Liberty Cycler Set

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

Intended 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).

Technological Characteristics

Single-use, sterile, EO-sterilized disposable set. Materials: Polypropylene, PVC, Polycarbonate, HDPE, Acrylic polymer, Silicone, Thermoplastic elastomer. Externally communicating, blood path indirect, prolonged contact (>24 hours to 30 days). No electrical components. No software. Cassette-based fluid management system.

Indications for Use

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)

Reference Devices

• Liberty PDx Cycler Set (K141145)

Submission Summary (Full Text)

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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 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 ([e-mail]) or phone [phone] 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: | [phone] |
| Fax: | [phone] |
| 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.