(73 days)
No
The summary describes a disposable extracorporeal circuit and fluid management system, focusing on standard renal replacement therapies. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
Yes
The device is described as providing "continuous fluid management and replacement therapies" and is "intended for patients who have acute renal failure, fluid overload, or both," indicating it is used for medical treatment.
No
The device is described as providing continuous fluid management and replacement therapies for patients with acute renal failure or fluid overload. It is a therapy device, not one that diagnoses conditions.
No
The device description explicitly states it is a "sterile disposable extracorporeal circuit containing a PAES hemofilter/dialyzer and fluid circuit," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing "continuous fluid management and replacement therapies" for patients with acute renal failure or fluid overload. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as an "extracorporeal circuit containing a PAES hemofilter/dialyzer and fluid circuit." This is consistent with a system used for blood filtration and fluid removal/replacement, which is a treatment, not a diagnostic process.
- Therapies Performed: The listed therapies (SCUF, CVVH, CVVHD, CVVHDF) are all forms of continuous renal replacement therapy (CRRT), which are therapeutic procedures.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, etc.) to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat a condition by managing fluids and filtering blood.
N/A
Intended Use / Indications for Use
The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
Product codes
78 KDI
Device Description
The Prismaflex disposable sets are sterile disposable extracorporeal circuits containing a PAES hemofilter/dialyzer and fluid circuit for use with the Prismaflex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed:
- SCUF : Slow Continuous Ultrafiltration .
- CVVH : Continous Veno-Venous Hemofiltartion .
- CVVHD : Continous Veno-Venous Hemodialysis .
- CVVHDF : Continuous Veno-Venous Hemodiafiltartion .
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
In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations. The results of the in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use.
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
JAN - 6 2005
Special 510(k) Notification Gambro Prismaflex™ HF 1000 Set / HF 1400 Set
K042938
Page 1 of 2
510(K) SUMMARY
| SUBMITTER: | Gambro Renal Products
10810 West Collins Avenue
Lakewood, CO 80215
USA | |
|-----------------------|----------------------------------------------------------------------------------------------|--------------------|
| CONTACT: | Thomas B. Dowell, Manager Regulatory Affairs
Phone: (303) 231-4094
Fax: (303) 542-5138 | |
| DATE PREPARED: | October 21, 2004 | |
| DEVICE NAME: | Prismaflex HF 1000 Set
Prismaflex HF 1400 Set | |
| COMMON/UNUSUAL NAME: | Hemofilter and Blood Tubing Set
High Permeability Hemodialyzer | |
| CLASSIFICATION NAMES: | High Permeability Hemodialysis System Accessory | |
| CLASSIFICATION PANEL: | KDI Gastroenterology - Urology | |
| CLASSIFICATION: | Class II per 21 CFR 876.5860 | |
| PREDICATE DEVICES: | Gambro Prisma HF1000 Set
Gambro Prismaflex M60/M100 Set | K011221
K041005 |
SUBSTANTIAL EQUIVALENCE:
The proposed Prismaflex HF 1000 and HF 1400 sets are substantially equivalent to the Prisma HF 1000 sets and Prismaflex M60/M100 sets currently on the market. The modifications in the proposed devices are substantially equivalent in design, function, composition, and operation, to the predicate devices that have FDA clearance under 510(k)'s K011221 and K041005.
DEVICE DESCRIPTION:
The Prismaflex disposable sets are sterile disposable extracorporeal circuits containing a PAES hemofilter/dialyzer and fluid circuit for use with the Prismaflex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed:
- SCUF : Slow Continuous Ultrafiltration .
- CVVH : Continous Veno-Venous Hemofiltartion .
- CVVHD : Continous Veno-Venous Hemodialysis .
- CVVHDF : Continuous Veno-Venous Hemodiafiltartion .
1
K042938
Page 2 of 2
INDICATIONS FOR USE:
The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
TECHNOLOGICAL CHARACTERISTICS:
The proposed device configurations have the same technological characteristics and are similar in design, function, and operation, to the currently marketed configurations.
SUMMARY OF NON-CLINICAL TESTS and CONCLUSION:
In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations. The results of the in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use.
SUMMARY OF CLINICAL TESTS and CONCLUSION:
Not applicable
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2005
Mr. Thomas B. Dowell Manager Regulatory Affairs Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K042938
Trade/Device Name: Prismaflex™ HF 1000 Set and Prismaflex™ HF 1400 Set Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: December 16, 2004 Received: December 17, 2004
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 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.
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); 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.
3
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 promation nedicate 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 If you does of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
K042938 510(k) Number (if known):
Device Name:
Prismaflex™ HF 1000 Set Prismaflex™ HF 1400 Set
Indications For Use:
The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing I he i nsmallex Oct is management and replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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 G. Sezman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number