(171 days)
No
The description focuses on automated control of fluid and solute removal based on pre-set parameters and operator input, without mentioning any learning or adaptive capabilities characteristic of AI/ML.
Yes
The device is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload, and it performs functions such as removal of waste products, restoration of acid-base balance, and correction of electrolyte imbalances, which are therapeutic interventions.
No
The device is described as an "acute renal failure treatment device" for removing waste products, correcting imbalances, and providing fluid removal. Its functions are related to administering therapies, not diagnosing conditions.
No
The device description explicitly states the system consists of a "control unit and a sterile disposable set with a hemofilter/dialyzer," indicating significant hardware components beyond just software.
Based on the provided text, the Prismaflex device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload." This describes a therapeutic intervention performed directly on the patient's blood, not a test performed on a sample outside the body to diagnose or monitor a condition.
- Device Description: The description details a system that pumps blood, controls fluid removal, delivers solutions, and monitors treatment data. These are all functions related to a therapeutic treatment, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, etc.) to detect or measure specific substances.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or assays.
The Prismaflex is clearly described as a device for performing Continuous Renal Replacement Therapy (CRRT), which is a life-support treatment for kidney failure.
N/A
Intended Use / Indications for Use
The Prismaflex is indicated for the following use: - continuous solute and/or fluid removal in patients with acute renal failure or fluid overload All treatments administered by the Prismaflex must be prescribed by a physician.
Product codes
78 KDI
Device Description
The Prismaflex System is an acute renal failure treatment device for removal of waste products, restoration of acid-base balance, correction of electrolyte imbalances (eg, hyperkalemia), patient fluid balance, nutritional support, and other conditions in which fluid removal is needed. The system consists of a control unit and a sterile disposable blood tubing set with a hemofilter/dialyzer. Prismaflex offers four Continuous Renal Replacement Therapy (CRRT) options: SLOW Continuous Ultrafiltration (SCUF), Continuous Veno-venous Hemofiltration (CVVH), Continuous Veno-venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodiafiltration (CVVHDF).
SCUF - Provides fluid removal by ultrafiltration.
CVVH - Provides convective solute clearance by hemofiltration. Can provide net fluid removal if desired.
CVVHD - Provides solute clearance by hemodialysis. Can provide net fluid removal if desired.
CVVHDF - Provides solute clearance by both convection and diffusion. Can provide net fluid removal if desired.
The Prismaflex performs the following functions related to the administration of supported therapies:
- Automatically loads the Gambro Cartridge blood tubing/hemofilter set.
- Primes the Gambro Cartridge set. Automatic or Manual priming may be done. Automated priming uses the Gambro Cartridge-specific settings for UFR, priming volume and alarm pressures. Manual priming allows the operator to manually select and control these priming parameters.
- Pumps blood through the blood flowpath of the Gambro Cartridge and delivers anticoagulant into the blood flowpath. Anticoagulant may be delivered continuously via an anticoagulant-filled syringe loaded into the syringe pump or via infusion using the Pre-Blood Pump infusion pump.
- Controls fluid removal from the patient. Calculates and controls the effluent pump rate required to achieve the current patient Fluid Removal Rate set by the operator by varying the dialysate and/or replacement pump flow(s).
- Delivers sterile replacement solution from pre-prepared bags.
- Pumps dialysate solution from pre-prepared bags.
- Monitors, displays, and charts treatment data.
- Monitors the system and alerts the operator to abnormal situations through alarms. An alarm is indicated by the alarm name and appropriate control buttons appearing on the machine display; by a red or yellow alarm light; and by an audible alarm (beeping sound).
- Provides automatic rinseback of blood in the Gambro Cartridge, if desired. If enabled, Auto Rinseback controls the blood pump rate and saline volume pumped, according to preset values. Manual Rinseback can also return blood, where the operator controls the blood pump and saline volume.
- Records patient prescription data on a removable storage media.
