Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used.

The solutions are perfused through the dialysis fluid compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.

CRRT is used for acute renal failure patients that may be too unstable to tolerate conventional hemodialysis, in which this function occurs much more rapidly (3-4 hours per treatment) and intermittently (3-6 times a week). In CRRT, the balancing is done on a continuous basis, 24 hours a day, in order to mimic kidney function.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dialysis solution, not a medical device that utilizes AI or requires a study comparing its performance to acceptance criteria in the way a diagnostic algorithm would. Therefore, most of the requested information (sample sizes, experts, adjudication methods, MRMC studies, standalone performance, training sets) is not applicable.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical or technical study of the device's diagnostic or predictive capabilities.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dialysis solution), the "acceptance criteria" are primarily related to its chemical composition, sterility, packaging, and intended use being equivalent to already cleared devices. The "reported device performance" is the statement of its characteristics.

Acceptance Criteria (based on Predicate Devices)	Reported Device Characteristics (Gambro PrismaSate)
Intended Use: Dialysate for use in Continuous Renal Replacement Therapy.	Dialysate for use in Continuous Renal Replacement Therapy. Indicated for treatment of acute renal failure and other cases necessitating fluid or solute removal.
Chemical Composition: Ranges of sodium, calcium, potassium, magnesium, bicarbonate, lactate, acetate, dextrose. (Specific ranges from predicate devices were compared).	Ranges of Sodium 137 - 142 mEq/L, Calcium 0 - 4 mEq/L, Potassium 0 - 4 mEq/L, Magnesium 0.5 - 1.5 mEq/L, Bicarbonate 0 - 36 mEq/L, Lactate 0 - 40 mEq/L, Acetate 0 mEq/L, Dextrose 0 - 2 g/L. (Note: Higher lactate concentration than predicates, but within European Pharmacopoeia Monograph standard).
Sterility: Terminally Sterilized or Manufactured as a sterile product.	Terminally Sterilized
Packaging: PVC Bag, Glass Vials, PP/PE containers.	PVC Bag

2. Sample size used for the test set and the data provenance

Not Applicable. This is a medical device submission for a dialysis solution, not an AI or diagnostic device that uses a test set of data. The "test" is the comparison of its characteristics and intended use to predicate devices and recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth, in the context of an AI or diagnostic device, is not relevant here. The "ground truth" for chemical composition would be established by analytical chemistry techniques, and for sterility by microbiological testing, but these are part of standard manufacturing and quality control, not a "test set" in the AI sense.

4. Adjudication method for the test set

Not Applicable. See reasons for #2 and #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic device.

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

Not Applicable. This device does not have an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the chemical composition and sterility, the "ground truth" would be established by analytical chemistry testing (e.g., spectrophotometry, chromatography) and microbiological testing (e.g., sterility tests). For the intended use and technological characteristics, the "ground truth" is established by comparison to regulatory definitions and established predicate devices. The document explicitly states: "Comparing the proposed device to the predicate devices, its ranges of chemical compositions, packaging, and sterility are equivalent to one or more of the predicate devices."

8. The sample size for the training set

Not Applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not Applicable. There is no training set.

Summary of the Study/Demonstration of Acceptance:

The "study" in this context is a comparative analysis of the device's characteristics against legally marketed predicate devices, as detailed in the "Comparison to Predicate Devices" section of the 510(k) summary. The manufacturer, Gambro Renal Products, asserts that their PrismaSate Dialysis Solutions are substantially equivalent to the following predicate devices:

Premixed Dialysate for Hemodiafiltration (K910270, Baxter Healthcare Corp.)
Normocarb Sterile Bicarbonate Renal Dialysis Concentrate (K001059, Dialysis Solutions, Inc. / Novex Pharma)
Hemodialysis Bath Concentrate Solutions for Hemodialysis (K864265, Dial Medical of Florida, Inc.)
Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis (K011368, Gambro Renal Products)

The documentation highlights that the PrismaSate solutions' chemical compositions, packaging, and sterility are equivalent to one or more of these predicates. A specific point of comparison was the lactate concentration, where PrismaSate's upper level (40 mEq/L) was higher than the predicate devices but was justified as being within the European Pharmacopoeia Monograph for Solutions for Hemofiltration and Hemodiafiltration (30-60 mEq/L), which is an accepted reference standard. The manufacturer argued that the higher lactate concentration brings the pH closer to physiological plasma pH and has no adverse effect on safety or effectiveness.

Ultimately, the FDA's letter states that they reviewed the 510(k) and "determined the device is substantially equivalent (...) to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets the necessary regulatory "acceptance criteria" for market clearance.

Summary

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GAMBRO Renal Products

K 013448
Page 1 of 3
510(k) Premarket Notification

510 (k) Summary

/JAN 1 5 2002

PrismaSate

Dialysis Solutions for Continuous Renal Replacement Therapy

Contact Information:

GAMBRO Renal Products

1845 Mason Avenue Daytona Beach, FL 32117 Phone: 386-274-2811 Fax: 386-274-2833 Contact: Fei Law

Prepared: October 10, 2001

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Image /page/1/Picture/0 description: The image shows the logo for Gambro Renal Products. The logo consists of the word "GAMBRO" in a bold, sans-serif font, with the words "Renal Products" in a smaller font to the right. There is a stylized "G" to the left of the word "GAMBRO".

