(108 days)
Not Found
No
The document describes a control unit for renal replacement and plasma exchange therapies, focusing on hardware, software validation, and compliance with medical device standards. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload, and Therapeutic Plasma Exchange (TPE) therapy, both of which are medical treatments for diseases where removal of plasma components or waste products is indicated. Its goals include removal of waste products, restoration of acid-base balance, correction of electrolyte imbalances, patient fluid balance, and nutritional support, all of which are therapeutic in nature.
No
The PrisMax control unit is intended for therapeutic treatments like Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE), which involve removing waste products or plasma components from the body. It does not mention any function for diagnosing diseases or conditions.
No
The device description explicitly states that the PrisMax System consists of the PrisMax Control Unit System, Blood Tubing Sets and Accessories, including an accessory for blood warming and a blood tubing set. This indicates the presence of hardware components beyond just software.
Based on the provided information, the PrisMax control unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes therapies performed directly on the patient's blood (Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange) to treat conditions like acute renal failure and fluid overload. This involves processing blood outside the body but for therapeutic purposes, not for diagnostic testing of samples.
- Device Description: The description details a system for performing blood filtration and exchange therapies. It mentions blood tubing sets and accessories for blood warming and plasma exchange. These are components used in a therapeutic process, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The PrisMax system's function is therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
The PrisMax control unit is intended for:
· Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the PrisMax control unit must be prescribed by a physician.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. Reference the PrisMax control unit in Figure 1.
The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodiafiltration (CVVHDF).
The proposed device PrisMax, which is the subject of this Traditional premarket notification (510(k)), consists of the PrisMax Control Unit System, Blood Tubing Sets and Accessories. Specific to this submission, is the accessory for blood warming and a blood tubing set for Therapeutic Plasma Exchange (TPE2000). The proposed device PrisMax uses the current marketed device PrisMax and Prismaflex as the predicates. Both devices have been cleared within the last two years. Prismaflex has been cleared for use with the TPE2000 since 2011 and both PrisMax and Prismaflex have previous clearances for blood warming accessories.
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
Not Found
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 was conducted on the PrisMax System to evaluate the functional performance of the system. The performance testing confirms PrisMax remains as safe and effective as the predicates and is substantially equivalent. Below are high level summary of tests used to demonstrate substantial equivalence along with FDA guidance's and FDA recognized consensus standards.
In summary, the PrisMax Control Unit has successfully implemented performance requirements and subsequent outputs verifying and validating:
. The PrisMax design validation meets the user needs and intended use and is substantially equivalent to the predicate.
. The device complies with IEC60601-2-16 Hemodialysis Equipment. Testing was confirmed by UL, the recognized test laboratory as part of the testing to 60601-1 Edition3.1. The testing specifically confirms the device meets the requirements for Essential Performance according to the particular standard.
. Electrical safety testing according to the most recent IEC60601-1 Edition 3.1 standard. The standard includes reports for software, alarms, usability, safety and performance.
. Electromagnetic compatibility (EMC) testing according to the most recent IEC60601-1-2 Edition 4 standard.
. Biocompatibility testing according to the most recent ISO109993-1:2009 FDA recognized consensus standards including a full battery of tests.
. Software Verification and Validation testing were conducted and documentation was provided as recommended by FDA's guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". The software for this device was considered as a "major" level of concern.
. Risk Assessment and risk control measures. A therapy level, product level and process level hazard analysis confirms the device doesn't perform in an unexpected or unsafe manor.
. Labeling, Software including cybersecurity, Human Factors, have been successfully implemented in accordance with FDA Guidance's.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 876.5860 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".