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
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)
The Prismaflex was verified & validated by thorough testing to the design specifications. The results of the testing demonstrate that Prismaflex meets the requirements. The results of the testing demonstrate that performance of the device is substantially equivalent to the currently marketed predicate devices. The Prismaflex has been evaluated by third party assessments:
- IEC 60601-1 (+ amendments 1 & 2)
- IEC 60601-1-1
- IEC 60601-1-2
- IEC 60601-1-4
- IEC 60601-2-16
- IEC 14971:2000
- ISO/IEC 12207
The Prismaflex M60/M100 disposable cartridge sets were tested to and met the requirements of ISO 10993-1 Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. Further, the sets were tested to and met the AAMI/ISO 1135 Evaluation and Routine Control of Ethylene Oxide Sterilization. Results of these tests and in-vitro performance tests for the system demonstrate suitability for the intended use.
SUMMARY OF CLINICAL TESTS and CONCLUSION: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021615 Baxter Accura System, K963440 B.Braun Diapact CRRT, K010805 Gambro Prisma System, K032431 Gambro Prisma M60/M100 Sets
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined lines that form the shape of a bird or a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2004
Mr. Thomas B. Dowell Manager Regulatory Affairs Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K041005
Trade/Device Name: Gambro Prismaflex™ System with M60 and M100 Sets Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: August 10, 2004 Received: August 11, 2004
Dear Mr. Dowell:
This letter corrects our substantially equivalent letter of October 7, 2004 regarding the incorrect product code listed for the Gambro Prismaflex™ System.
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 (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 (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
1
Page 2 - Mr. Thomas B. Dowell
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 continue 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 (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
NancyC brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Abbreviated 510(k) Notification -Gambro Prismaflex™ System
Indications For Use
510(k) Number (if known):
Device Name:
Prismaflex™ System Prismaflex™ M60 Set Prismaflex™ M100 Set
Indications For Use:
The Prismaflex is indicated for the following use:
- continuous solute and/or fluid removal in patients with acute renal failure or ● fluid overload
All treatments administered by the Prismaflex must be prescribed by a physician.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Horton
(Division Sign-Off)
Division of Reproductiv Abdomir and Radiological Devic 510(k) Number
Confidential
Page 1
3
K041005 Page 1 of 3
Abbreviated 510(k) Notification Gambro Prismaflex™ System
OCT 7 - 2004
510(k) SUMMARY
SUBMITTER:
Gambro Renal Products 10810 West Collins Avenue Lakewood, CO 80215 USA
Thomas B. Dowell, Manager Regulatory Affairs CONTACT: Phone: (303) 231-4094 (303) 542-5138 Fax:
April 16, 2004 DATE PREPARED:
Prismaflex System DEVICE NAME: Prismaflex M60 Set Prismaflex M100 Set
Hemodialysis System COMMON/UNUSUAL NAME:
High Permeability Hemodialysis System CLASSIFICATION NAMES:
KDI PRODUCT CODE:
Gastroenterology - Urology (GU) CLASSIFICATION PANEL:
Class II per 21 CFR 876.5860 CLASSIFICATION:
K021615 Baxter Accura System PREDICATE DEVICES: K963440 B.Braun Diapact CRRT K010805 Gambro Prisma System K032431 Gambro Prisma M60/M100 Sets
DEVICE DESCRIPTION:
The Prismaflex System is an acute renal failure treatment device for removal of waste products, restoration of acid-base balance, correction of electrolyte imbalances (eg, hyperkalemia), patient fluid balance, nutritional support, and other conditions in which flyperkalomia); pationed. The system consists of a control unit and a sterile disposable nulla removal is nouth a hemofilter/dialyzer. Prismaflex offers four Continuous Renal Replacement Therapy (CRRT) options: Slow Continuous Ultrafiltration (SCUF), Ropiaosmonion Hemofiltration (CVVH), Continuous Veno-venous Hemodialysis (CVVHD), and Continuous Veno-venous Hemodiafiltration (CVVHDF).
