(86 days)
Prisma ® 3.03 System
Not Found
No
The description focuses on the mechanical and control functions of the device for continuous renal replacement therapies and plasma exchange, with no mention of AI or ML capabilities.
Yes
The device is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange, which are treatments for medical conditions.
No
Explanation: The Prisma System is described as a device for continuous solute and/or fluid removal, and therapeutic plasma exchange. Its functions include pumping blood, delivering anticoagulants, controlling fluid removal, and pumping replacement solutions. These are all therapeutic actions, not diagnostic ones. The device treats conditions like acute renal failure and fluid overload, but it does not perform any diagnostic measurements or analyses to identify or characterize these conditions.
No
The device description explicitly states that the Prisma System consists of a "Prisma Control Unit" and "disposable extracorporeal blood circuits (Prisma Sets)", which are hardware components. The control unit performs physical functions like pumping blood and fluids.
Based on the provided information, the Prisma® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being used for continuous solute and/or fluid removal and therapeutic plasma exchange in patients. This is a direct treatment applied to the patient's body.
- Device Description: The device description details a system that pumps blood, delivers solutions, controls fluid removal, and monitors the system during treatment. These are all functions related to directly interacting with the patient's blood and fluids for therapeutic purposes.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Prisma System does not perform this function. It is a therapeutic device used for treatment.
Therefore, the Prisma® System falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"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."
Product codes (comma separated list FDA assigned to the subject device)
78KDI
Device Description
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. All treatment administered via the Prisma® System must be prescribed by a physician. The Prisma® System is designed for use on critically ill patients in the intensive care unit to provide the following treatments: SCUD (slow Continuous Ultrafiltrtion), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), CVVHDF (Continuous Veno-venous Hemodialfiltration) and TPE (Therapeutic Plasma Exchange). The Prisma® System consists of the Prisma Control Unit and a series of disposable extracorporeal blood circuits (Prisma Sets) to allow four types of continuous renal replacements therapies as well as therapeutic plasma exchange (TPE) therapy. The blood circuit utilized will be dependent on the individual patient's therapy and needs. The Prisma Control Unit performs the following functions: 1. Loads and primes the Prisma Set automatically. 2. Pumps blood through the blood flowpath of the set. 3. Delivers anti-coagulant solution into blood flowpath. 4. Controls fluid removal/plasma loss from the patient. 5. Pumps sterile replacement solution/fluid and/or sterile dialysate. Pumps effluent. 6. Monitors the system and alerts the operator to abnormal situations through alarms.
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)
The nonclinical testing included unit testing, code inspections, testing targeted to the changes implemented in R03.10A, regression testing and human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills. The successful non-clinical testing demonstrates the safety and effectiveness of the Prisma® R03.10A System when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed device.
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.
Prisma ® 3.03 System
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
K062090
Page 1 of 5
Traditional 510(k)
Prisma® 3.10 System
12.0 510(k) SUMMARY
OCT 1 8 2006
| Submitter's Name | Gambro Renal Products |
|---|---|
| Address | 10810 West Collins Avenue |
| Lakewood, CO 80215 | |
| Establishment | |
| Registration Number | 1713683 |