July 25, 2019
Baxter Healthcare Corp Gambro UF Solutions, Inc. Chris Scavotto Senior Manager Regulatory Affairs 7601 Northland Drive Suite 170 Brooklyn Park, MN 55428
Re: K190910
Trade/Device Name: PrisMax System Version 2 Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: June 27, 2019 Received: June 28, 2019
Dear Chris Scavotto:
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,
Carolyn Y. Neuland, Ph.D. Assistant Division 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
2
Indications for Use
510(k) Number (if known) K190910
Device Name PrisMax System Version 2
Indications for Use (Describe)
The PrisMax control unit is intended for:
· Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
• Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the PrisMax control unit must be prescribed by a 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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Section 5. 510(k) Summary
April 5th, 2019
SUBMITTER / OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Chris Scavotto Senior Regulatory Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: 763-463-4621 Fax: 763-463-4606
IDENTIFICATION OF THE DEVICE:
Common Name: Hemodialysis Delivery System Trade Name or Proprietary Name: PrisMax System Version 2 Classification Panel: 78 Gastroenterology and Urology Classification: High Permeability Hemodialysis System (876.5860) Class: Class II Product Code: 78KDI
| Code Number | Name |
|---|---|
| 955626 | PrisMax control unit |
| 955515 | PrisMax Accessory, TherMax Blood Warmer Unit |
| 955516 | PrisMax Accessory, TherMax Blood Warmer Disposable |
Table 1. Product Code(s) for PrisMax System
PREDICATE DEVICE:
Table 2. Predicate Device(s)
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Prismaflex 8.10 | Baxter Healthcare, | K171671 | February 2018 |
4
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Gambro Lundia AB | |||
| PrisMax 1.06 | Baxter Healthcare, | ||
| Gambro UF Solutions | K163530 | May 2016 |
Table 2. Predicate Device(s)
DEVICE DESCRIPTION:
The PrisMax System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload. Reference the PrisMax control unit in Figure 1.
The goals of acute renal failure treatments are removal of waste products, restoration of acid-base balance; correction of electrolyte imbalances (e.g., hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. PrisMax System offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous VenoVenous Hemodialysis (CVVHD), and Continuous Venovenous Hemodialfiltration (CVVHDF).
Image /page/4/Figure/7 description: This image is a figure that is labeled as "Figure 1. PrisMax control unit". The figure is showing the PrisMax control unit. The text is in bold font.
Image /page/4/Picture/8 description: The image shows a medical device with a screen on top. The device has various tubes, containers, and controls on its front panel. Below the device are several bags, possibly for collecting fluids. The device appears to be a sophisticated piece of medical equipment, likely used in a hospital or clinical setting.
5
The proposed device PrisMax, which is the subject of this Traditional premarket notification (510(k)), consists of the PrisMax Control Unit System, Blood Tubing Sets and Accessories. Specific to this submission, is the accessory for blood warming and a blood tubing set for Therapeutic Plasma Exchange (TPE2000). The proposed device PrisMax uses the current marketed device PrisMax and Prismaflex as the predicates. Both devices have been cleared within the last two years. Prismaflex has been cleared for use with the TPE2000 since 2011 and both PrisMax and Prismaflex have previous clearances for blood warming accessories.
INDICATIONS FOR USE:
The PrisMax control unit is intended for:
- Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
- Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the PrisMax control unit must be prescribed by a physician.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Substantial Equivalence Summary
The differences between the PrisMax System Version 2 and its predicate device do not introduce new questions of safety and effectiveness. All modifications have been verified and validated per Design Controls Activities. As shown through successful verification and validation testing, the PrisMax Control Unit System is considered substantially equivalent to its predicates. Reference Table 3.
