The Liberty Cycler is a computer-controlled electro-mechanical medical device designed for use in Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Cycler design incorporates software-controlled pumping action for fluid movement. The Liberty Cycler heats the peritoneal dialysate solution prior to user infusion, measures and delivers a pre-determined amount of fluid to the user and monitors the drained volume from the user. The Liberty Cycler is designed as a table-top unit and is prescribed in both professional and home treatment settings. Modifications to the predicate Liberty Cycler include changes to the performance specifications to allow use of a 6-liter dialysate solution bag. The Liberty Cycler can now accommodate a 1 to 6-liter dialysate solution bag configuration. Additional modifications are included in this submission which are intended to enhance performance and data management within predicate specifications.

AI/ML Overview

The provided text describes modifications to an existing medical device, the Fresenius Liberty Cycler, and the testing conducted to ensure its continued safety and effectiveness. It is not an AI/ML device, therefore, some of the information requested in the prompt is not available in the given text.

Here's an analysis of the acceptance criteria and study information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Test results demonstrated that all modifications functioned as intended and met predetermined acceptance criteria" and that "The essential performance of the Liberty Cycler is not affected by the modifications." However, specific numerical acceptance criteria for each test and their corresponding reported performance values are not detailed in the provided text.

The text mentions several types of tests, implying that acceptance criteria were established for each. Here's a general table based on the information provided, noting the lack of specific numerical criteria:

Acceptance Criteria Category	Reported Device Performance
Software Validation & Regression Testing	All modifications functioned as intended and met predetermined acceptance criteria.
System Performance (6L Bag)	The device demonstrated system performance using the 6-liter dialysate solution bag, and all modifications functioned as intended and met predetermined acceptance criteria. The essential performance of the Liberty Cycler is not affected.
Human Factors (Usability) Testing	The modified Liberty Cycler met prescribed criteria (according to IEC 62366).
Electrical Safety Testing	The modified Liberty Cycler was found to comply with UL 60601-1 (1st Edition, 2006-04-26).
Peritoneal Dialysis Device Performance	The modified Liberty Cycler complied with IEC 60601-2-39: 1999 (First Edition) for use in conjunction with IEC 60601-1.
Electromagnetic Compatibility (EMC) Testing	The modified Liberty Cycler complied with IEC 60601-1-2 (2007), Class B testing criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not specify the sample size for any of the tests. For example, it doesn't mention how many units were tested for electrical safety or how many participants were involved in human factors testing.
Data Provenance: The testing was conducted by Fresenius Medical Care North America according to their internal procedures, protocols, and quality system regulations (21 CFR 820). The country of origin of the data is implicitly the United States (Fresenius Medical Care North America is located in Waltham, MA) and is prospective for the modified device, as the testing was done to verify the modifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided in the document. The device is a medical cycler, not an AI/ML diagnostic tool that requires expert consensus for ground truth establishment. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of images or data to establish a ground truth, which is not relevant to the performance testing of a peritoneal dialysis cycler.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable and not provided in the document. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to this electromechanical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This information is not applicable to this device in the context of an AI algorithm. The device has software control for pumping and other functions, but it's not an AI/ML algorithm being evaluated in isolation. The "standalone performance" of the device refers to its ability to function according to specifications.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance testing is:

Compliance with established engineering standards and regulations: UL 60601-1, IEC 62366, IEC 60601-2-39, IEC 60601-1-2.
Meeting pre-determined internal Fresenius Medical Care acceptance criteria for system validation, software functionality, and functional performance (e.g., fluid measurement accuracy, heating capabilities, ability to accommodate a 6-liter bag).

8. Sample Size for the Training Set:

This information is not applicable and not provided in the document, as the device is not an AI/ML model that undergoes a "training set." The software within the device is validated, not trained in the machine learning sense.

9. How Ground Truth for the Training Set Was Established:

This information is not applicable and not provided. As explained above, there is no "training set" in the context of an AI/ML model for this device. The software's functionality is verified against design specifications and industry standards.

Summary

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K123630

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Fresenius Liberty Cycler Traditional 510(k) Notification

This 510(k) Summary is in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The content of this 510(k) summary conforms with 21 CFR Part 807.92.