| Date of Summary | July 23, 2006 |
| Telephone Number | (303) 231-4094 |
| Fax Number | (303) 542-5138 |
| Contact Person | Thomas B. Dowell, Manager Regulatory Affairs |
| Name of the Device | Prisma ® R03.10A System |
| Catalogue Number: 018089-507 | |
| 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 | |
| Indications for Use | 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. | |
| Identification of the | |
| Legally Marketed Device | |
| (Predicate Device) | Prisma ® 3.03 System |
| Catalogue Number: 018089-507 | |
| Classification Name: High Permeability Hemodialysis System | |
| Device Class: II | |
| Product Code: 78KDI | |
| Regulation Number: 876.5860 |
1
K062090
Page 2 of 5
Traditional 510(k)
Prisma® 3.10 System
510(k) SUMMARY, continued
| Device Description | 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. All treatment administered via the Prisma® System must be prescribed by a physician. The Prisma® System is designed for use on critically ill patients in the intensive care unit to provide the following treatments: SCUD (slow Continuous Ultrafiltrtion), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), CVVHDF (Continuous Veno-venous Hemodialfiltration) and TPE (Therapeutic Plasma Exchange). The Prisma® System consists of the Prisma Control Unit and a series of disposable extracorporeal blood circuits (Prisma Sets) to allow four types of continuous renal replacements therapies as well as therapeutic plasma exchange (TPE) therapy. The blood circuit utilized will be dependent on the individual patient's therapy and needs. |
|---|---|
| The Prisma Control Unit performs the following functions: | |
| 1. Loads and primes the Prisma Set automatically. | |
| 2. Pumps blood through the blood flowpath of the set. | |
| 3. Delivers anti-coagulant solution into blood flowpath. | |
| 4. Controls fluid removal/plasma loss from the patient. | |
| 5. Pumps sterile replacement solution/fluid and/or sterile dialysate. Pumps effluent. | |
| 6. Monitors the system and alerts the operator to abnormal situations through alarms. |
2
K062090
Page 3 of 5
Traditional 510(k)
Prisma® 3.10 System
:
510(k) SUMMARY, continued
Comparison Table
| | PREDICATE
Prisma ® System V 3.03 | MODIFIED DEVICE
Prisma ® System R03.10A |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | 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 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 |
| Dedicated
Disposable Sets | M60/M100 (K032431), 66D pre and
post dilution sets, PF2000N (PMA
P830063) HF1000 | M60/M100 (K032431), 66D pre and
post dilution sets, PF2000N (PMA
P830063) HF1000 |
| Replacement
Solutions Used | Sterile commercial fluid labeled for
intravenous injection or solution
prepared in the hospital pharmacy.
Prescribed by physician. | Sterile commercial fluid labeled for
intravenous injection or solution
prepared in the hospital pharmacy.
Prescribed by physician. |
| Dialysate Solutions
Used | AAMI RD-5 Standard dialysate
solution, composition prescribed by
physician and Prismasate (K013448).
None used for TPE. | AAMI RD-5 Standard dialysate
solution, composition prescribed by
physician and Prismasate (K013448).
None used for TPE. |
| Anticoagulantion | Delivered continuously or in bolus into
blood path at a point before blood enters
the dialyzer. | Delivered continuously or in bolus into
blood path at a point before blood
enters the dialyzer. |
| Fluid Removal
Rate from Patient | SCUF: up to 2 L/hr.
CVVH: up to 1 L/hr.
CVVHD: up to 1 L/hr.
CVVHDF: up to 1 L/hr.
TPE: 0 - 1000 ml/hr. | SCUF: up to 2 L/hr.
CVVH: up to 1 L/hr.
CVVHD: up to 1 L/hr.
CVVHDF: up to 1 L/hr.
TPE: 0 - 1000 ml/hr. |
| Blood Flow Rate | Up to 180 ml/min. | Up to 180 ml/min. |
| Fluid Replacement
Rate | SCUF: 0 L/hr.
CVVH: up to 4.5 L/hr.
CVVHD: 0 L/hr.
CVVHDF: up to 2 L/hr.
TPE: up to 2 L/hr. | SCUF: 0 L/hr.
CVVH: 0, or 0.1 to 4.5 L/hr.
CVVHD: 0 L/hr.
CVVHDF: 0, or 0.1 to 2 L/hr.
TPE: up to 2 L/hr. |
| Effluent Flow Rate | SCUF: up to 2 L/hr.
CVVH: up to 5.5 L/hr.
CVVHD: up to 3.5 L/hr.
CVVHDF: 10-5500 ml/hr
TPE: up to 3 L/hr. | SCUF: up to 2 L/hr.
CVVH: up to 5.5 L/hr.
CVVHD: up to 3.5 L/hr.
