(262 days)
Not Found
No
The description focuses on automated control and monitoring functions, which are typical of software-controlled medical devices but do not explicitly mention or imply the use of AI or ML for decision-making, pattern recognition, or adaptive learning. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is described as performing therapies such as Continuous Renal Replacement Therapy (CRT) and Therapeutic Plasma Exchange (TPE) to treat specific medical conditions, which inherently defines it as a therapeutic device.
No
The device description indicates that the Prismaflex control unit is used for therapies involving blood and fluid management, such as Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange. It performs functions like pumping blood, delivering solutions, and controlling fluid removal, rather than diagnosing conditions.
No
The device description explicitly states it is a "software controlled device" that performs physical functions like pumping blood, delivering solutions, and controlling fluid removal, indicating it includes hardware components beyond just software.
Based on the provided information, the Prismaflex control unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for treating patients through therapies like Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE). These are direct patient treatments, not tests performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device description details functions related to managing blood flow, delivering solutions, controlling fluid removal, and monitoring the system during treatment. These are all actions performed on or in relation to the patient's blood and body fluids during therapy, not on samples outside the body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Prismaflex control unit's function is to perform therapeutic procedures directly on the patient.
N/A
Intended Use / Indications for Use
The Prismaflex control unit is intended for:
· Continuous Renal Replacement Therapy (CRT) 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 Prismaflex control unit must be prescribed by a physician.
Product codes
KDI
Device Description
The Prismaflex control unit is a software controlled device that performs the following functions:
Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
· Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
· Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
· Provides treatment data to an external Patient Data Management Systems (PDMS)
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
The Prismaflex control unit is intended for:
· Continuous Renal Replacement Therapy (CRT) 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.
Intended User / Care Setting
All treatments administered via the Prismaflex 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
Testing was performed for the Prismaflex System 8.10, in order to determine substantial equivalence with predicate devices included:
Software and system verification and validation including functional, performance and safety requirements; see section 16 for a summary and referenced reports
Compliance has been demonstrated to the following international standards;
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-8: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-2-16: Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 62304: Medical device software - Software life cycle processes
IEC 62366: Medical devices -- Application of usability engineering to medical devices
Key Metrics
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
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 Department of Health and Human Services seal 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, "U.S. Food & Drug Administration," written out to the right of it.
February 23, 2018
Baxter Healthcare Corporation Rick Lukacovic Manager, Regulatory Affairs 32650 North Wilson Road Round Lake, IL 60073
Re: K171671
Trade/Device Name: Prismaflex System 8.10 Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: January 23, 2018 Received: January 26, 2018
Dear Rick Lukacovic:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be the primary focus of the image. The background is plain and does not distract from the text.
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
Prismaflex System 8.10
Indications for Use (Describe)
The Prismaflex control unit is intended for:
· Continuous Renal Replacement Therapy (CRT) 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 Prismaflex 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Section 5. 510(k) Summary
1. SUBMITTER'S NAME:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
Establishment Registration #: 1416980
2. CONTACT PERSON:
Richard Lukacovic Regulatory Affairs Manager Baxter Healthcare Corporation Telephone: 224 270 2476 Fax: 224 270 4119 fax Email Rick Lukacovic(@Baxter.com
Alternately, please contact: Tito Aldape Director, Global Regulatory Affairs Baxter Healthcare Corporation 32650 N. Wilson Road Round Lake, IL 60073 Telephone 224-270-4867 Fax: 224 270 4119 Email: fortunato aldape@baxter.com
3. IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Prismaflex System 8.10 Classification Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system. Regulatory Class: II Product Code: KDI
4
This submission for Prismaflex System 8.10 is a change to the Prismaflex Control Unit which has been updated to Software Version 8.10 and has undergone hardware and labeling changes. None of these changes affect the performance parameters discussed in Table 2 Substantial Equivilence Table.
4. PREDICATE DEVICE:
| Device | Predicate 510(k) | Clearance Date |
|---|---|---|
| Prismaflex System 7.10 | K131516 | January 3, 2014 |
5. DESCRIPTION OF THE DEVICE:
Image /page/4/Picture/6 description: The image shows a medical device on a stand with wheels. The device has a screen at the top and several buttons and dials on the front. The stand is made of metal and has a green base with four wheels. The device is likely used for medical treatments or procedures.