Submitter's Information:

Name:	Fresenius Medical Care North America
Address:	920 Winter StreetWaltham, MA 02451-1457
Phone:	781-699-4479
Fax:	781-699-9635
Contact Person:	Denise OppermannSenior Director, Regulatory Affairs - Devices
Date of Preparation:	21 November 2012
Device Name:
Trade Name:	Fresenius Liberty Cycler
Common Name:	Peritoneal Dialysis Cycler

Product Code/Classification Panel: FKX / Gastroenterology - Urology System, Peritoneal, Automatic Delivery Classification Name: Class II per §876.5630

Legally Marketed Predicate Device (unmodified device):

Fresenius Liberty Cycler (K043363)

Device Description:

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Fresenius Liberty Cycler Traditional 510(k) Notification

measures and delivers a pre-determined amount of fluid to the user and monitors the drained volume from the user.

The Liberty Cycler is designed as a table-top unit and is prescribed in both professional and home treatment settings.

Modifications to the predicate Liberty Cycler include changes to the performance specifications to allow use of a 6-liter dialysate solution bag. The Liberty Cycler can now accommodate a 1 to 6-liter dialysate solution bag configuration. Additional modifications are included in this submission which are intended to enhance performance and data management within predicate specifications.

Indications for Use:

The Fresenius Liberty Cycler is indicated for acute and chronic peritoneal dialysis. There is no change to the indications for use.

Technological Characteristics:

The design and technological characteristics of the Liberty Cycler device described within this submission are identical to the predicate Liberty Cycler (K043363), with the exception of the change to accommodate a 6-liter dialysate solution bag and other modifications to enhance performance and data management within predicate specifications.

A risk analysis has been completed and potential hazards associated with the modifications were identified and mitigated. Mitigations are verified wherever applicable. Performance and safety tests were conducted to ensure the safety and effectiveness of the device after the proposed modifications.

Performance Data:

The performance of the modified Liberty Cycler was evaluated according to existing Fresenius Medical Care procedures, protocols, and declared performance standards and guidelines of the quality system regulation (21 CFR 820). Design verification tests were conducted to ensure that the modifications described in this submission did not affect the essential performance of the device and the device functions as intended.

The following testing was conducted:

। Full system validation and software testing, including:
- Software validation and regression testing ၊
- ı System performance testing using the 6-liter dialysate solution bag

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Fresenius Liberty Cycler Traditional 510(k) Notification

Test results demonstrated that all modifications functioned as intended and met predetermined acceptance criteria. The essential performance of the Liberty Cycler is not affected by the modifications.

Human factors (usability) testing according to IEC 62366 Application of usability l engineering to medical devices. The modified Liberty Cycler met prescribed criteria.
Electrical safety testing (UL 60601-1, 1st Edition, 2006-04-26, (Medical Electrical । Equipment, Part 1: General Requirements for Safety)). The modified Liberty Cycler was found to comply with the standard.
Peritoneal dialysis device performance testing (IEC 60601-2-39: 1999 (First Edition) for । use in conjunction with IEC 60601-1, 1st Edition, 2006-04-26). The modified Liberty Cycler complied with the standard.
Electromagnetic compatibility testing (EMC; IEC 60601-1-2 (2007), Class B testing l criteria). The modified Liberty Cycler complied with the standard.

Conclusion:

The performance data demonstrate that the Liberty Cycler is as safe and effective, and performs as well as the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

September 9. 2013

Fresenius Medical Care - North America % Denise Oppermann Senior Director, Regulatory Affairs - Devices 920 Winter Street Waltham, MA 02451

Re: · K123630

Trade/Device Name: Fresenius Liberty Cycler Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: FKX Dated: August 23, 2013 Received: August 26, 2013

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.

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Page 2 - Denise Oppermann

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

Sincerely yours,

Herbert P. Lerner -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

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Image /page/5/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 downward-pointing shapes, with the top two shapes having a curved appearance. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

510(k) Number (if known): K123630

Device Name:

Fresenius Liberty Cycler

Indications for Use:

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

X Prescription Use

AND/OR

Over-the-Counter Use

(Per 21 CFR 801 Subpart D)

(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)

Herbert P. Lerne -2

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
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.
(b)
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.