicate Liberty Cycler have equivalent technological characteristics:

- 1. Fundamental Scientific Technology/Operating Principle: Software-controlled electromechanical pumping system with actuating linear pump heads interfacing with the cassette fluid chamber to direct the flow of dialysis solution between the cycler and the patient. Flow direction is controlled by the pump movement.
- 2. Design/Configuration: Software-controlled electromechanical device with control (pumps and valves) and monitoring (sensors) components which interface with a disposable cycler set for fluid displacement. The single-use disposable cycler set is comprised of dialysate fluid-contacting components such as a pump cassette assembly, male Safe-Lock connectors, tubing, and stay safe patient connector to allow for the movement of peritoneal dialysate to and from the patient.

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Image /page/3/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three stacked chevrons, with the top two chevrons being larger than the bottom one. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

K141145 Page 4 of 4

- 3. User Interface: Control panel with integrated touchscreen display and front panel keys.
- 4. Sterility (Cycler Set): Ethylene oxide, fluid path only

#### 5.8. 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 to IEC 60601-2-39:2007, ES 60601-1:2005, IEC 60601-1-2:2007, and IEC 60601-1-11:2010. The Liberty PDx Cycler sets were tested to ISO 10993-1:2009, ISO 10993-7:2008, and ISO 11135-1:2007.

#### 5.9. Conclusion

The information provided in this submission, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility and usability testing demonstrates the Liberty PDx Cycler functions as intended and supports the determination of substantial equivalence to the predicate device. Test results demonstrate that the differences between the proposed and the predicate device are not significant and do not raise any new concerns with regard to safety or effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 30, 2014

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

Re: K141145

> Trade/Device Name: Liberty PDx Cycler Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: May 1, 2014 Received: May 2, 2014

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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Page 2 - Denise Oppermann

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 (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.

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/CDRHQffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141145

Device Name

Liberty PDx Cycler

Indications for Use (Describe) The Liberty PDx Cycler is indicated for acute and chronic peritoneal dialysis.

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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