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| Features | SE | Proposed KxxXXXX
PrisMax Version 2 | K163530
PrisMax Version 1 | K171671
Prismaflex sw8.10 |
|------------------------------------------------------|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | SE | The PrisMax control unit
is intended for: | The PrisMax control unit
is intended for: | The Prismaflex control
unit is intended for: |
| | | ● Continuous Renal
Replacement
Therapy (CRRT)
for patients
weighing 20
kilograms or more
with acute renal
failure and/or fluid
overload. | ● Continuous Renal
Replacement
Therapy (CRRT)
for patients
weighing 20
kilograms or more
with acute renal
failure and/or fluid
overload. | ● Continuous Renal
Replacement
Therapy (CRRT)
for patients
weighing 20
kilograms or more
with acute renal
failure and/or fluid
overload. |
| | | ● Therapeutic
Plasma Exchange
(TPE) therapy for
patients weighing
20 kilograms or
more with diseases
where removal of
plasma
components is
indicated. | | ● Therapeutic
Plasma Exchange
(TPE) therapy for
patients weighing
20 kilograms or
more with diseases
where removal of
plasma
components is
indicated. |
| | | All treatments
administered via the
Prismaflex control unit
must be prescribed by a
physician. | All treatments
administered via the
Prismaflex control unit
must be prescribed by a
physician. | All treatments
administered via the
Prismaflex control unit
must be prescribed by a
physician. |
| Dedicated
Disposable Sets
Available in
U.S. | | For CRRT:
M60/M100/M150
HF1000 & HF1400 | For CRRT:
M60/M100/M150
HF1000 & HF1400 | For CRRT:
M60/M100/M150
HF1000 & HF1400 |
| | | For TPE:
TPE 2000 Set | TPE not in scope for this
Version. | For TPE:
TPE 2000 Set |
| Syringe Sizes | | 20 & 50 ml | 20 & 50 ml | 20,30 & 50 ml |
| Anticoagulation | | User-controllable as
continuous or bolus | User-controllable as
continuous or bolus | User-controllable as
continuous or bolus |
| Dialysate Flow
Rate | SE | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 10 ml/hr | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 10 ml/hr | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr |
| Dialysate Flow
Rate Accuracy | SE | ± 30 ml/hr | ± 30 ml/hr | ± 30 ml/hr |
| Table 3. Substantial Equivalence Table Device Comparison | ||||
|---|---|---|---|---|
| Features | SE | Proposed Kxxxxxx | ||
| PrisMax Version 2 | K163530 | |||
| PrisMax Version 1 | K171671 | |||
| Prismaflex sw8.10 | ||||
| Replacement | ||||
| solution / Fluid | ||||
| Flow Rate | SE | CVVH & CVVHDF: | ||
| Range: 0 to 8000 ml/hr | ||||
| Increment: 10 ml/hr |
TPE:
Range: 0 to 5000 ml/hr
Increment: 10 ml/hr | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 10 ml/hr
TPE not in scope for this
Version. | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr
TPE:
Range: 0 to 5000 ml/hr
Increment: 10 ml/hr |
| Replacement
Flow Rate
Accuracy | SE | ± 30 ml/hr | ± 30 ml/hr | ± 30 ml/hr |
| Blood Flow
Rate | SE | Range: 10-450 ml/min | Range: 10-450 ml/min | Range: 10-450 ml/min |
| Blood Flow
Rate Accuracy | SE | ±10 % of user set rate at
nominal blood flow of
450 ml/min or the highest
achievable disposable
blood flow, having 37 °C,
at an access pressure of -
200 mmHg and without
any PBP flow | ±10 % of user set rate at
nominal blood flow of
450 ml/min or the highest
achievable disposable
blood flow, having 37 °C,
at an access pressure of -
200 mmHg and without
any PBP flow | ±10 % of user set rate at
nominal blood flow of
450 ml/min or the highest
achievable disposable
blood flow at 37 °C, at an
access pressure of -200
mmHg and without any
PBP flow |
| Pre-Blood
Pump Flow
Rate | SE | SCUF:
Range: 0 to 2000 ml/hr
