(198 days)
No.
The device description and testing summaries do not mention any AI, DNN, or ML components. The device operates based on pre-programmed parameters from a physician's prescription and monitors physical parameters like volume and pressure, which does not inherently require an AI model.
Yes
The device is described as an "Automated Peritoneal Dialysis System" and is "intended for acute and chronic peritoneal dialysis," which is a medical treatment. It "uses a peristaltic pumping mechanism to infuse the dialysate... into the peritoneal cavity and drain it" to remove waste products from the patient, indicating a direct therapeutic action. The usage is "prescription-use-only" and therapies are "prescribed by a physician," further supporting its role as a therapeutic device.
No
Explanation: The device description states that the Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that infuses and drains dialysate. It is a treatment device, not a diagnostic one.
No
The device description explicitly mentions a "main control unit (Cycler)" and a "disposable tubing set," indicating physical hardware components beyond software. The performance testing also includes evaluation of mechanical aspects like pump mechanisms, fluid flow, structural integrity of the tubing set, and electrical safety/EMC testing of the physical unit.
No
The device performs automated peritoneal dialysis, which is a treatment modality, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
Product codes (comma separated list FDA assigned to the subject device)
FKX, KDJ
Device Description
The Byonyks X-1 APD Cycler System includes an Automated Peritoneal Dialysis Cycler and a disposable tubing set. The Byonyks X-1 APD Cycler is intended for acute and chronic peritoneal dialysis. Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that uses a peristaltic pumping mechanism to infuse the dialysate (Dialyzing Solution) into the peritoneal cavity and drain it after the dialysate has dwelled within a patient's peritoneal cavity for a specified amount of time. Byonyks X-1 APD Cycler is a prescription-use-only device and the therapies administered using Byonyks X-1 APD Cycler are prescribed by a physician. The device operates according to a therapy prescription provided by the patient's physician. The device is designed to be used in dialysis clinics, outpatient care areas, and home treatment settings with dialyzing solutions approved for peritoneal dialysis. Dialysate is infused into the patient's peritoneal cavity from a dialysate bag through a surgically implanted catheter which provides a fluid connection to the device's disposable tubing set. The dialysate remains in the peritoneal cavity for the dwell time which is a programmed length of time prescribed by the patient's physician. After the dwell time has elapsed, the fluid is drained from the patient using the device's peristaltic pumping system to extract the fluid from the patient's peritoneal cavity. Peristaltic pumping mechanism of the Byonyks X-1 APD cycler assist the dialysate flow at pre- programmed flowrate up to the volume prescribed by the patient's physicians, device continuously monitors volume of dialysate exchanges along with the fluid pressure external to the cassette of disposable set, fluid pressure detects resistance in dialysate exchanges at which pumping regulates the overall flow.
The Byonyks X-1 APD Cycler System consists of the (i) main control unit (Cycler) and the (ii) disposable set. The cumulative patient contact duration for Byonyks Automated PD Set DS-1 should not exceed 10 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribed by a physician. The device is designed to be used in dialysis clinics, outpatient care areas, 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)
Cycler Performance Testing Summary:
- User Interface Workflow: Confirmed transitions between screens and associated screen transition triggers in accordance with workflow, and range checking of data entry fields and displayed math.
- Functional: Verified functional specifications by tracing tagged requirements to test objectives, including code inspections, design inspections, unit-level/black-box testing, and formal functional testing.
- Alarms: Confirmed alarm conditions are raised when expected and alarm handling is performed per specification, separately evaluating accuracy of alarm conditions.
- Fault Insertion Testing: Tested hazard mitigations (sensors/software checks) by creating failure situations, ensuring Power on Self Tests detect failures and software exception handling is correct.
- Safety System: Verified system safety requirements including alarms, solution flow stoppage, and sensor functionality according to pre-determined performance specifications.
- EN60601 Safety Certification: Conducted testing in accordance with EN60601-2-39, including electrical safety, performance, IEC 60601-1 for product safety, and IEC 60601-1-1 for EMC/EMI. Confirmed cleaning validation using specified agents.
