(102 days)
No
The summary describes a software-controlled electro-mechanical device with programmed treatment settings and standard performance testing, with no mention of AI or ML terms or methodologies.
Yes
The device is indicated for "acute and chronic peritoneal dialysis" and "delivers Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD)," which are therapeutic interventions.
No.
The device description and intended use clearly state that the Liberty Select Cycler is used for peritoneal dialysis treatment, which is a therapeutic process for end-stage renal disease, not a diagnostic one.
No
The device description explicitly states that the Liberty Select Cycler is an "electro-mechanical medical device" and a "table-top unit," indicating it includes hardware components beyond just software. While software controls the functions, it is integrated into a physical machine.
Based on the provided information, the Fresenius Liberty Select Cycler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "acute and chronic peritoneal dialysis." This is a treatment for end-stage renal disease, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical and software functions related to delivering peritoneal dialysis therapy (fluid flow, heating, alarms). It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or screening.
The device is clearly described as a therapeutic device used to perform peritoneal dialysis, which is a treatment process.
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 the functions of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms.
The Liberty Select 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 Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription. The Liberty Select Cycler accommodates three (3) accessory devices:
- Cassette and tubing set
- IQdrive
- Optional wireless modem
The cassette and tubing set and the IQdrive are the same accessory devices described in K123630. The peripheral wireless modem has been updated to support AT&T and Verizon 3G/4G LTE networks.
Performance modifications were made to the device. Selectable drain exit criteria and additional STAT Drain options were added. Alarm modifications introduce Soft Alarms that provide the user with an opportunity to correct drain and fill complications before issuing an alarm. The labeling has been modified to align with the software modifications and with the secondary predicate Liberty PDx Cycler.
The Liberty Select Cycler enclosure consists of the following materials: - Plastic housing o
- o 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 designed as a table-top unit and 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 876.5630). Performance testing to support the determination of substantial equivalence included testing in compliance with ANSI/AAMI/IEC 62304:2006 and ANSI/AAMI/IEC 62366-1:2015.
- Software Verification and Validation Testing: Unit, integration and system level software verification testing was performed to demonstrate the effectiveness of the software modifications and to confirm operation of the machine.
- Mechanical and Acoustic Testing: Mechanical testing was conducted to verify that the Liberty Select Cycler noise level does not exceed 40 dBA while performing a treatment.
- Human Factors Testing: Testing was performed on the modifications found to impact Human Factors:
- Add selectable drain exit criteria (70% or 85%)
- Add selectable additional drain option with option for additional drain alert
- Add STAT drain at the end of the treatment
- Implement soft alarms
The remaining essential and critical user tasks were determined to be equivalent to the user tasks of the predicate devices.
FMCRTG concludes that the four (4) new features tested on the Liberty Select Cycler (software version 2.8.7) are safe and effective for the intended users, uses, and use environments.
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
Fresenius Medical Care Renal Therapies Group. LLC Denise Oppermann Senior Director. Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K171652
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: June 2, 2017 Received: June 5, 2017
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 (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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
Indications for Use
510(k) Number (if known) Unknown K171652
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/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.
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 |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs – Devices | |
| Preparation Date: | 2 June 2017 |
5.2. Device Name
| Trade Name: | Fresenius Liberty Select Cycler |
|---|---|
| Common Name: | Peritoneal Dialysis Cycler |
| Classification Name : | System, Peritoneal, Automatic Delivery |
| Regulatory Class: | Class II per 21 CFR 876.5630 |
| Product Code: | FKX |
| Classification Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
Primary Predicate – Liberty Cycler (K123630) 5.3.1.
The Liberty Cycler, K123630, will serve as the primary predicate for the Liberty Select Cycler as described in the 8 September 2016 pre-submission (Q161532).
Secondary Predicate – Liberty PDx Cycler (K141145) 5.3.2.
The Liberty PDx Cycler will serve as the secondary predicate for the Liberty Select Cycler.
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Image /page/4/Picture/1 description: The image contains 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.
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 |
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 designed as a table-top unit and is prescribed for use in both professional and home treatment settings.
5.4.4. Brief Written Description of the Device
The Liberty Select 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 Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription. The Liberty Select Cycler accommodates three (3) accessory devices:
- Cassette and tubing set ●
- IQdrive
- Optional wireless modem ●
The cassette and tubing set and the IQdrive are the same accessory devices described in K123630. The peripheral wireless modem has been updated to support AT&T and Verizon 3G/4G LTE networks.
Performance modifications were made to the device. Selectable drain exit criteria and additional STAT Drain options were added. Alarm modifications introduce Soft Alarms that provide the user with an opportunity to correct drain and fill complications before issuing an alarm. The labeling has been modified to align with the software modifications and with the secondary predicate Liberty PDx Cycler.
5.4.5. Materials of Use
There are no changes to the materials of use from the previous 510(k) submission (K123630).
The Liberty Select Cycler enclosure consists of the following materials:
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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.
- Plastic housing o
- o 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 (K123630) as 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
Indications for Use 5.5.
The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.
5.6. Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the Liberty Select Cycler are equivalent to the predicate device. Although software modifications were made to improve the user experience, all other electrical components, mechanical components, pump module components, and safety components are identical to the predicate device.
The following technical specifications of the Liberty Select Cycler remain the same as those of the predicate device:
- Environmental requirements
- Accessories ●
- Transportation and storage specifications
- Hardware specifications
- Manufacturing location ●
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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 and is also blue.
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 and ANSI/AAMI/IEC 62366-1:2015.
5.7.1. Software Verification and Validation Testing
Unit, integration and system level software verification testing was performed to demonstrate the effectiveness of the software modifications and to confirm operation of the machine.
5.7.2. Mechanical and Acoustic Testing
Mechanical testing was conducted to verify that the Liberty Select Cycler noise level does not exceed 40 dBA while performing a treatment.
5.7.3. Human Factors Testing
Testing was performed on the modifications found to impact Human Factors:
- Add selectable drain exit criteria (70% or 85%) 0
- Add selectable additional drain option with option for additional drain alert ●
- Add STAT drain at the end of the treatment ●
- Implement soft alarms
The remaining essential and critical user tasks were determined to be equivalent to the user tasks of the predicate devices.
FMCRTG concludes that the four (4) new features tested on the Liberty Select Cycler (software version 2.8.7) are safe and effective for the intended users, uses, and use environments.
5.8. Conclusion
The indications for use, materials of construction, and technological characteristics of the Liberty Select Cycler are the same as the predicate devices. Differences between the Liberty Select Cycler and the predicates 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 proposed Liberty Select Cycler is substantially equivalent to the primary predicate device, Liberty Cycler (K123630).