(119 days)
KDI
Not Found
No
The description focuses on the physical components and function of a disposable extracorporeal circuit for renal replacement therapies, with no mention of AI or ML.
Yes
The device is indicated for "continuous fluid management and renal replacement therapies" for patients with "acute renal failure, fluid overload, or both," specifically mentioning therapies like "hemofiltration" and "hemodiafiltration," which are therapeutic interventions.
No
The device is described as a set for continuous fluid management and renal replacement therapies, treating conditions like acute renal failure or fluid overload. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the PRISMA M10 Pre Set is a "disposable, extracorporeal circuit" consisting of a "hollow fiber hemofiter / dialyzer and tubing lines," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases or other conditions. They are used to provide information for diagnosis, treatment, or prevention of disease.
- Device Function: The PRISMA M10 Pre Set is a disposable extracorporeal circuit used with a control unit to provide continuous fluid management and renal replacement therapies. It filters blood and manages fluids outside of the body.
- Lack of Diagnostic Testing: The description focuses on the physical components and their role in filtering blood and managing fluids. There is no mention of analyzing samples from the body for diagnostic purposes.
The device is a therapeutic device used for treating conditions like acute renal failure and fluid overload, not for diagnosing them.
N/A
Intended Use / Indications for Use
The PRISMA M10 Pre Set is indicated for use with the PRISMA control unit only in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
The set is intended for use in the following veno-venous therapies:
- slow continuous ultrafiltration (SCUF)
- continuous veno-venous hemofiltration (CVVH)
- continuous veno-venous hemodialysis (CVVHD)
- continuous veno-venous hemodiafiltration (CVVHDF)
The PRISMA M10 Pre Set is intended for treatment of neonates and infants with a body weight ranging between 2 and 15 kg.
Product codes
KDI
Device Description
The PRISMA M10 Pre Set is a disposable, extracorporeal circuit for use with the PRISMA control unit. The PRISMA M10 Pre Set consists of a AN 69 hollow fiber hemofiter / dialyzer and tubing lines.
The filter is permanently connected:
- on the blood compartment to an access line (red-striped), a return line (blue-striped) .
- on the dialysate compartment to a dialysate inlet line (green-striped) and to anceff)vent . outlet line (yellow-striped).
Other lines of the set include a replacement solution line (purple-striped) and anticoagulant line.
- A 1-liter bag is connected to the end of the blood access line to collect the priming . liquid.
- A 5-liter bag is connected to the end of the effluent outlet line to collect the ultrafil trate . and/or dialysate.
Pre-dilution: the PRISMA M10 Pre Set is a set provided for addition of replacement solution before blood enters the filter.
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
neonates and infants
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 performance and clinical testing was performed to establish and compare performance characteristics to the predicate devices. The results of in vitro and clinical testing demonstrate that the proposed device is substantially equivalent to the predicate devices and is suitable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
PRISMA M60 Set, Gambro FH 22H
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
2063183
FEB 1 5 2007
GAMBRO Renal Products
510K(k) SUMMARY
SUBMITTER:
Gambro Renal Products 10810 West Collins Avenue Lakewood, CO 80215 (303) 231-5075
DATE PREPARED: October 16th 2006
Prisma M10 Pre Set DEVICE NAME:
CLASSIFICATION NAMES: High Permeability Hemodialysis System
PREDICATE DEVICES:
PRISMA M60 Set & Gambro FH 22H
Device Description:
The PRISMA M10 Pre Set is a disposable, extracorporeal circuit for use with the PRISMA control unit. The PRISMA M10 Pre Set consists of a AN 69 hollow fiber hemofiter / dialyzer and tubing lines.
The filter is permanently connected:
- on the blood compartment to an access line (red-striped), a return line (blue-striped) .
- on the dialysate compartment to a dialysate inlet line (green-striped) and to anceff)vent . outlet line (yellow-striped).
Other lines of the set include a replacement solution line (purple-striped) and anticoagulant line.
- A 1-liter bag is connected to the end of the blood access line to collect the priming . liquid.
- A 5-liter bag is connected to the end of the effluent outlet line to collect the ultrafil trate . and/or dialysate.
Pre-dilution: the PRISMA M10 Pre Set is a set provided for addition of replacement solution before blood enters the filter.
Predicate Device:
Prisma M60 Set and Gambro FH 22H
Intended Use:
The PRISMA M10 Pre Set is indicated for use with the PRISMA control unit only in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
The set is intended for use in the following veno-venous therapies:
- . slow continuous ultrafiltration (SCUF)
- continuous veno-venous hemofiltration (CVVH) ●
- continuous veno-venous hemodialysis (CVVHD)
1
"GAMBRO Renal Products
continuous veno-venous hemodiafiltration (CVVHDF) .
The PRISMA M10 Pre Set is intended for treatment of neonates and infants with a body weight ranging between 2 and 15 kg.
Technological Characteristics:
Comparing the proposed devices to the predicate devices, they are substantially equivalent to the predicate devices.
Summary of Non-Clinical & Clinical Tests:
In vitro performance and clinical testing was performed to establish and compare performance characteristics to the predicate devices. The results of in vitro and clinical testing demonstrate that the proposed device is substantially equivalent to the predicate devices and is suitable for the intended use.
Conclusions:
Testing performed on the Gambro Prisma M10 Pre Set indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use. In vitro performance data / specifications are included in the labeling.
October 16th, 2006
Shideman Director. Clinical Research Gambro Research
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around the perimeter. In the center is a stylized graphic of an eagle or bird-like figure, with three wave-like lines extending from its body, possibly symbolizing the services provided by the department.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Gambro Renal Products, Inc. c/o Jeffrey R. Shideman, Ph.D. Director, Clinical Research Therapy Group Americas 7307 Glouchester Drive EDINA MN 55435
EB 1 5 2007
Re: K063183
Trade/Device Name: PRISMA M10 Pre Set Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 17, 2007 Received: January 19, 2007
Dear Dr. Shideman:
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 max. 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 Approval), it may be subject to such additional controls. Existing major regulations affectively volume device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition FFA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 100 years from 1906-2006. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in cursive. Three stars are arranged beneath the word "Centennial".
Protecting and Promoting Public Health
3
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) 11 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.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/cdrh/industry/support/index.html
Sincerely vours.
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
ි GAMBRO Renal Products
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Gambro Prisma M10 Pre Set
Indications for Use:
The PRISMA M10 Pre Set is indicated for use with the PRISMA control unit only in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
The set is intended for use in the following veno-venous therapies:
- slow continuous ultrafiltration (SCUF)
- . continuous veno-venous hemofiltration (CVVH)
- continuous veno-venous hemodialysis (CVVHD) .
- continuous veno-venous hemodiafiltration (CVVHDF) .
The PRISMA M10 Pre Set is intended for treatment of neonates and infants with a body weight ranging between 2 and 15 kg.
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)
Page of
(Posted November 13, 2003)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Regulatory Affairs - Dialyzer Division