- Fill and Drain Volumetric Accuracy Testing: Conducted to confirm the device delivers specified volume in each mode and across the range of fill and drain volumes, and performs drain within specifications. Also ensured fluid flow rate accuracy.
- Reliability: Maximized simulated use to exercise each component (pump, doors, flow control mechanisms, heater, etc.) in an accelerated manner to meet overall life requirements. Reviewed manufacturer specifications for components with longer life expectancy.
- COTS and SOUP: Verified and validated Commercial Off-The-Shelf (COTS) and Software Of Unknown Provenance (SOUP) within the product. Performed full system regression tests for changes to ensure no impact on design structure or logic.
- Validation: Utilized Human Factors Simulations (Formative and Summative) to validate the product for safe and effective use. Formative evaluations were iterative learning tools to identify and mitigate use errors. Summative trials demonstrated safety and effectiveness.
- Test Execution & Reporting: Test results recorded per Good Documentation Practices. Test failures tracked to closure in Helix ALM.
- Re-Verification and Validation: Reviewed changes to unit under test for impact on prior testing and performed regression testing as required. Performed re-verification and validation for evolving integrated COTS and SOUP, and for changes after Verification and Validation testing per Design Controls.
Byonyks Automated PD Set DS-1 Performance Testing:
- Performance Test: Load to close the tubing clamp: Determined maximum load force (N) to close the clamp using a calibrated electromechanical force gauge.
- Occlusion test: Determined the ability of the patient, solution, and drain line clamps to occlude lines by subjecting to positive pressure of ~60 kPa and observing for air bubble leakage.
- Bond Strength: Performed a pull-off test for each bonded engagement using a calibrated electromechanical force gauge.
- Shipping Test: Conducted a simulated shipping and distribution test per ISTA-3A standard to ensure product's structural integrity during shipping.
- Heater Bag Seal: Determined the ability of the heater bag to withstand 1.5X labeled maximum positive and negative pressures under a constrained volume.
- Structural Integrity: Determined the ability of the disposable sets to withstand 1.5X labeled maximum positive and negative pressures.
Biocompatibility Testing:
- Conducted in accordance with ISO 10993-1:2018 and FDA guidance.
- Evaluated endpoints: toxicological risk assessment (chemical characterization), cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, hemocompatibility, acute systemic toxicity, sub-acute systemic toxicity, genotoxicity.
Human Factors Validation Testing:
- Validated for safe and effective use in accordance with FDA guidance.
Electrical Safety and Electromagnetic Compatibility (EMC):
- Electrical Safety: IEC 60601-1:2005.
- EMC: IEC 60601-1-2:2014, including 5G Ad hoc testing (Cellular 5G – Radiated Immunity & WPT (IEC 61000-4-3) - Additional FDA Considerations for 5G Spot Frequencies).
Software Verification and Validation Testing:
- Performed unit, software, regression (system verification), and validation testing.
- Conducted in accordance with ANSI/AAMI/IEC 62304:2006+AMD1:2015, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions [26 September 2023], and Post market Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff. (01 October 2018).
Animal Studies: No animal studies were conducted.
Clinical Studies: No clinical studies were conducted.
Key Results: The information provided, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility, and usability testing, demonstrates the Byonyks X-1 APD Cycler functions as intended and supports the determination of substantial equivalence to the predicate devices. 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.)
The volumetric accuracy of the Byonyks device is +/- 2% of the fill volume and +/- 3% of the drain volume.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
FDA 510(k) Clearance Letter - Byonyks X-1 APD Cycler
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 16, 2025
Byonyks Pvt Ltd
Eric Flachbart
Vice President, Regulatory Affairs
45/A XX Block Khayban-e-iqbal
Phase III DHA
Lahore, Punjab 54000
Pakistan
Re: K243371
Trade/Device Name: Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
Regulation Number: 21 CFR 876.5630
Regulation Name: Peritoneal Dialysis System And Accessories
Regulatory Class: Class II
Product Code: FKX, KDJ
Dated: October 30, 2024
Received: April 17, 2025
Dear Eric Flachbart:
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 (the 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 available 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.
