(87 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard medical device functionalities and regulatory compliance.
Yes
The device is described as performing therapies like Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) for various medical conditions.
No
The device description clearly states its purpose is for treatment (Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange), not diagnosis. It focuses on removing waste products, correcting imbalances, and managing fluid, which are therapeutic actions.
No
The device description explicitly refers to a "PrisMax control unit" and "PrisMax System," which are physical hardware components used for performing medical therapies like CRRT and TPE. The performance studies also mention testing related to electrical safety, EMC, and compliance with hardware standards (IEC60601-2-16, IEC60601-1, IEC60601-1-2), indicating it is not solely 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 a system for performing therapeutic procedures on patients (Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange). These are treatments performed directly on the patient's body, not tests performed on samples taken from the body.
- Device Description: The description details a system for filtering blood and plasma, which is a direct treatment modality. It doesn't mention analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Using reagents or assays
The PrisMax system is a therapeutic device used for treating patients with specific medical conditions.
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 System Version 3. The proposed device PrisMax System Version 3 uses the current marketed device PrisMax System Version 2 as the predicate. The device has been cleared within the last year.
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
patients weighing 20 kilograms or more
Intended User / Care Setting
All treatments administered via the PrisMax control unit must be prescribed by a 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 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 System 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.
- 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 13, 2020
Baxter Healthcare Corporation Christopher Scavotto Senior Manager, Global Regulatory Affairs 7601 Northland Drive Brooklyn Park, MN 55428
Re: K193482
Trade/Device Name: PrisMax System Version 3 Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: December 16, 2019 Received: December 17, 2019
Dear Christopher 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 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
PrisMax System Version 3
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
K193482 510(k) Summarv
December 16th, 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 3 Classification Panel: 78 Gastroenterology and Urology Classification: High Permeability Hemodialysis System (876.5860) Class: Class II Product Code: KDI
Table 1. Product Code(s) for PrisMax System
| Code Number | Name |
|---|---|
| 955724 | PrisMax System Version 3 |
PREDICATE DEVICE:
Table 2. Predicate Device(s)
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| PrisMax System Version 2 | Baxter Healthcare, | ||
| Gambro UF Solutions, Inc. | K190910 | July 2019 |
4
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/5 description: This image contains the text "Figure 1. PrisMax control unit". The text is written in a bold, sans-serif font. The text is likely a figure caption from a document or publication. The text indicates that the figure is related to a PrisMax control unit.
Image /page/4/Picture/6 description: The image shows a medical device, specifically a continuous renal replacement therapy (CRRT) machine. The machine has a screen at the top displaying various parameters and settings. Below the screen, there are several pumps, tubes, and filters, which are essential components for blood purification. At the bottom, there are bags for collecting waste fluids.
The proposed device PrisMax, which is the subject of this Traditional premarket notification (510(k)), consists of the PrisMax System Version 3. The proposed device PrisMax System Version 3 uses the current marketed device PrisMax System Version 2 as the predicate. The device has been cleared within the last year.
5
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 3 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.
| Features | SE | Proposed K19XXXX
PrisMax Version 3 | Proposed K190910
PrisMax Version 2 |
|---------------------|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | SE | 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 | 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 |
6
| Features | SE | Proposed K19XXXX
PrisMax Version 3 | Proposed K190910
PrisMax Version 2 |
|------------------------------------------------|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | plasma components is
indicated. | 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. |
| Dedicated Disposable
Sets Available in U.S. | SE | For CRRT:
M60/M100/M150
HF1000 & HF1400
For TPE:
TPE 2000 Set | For CRRT:
M60/M100/M150
HF1000 & HF1400
For TPE:
TPE 2000 Set |
| Syringe Sizes | SE | 20 & 50 ml | 20 & 50 ml |
| Anticoagulation | SE | 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 |
| Dialysate Flow Rate
Accuracy | SE | $\pm$ 30 ml/hr | $\pm$ 30 ml/hr |
| 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:
Range: 0 to 5000 ml/hr
Increment: 10 ml/hr |
| Replacement Flow Rate
Accuracy | SE | $\pm$ 30 ml/hr | $\pm$ 30 ml/hr |
| Blood Flow Rate | SE | Range: 10-450 ml/min | Range: 10-450 ml/min |
| Blood Flow Rate
Accuracy | SE | $\pm$ 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 | $\pm$ 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 |
| Pre-Blood Pump Flow
Rate | SE | SCUF:
Range: 0 to 2000 ml/hr | SCUF:
Range: 0 to 2000 ml/hr |
Table 3. Substantial Equivalence Table
7
| Features | SE | Proposed K19XXXX
PrisMax Version 3 | Proposed K190910
PrisMax Version 2 |
|------------------------------------------------------------------------------------------------------------------------------------------------|----|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 TPE2000 | SE | CVVH, CVVHD, CVVHDF:
Range: 0 to 4000 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 TPE2000 |
| Pre-Blood Pump
Accuracy | SE | $\pm$ 30 ml/hr | $\pm$ 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. |
| ECG Discharger | SE | YES | YES |
| Therapies | SE | SCUF
CVVH
CVVHD
CVVHDF
TPE | SCUF
CVVH
CVVHD
CVVHDF
TPE |
| Pumps | SE | 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) |
| Trans Membrane Pressure
TMP Alarms
(CRRT) | SE | CRRT TMP:
Default: +300 mmHg | CRRT TMP:
Default: +300 mmHg |
| TMPa (TPE) | SE | TMPa:
User settable; +50 to +100
mmHg
Default: +100 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 |
| Patient Fluid Removal | SE | CRRT: 0 to 2000 ml/hr | CRRT: 0 to 2000 ml/hr |
Table 3. Substantial Equivalence Table
8
| Features | SE | Proposed K19XXXX
PrisMax Version 3 | Proposed K190910
PrisMax Version 2 |
|-------------------------------------------------|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance (Range) | | Increment: 5 ml/hr | Increment: 5 ml/hr |
| | | TPE: 0 to 1000 ml/hr | TPE: 0 to 1000 ml/hr |
| | | Increment: 5 ml/hr | Increment: 5 ml/hr |
| | | ± 30 ml/hr | ± 30 ml/hr |
| | | ± 70 ml/3hr | ± 70 ml/3hr |
| | | ± 300 ml/24hr | ± 300 ml/24hr |
| Patient Fluid Removal
Performance (Accuracy) | 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. |
| Access Pressure Sensor | SE | Range: -250 to +450 mmHg
Accuracy: ±15 mmHg | Range: -250 to +450 mmHg
Accuracy: ±15 mmHg |
| Return Pressure Sensor | SE | Range: -50 to +350 mmHg
Accuracy: ±5 mmHg | Range: -50 to +350 mmHg
Accuracy: ±5 mmHg |
| | SE | Range: -50 to +450 mmHg | Range: -50 to +450 mmHg |
| Filter Pressure Sensor | | Accuracy: ±15 mmHg | Accuracy: ±15 mmHg |
| Effluent Pressure Sensor | SE | Range:
-350 to +400 mmHg (CRRT)
-350 to +400 mmHg (TPE)
Accuracy:
±15 mmHg | Range:
-350 to +400 mmHg (CRRT)
-350 to +400 mmHg (TPE)
Accuracy:
±15 mmHg |
| TPE Specific Settings | SE | Patient Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 30% | Patient Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 30% |
| TPE Specific Settings | SE | Total Replacement Volume
Range: 0 to 10,000 ml
Increment: 1 ml
Default: 0 ml | Total Replacement Volume
Range: 0 to 10,000 ml
Increment: 1 ml
Default: 0 ml |
| TPE Specific Settings | SE | Patient Plasma Loss Rate
Range: 0. or 10 to 1000 ml/hr
Increment: 5 ml/hr
Default: 0 ml/hr | Patient Plasma Loss Rate
Range: 0, or 10 to 1000 ml/hr
Increment: 5 ml/hr
Default: 0 ml/hr |
| TPE Specific Settings | SE | Replacement Container
Volume
Range: 0 to 5000 ml
Increment: 0.1 ml | Replacement Container
Volume
Range: 0 to 5000 ml
Increment: 0.1 ml |
| Control Unit Software [A] | SE | PrisMax Version 3 | PrisMax Version 2 |
| Blood Warmer Accessory | SE | Prismatherm Warmer | Prismatherm Warmer |
Table 3. Substantial Equivalence Table
9
| Features | SE | Proposed K19XXXX
PrisMax Version 3 | Proposed K190910
PrisMax Version 2 |
|----------|----|---------------------------------------|---------------------------------------|
| | | PrismaFlo Blood Warmer | PrismaFlo Blood Warmer |
| | | Prismacomfort Blood
Warmer | Prismacomfort Blood
Warmer |
| | | TherMax Blood Warmer | TherMax Blood Warmer |
Table 3. Substantial Equivalence Table
TABLE 3: FOOT NOTES:
1. DISCUSSION OF WHY DIFFERENCES DON'T RAISE NEW QUESTIONS OF SAFETY AND EFFECTIVENESS
[A] Control Unit Software: Software Version 3 from 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 device.
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 3 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 System Version 3 is considered substantially equivalent to its predicate.
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.
10
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 System 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.
- . 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.
11
- 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 3 performs comparably to the predicate devices that is currently marketed for the same intended use.