(157 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on electromechanical and software control for a hemodialysis system.
Yes
The device is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. These are therapeutic interventions aimed at managing and treating a medical condition.
No
The device is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states it is comprised of an electromechanical control unit (NxStage Cycler) and a disposable extracorporeal blood and fluid management circuit (NxStage Cartridge), which are hardware components. While it includes "GuideMe Software," it is part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the treatment of renal failure and fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. These are therapeutic procedures performed directly on the patient's blood, not tests performed on samples outside the body to diagnose or monitor a condition.
- Device Description: The device is described as an electromechanical control unit and a disposable circuit that manages blood and fluid flow. This aligns with a system for performing dialysis, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample analysis, or the generation of diagnostic results from biological specimens.
In summary, the NxStage system is a therapeutic device used for dialysis, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The NxStage system is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
The system is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.
All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
Product codes
KDI
Device Description
The VersiHD with GuideMe Software is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge (disposable) extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler.
The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. It is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.
The VersiHD with GuideMe Software system is software driven, consisting of the cycler (machine) and a Cartridge (disposable). Depending on the use environment and materials used with the system, the VersiHD is able to perform a variety of renal therapy types as required by the health care provider including nocturnal and solo dialysis.
The VersiHD with GuideMe Software includes a cycler and disposable NxStage Cartridge.
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
Acute or chronic care facility, Dialysis center or Dialysis Clinic (health care facility), Home, and Community at Large (such as Travel Use (e.g. Hotel)). All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
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 Data:
Simulated Treatments (Intended Users, Uses and Use Environment): Simulated home hemodialysis treatments were performed in a simulated use environment (dialysis center/clinic or home setting).
Software V&V: Software requirements were verified according to pre-determined performance specifications.
System V&V: System requirements were verified according to pre-determined performance specifications.
Basic Safety and Essential Performance: Complies with IEC 60601-1 standards and IEC 60601-2-16.
Human Factors Validation Testing: The VersiHD with GuideMe Software was validated for safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016).
Electrical Safety and Electromagnetic Compatibility (EMC): Electromagnetic Compatibility testing was performed in accordance with IEC 60601-1-2:2014 (4th Edition).
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.
Animal Studies: N/A. No animal studies were conducted.
Clinical Studies: N/A. No clinical studies were conducted.
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
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
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August 11, 2023
NxStage Medical, Inc. Denise Oppermann VP Regulatory Affairs North America 350 Merrimack St. Lawrence, Massachusetts 01843
Re: K230632
Trade/Device Name: VersiHD with GuideMe software Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: July 14, 2023 Received: July 14, 2023
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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,
Anil K. Kochhar -S
Acting 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230632
Device Name VersiHD with GuideMe Software
Indications for Use (Describe)
The NxStage system is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
The system is also indicated for home hemodialysis. including home nocturnal hemodialysis and solo home hemodialysis during waking hours.
All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
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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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.
5.1. Submitter's Information
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 350 Merrimack St. |
| Lawrence, MA 01843 USA | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, VP Regulatory Affairs North |
| America | |
| Preparation Date: | March 2, 2023 |
5.2. Device Name
| Trade Name: | VersiHD with GuideMe Software |
|---|---|
| Common Name: | Dialyzer, High Permeability With Or Without Sealed |
| Dialysate System | |
| Regulation Name: | High permeability hemodialysis system |
| Regulatory Class: | Class II per 21 CFR § 876.5860 |
| Product Code: | KDI |
| Product Code Name: | Dialyzer, High Permeability With Or Without Sealed |
| Dialysate System |
FDA Review Panel: Gastroenterology/Urology
5.3. Legally Marketed Predicate Device
The legally marketed predicate device is the NxStage System One Plus cleared under K170469. This predicate has not been subject to a design-related recall.
Device Description 5.4.
The VersiHD with GuideMe Software is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge (disposable) extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler.
The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. It is also indicated for home
4
hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.