Page 2
K243371 - Eric Flachbart
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243371 - Eric Flachbart
Page 3
assistance/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,
Maura Rooney -S
Maura Rooney
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 Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243371
Device Name
Byonyks X-1 APD Cycler;
Byonyks Automated PD Set DS-1
Indications for Use (Describe)
The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
K243371
BYONYKS PVT LTD
X-1 APD CYCLER
PAGE 1 OF 12
1. 510(K) SUMMARY
This 510(k) summary is provided in conformance with 21 CFR 807.92.
2. Applicant Information
| Field | Information |
|---|---|
| Name | Byonyks Pvt Ltd |
| Address | 45/A XX Block Khayban-e-iqbal Phase III DHA Lahore Punjab 54000 Pakistan |
| Contact Telephone | +18139973230 |
| Applicant Contact | Mr. Eric Flachbart |
| Applicant Contact Email | eric@byonyks.com |
| Preparation date | 11 May 2025 |
3. Device Name
| Field | Information |
|---|---|
| Trade Name | Byonyks X-1 APD Cycler. Byonyks Automated PD Set DS-1 |
| Common Name | Peritoneal dialysis cycler |
| Classification Name | Peritoneal dialysis system and accessories |
| Regulation Number | 876.5630 |
| Product Code(s) | FKX, KDJ |
4. Classification
| Field | Information |
|---|---|
| Medical Specialty | Gastroenterology & Urology |
| Regulation | 876.5630 - Peritoneal dialysis system and accessories |
| Product Code | FKX (Class 2) – System, Peritoneal, Automatic Delivery |
| Associated Product Code | KDJ |
5. Predicate Device
The legally marketed predicate device is the Fresenius Liberty Select Cycler cleared under K181108. The Fresenius Multiple Tubing Segment (MTS) Set with stay•safe® PIN Connectors (K173651) is a reference device with respect to bonding strength of the tubing connections.
Page 6
510(k) Summary
K243371
BYONYKS PVT LTD
X-1 APD CYCLER
PAGE 2 OF 12
6. Indications for Use
The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
7. Environment of Use
The Byonyks X-1 APD Cyler is prescribed for use in both professional healthcare Facility and Home Environment.
8. Device Description Summary:
The Byonyks X-1 APD Cycler System includes an Automated Peritoneal Dialysis Cycler and a disposable tubing set. The Byonyks X-1 APD Cycler is intended for acute and chronic peritoneal dialysis. Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that uses a peristaltic pumping mechanism to infuse the dialysate (Dialyzing Solution) into the peritoneal cavity and drain it after the dialysate has dwelled within a patient's peritoneal cavity for a specified amount of time. Byonyks X-1 APD Cycler is a prescription-use-only device and the therapies administered using Byonyks X-1 APD Cycler are prescribed by a physician. The device operates according to a therapy prescription provided by the patient's physician. The device is designed to be used in dialysis clinics, outpatient care areas, and home treatment settings with dialyzing solutions approved for peritoneal dialysis. Dialysate is infused into the patient's peritoneal cavity from a dialysate bag through a surgically implanted catheter which provides a fluid connection to the device's disposable tubing set. The dialysate remains in the peritoneal cavity for the dwell time which is a programmed length of time prescribed by the patient's physician. After the dwell time has elapsed, the fluid is drained from the patient using the device's peristaltic pumping system to extract the fluid from the patient's peritoneal cavity. Peristaltic pumping mechanism of the Byonyks X-1 APD cycler assist the dialysate flow at pre- programmed flowrate up to the volume prescribed by the patient's physicians, device continuously monitors volume of dialysate exchanges along with the fluid pressure external to the cassette of disposable set, fluid pressure detects resistance in dialysate exchanges at which pumping regulates the overall flow.
