(90 days)
No
The summary describes a software update for remote programming, but there is no mention of AI, ML, or related concepts in the device description, performance studies, or other sections.
Yes
The device is indicated for acute and chronic peritoneal dialysis, which is a therapy for end-stage renal disease (ESRD). It is designed to deliver Automated Peritoneal Dialysis (APD) therapy.
No
The device is indicated for treatment (peritoneal dialysis for end-stage renal disease), not for diagnosing conditions.
No
The device description explicitly states it is an "electro-mechanical medical device" and a "table-top unit," indicating it includes hardware components beyond just software. The software update is a feature added to this existing hardware device.
Based on the provided information, the Fresenius Liberty Select Cycler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "acute and chronic peritoneal dialysis," which is a treatment for end-stage renal disease. This is a therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details an "electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy." This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Liberty Select Cycler's function is to perform a treatment directly on the patient.
N/A
Intended Use / Indications for Use
The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.
Product codes
FKX
Device Description
The Liberty Select Cycler is an electro-mechanical medical device. Software controls of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms.
Like the predicate device, the modified Liberty Select Cycler (hereinafter referred to as the "Cycler") is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Cycler is designed as a table-top unit that can be used to perform peritoneal dialysis (PD) in hospitals, dialysis clinics, and at home.
The modified Liberty Select Cycler is compatible with the following accessories:
- Cassette and tubing set (Cycler Set)
- IQdrive
- Optional peripheral wireless modem/gateway (AT&T and Verizon 3G/4G LTE networks)
The software has been updated from version 2.9.2 to introduce the Remote Therapy Programming feature. This feature allows the Cycler to securely receive prescription settings remotely from a Fresenius server. The remote programming feature streamlines the prescription alteration process because it provides the patient with an alternative to physically bringing their IQdrive (i.e., removable USB drive) to the clinic to receive their prescription settings.
The Liberty Select Cycler enclosure consists of the following materials:
- Plastic housing
- Aluminum heater tray
- Aluminum cassette housing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Liberty Select Cycler is prescribed for use in both professional and home treatment settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing requirements were determined through the application of a risk management process, applicable FDA guidance documents, and performance standards (21 CFR 8 876.5630). Performance testing to support the determination of substantial equivalence included testing in compliance with ANSI/AAMI/IEC 62304:2006/A1:2016 and ANSI/AAMI/IEC 62366-1:2015.
Software Verification and Validation Testing
Unit, software, regression (system verification), and validation testing were performed to demonstrate the effectiveness of the software modification and to confirm operation of the machine.
Human Factors Validation Testing
The Liberty Select Cycler was validated for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (06 September 2018) for modifications due to Remote Programming features. The remaining essential and critical user tasks were determined to be equivalent to the user tasks of the predicate device.
Key Results: The information provided in this submission demonstrates the Liberty Select Cycler functions as intended and supports the determination of substantial equivalence to the predicate device, Liberty Select Cycler (K181108). Test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
October 31, 2022
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs Devices 920 Winter Street Waltham, Massachusetts 02451
Re: K222318
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: August 1, 2022 Received: August 2, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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)
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. The logo consists of a blue geometric shape on the left, resembling a stylized downward-pointing arrow or chevron made up of three stacked elements. To the right of the geometric shape are the words "FRESENIUS" and "MEDICAL CARE" stacked on top of each other, also in blue. The text is in a bold, sans-serif font.
K222318 Page 1 of 4
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) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 29 July 2022 |
5.2. Device Name
| Trade Name: | 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 | |
| Product Code Name: | System, Peritoneal, Automatic Delivery | |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Fresenius Liberty Select Cycler (K181108). This device has not been subject to a design-related recall.
5.4. Device Description
5.4.1. Device Identification
The Liberty Select Cycler is the subject of this 510(k).
5.4.2. Device Characteristics
The Liberty Select Cycler is an electro-mechanical medical device. Software controls 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.
4
Image /page/4/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the geometric shape, the text "FRESENIUS MEDICAL CARE" is displayed in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The overall design is clean and corporate, suggesting a professional and reliable medical organization.
Brief Written Description of the Device 5.4.4.
Like the predicate device, the modified Liberty Select Cycler (hereinafter referred to as the "Cycler") is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Cycler is designed as a table-top unit that can be used to perform peritoneal dialysis (PD) in hospitals, dialysis clinics, and at home.
The modified Liberty Select Cycler is compatible with the following accessories:
- Cassette and tubing set (Cycler Set) ●
- o IQdrive
- Optional peripheral wireless modem/gateway (AT&T and Verizon 3G/4G LTE networks) ●
The software has been updated from version 2.9.2 to introduce the Remote Therapy Programming feature. This feature allows the Cycler to securely receive prescription settings remotely from a Fresenius server. The remote programming feature streamlines the prescription alteration process because it provides the patient with an alternative to physically bringing their IQdrive (i.e., removable USB drive) to the clinic to receive their prescription settings.
5.4.5. Materials of Use
There are no changes to the materials of use from the previous 510(k) submission (K181108). The Liberty Select Cycler enclosure consists of the following materials:
- Plastic housing ●
- 0 Aluminum heater tray
- Aluminum cassette housing
Key Performance Specifications/Characteristic 5.4.6.
The Liberty Select Cycler has the same essential performance characteristics as the predicate device (K181108) listed in Table 1.
| Feature | Specification |
|---|---|
| Inflow | 45-316 mL/min |
| Outflow | Minimum: 30 mL/min |
| 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 |
|---|---|
| ---------- | ------------------------------------------------------------- |
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. 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 downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font and is also blue.
Indications for Use 5.5.
The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.
Comparison of Technological Characteristics with the Predicate Device 5.6.
There are no changes in the technological characteristics of the previously cleared Liberty Select Cycler (K181108). The proposed modification to the Liberty Select Cycler pertains only to software.
The following technical specifications of the Liberty Select Cycler remain the same as those of the predicate device:
- Principle of operation
- Accessories
- Environmental requirements
- Transportation and storage specifications ●
- Hardware specifications ●
- o 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 8 876.5630). Performance testing to support the determination of substantial equivalence included testing in compliance with ANSI/AAMI/IEC 62304:2006/A1:2016 and ANSI/AAMI/IEC 62366-1:2015.
5.7.1. Software Verification and Validation Testing
Unit, software, regression (system verification), and validation testing were performed to demonstrate the effectiveness of the software modification and to confirm operation of the machine. Software verification information within this submission is provided in accordance with the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical 0 Devices (11 May 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Device ● (02 October 2014)
- . Design Considerations and Pre-Market Submission recommendations for Interoperable Medical Devices (06 September 2017)
5.7.2. Human Factors Validation Testing
The Liberty Select Cycler was validated for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (06 September 2018) for modifications due to Remote Programming features.
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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. 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 stacked on top of each other, pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
The remaining essential and critical user tasks were determined to be equivalent to the user tasks of the predicate device.
5.8. Conclusion
The information provided in this submission demonstrates the Liberty Select Cycler functions as intended and supports the determination of substantial equivalence to the predicate device, Liberty Select Cycler (K181108).
The Indications for Use, materials of construction, and technological characteristics of the modified Liberty Select Cycler are the same as those of the predicate device. Test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the modified Liberty Select Cycler is safe and effective for its intended use.