(85 days)
No
The description focuses on automated control of pumps, fluid delivery, and monitoring based on pre-programmed logic, not adaptive learning or pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE), which are medical treatments designed to provide therapy for specific conditions like acute renal failure or removal of plasma components.
No
The device is described as a control unit for therapies like CRRT and TPE, performing functions such as pumping fluids and monitoring the system, rather than diagnosing conditions or diseases.
No
The device description clearly outlines multiple hardware components and functions controlled by the software, such as pumps, a touch screen interface, and a system that loads and primes disposable sets. The performance studies also mention system verification and validation, indicating hardware is involved.
Based on the provided information, the Prismaflex® control unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for performing medical therapies (CRRT and TPE) directly on patients. These therapies involve processing blood and fluids within the patient's body or in an extracorporeal circuit connected to the patient.
- Device Description: The description details a machine that pumps fluids, controls flow, monitors the system, and interacts with disposable sets. These are all functions related to delivering therapy, not analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition. IVD devices are typically used to detect, measure, or identify substances in these samples.
The Prismaflex® is a therapeutic device used for extracorporeal blood purification and fluid management.
N/A
Intended Use / 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.
Product codes
78KDI
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.
The Prismaflex® has a touch screen user interface that provides operating instructions.
The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.
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
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)
The testing performed for the Prismaflex® equipped with software version 5.10, in order to determine the substantial equivalence with predicate devices included:
- · Complete software and system verification and validation including functional, performance and safety requirements;
- · Compliance has been demonstrated to the following international standards;
- o IEC 60601-1: Medical electrical equipment: Part 1: General requirements for safety
- IEC 60601-1-1: Medical electrical equipment: Part 1-1: General requirements for o safety - Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for o safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4: Medical electrical equipment: Part 1-4: General requirements for ಂ Collateral Standard: Programmable electrical Medical Systems
- IEC 60601-2-16: Medical electrical equipment Part 2-16: Particular 0 requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
The successful testing of the Prismaflex® equipped with software version 5.10 demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401
Traditional 510(k) for the Prismaflex® System
JUN 1 7 2011
5.0 510(k) SUMMARY
| Submitter's Name | Gambro Renal Products, Inc. |
|---|---|
| Address | 14143 Denver West Parkway, Suite 400 |
| Lakewood, Colorado 80401 | |
| Establishment Registration | |
| Number | 2087532 |
| Contact Person | Kae Miller |
| Regulatory Affairs Manager, Americas | |
| Telephone Number | 303.222.6724 |
| Fax Number | 303.222.6916 |
| Date of Summary | March 21, 2011 |
| Device under clearance | |
|---|---|
| Name of the Device | Prismaflex® |
| Catalogue Number: 113081 | |
| Common or Usual Name | Hemodialysis Delivery System |
| Classification Name | Classification Name: High Permeability Hemodialysis System |
| Device Class | II |
| Product Code | 78KDI |
| Regulation Number | 876.5860 |
1
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401
Traditional 510(k) for the Prismaflex® System
,
510(k) SUMMARY, continued
| Predicate Device Information (1) | |
|---|---|
| Name of the Device | Prisma System R 03.10A |
| Catalogue Number: | 018089-507 |
| 510(k) Number: | K062090 |
| Classification Name | High Permeability Hemodialysis System |
| Device Class | II |
| Product Code | 78KDI |
| Regulation Number | 876.5860 |
| Predicate Device Information (2) | |
|---|---|
| Name of the Device | Prismaflex® System 3.20 |
| Catalogue Number: | 107493 |
| 510(k) Number: | K072093 |
| Classification Name | High Permeability Hemodialysis System |
| Device Class | II |
| Product Code | 78KDI |
| Regulation Number | 876.5860 |
2
K110823
Traditional 510(k) for the
Prismaflex® System
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401
510(k) SUMMARY, continued
Image /page/2/Picture/4 description: The image shows a piece of medical equipment. The equipment has a screen at the top, followed by a series of buttons and controls. Below the controls, there are three levers or handles. The equipment is mounted on a stand or base.
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.
The Prismaflex® has a touch screen user interface that provides operating instructions.
The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.