The Byonyks X-1 APD Cycler System consists of the (i) main control unit (Cycler) and the (ii) disposable set. The cumulative patient contact duration for Byonyks Automated PD Set DS-1 should not exceed 10 years.
Page 7
510(k) Summary
K243371
BYONYKS PVT LTD
X-1 APD CYCLER
PAGE 3 OF 12
9. Disposable Set Materials of Use:
| Component | Materials | Patient Contact |
|---|---|---|
| Cassette | Polycarbonate (PC) | Yes |
| Tubing and Connectors | Polyvinyl chloride (PVC) Acrylonitrile Butadiene Styrene (ABS) Polycarbonate (PC) | Yes |
| Heater Bag | Polyvinyl Chloride (PVC) | Yes |
| Clamps | Polyoxymethylene (POM) Polypropylene (PP) | No |
| Connector Caps | Polypropylene (PP) | No |
10. Sterility:
Just like the predicate, The Cycler is a non-sterile, multi-use device. The Disposable Set is provided sterile for single use.
10.1 Sterilization Testing (Disposable Sets)
The Disposable Sets are sterilized by exposure to ethylene oxide (EO). The sterility assurance level (SAL) is 10-6. Sterility and non-pyrogenicity are claimed for the fluid pathway of the disposable set.
10.2 EO Residual Testing
Residual testing for EO and ethylene chlorohydrin (ECh) was performed in accordance with AAMI/ANSI/ISO 10993-7:2008/(R) 2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Acceptable results (i.e., 30 days), Category C devices in accordance with FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (08 September 2023).
The following endpoints were evaluated to support the biological safety of the Byonyks Automated PD Set DS-1.
- Toxicological risk assessment following chemical characterization.
- Cytotoxicity
- Sensitization
- Irritation
- Material-Mediated Pyrogenicity
- Hemocompatibility
- Acute Systemic Toxicity
- Sub-Acute Systemic Toxicity
- Genotoxicity
13. Human Factors Validation Testing
The Byonyks X-1 APD Cycler was validated for safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
14. Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety testing was performed in accordance with IEC 60601-1:2005. Electromagnetic Compatibility testing was performed in accordance with IEC 60601-1-2:2014. 5G Ad hoc testing in accordance with Cellular 5G – Radiated Immunity & WPT (IEC 61000-4-3) - Additional FDA Considerations for 5G Spot Frequencies. Electromagnetic Compatibility information within this submission is provided in accordance with FDA guidance document Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (11 July 2016).
Page 14
510(k) Summary
K243371
BYONYKS PVT LTD
X-1 APD CYCLER
PAGE 10 OF 12
15. Software Verification and Validation Testing
Unit, software, regression (system verification), and validation testing were performed to demonstrate the effectiveness of the software and to confirm operation of the machine. Software verification information within this submission is provided in accordance with the following FDA guidance documents:
- ANSI/AAMI/IEC 62304:2006+AMD1:2015: Medical device software - Software life cycle processes
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions [26 September 2023]
- Post market Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff. (01 October 2018)
16. Animal Studies
No animal studies were conducted.
17. Clinical Studies
No clinical studies were conducted.
18. Intended use / Indications for Use: 21 CFR 807.92(a)(5)
The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
19. Indications for Use comparison: 21 CFR 807.92(a)(5)
The Indications for use for the Byonyks X-1 APD Cycler and the Fresenius Liberty Cycler are the same.
20. Technological Comparison: 21 CFR 807.92(a)(6)
The Byonyks X-1 APD Cycler and the Fresenius Liberty Cycler share the same intended use and are portable APD Cyclers intended for peritoneal dialysis therapy for renal patients.
The fundamental technology for pumping fluid in the Byonyks X-1 APD Cycler as well as the Fresenius Liberty Cycler is that a motor drives mechanical moving parts through a custom disposable set to move fluid to and from the patient's peritoneal cavity.