5.4.1. Device Identification
The Model Numbers for subject to this submission are listed in Table 1.
Table 1. VersiHD with GuideMe Software Model Numbers and Description
| Model Number | Description |
|---|---|
| NX1000-10-E | VersiHD with GuideMe software |
VersiHD units that get serviced will be assigned NX1000-10-F or NX1000-16-F when upgraded to include VersiHD with GuideMe Software.
5.4.2. Device Characteristics
The VersiHD with GuideMe Software system is software driven, consisting of the cycler (machine) and a Cartridge (disposable). Depending on the use environment and materials used with the system, the VersiHD is able to perform a variety of renal therapy types as required by the health care provider including nocturnal and solo dialysis.
5.4.3. Environment of Use
The intended environments are Dialysis center or Dialysis Clinic (health care facility), Home, and Community at Large (such as Travel Use (e.g. Hotel)).
Brief Written Description of the Device 5.4.4.
The VersiHD with GuideMe Software includes a cycler and disposable NxStage Cartridge. The system components are described in Table 2.
| Component | Description |
|---|---|
| Control Panel | All user inputs and informational readouts are |
| communicated via the control panel | |
| Pumps | The NxStage Cycler houses four peristaltic |
| pumps: the blood pump, ultrafiltration pump, waste | |
| fluid pump and therapy fluid pump | |
| Balance Chambers | Volumetric fluid management is controlled by the |
| balance chamber subsystem, which ensures that | |
| the volume of waste fluid removed from the patient | |
| is equivalent to the volume of sterile replacement | |
| fluid infused into the patient for hemofiltration; or | |
| ensures flow rate and volume control of dialysate | |
| in hemodialysis. | |
| Pressure Transducers | Electronic pressure transducers monitor the |
| pressures in the Cartridge blood and fluid | |
| pathways. | |
| Pinch Clamp Actuators | Solenoid and cam-driven pinch clamp actuators |
| control the flow of blood and fluids in the | |
| Cartridge. | |
| Air Detection Sensor | An ultrasonic air detector monitors for air in the |
| venous blood return line. | |
| Blood Leak Detector | An optical blood leak sensor monitors for blood in |
| the waste fluid pathway. | |
| Fluid Temperature | |
| Sensor | An additional, redundant safety feature which |
| monitors the dialysate fluid temperature. | |
| Software | There are two separate microprocessors: the |
| Control Processor and the Safety Processor. The | |
| two processors communicate with each other via | |
| the Serial Communications Interface. The Control | |
| Processor controls the functions of the Cycler. The | |
| Safety Processor monitors the Cycler, creates | |
| alarms, and alerts when necessary |
Table 2. VersiHD with GuideMe Software Components Description
5
The Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cycler performs the following functions:
- Loads and primes the NxStage Cartridge and filter .
- Performs pressure tests and alarms tests .
6
- Pumps blood from the patient, through the filter, and returns the filtered . blood to the patient.
- Controls net fluid removal from the patient (ultrafiltration) .
- Balances the removal of waste fluid with the infusion of sterile . replacement fluid (hemofiltration).
- o Balances and maintains the dialysate flow (hemodialysis)
- Monitors critical operating parameters relating to patient safety. It also . monitors treatment parameters and alerts the operator for possible intervention.
- Rinses back blood to the patient at the conclusion of treatment. .
Key Performance Specifications/Characteristic 5.4.5.