PHYSICAL CHARACTERISTICS OF PRISMAFLEX®:
| WEIGHT: | Approximately 60 kg (132 lb) without fluid bags and Prismaflex disposable set |
|---|---|
| HEIGHT: | Approximately 162 cm (64 in) |
| WIDTH: | Approximately 49 cm (19 in) |
| BASE: | Approximately 60 cm x 63 cm (24 in x 25 in) |
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
3
Tra
Gambro Renal Products, Inc.
4143 Denver West Parkway, Suite 400
Lakewood, Colorado 80401
raditional 510(k)
Prismaflex®
0(k) SUMMARY, continuo
5.1
Device Comparison Table
In the following table the Prismallex " with software version 5.10 is compared for the TPE therapy with the predicate Prisma System R 03.
add for the
| and for the CRRT therapies with the predicate Prismaflex® System 3.20. | |||
|---|---|---|---|
| DEVICE | PREDICATE [for TPE] | ||
| Prisma System R 03.10A | PREDICATE [for CRRT] | ||
| Prismaflex® System 3.20 | |||
| Prismaflex® | |||
| The Prismaflex control unit is intended for: | The Prisma System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated. | The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician. | |
| 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. | |||
| Dedicated Disposable | |||
| Sets Available in U.S. | For CRRT: | ||
| M60/M100/M150 | |||
| HF1000 & HF1400 |
For TPE:
TPE 2000 Set | Gambro TPE Set with Plasmafilter PF2000N | M60/M100
HF1000 & HF1400 |
| Syringe | 10, 20, 30 & 50 ml | 20 ml | 10, 20, 30 & 50 ml |
RA 11-019
4
| Gambro Renal Products, Inc. |
|---|
| 14143 Denver West Parkway, Suite 400 |
| Lakewood, CO 80401 |
raditional 510(k) for the
Prismaflex® System
| | DEVICE
Prismaflex® | PREDICATE [for TPE]
Prisma System R 03.10A | PREDICATE [for CRRT]
Prismaflex® System 3.20 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Anticoagulation | User-controllable as continuous or
bolus | Delivered continuously or in bolus | User-controllable as continuous or
bolus |
| Dialysate Flow Rate | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr | Not for TPE. | CVVHD & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr |
| Dialysate Flow Rate
Accuracy | ± 30 ml/hr | Not for TPE. | ± 30 ml/hr |
| 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 | TPE:
up to 2000 ml/hr. | CVVH & CVVHDF:
Range: 0 to 8000 ml/hr
Increment: 50 ml/hr |
| Replacement Flow
Rate Accuracy | ± 30 ml/hr | ± 30 ml/hr | ± 30 ml/hr |
| Blood Flow Rate | Range: 10-450 ml/min. | Up to 180 ml/min. | Range: 10-450 ml/min.
Flow rate depends on the Prismaflex
therapy/set combination selected by
operator |
| Blood Flow Rate
Accuracy | ±10% of user set rate
The accuracy of blood flow is
maintained if:
- the inlet pressure is higher (less
negative) than -250 mmHg; - the outlet pressure is lower than
+350 mmHg | ±25% of user set rate. | ±10% of user set point
Treatment time up to 72 hours |
RA 11-019
5
| Gambro Renal Products, Inc. |
|---|
| 14143 Denver West Parkway, Suite 400 |
| Lakewood, CO 80401 |
raditional 510(k) for th
Prismaflex® System
| | DEVICE
Prismaflex® | PREDICATE [for TPE]
Prisma System R 03.10A | PREDICATE [for CRRT]
Prismaflex® System 3.20 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------|
| Pre-Blood Pump
Flow Rate | SCUF, TPE:
Range: 0 to 1000 ml/hr
Note: Total PBP Volume is
2000 ml/treatment for TPE
CVVH, CVVHD, CVVHDF:
Range: 0 to 4000 ml/hr | This pump is not available with Prisma | SCUF:
0 to 1000 ml/hr
CVVH, CVVHD, CVVHDF:
0 to 8000 ml/hr |
| Pre-Blood Pump
Accuracy | $\pm$ 30 ml/hr | This pump is not available with Prisma | $\pm$ 30 ml/hr |
| Effluent Pump Flow
Rate | 0 to 10000 ml/hr depending on the
therapy | 0, or 1000 to 5500 ml/hr | 0 to 10000 ml/hr depending on the
therapy |
| ECG Discharger | YES | Electrodes with low contact impedance
are required | YES |
| Therapies | SCUF
CVVH
CVVHD
CVVHDF
TPE | SCUF
CVVH
CVVHD
CVVHDF
TPE | SCUF
CVVH
CVVHD
CVVHDF |
| Pumps | PBP solution
Replacement solution
Dialysate solution
Effluent
Blood | Dialysate
Replacement
Effluent
Blood | PBP solution
Replacement solution
Dialysate solution
Effluent
Blood |
| Scales | Dialysate
Replacement
Effluent | Dialysate
Replacement
Effluent | Dialysate
Replacement
Effluent |
6
| 400
| uite |
|---|
Gambro Renal Products, Inc.