Page 15
510(k) Summary
K243371
BYONYKS PVT LTD
X-1 APD CYCLER
PAGE 11 OF 12
Each device uses a series of controllable valves to direct the flow of fluid to and from the patient. Both devices use pressure sensors to ensure the fluid pressure is within safe limits. Both devices provide warming of the fluid prior to delivery. Both devices utilize loadcells to measure the weight of fluid filled and drained from which volume and flowrate is calculated.
The volumetric accuracy of the Fresenius Liberty Cycler is +/- 2% of the fill volume and +/- 3% of the drain volume.
The volumetric accuracy of the Byonyks device is+/- 2% of the fill volume and+/- 3% of the drain volume.
Each device is powered via 100-240 VAC with an available internal lithium-ion battery pack for power interruptions, allowing patients to safely finish their therapy and the machine to save the parameters.
Each device has a color touchscreen LCD display for interfacing with users. Each device is controlled by an embedded microcomputer which controls the delivery of fluid and provides a means to program the device for a prescribed therapy.
The flow rate of both devices is pre-programmed with their respective pumping technology at a nominal rate to fill up to the prescription volume, in case during the flow any resistance in the fluid path is detected through the fluid pressure, this results in reduced or no flow. Pumping of the both devices are associated with the fluid pressure limits as it terminates completely if high pressure is measured and act as safety interlock which is a protective system requirement as part of its essential performance of APD Devices.
In reduced flow or no flow, each device allows for the extension of the estimated time to meet the prescription volume. Dialysate volume is the critical parameter in peritoneal dialysis and not flow rate.
The flow rate control does not affect the dialysate volume accuracy. Neither device changes the prescribed volume delivered to the patient.
Both devices continuously monitor the fluid pressure, fluid delivery to and from the patient temporarily stops if high pressure is measured, it resumes pumping fluid automatically as the pressure falls back into operating pressure ranges within the estimated exchange duration or otherwise alarms the patient to check fluid line resistance and then to resume treatment manually.
The fluid flow rate control algorithm is related with the continuous monitoring of fluid pressure and the principle of operation is similar in both devices regardless of different pumping technologies.
The Byonyks device utilizes a simple rotary peristaltic pump combined with a stepper motor driven valving system, the Fresenius Liberty Cycler uses two stepper motors driving mechanical plungers acting upon flexible fluid chambers in a cassette connected by check valves to move fluid. Basically, functioning as a diaphragm pump.
Rotary peristaltic pumps function by using rotating rollers to compress a flexible tube against a fixed casing or track. As the rollers rotate, they compress the tube or hose, creating a seal and moving
Page 16
510(k) Summary
K243371
BYONYKS PVT LTD
X-1 APD CYCLER
PAGE 12 OF 12
fluid through the pump. The pump's flow rate is controlled by adjusting the speed of the motor driving the rollers.
Diaphragm pumps function by using a flexible diaphragm to create suction and discharge pressure in a pumping chamber. As the diaphragm moves up, it creates a vacuum, which draws fluid into the chamber.
When the diaphragm moves down, it compresses the fluid, pushing it out of the chamber and through the discharge outlet. This process is repeated with each stroke of the diaphragm, resulting in a continuous flow of fluid.
Each of the above methods perform equivalently in terms of fluid flow and accuracy.
The safety mechanisms are similar for the two systems in that each device is equipped with an identical list of device safety alarms: over fluid pressure, over temperature and air-in-line, along with various warnings and alarms for machine-related issues such as low battery and proper placement of the disposable.
21. Non-Clinical and/or Clinical Tests Summary and conclusions 21 CFR 807.92(b)
The information provided in this submission, including design verification, risk management, electrical safety, electromagnetic compatibility (EMC), biocompatibility, and usability testing, demonstrates the Byonyks X-1 APD Cycler functions as intended and supports the determination of substantial equivalence to the predicate devices. 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.
The Indications for Use, technological characteristics, design, and performance requirements of the Byonyks X-1 APD Cycler are substantially equivalent to those of the predicate devices.