SCUF - Provides fluid removal by ultrafiltration.
CVVH - Provides convective solute clearance by hemofiltration. Can provide net fluid removal if desired.
nula formoval if docure solute clearance by hemodialysis. Can provide net fluid removal if desired.
CVVHDF - Provides solute clearance by both convection and diffusion. Can provide net fluid removal if desired.
Confidential
4
K041005 Page 2 of 3
Abbreviated 510(k) Notification Gambro Prismaflex™ System
The Prismaflex performs the following functions related to the administration of supported therapies:
- Automatically loads the Gambro Cartridge blood tubing/hemofilter set. .
- Primes the Gambro Cartridge set. Automatic or Manual priming may be done. . Frithes the Gambro Cartridge-specific settings for UFR, priming volume Automatic priming asso proces, sal priming allows the operator to manually select and control these priming parameters.
- Pumps blood through the blood flowpath of the Gambro Cartridge and delivers . Fullips blood through the blood flowpath. Anticoagulant may be delivered continuously anticoagulant mo the blood frompatulant-filled syringe loaded into the syringe pump or via infusion using the Pre-Blood Pump infusion pump.
- Controls fluid removal from the patient. Calculates and controls the effluent pump . oontrold from varieve the current patient Fluid Removal Rate set by the operator rate required to acon the dialysate and/or replacement pump flow(s).
- Delivers sterile replacement solution from pre-prepared bags. .
- Pumps dialysate solution from pre-prepared bags. .
- Monitors, displays, and charts treatment data. .
- Monitors the system and alerts the operator to abnormal situations through alarms. . An alarm is indicated by the alarm name and appropriate control buttons appearing on the machine display; by a red or yellow alarm light; and by an audible alarm (beeping sound).
- Provides automatic rinseback of blood in the Gambro Cartridge, if desired. If . enabled, Auto Rinseback controls the blood pump rate and saline volume pumped, according to preset values. Manual Rinseback can also return blood, where the operator controls the blood pump and saline volume.
- Records patient prescription data on a removable storage media. .
INDICATIONS FOR USE:
The Prismaflex is indicated for the following use:
- Continuous solute and/or fluid removal in patients with acute renal failure or fluid . overload
All treatments administered by the Prismaflex must be prescribed by a physician.
TECHNOLOGICAL CHARACTERISTICS:
The Prismaflex is similar to the cited predicate devices in the ranges for fluid flow rates, patient fluid balance rates, operating pressures, and anticoagulation. Operation of the device and the cited predicates is similar. The number of scales and pumps included in the design varies from device to device, but the resulting performance capabilities are
Confidential
5
K041005 Page 3 of 3
Abbreviated 510(k) Notification Gambro Prismaflex™ System
similar. With respect to the original Prisma, Prismaflex incorporates an additional scale similar. With respect to the orginal Priomer, replacement solution flexibility.
SUMMARY OF NON-CLINICAL TESTS and CONCLUSION:
The Prismaflex was verified & validated by thorough testing to the design specifications. The results of the testing demonstrate that Prismaflex meets the requirements. The results of the testing domonatiate that . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . party assessments:
- IEC 60601-1 (+ amendments 1 & 2) .
- IEC 60601-1-1 .
- IEC 60601-1-2 .
- IEC 60601-1-4 .
- IEC 60601-2-16 .
- IEC 14971:2000 .
- ISO/IEC 12207 .
The Prismaflex M60/M100 disposable cartridge sets were tested to and met the requirements of ISO 10993-1 Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. Further, the sets were tested to and met the AAMI/ISO 1135 Evaluation and Routine Control of Ethylene Oxide Sterilization. Results of these tests and in-vitro performance tests for the system demonstrate suitability for the intended use.
SUMMARY OF CLINICAL TESTS and CONCLUSION:
Not applicable