CVVH, CVVHD,
CVVHDF:
Range: 0 to 4000 ml/hr
TPE Range
Range: 0 to 1000 ml/hr
Note: PBP Volume is
2000 ml/treatment for
ΤΡΕ2000 | SCUF:
Range: 0 to 2000 ml/hr
CVVH, CVVHD,
CVVHDF:
Range: 0 to 4000 ml/hr
TPE not in scope for
PrisMax V1. | CRRT Range
Range: 0 to 4000 ml/hr
TPE Range
Range: 0 to 1000 ml/hr
Note: PBP Volume is
2000 ml/treatment for
ΤΡΕ2000 |
| Pre-Blood
Pump Accuracy | SE | ± 30 ml/hr | ± 30 ml/hr | ± 30 ml/hr |
| Effluent Pump
Flow Rate | SE | Range: 0 to 10,000 ml/h
Depending on the therapy
selected. | Range: 0 to 10,000 ml/h
Depending on the therapy
selected. | Range: 0 to 10,000 ml/h
Depending on the therapy
selected. |
| ECG
Discharger | SE | YES | YES | YES |
| | | Proposed Kxxxxxx | K163530 | K171671 |
| Features | SE | PrisMax Version 2 | PrisMax Version 1 | Prismaflex sw8.10 |
| Therapies | SE | SCUF
CVVH
CVVHD
CVVHDF
TPE | SCUF
CVVH
CVVHD
CVVHDF
TPE not in scope for
PrisMax V1. | SCUF
CVVH
CVVHD
CVVHDF
TPE |
| Pumps | SE | PBP solution
Replacement solution
Dialysate solution
Effluent
Blood | PBP solution
Replacement solution
Dialysate solution
Effluent
Blood | PBP solution
Replacement solution
Dialysate solution
Effluent
Blood |
| Scales | SE | Dialysate
Replacement
Effluent
Pre Blood Pump (PBP) | Dialysate
Replacement
Effluent
Pre Blood Pump (PBP) | Dialysate
Replacement
Effluent
Pre Blood Pump (PBP) |
| Trans
Membrane
Pressure TMP
Alarms
(CRRT)
TMPa (TPE) | SE | CRRT TMP:
Default: +300 mmHg
TMPa:
User settable: +50 to
+100 mmHg
Default: +100 mmHg | CRRT TMP:
Default: +300 mmHg | TMP:
User settable: +70 to
+350 mmHg
Default: +350 mmHg
TMPa:
User settable: +50 to
+100 mmHg
Default: +100 mmHg |
| Dialysate
Conductivity
and
Temperature | SE | Dialysate Conductivity
and Temperature are not
controlled by PrisMax | Dialysate Conductivity
and Temperature are not
controlled by PrisMax | Dialysate Conductivity
and Temperature are not
controlled by Prismaflex |
| Patient Fluid
Removal
Performance
(Range)
[C] | SE | CRRT: 0 to 2000 ml/hr
Increment: 5 ml/hr
TPE: 0 to 1000 ml/hr
Increment: 5 ml/hr | CRRT: 0 to 2000 ml/hr
Increment: 5 ml/hr
TPE not in scope for
PrisMax V1. | CRRT: 0 to 2000 ml/hr
Increment: 10 ml/hr
TPE: 0 to 1000 ml/hr
Increment: 10 ml/hr |
| | | Proposed KxXXXXX | K163530 | K171671 |
| Features | SE | PrisMax Version 2 | PrisMax Version 1 | Prismaflex sw8.10 |
| Patient Fluid
Removal
Performance
(Accuracy) | SE | ± 30 ml/hr | ± 30 ml/hr | ± 30 ml/hr |
| | SE | ± 70 ml/3hr | ± 70 ml/3hr | ± 70 ml/3hr |
| | SE | ± 300 ml/24hr | ± 300 ml/24hr | ± 300 ml/24hr |
| | SE | Scales calibrated at
ambient temperature at
which they will be used.
Ambient temperature
change less than ±3 °C
(5.4 °F) during treatment. | Scales calibrated at
ambient temperature at
which they will be used.
Ambient temperature
change less than ±3 °C
(5.4 °F) during treatment. | Scales calibrated at
ambient temperature at
which they will be used.
Ambient temperature
change less than ±3 °C
(5.4 °F) during treatment. |
| Access
Pressure Sensor | SE | Range: -250 to +450
mmHg | Range: -250 to +450
mmHg | Range: -250 to +450
mmHg |
| | | Accuracy: ±15 mmHg | Accuracy: ±15 mmHg | Accuracy: ±15 mmHg |
| Return Pressure
Sensor | SE | Range: -50 to +350
mmHg | Range: -50 to +350
mmHg | Range: -50 to +350
mmHg |
| | | Accuracy: ±5 mmHg | Accuracy: ±5 mmHg | Accuracy: ±5 mmHg |
| Filter Pressure
Sensor | SE | Range: -50 to +450
mmHg | Range: -50 to +450
mmHg | Range: -50 to +450
mmHg |
| | | Accuracy: ±15 mmHg | Accuracy: ±15 mmHg | Accuracy: ±10% of
reading or ±8mmHg |
| Effluent
Pressure Sensor | SE | Range:
-350 to +400 mmHg
(CRRT)
-350 to +400 mmHg
(TPE) | Range:
-350 to +400 mmHg
(CRRT)
NA. TPE not in scope.