CVVHDF: 10-5500 ml/hr
TPE: up to 3 L/hr. |
| Primary Solute
Removal
Mechanism | SCUF: Convection
CVVHD: Convection
CVVHD: Diffusion
CVVHDF: Convection & Diffusion
TPE: Convection | SCUF: Convection
CVVHD: Convection
CVVHD: Diffusion
CVVHDF: Convection & Diffusion
TPE: Convection |
| | PREDICATE
Prisma® System V 3.03 | MODIFIED DEVICE
Prisma® System R03.10A |
| Transmembrane
Pressure | See table below | See table below |
| Ultrafiltration Rate | Off, 10 - 5500 ml/hr | Off, 10 - 5500 ml/hr |
| Dialysate
Temperature | *N/A: See explanation below | *N/A: See explanation below |
| Dialysate
Conductivity | **N/A: See explanation below | **N/A: See explanation below |
| Arterial and
Venous Pressure | Operating Range -250 to +50 mmHg
Accuracy ±10% of reading or ±8
mmHg, whichever is greater | Operating Range -250 to +50 mmHg
Accuracy ±10% of reading or ±8
mmHg, whichever is greater |
:
3
K062090
Page 4 of 5
Traditional 510(k)
Prisma® 3.10 System
510(k) SUMMARY, continued
TMP Alarm Limits in Prisma (same for 3_03 & 3_10)
| Alarm | Default | Option |
|---|---|---|
| "TMP Too High" | ||
| Advisory Limit | +350 mmHg | +70 to +350 mmHg |
| Increment: 10 mmHg | ||
| "Filter Is Clotting" | ||
| Advisory Limits | Advisory alarm occurs | One or more limits are reached. |
| a) Filter pressure dropb (ΔP filter) variation | 100 mmHg | a) User settable: 10 to 100 mmHg |
| greater than initial ΔP. | ||
| Increment: 10 mmHg | ||
| b) TMP increase | Default: 150 mmHg | Service settable: 50 to 200 mmHg |
| greater than initial TMP. | ||
| Increment: 5 mmHg | ||
| Filter Clotted" Warning | ||
| Limit | Filter pressure minus return | |
| pressure is ≥ 250 mmHg OR One | ||
| or both of the "Filter is Clotting" | ||
| Advisory Limits are reached and | ||
| TMP is ≥ 450 mmHg. | N/A | |
| "TMP Excessive" Caution | ||
| Limit | TMP ≥ 450 mmHg | N/A |
TMP = (Filter Pressure + Return Pressure)/2 - Effluent Pressure
4
Koc 2090
Page 5 of 5
Traditional 510(k) Prisma® 3.10 System
510(k) SUMMARY, continued
- Dialysate conductivity is not applicable because the Prisma does not mix water and concentrates to produce dialysate. There is also no temperature control or monitoring included in Prisma. Accessory warmers for Prisma include appropriate protective measures. There are no conductivity or temperature controls or monitoring.
** The term Access Pressure in Prisma is equivalent to Arterial Pressure; the term Return Pressure in Prisma is equivalent to Venous Pressure. Prisma includes an Effluent Flow Rate in therapies where dialysate is not used, the effluent rate is the ultrafiltration rate (everything pulled in to the effluent bag is coming across the dialyzer membrane). In therapies where there is also a dialysate flow (CVVHD, CVVHDF), the ultrafiltration rate is the difference between effluent rate and the dialysate rate.
TMP (CRRT) and TMPa (TPE) are values calculated from measured pressures. There is no control to TMP (TMPa) in the system, but there are various alarms that are triggered by the calculated TMP.
Description and Nonclinical Testing: The nonclinical testing included unit testing, code inspections, testing Conclusion of Testing targeted to the changes implemented in R03.10A, regression testing and human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills.
Conclusion:
The successful non-clinical testing demonstrates the safety and effectiveness of the Prisma® R03.10A System when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed device.
5
Image /page/5/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The text is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 8 2006
Mr. Thomas B. Dowell Regulatory Project Manager Gambro Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K062090
Trade/Device Name: Prisma® R03.10A System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: July 23, 2006 Received: July 24, 2006
Dear Mr. Dowell:
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 arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that prove to the first and 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your ab, it may be subject to such 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.
Image /page/5/Picture/10 description: The image is a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle.
Protecting and Promoting Public Health
6
Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Traditional 510(k) Prisma® 3.10 System
Indications for Use
510(k) Number (if known): K062080
Device Name: Prisma® R03.10A System
Indications for Use:
"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."
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number.