The VersiHD with GuideMe Software performance requirements are provided in Table 3.
| Feature | Specification |
|---|---|
| Technology / Components: | |
| Hemodialysis | Yes |
| Hemofiltration | Yes |
| Ultrafiltration | Yes |
| Pumps | 4 peristaltic pumps |
| Valves (clamps) | 2 solenoid actuated pinch clamps |
| 8 cam driven pinch clamps | |
| Air / fluid detectors | 3 ultrasonic air/ fluid detectors |
| Blood leak detector | 1 optical blood leak detector |
| Pressure transducers | 5 electronic pressure transducers |
| Flow Rates: |
Table 3. VersiHD with GuideMe Software performance requirements
7
| Feature | Specification |
|---|---|
| Blood | 10-600 ml/min |
| Prescription Fluid /Dialysate Flow | 0-18000 ml/hr |
| Ultrafiltration | 0-2400 ml/hr |
| Transmembrane Pressure Monitoring Specification | Yes |
| Venous Pressure Monitor | 0 to 400 mmHg |
| IV Prescription Fluid | Off-line, sterile- physician prescribed, indicated for infusion |
| Dialysate | Dialysate available as pre-packaged pre- mixed sterile fluids or via the PureFlow SL (K043436, K060296, K080919, K111174 & K140571) |
| Compatible Blood Tubing Set | NxStage Standard Cartridge |
| User Interface | Touch Screen |
| Alarms | 75 dB |
| Software | VersiHD with GuideMe Software version 2.0 |
5.5. Intended Use
The VersiHD with GuideMe software is intended for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and / or ultrafiltration, in an acute or chronic care facility. The system is also intended for hemodialysis with or without ultrafiltration in the home.
5.6. Indications for Use
The NxStage system is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.
8
The system is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.
All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the VersiHD with GuideMe Software remain unchanged when compared to the predicate device, NxStage System One Plus (K170469).
- . Intended Use
- Fundamental Scientific Technology/Operating Principle ●
- . Energy Source
- Materials
- Essential Performance Requirements .
The VersiHD with GuideMe Software is a software only modification to the current, in market, VersiHD cycler's graphical user interface (GUI) touch screen. The VersiHD with GuideMe Software is utilizing a new optional "Guide Me" feature in which step-by-step instructions are available for users if they press the "Guide Me" button on the updated user interface .
5.8. Performance Data
Testing conducted to support the determination of substantial equivalence is summarized in Table 4.
| Test Conducted | Test Method Description |
|---|---|
| Simulated Treatments | |
| (Intended Users, Uses | |
| and Use Environment) | Simulated home hemodialysis treatments were |
| performed in a simulated use environment (dialysis | |
| center/clinic or home setting). | |
| Software V&V | Software requirements were verified according to pre- |
| determined performance specifications. | |
| System V&V | System requirements were verified according to pre- |
| determined performance specifications. |
| Table 4. Performance Testing Summary |
|---|
9
| Test Conducted | Test Method Description |
|---|---|
| Basic Safety and | |
| Essential Performance | Complies with IEC 60601-1 standards and IEC |
| 60601-2-16 |
5.8.1. Human Factors Validation Testing
The VersiHD with GuideMe Software was validated for safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016).
5.8.2. Electrical Safety and Electromagnetic Compatibility (EMC)
Electromaqnetic Compatibility testing was performed in accordance with IEC 60601-1-2:2014 (4th Edition). Note: The IEC 60601-1-2:2007 (3rd Edition), Model NX1000-16-F and NX1000-10-F (4th edition), serviced cyclers will be upgraded with the VersiHD with GuideMe Software. Electromagnetic Compatibility information within this submission is provided in accordance with FDA quidance document Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (11 July 2016).
Software Verification and Validation Testing 5.8.3.
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:
- o Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (11 May 2005)
- Content of Premarket Submissions for Management of . Cybersecurity in Medical device (02 October 2014)
5.8.4. Animal Studies
N/A. No animal studies were conducted.
5.8.5. Clinical Studies
N/A. No clinical studies were conducted.
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5.9. Conclusion
The information provided in this submission demonstrates the VersiHD with GuideMe Software functions as intended and supports the determination of substantial equivalence to 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.
The Indications for Use, technological characteristics, design, and performance requirements of the VersiHD with GuideMe Software are substantially equivalent to those of the predicate device. NxStage Medical, Inc. concludes that within the meaning of the Medical Device Amendments Act of 1976, the VersiHD with GuideMe Software is safe and effective for the intended use.