Accuracy: | Range:
-350 to +400 mmHg
(CRRT)
-350 to +400 mmHg
(TPE) |
| | | Accuracy:
±15 mmHg | ±15 mmHg | Accuracy: |
| | | | | ±10% of reading or
±8mmHg |
| | | TPE Specific
Settings | SE | Patient Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 30% |
| TPE Specific
Settings [C, D] | SE | Total Replacement
Volume
Range: 0 to 10,000 ml
Increment: 1 ml
Default: 0 ml | TPE not in scope for
PrisMax V1. | Total Replacement
Volume
Range: 0 to 10,000 ml
Increment: 100 ml
Default: 3000 ml |
| TPE Specific
Settings [C] | SE | Patient Plasma Loss Rate
Range: 0, or 10 to 1000
ml/hr
Increment: 5 ml/hr
Default: 0 ml/hr | TPE not in scope for
PrisMax V1. | Patient Plasma Loss Rate
Range: 0, or 10 to 1000
ml/hr
Increment: 10 ml/hr
Default: 0 ml/hr |
| Features | SE | Proposed Kxxxxxxx
PrisMax Version 2 | K163530
PrisMax Version 1 | K171671
Prismaflex sw8.10 |
| TPE Specific
Settings [C] | SE | Replacement Container
Volume
Range: 0 to 5000 ml
Increment: 0.1 ml | TPE not in scope for
PrisMax V1. | Replacement Container
Volume
Range: 0 to 5000 ml
Increment: 10 ml |
| Control Unit
Software [A] | SE | PrisMax Version 2 | PrisMax Version 1 | Prismaflex sw8.10 |
| Blood Warmer
Accessory [B] | SE | Prismatherm Warmer
PrismaFlo Blood Warmer
Prismacomfort Blood
Warmer
TherMax Blood Warmer | Prismatherm Warmer
PrismaFlo Blood Warmer
Prismacomfort Blood
Warmer | Prismatherm Warmer
PrismaFlo Blood Warmer
Prismacomfort Blood
Warmer |
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Table 3. Substantial Equivalence Table Device Comparison
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Table 3. Substantial Equivalence Table Device Comparison
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Table 3. Substantial Equivalence Table Device Comparison
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TABLE 3: FOOT NOTES:
1. DISCUSSION OF WHY DIFFERENCES DON'T RAISE NEW QUESTIONS OF SAFETY AND EFFECTIVENESS
[A] Control Unit Software: Software Version 1 to Software Version 2.
The device software on the PrisMax has been implemented correctly. The software has been verified and validated subsequent to risk analysis. The verification and validation tests including Human Factors and Software Validation. The software does not raise questions of safety and effectiveness. PrisMax is considered substantially equivalent to the predicate devices.
[B] Blood Warmer Accessory: TherMax Blood Warmer Accessory.
- . Increase practitioners control of blood warming by integrating the blood warmer control into the PrisMax control unit. This allows the practitioner to increase usability and clearly understand the blood warmer status. Performance, safety and effectiveness attributes are united with the PrisMax control unit and displayed on the GUI. This includes visual and audible alarms as well as compliance to standards for 60601-1 Electrical Safety, 60601-1-8 Alarms and 60601-1-2 EMC.
The TherMax Blood Warming Accessory used only with the PrisMax control unit has been implemented correctly into the system. The software has been verified and validated independently as well as from a system point of view with PrisMax subsequent to risk analysis. The verification and validation tests including EMC, Electrical Safety, Human
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Factors. Software Validation and Performance Testing implemented on a system level with Prismax and independently. The integration of the TherMax does not raise questions of safety and effectiveness. PrisMax with TherMax is considered substantially equivalent to the predicate devices based on equivalent indications, compliance to standards as well as compliance to material standards.
[C] TPE Specific Settings: Updates to setting increments.
- . The setting range precision was increased while maintaining overall ranges. This allows the practitioner to select a more precise setting across the entire range more accurately and reduces limitation existing with larger increment. No impact to range.
The undated specification does not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of the PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.