510(k) Premarket Notification

510 (k) Summary

Name of the device:	PrismaSate		Intended Use	Chemical Composition	Sterility	Packaging
Common Name:	Dialysis Solutions for Continuous Renal Replacement TherapyReady to Use Sterile Dialysate	GambroPrismaSateDialysisSolutions forContinuousRenalReplacementTherapy	Dialysate for use inContinuous RenalReplacement Therapy.	Sodium 137 - 142 mEq/LCalcium 0 - 4 mEq/LPotassium 0 - 4 mEq/LMagnesium 0.5 - 1.5 mEq/LBicarbonate 0 - 36 mEq/LLactate 0 - 40 mEq/LAcetate 0 mEq/LDextrose 0 - 2 g/L	TerminallySterilized	PVC Bag
Classification Name:	Dialysate Concentrate for Hemodialysis (Liquid or Powder) per21 CFR 876.5820. The Product/Classification Code is KPO.	BaxterHealthcarePremixedDialysate forHemodiafiltrationK 910270Cleared04/18/1991	For acute dialysismodalities that employhemodiafiltration, such ascontinuous arteriovenoushemodiafiltration (CAVHD)and continuous venuous-venous hemodiafiltration(CWHD), when treatmentof acute renal failurepatients with hypervolemiaand uremia requires highsolute clearance	Sodium 140 mEq/LCalcium 3.5 mEq/LPotassium 2 mEq/LMagnesium 1.5 mEq/LBicarbonate 0 mEq/LLactate 30 mEq/LAcetate 0 mEq/LDextrose 1 g/L	TerminallySterilized	PVC bag
Predicate Devices:	Premixed Dialysate for HemodiafiltrationK910270 cleared 04/18/1991Baxter Healthcare Corp.	DialysisSolutions, Inc.Novex PharmaNormocarbSterileBicarbonateRenal DialysisConcentrateK 001059Cleared06/30/2000	Dialysate concentrate foruse in hemodialysis.(Described as intended foruse in Continuous RenalReplacement Therapy)	Sodium 140 mEq/LCalcium 0 mEq/LPotassium 0 mEq/LMagnesium 1.5 mEq/LBicarbonate 35 mEq/LLactate 0 mEq/LAcetate 0 mEq/LDextrose 10.2 mEq/L (1.8 g/L)	Manufacturedas a sterileproduct	Glass vials
	Normocarb Sterile Bicarbonate Renal Dialysis ConcentrateK001059 cleared 06/30/2000Dialysis Solutions, Inc. / Novex Pharma	Dial Medical ofFloridaHemodialysisBathConcentrateSolutions forHemodialysisK 864265Cleared03/17/1987	Formulated to be used inconjunction with a SodiumBicarbonate Concentrate ina three stream artificialkidney machine.	Sodium* 137 - 143 mEq/LCalcium 0 - 3.5 mEq/LPotassium 0 - 4 mEq/LMagnesium 0.5 - 1.5 mEq/LBicarbonate* 32 - 36 mEq/LLactate 0 mEq/LAcetate 3 - 4 mEq/LDextrose 0 - 2 g/L	Notmanufacturedas a sterileproduct	PP/PEcontainers
	Hemodialysis Bath Concentrate Solutions for HemodialysisK864265 cleared 03/17/1987Dial Medical of Florida, Inc.	Gambro RenalProducts Dry ACAcidConcentrate Mixfor BicarbonateHemodialysisK011368Cleared08/02/2001	For use with concentratedbicarbonate solution in 3-stream proportioningartificial kidney equipmentusing purified, AAMIstandard water.	Sodium* 137 - 143 mEq/LCalcium 0 - 4 mEq/LPotassium 0 - 3 mEq/LMagnesium 0.5 - 1.5 mEq/LBicarbonate* 32 - 36 mEq/LLactate 0 mEq/LAcetate 3 - 4 mEq/LDextrose 0 - 2 g/L	Notmanufacturedas a sterileproduct	PP/PEcontainers
	Dry AC Acid Concentrate Mix for Bicarbonate HemodialysisK011368 cleared 08/02/2001Gambro Renal Products

Device Description:

Gambro PrismaSate solutions are indicated for use as a Indications for Use: dialysate in Continuous Renal Replacement Therapy.

Comparison to Predicate Devices:

The Gambro PrismaSate Dialysate Solutions for Continuous Renal Replacement Therapy are equivalent to other dialysate products that are currently approved by the FDA, as demonstrated in the following table:

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Image /page/2/Picture/0 description: The image shows the logo for GAMBRO Renal Products. The word "GAMBRO" is in a bold, sans-serif font, and the words "Renal Products" are in a smaller, italicized font. To the left of the word "GAMBRO" is a circular graphic. The logo is simple and professional.

510(k) Premarket Notification

510 (k) Summary

*final dialysate concentration when mixed with sodium chloride/sodium bicarbonate buffer

Comparing the proposed device to the predicate devices, its ranges of chemical compositions, packaging, and sterility are equivalent to one or more of the predicate devices. Although the upper level of the lactate concentration is higher than the predicate devices, it is within the 30-60 mEq/L range specified by the European Pharmacopoeia Monograph for Solutions for Hemofiltration and Hemodiafiltration, an accepted reference standard. The primary function of the lactate is as a buffer. In this case, the higher lactate concentration brings the pH of the solution closer to the physiological plasma pH. There is no adverse effect on safety or effectiveness of the solution by offering a lactate concentration which is higher than the predicate devices. There are no significant differences in technological characteristics, and its intended use as dialysate is equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Ms. Fei Law Quality Assurance Manager Gambro Renal Products 1845 Mason Avenue DAYTONA BEACH FL 32117 Re: K013448 Trade/Device Name: Gambro PrismaSate™ Dialysis Solutions for Continuous Renal Replacement Therapy Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: October 10, 2001 Received: October 17, 2001

Dear Ms. Law:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Nancy Cbrogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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of I Page 1

K013448

510(k) Number (if known):

PrismaSate™ Device Name:

Indications For Use:

Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brandon
(Division Sign-On)

Prescription Use

(Divisio (Optional Format 3-10-98 Division and Radiolog 5 10(k) Numbe

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.