The Prismaflex control unit is a software controlled device that performs the following functions:
Loads and primes the Prismaflex disposable set automatically.
• Pumps blood through the blood flow path of the Prismaflex disposable set.
· Delivers anticoagulant solution into the blood flow path.
• Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
· Controls the patient fluid removal or plasma loss according to the therapy in use.
• Monitors the system and alerts the operator to abnormal situations through alarms.
· Provides treatment data to an external Patient Data Management Systems (PDMS)
Physical characteristics of Prismaflex Control Unit
5
| Weight | Approximately 78 kg (172 lb) (without fluid bags and Prismaflex disposable set) |
|---|---|
| Height | Approximately 163 cm (64 in) |
| Width | Approximately 49 cm (19 in) |
| Base | Approximately 70 cm x 70 cm (28 in x 28 in) |
Table 1. Physical Characteristics
5.1 INDICATIONS FOR USE:
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.
- 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.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
In Table 2 the Prismaflex System 8.10 is compared with the predicate Prismaflex System 7.10
6
| | Predicate
Prismaflex System 7.10
K131516 | Device
Prismaflex System 8.10 | Difference |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Devices | The Prismaflex control unit is
intended for: | The Prismaflex control unit is
intended for: | same |
| Indication for
Use | 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
Prismaflex control unit must be
prescribed by a physician. | 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
Prismaflex control unit must be
prescribed by a physician. | same |
| | Dedicated
Disposable Sets
Available in
U.S. | 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 | | 20, 30 & 50 ml | 20, 30 & 50 ml |
| Anticoagulation | User-controllable as continuous or
bolus | User-controllable as continuous or
bolus | same |
| Dialysate Flow
Rate | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr | same |
| Dialysate Flow
Rate
Accuracy | ± 30 ml/hr | ± 30 ml/hr | same |
| Devices | Predicate
Prismaflex System 7.10
K131516 | Device
Prismaflex System 8.10 | Difference |
| Replacement
solution / Fluid
Flow Rate | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr
TPE:
Range: 0 to 5000 ml/hr
Increment: 10 ml/hr | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr
TPE:
Range: 0 to 5000 ml/hr
Increment: 10 ml/hr | same |
| Replacement
Flow Rate
Accuracy | ± 30 ml/hr | ± 30 ml/hr | same |
| Blood Flow
Rate | Range: 10-450 ml/min. | Range: 10-450 ml/min. | same |
| Blood Flow
Rate Accuracy | ±10% of user set rate at nominal
blood flow of 450 ml/min or the
highest achievable disposable bloodflow at 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. | same |
| Pre-Blood
Pump Flow
Rate | CRRT Range
Range: 0 to 4000 ml/hr
TPE Range
Range: 0 to 1000 ml/hr
Note: Total PBP Volume is
2000 ml/treatment for TPE | CRRT Range
Range: 0 to 4000 ml/hr
TPE Range
Range: 0 to 1000 ml/hr
Note: Total PBP Volume is
2000 ml/treatment for TPE | same |
| Pre-Blood
Pump Accuracy | ± 30 ml/hr | ± 30 ml/hr | same |
| Effluent Pump
Flow Rate | 0 to 10000 ml/hr depending on the
therapy | 0 to 10000 ml/hr depending on the
therapy | same |
| ECG
Discharger | YES | YES | same |
| Devices | Predicate
Prismaflex System 7.10
K131516 | Device
Prismaflex System 8.10 | Difference |
| Therapies | SCUF | SCUF | same |
| | CVVH | CVVH | same |
| | CVVHD | CVVHD | same |
| | CVVHDF | CVVHDF | same |
| | TPE | TPE | same |
| Pumps | PBP solution | PBP solution | same |
| | Replacement solution | Replacement solution | same |
| | Dialysate solution | Dialysate solution | same |
| | Effluent | Effluent | same |
| | Blood | Blood | same |
| Scales | Dialysate | Dialysate | same |
| | Replacement | Replacement | same |
| | Effluent | Effluent | same |
| | Pre blood (PBP) | Pre blood (PBP) | same |
| Transmembrane
Pressure
TMP (CRRT)