[C, D] Total Replacement Volume: Update from [Range 0 to 10,000 ml, Increment: 100 ml, Default 3000 ml] to [Range 0 to 10,000 ml, Increment: 0.1 ml, Default 0 ml]
- . The setting range precision was increased while maintaining overall ranges. This allows the practitioner to select a more precise setting across the entire range more accurately and reduces limitation existing with larger increment.
- The default setting was set to 0 from 3000 to ensure the health practitioner is choosing the value vs the machine setting the default.
The updated specifications do not introduce new or increased risks to the system and does not introduce new questions of safety and effectiveness. Compliance of the PrisMax System to the updated specifications has been verified successfully. Successful validation has substantiated that the system does not raise new questions of safety and effectiveness.
2. SUBSTANTIAL EQUIVALENCE SUMMARY
The differences between the PrisMax System Version 2 and its predicate device do not introduce new questions of safety and effectiveness. All modifications have been verified and validated per Design Controls Activities. As shown through successful verification
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and validation testing, the PrisMax Control Unit System is considered substantially equivalent to its predicates.
3. SUBSTANTIAL EQUIVALENCE DECISION
Based on the the information provided in this premarket notification, Baxter Healthcare Corporation believes the proposed PrisMax is substantially equivalent, for purposes of section 510(k) of the Federal Food, Drug and Cosmetic Act only, to the predicate devices identified in this premarket notification.
4. MEANING OF SUBSTANTIAL EQUIVALENCE
The term "substantial equivalence" is only used herein in the premarket notification and supporting information to indicate substantial similarity to predicate products to refer to the standard by which the U.S. Food and Drug Administration reviews and clears certain devices through the 510(k) process pursuant to the Federal Food, Drug and Cosmetic Act. The term "equivalence," as used in this premarket submission, is not intended to relate to or suggest the use of the term "equivalence" or similar terminology in the context of any factual or legal determination in the patent law context.
PERFORMANCE DATA
DISCUSSION OF NONCLINICAL TESTS:
Performance testing was conducted on the PrisMax System to evaluate the functional performance of the system. The performance testing confirms PrisMax remains as safe and effective as the predicates and is substantially equivalent. Below are high level summary of tests used to demonstrate substantial equivalence along with FDA guidance's and FDA recognized consensus standards.
In summary, the PrisMax Control Unit has successfully implemented performance requirements and subsequent outputs verifying and validating:
- . The PrisMax design validation meets the user needs and intended use and is substantially equivalent to the predicate.
- . The device complies with IEC60601-2-16 Hemodialysis Equipment. Testing was confirmed by UL, the recognized test laboratory as part of the testing to 60601-1 Edition3.1. The testing specifically confirms the device meets the requirements for Essential Performance according to the particular standard.
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- . Electrical safety testing according to the most recent IEC60601-1 Edition 3.1 standard. The standard includes reports for software, alarms, usability, safety and performance.
- Electromagnetic compatibility (EMC) testing according to the most recent IEC60601-1-2 Edition 4 standard.
- . Biocompatibility testing according to the most recent ISO109993-1:2009 FDA recognized consensus standards including a full battery of tests.
- . Software Verification and Validation testing were conducted and documentation was provided as recommended by FDA's guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". The software for this device was considered as a "major" level of concern.
- Risk Assessment and risk control measures. A therapy level, product level and process level hazard analysis confirms the device doesn't perform in an unexpected or unsafe manor.
- . Labeling, Software including cybersecurity, Human Factors, have been successfully implemented in accordance with FDA Guidance's.
DISCUSSION OF CLINICAL TESTS:
There are no clinical tests submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence for the PrisMax device or its predicate.
CONCLUSIONS
Based on the the information provided in this premarket notification, Baxter Healthcare Corporation concludes and believes the proposed PrisMax is substantially equivalent, for purposes of section 510(k) of the Federal Food, Drug and Cosmetic Act only, to the predicate devices identified in this premarket notification. The device is as safe, as effective and performs as well as the legally marketed Predicate device.
The nonclinical data demonstrate that the PrisMax System Version 2 performs comparably to the predicate devices that is currently marketed for the same intended use.