The PRISMA™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.

Device Description

In accordance with Section 510(k) of the Food, Drug and Cosmetics Act, Gambro Renal Care Products intends to introduce a modification of the Prisma Continuous Fluid Management System into commercial distribution. The modification creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer manufactured by Stihler Electronic GmbH (K991159) to be used with the Prisma system during continuous renal replacement therapy. The integration of the Blood Warmer into the Prisma System will provide gentle warming of the treated blood, prior to its return to the patient. No modifications of the Prisma Dialysis Control Unit were made as part of this change. A modification is made to the Prisma Blood Tubing Set that places two luer fittings into the tubing set return line proximal to the air detector. When using the optional Blood Warmer, the user separates the new luer fittings and attaches the new warmer Extension Line. New labeling is created for the Extension Line and the Blood Tubing Set.

AI/ML Overview

This document is a 510(k) summary for a modification to the Gambro Renal Care Products' PRISMA CFM System, specifically to allow the use of an accessory blood warmer. It is not a study reporting on the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted as it pertains to AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Safety and Effectiveness" section describes the approach taken to ensure the modification does not introduce new safety or effectiveness issues.

Here's an interpretation of the relevant sections in the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied): The modification must not introduce significant new safety and effectiveness issues compared to the predicate devices. This is assessed by ensuring:
- The design control system (21 CFR Part 820.30) is in place and addresses identified hazards.
- System-level verification and validation protocols are completed with "acceptable, pre-determined results."
- New hazards associated with the modification are considered in the design.
Reported Device Performance:
- The modification "creates an accessory sterile extension line that will allow the Prismatherm II Blood Warmer...to be used with the Prisma system."
- The integration "will provide gentle warming of the treated blood, prior to its return to the patient."
- "No modifications of the Prisma Dialysis Control Unit were made as part of this change."
- The modified system "uses similar design, technology and safety systems as the predicate devices to perform heating of the patient blood in the return line."
- "There were no significant new safety and effectiveness issues identified by this modification."
- A list of all system level verification and validation protocols completed with acceptable, pre-determined results is provided in the notification (though not detailed in this summary).

Note: For a traditional device modification like this, acceptance criteria would typically involve engineering specifications, performance benchmarks (e.g., temperature control range, flow rates, sterility), and safety assessments, all aligned with the pre-determined results mentioned. This summary does not provide specific numerical criteria or performance data as it's a high-level overview for a 510(k).

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable. The document describes a device modification for which a 510(k) submission was made, not an AI/ML study involving a test set. Evaluation relies on engineering verification and validation, risk analysis, and comparison to predicate devices, rather than a "test set" in the context of an AI algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. There is no "ground truth" establishment in the context of an AI/ML study, nor a "test set" as defined for such. Device safety and effectiveness are established through design controls, testing protocols, and regulatory review by the FDA.

4. Adjudication Method for the Test Set:

This information is not applicable. There is no "adjudication method" for a test set in this context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This device is not an AI/ML diagnostic or assistive tool, so human reader performance with or without AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This is a hardware modification for a medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

This information is not applicable. There is no concept of "ground truth" (e.g., pathology, outcomes data) as it would apply to an AI/ML diagnostic model. Device safety and effectiveness are established through engineering principles, bench testing, and regulatory requirements.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is a hardware modification, not an AI/ML model.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as there is no training set or associated ground truth.

Summary

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OCT 6 1999

510(k) Summary of Safety and Effectiveness Information in Accordance with SMDA 1990

Gambro Renal Care Products1185 Oak StreetLakewood, CO 80215(800) 525-2623
OFFICIAL CONTACT:		William M. Townsend, Sr. Regulatory Specialist
PRODUCT NAME:	PRISMA CFM System Modification to Use an AccessoryBlood Warmer
PREVIOUS DEVICE CLEARANCE(s):		K942679 Date: 2/10/97 (Original)K981681 Date: 8/11/98 (CVVHDF Mode)
TRADE NAME:	Dialyzer, High Permeability With or Without SealedDialysate System
CLASSIFICATION NAME:		Gastroenterology and UrologyClass III, 78 KDI21 CFR 876.5860

SUBSTANTIAL EQUIVALENCE TO:

510(k) Number	Applicant	Device
K970253	Gambro Healthcare	COBE Model Centrysystem 3+ DialysisDelivery Device
K982760	Gambro Healthcare	COBE Model Cx Hemodialysis DeliverySystem
K970446	Althin Medical	Drake Wilock System 1000 DialysisDelivery System

DEVICE DESCRIPTION:

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Image /page/1/Picture/0 description: The image shows the text "510(k) #: K 993064 Page 2 of 2". The text indicates that this is a page from a 510(k) premarket submission to the FDA. The number 993064 is the specific 510(k) number for this submission. The page number indicates that this is page 2 of 2.

SUBSTANTIAL EQUIVALENCE:

In our notification, we demonstrate substantial equivalence to the identified predicate devices by demonstrating that the predicate devices provide solution heating through the use of heaters to warm either the dialysis water or dialysate prior to the solution passing through the dialyzer. The heat exchanger characteristics of the dialyzers cause heating of the patient's blood in the dialyzer. We demonstrated that the modified Prisma system uses similar design, technology and safety systems as the predicate devices to perform heating of the patient blood in the return line. There were no significant new safety and effectiveness issues identified by this modification to the Prisma CFM 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. All treatments administered via the PRISMA System must be prescribed by a physician." The device indications for use do not change as a result of this modification.

SAFETY AND EFFECTIVENESS:

We demonstrate and certify in the notification that a Design Control System is in place that is in compliance with the requirements listed in 21CFR Part 820.30. We further demonstrate that the design control system addresses hazards identified through both information searches and our own Risk Analysis program. A list of all system level verification and validation protocols completed with acceptable, pre-determined results is provided in the notification.

A search of the FDA's MAUDE database and the MEDLINE database were conducted for information on known manufacturer or user problems with the use of solution warmers with dialysis. In most cases, the hazards identified are recognized in the manufacture and use of dialysis therapy devices. We demonstrate in the notification that the new hazards are considered in the design of the modifications to the Prisma System. and that they do not represent significant new issues of safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1999 OCT

Mr. William M. Townsend Senior Regulatory Affairs Specialist Gambro Renal Care Products 1185 Oak Street Lakewood, CO 80215-4498

Re: K993064 PRISMA™ Continuous Fluid Management System Dated: September 9, 1999 Received: September 13, 1999 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI

Dear Mr. Townsend:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 9.0

510(k) Number (if known): K993064

Device Name: PRISMA™ Continuous Fluid Management 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. All treatments administered via the PRISMA System must be prescribed by a physician."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K993064

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_ (Optional Format 1-2-96)

Regulation Number and Section

§ 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.”