4143 Denver West Parkway
Lakewood, CO 80401
aditional 510(k) for th
Prismaflex® System
| | DEVICE
Prismaflex® | PREDICATE [for TPE]
Prisma System R 03.10A | PREDICATE [for CRRT]
Prismaflex® System 3.20 |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | TMPa:
User settable: 0 to +100 mmHg
Default: +100 mmHg | TMP:
User settable: +70 to +300 mmHg
Default: +300 mmHg |
| Dialysate
Conductivity and
Temperature | Dialysate Conductivity and
Temperature are not controlled by
Prismaflex | Dialysate Conductivity and
Temperature are not controlled by
Prisma | Dialysate Conductivity and
Temperature are not controlled by
Prismaflex |
| 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
Increment: 10 ml/hr | 0 to 2000 ml/hr
Increment: 10 ml/hr |
| 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
Scales calibrated at ambient
temperature at which they will be used.
Ambient temperature change less than
±1°C (5.4 °F) during treatment.
± 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. |
| Access Pressure and
Return Pressure | Access Pressure:
-250 to +300 mmHg
Return Pressure:
-50 to +350 mmHg | Access Pressure:
-250 to +50 mmHg
Return Pressure:
-50 to +350 mmHg | Access Pressure:
-250 to +300 mmHg
Return Pressure:
-50 to +350 mmHg |
| Access Pressure and
Return Pressure
Accuracy | ±10% of reading or ± 8 mmHg
(whichever is greater) | ±10% of reading or ± 8 mmHg
(whichever is greater) | ±10% of reading or ± 8 mmHg
(whichever is greater) |
7
| Gambro Renal Products, Inc. |
|---|
| 14143 Denver, West Parkway, Suite 400 |
| Lakewood, CO 80401 |
:
raditional 510(k) for the
Prismaflex® System
| | DEVICE
Prismaflex® | PREDICATE [for TPE]
Prisma System R 03.10A | PREDICATE [for CRRT]
Prismaflex® System 3.20 |
|--------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| PE Settings: | Pre-treatment Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 30% | Pre-treatment Hematocrit
Range: 10 to 60%
Increment: 1%
Default: 43% | N/A for CRRT. |
| | 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 | N/A for CRRT |
| | 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 | N/A for CRRT |
| | Replacement Container Volume
Range: 0 to 5000 ml
Increment: 10 ml | Replacement Container Volume
Range: 0 to 5000 ml
Increment: 10 ml | N/A for CRRT |
Page 22 of 101
RA 11-019
8
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401
Traditional 510(k) Prismaflex®
510(k) SUMMARY, continued
Assessment of performance data
The testing performed for the Prismaflex® equipped with software version 5.10, in order to determine the substantial equivalence with predicate devices included:
- · Complete software and system verification and validation including functional, performance and safety requirements;
- · Compliance has been demonstrated to the following international standards;
- o IEC 60601-1: Medical electrical equipment: Part 1: General requirements for safety
- IEC 60601-1-1: Medical electrical equipment: Part 1-1: General requirements for o safety - Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for o safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4: Medical electrical equipment: Part 1-4: General requirements for ಂ Collateral Standard: Programmable electrical Medical Systems
- IEC 60601-2-16: Medical electrical equipment Part 2-16: Particular 0 requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Conclusion
,
The successful testing of the Prismaflex® equipped with software version 5.10 demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.
9
Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted with three curved lines representing the wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401
Re: K110823
JUN 1 7 2011
Trade/Device Name: Prismaflex® Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 21, 2011 Received: March 24, 2011
Dear Ms. Miller:
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. 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
10
Page 2
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemon MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
11
Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401
Traditional 510(k) for the Prismaflex® System
Indications for Use
510(k) Number (if known): K110823
Device Name:
Prismaflex®
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.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| RA 11-019 | Page 14 of 101 |
| 510(k) Number | K110823 |