TMPa (TPE) | TMP:
User settable: +70 to +350 mmHg
Default: +350 mmHg
TMPa:
User settable; +50 to +100 mmHg
Default: +100 mmHg | TMP:
User settable: +70 to +350 mmHg
Default: +350 mmHg
TMPa:
User settable; +50 to +100 mmHg
Default: +100 mmHg | same |
| | | | |
| | | | |
| Dialysate
Conductivity
and
Temperature | Dialysate Conductivity and
Temperature are not controlled by
Prismaflex | Dialysate Conductivity and
Temperature are not controlled by
Prismaflex | same |
| Patient Fluid
Removal
Performance
Range | 0 to 2000 ml/hr maximum for
CRRT
0 to 1000 ml/hr for TPE
Increment: 10 ml/hr | 0 to 2000 ml/hr maximum for
CRRT
0 to 1000 ml/hr for TPE
Increment: 10 ml/hr | same |
| | | | |
| | | | |
| Patient Fluid
Removal
Performance
Range
Accuracy | ± 30 ml/hr
± 70 ml/3hr
± 300 ml/24hr
Scales calibrated at ambient
temperature at which they will be
used. Ambient temperature change
less than ±3 °C
(5.4 °F) during treatment | ± 30 ml/hr
± 70 ml/3hr
± 300 ml/24hr
Scales calibrated at ambient
temperature at which they will be
used. Ambient temperature change
less than ±3 °C
(5.4 °F) during treatment | same |
| | | | |
| | | | |
| | | | |
| Devices | Predicate
Prismaflex System 7.10
K131516 | Device
Prismaflex System 8.10 | Difference |
| Access Pressure
and Accuracy | Range -250 to +450 mmHg
Accuracy ±15 mmHg | Range -250 to +450 mmHg
Accuracy ±15 mmHg | same |
| Return Pressure
and Accuracy | Range -50 to +350 mmHg Accuracy
±5 mmHg | Range -50 to +350 mmHg
Accuracy ±5 mmHg | same |
| Filter Pressure
Sensor | Range -50 to +450 mmHg
Accuracy ±10% of reading or ±8
mmHg | Range -50 to +450 mmHg
Accuracy ±10% of reading or ±8
mmHg | same |
| Effluent
Pressure Sensor | Range -350 to +400 mmHg (CRRT)
Range -350 to +350 mmHg (TPE)
Accuracy ±10% of reading or ±8
mmHg | Range -350 to +400 mmHg
(CRRT)
Range -350 to +350 mmHg (TPE)
Accuracy ±10% of reading or ±8
mmHg | same |
| TPE Settings: | Pre-treatment Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 30% | Pre-treatment Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 30% | same |
| TPE Settings | Total Replacement Volume
Range: 0 to 10,000 ml
Increment: 100 ml
Default: 3000 ml | Total Replacement Volume
Range: 0 to 10,000 ml
Increment: 100 ml
Default: 3000 ml | same |
| TPE Settings | Patient Plasma Loss Rate
Range: 0, or 10 to 1000 ml/hr
Increment: 10 ml/hr
Default: 0 ml/hr | Patient Plasma Loss Rate
Range: 0, or 10 to 1000 ml/hr
Increment: 10 ml/hr
Default: 0 ml/hr | same |
| TPE Settings | Replacement Container Volume
Range: 0 to 5000 ml
Increment: 10 ml | Replacement Container Volume
Range: 0 to 5000 ml
Increment: 10 ml | same |
Table 2. Substantial Equivelence Table
7
Table 2. Substantial Equivelence Table
8
Table 2. Substantial Equivelence Table
9
Table 2. Substantial Equivelence Table
7. DISCUSSION OF NONCLINICAL TESTS:
Testing was performed for the Prismaflex System 8.10, in order to determine substantial equivalence with predicate devices included:
10
-
. Software and system verification and validation including functional, performance and safety requirements; see section 16 for a summary and referenced reports
Compliance has been demonstrated to the following international standards ; -
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
IEC 60601-1-8: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-
IEC 60601-2-16: Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
-
IEC 62304: Medical device software - Software life cycle processes
-
IEC 62366: Medical devices -- Application of usability engineering to medical devices
8. BIOCOMPATIBILITY:
The Prismaflex Control Unit is not in direct contact with patient. Patient contact is via 510(k) cleared or PMA approved medical devices.
9. STERILITY AND SHELF LIFE:
The Prismaflex Control Unit is not sold as sterile and therefore this section is not applicable. This device does not claim an expiration date.
11
10. CONCLUSION:
The successful testing of the Prismaflex System 8.10 demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.