(109 days)
The Prismaflex M150 Set is indicated for use only with the Prismaflex Control Unit 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 Prismatlex disposable sets are sterile disposable extracomoreal circuits containing an AN69 hemofilter/dialyzer and fluid circuit for use with the Prismatlex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed:
- . SCUF: Slow Continuous Ultrafiltration
- CVVH: Continuous Veno-Venous Hemofiltration .
- Continuous Veno-Venous Hemodialysis CVVHD:
- CVVHDF: Continuous Veno-Venous Hemodiafiltration .
The provided text describes a 510(k) premarket notification for the "Prismaflex M150 Set," which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel effectiveness through studies that would typically involve acceptance criteria for artificial intelligence or image processing algorithms.
Therefore, many of the requested points are not applicable to this document as it pertains to a physical medical device (hemofilter and blood tubing set) and not a software algorithm or AI-powered diagnostic tool. The document explicitly states "Summary of Clinical Tests: Not applicable."
Here's a breakdown based on the provided text and the nature of a 510(k) for a physical device:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable as described for AI/algorithm performance. The submission focuses on demonstrating substantial equivalence to a predicate device (Prismaflex M100 Set). The "acceptance criteria" here relate to the non-clinical testing performed to show that the modified device performs as well as the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Submission) |
|---|---|
| Design, Function, Composition, and Operation equivalence | "substantially equivalent in design, function, composition, and operation, to the predicate device" |
| Performance equivalence through in vitro testing | "demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended used." |
| Safety and Effectiveness | "demonstrates that it is safe, effective and performs as well as the predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" and "data provenance" concepts are typically used for evaluating algorithms on specific datasets. For this physical device, "in vitro testing" was conducted to compare performance to the predicate device. The document does not specify sample sizes for these in vitro tests, nor does it refer to data provenance in the context of patient data for an algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth establishment by experts is relevant for diagnostic algorithms. This is a physical device, and its performance was assessed through in vitro and manufacturing controls, rather than expert consensus on diagnostic outputs.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements in expert interpretations for establishing ground truth for algorithmic evaluation. This process is not relevant to the 510(k) submission for this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states, "Summary of Clinical Tests: Not applicable." MRMC studies are used to evaluate the impact of a diagnostic aid on human reader performance. This device is a hemofilter and blood tubing set, not a diagnostic aid, and no clinical studies were deemed necessary for this 510(k) submission.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical medical product, not an algorithm, so the concept of standalone algorithmic performance is irrelevant.
7. The Type of Ground Truth Used
Not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) is for evaluating the accuracy of a diagnostic or predictive system against a gold standard. For this physical device, the "ground truth" relates to its physical and functional specifications and its performance metrics (e.g., fluid management, filtration efficacy) which are assessed through engineering and bench testing.
8. The Sample Size for the Training Set
Not applicable. Training sets are used for machine learning algorithms. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, training sets and their ground truth are for machine learning.
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K08 0519
Image /page/0/Picture/1 description: The image shows the word "GAMBRO" in a bold, sans-serif font. To the left of the word is a stylized, circular logo that appears to be a stylized letter "G". The logo is black, and the word "GAMBRO" is also black. There is a small registered trademark symbol to the right of the word.
CONFIDENTIAL
510(k) Summary
| Submitter: | Gambro Renal Products, Inc.14143 Denver West ParkwayLakewood, Colorado 80401 | JUN 13 2008 |
|---|---|---|
| Contact: | Kae Miller, Manager, Regulatory AffairsPhone: 303-542-5045Fax: 303-876-9264 | |
| Date prepared: | February 22, 2008 | |
| Device name: | Prismaflex M150 Set | |
| Common name: | Hemofilter and Blood Tubing SetHigh Permeability Hemodialyzer | |
| Classification names: | High Permeability Hemodialysis System Accessory (876.5860) | |
| Classification panel | KDI Gastroenterology - Urology | |
| Classification | Class II per 21 CFR 876.5860 | |
| Predicate Devices: |
Gambro Prismaflex M100 Set K041005
Substantial Equivalence: The proposed Prismaflex M150 Set is substantially equivalent to the Prismaflex M100 set currently on the market. The modifications in the proposed device are substantially equivalent in design, function, composition, and operation, to the predicate device that has FDA clearance under 510(k) K041005.
Device Description: The Prismatlex disposable sets are sterile disposable extracomoreal circuits containing an AN69 hemofilter/dialyzer and fluid circuit for use with the Prismatlex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed:
- . SCUF: Slow Continuous Ultrafiltration
- CVVH: Continuous Veno-Venous Hemofiltration .
- Continuous Veno-Venous Hemodialysis CVVHD: �
- CVVHDF: Continuous Veno-Venous Hemodiafiltration .
Indications For Use: The Prismaflex M150 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.
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CONFIDENTIAL
Page 2/2
KU80519
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: In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations. The in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended used.
Summary of Clinical Tests: Not applicable.
Conclusion: Testing performed on Prismaflex M150 Set demonstrates that it is safe, effective and performs as well as the predicate devices, when used in accordance with instructions for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2008
Ms. Kae Miller Manager, Regulatory Affairs Gambro Renal Products, Inc. 14143 Denver West Parkway LAKEWOOD CO 80401
K080519 Re:
Trade/Device Name: Prismaflex M150 Set Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 11, 2008 Received: April 14, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.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
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CONFIDENTIAL
Indications for Use Statement
| 510(k) number: (if known) | K080519 |
|---|---|
| Device Name: | Prismaflex M150 Set |
| Indications for Use: | The Prismaflex M150 Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both. |
| Prescription Use (Per 21 CFR 801 Subpart D) | X |
| AND / OR | |
| Over-The-Counter Use (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helun Leuer
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices
510(k) Number K080519
§ 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.”