The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.

Device Description

The consistent mixing and delivery of bicarbonate solution for use in hemodialysis

AI/ML Overview

The provided document is a 510(k) summary for the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, many of the requested categories for a study proving device performance (such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating equivalence.

Here's a breakdown of the information that can be extracted and the reasons why other requested categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional performance metrics like sensitivity/specificity, the "acceptance criteria" here relate to demonstrating that the new device is fundamentally similar and performs comparably to a legally marketed predicate device. The document uses a comparison table to show substantial equivalence in specifications and intended use.

Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate)	Reported Device Performance (USFilter Bicarb System)	Predicate Device Performance (MAR COR MCB 210)
Intended Use	The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to be used in a Hemodialysis facility to allow safe and effective delivery of concentrates as well as central mixing and delivery of sodium bicarbonate solution necessary for a hemodialysis treatment.	The Bicarb Mixing and Distribution System (Bicarb System) designed and manufactured by Mar Cor Services is, safe, reliable and easy to use. This system will reduce staff time by providing consistent bicarb mixing, and through system cleaning and disinfection.
Utility Requirements
Water Feed	RO or DI water produced to AAMI standards for Hemodialysis	RO or DI water produced to AAMI standards for Hemodialysis
Electrical requirements	115 VAC, Single Phase, 20 AMP	115 VAC, Single Phase, 20 AMP
Drain	1" Minimum	1" Minimum
Physical Dimensions (50 Gallon System)
Length	70"	85"
Depth	27"	32"
Height	60"	57"
Operating Weight	1800 LBS	1300 LBS
Physical Dimensions (100 Gallon System)
Length	83"	85"
Depth	35"	32"
Height	60"	61"
Operating Weight	2500 LBS	2050 LBS
Dimensional/Operating Room (Common)
Width	6' 10"	6' 10"
Depth	3' 3"	3' 3"
Height	6' 0"	6' 0"
Installation Piping (Common)
Feedwater	½" schedule 80 PVC	½" schedule 80 PVC
Loop Distribution	¾" schedule 80 PVC	¾" schedule 80 PVC
Loop Return	¾" schedule 80 PVC	¾" schedule 80 PVC
Drain	1" schedule 80 PVC	1" schedule 80 PVC
System Floats (Mix Tank)	The mix tank is equipped with a high level float that will close the fill valve if the water in the tank exceeds 100 gallons (50 gallons for 50 gallon systems). The fill valve controller will not reactivate unless the water level is below the float level.	The mix tank is equipped with a high level float that will close the fill valve if the water in the tank exceeds 100 gallons (50 gallons for 50 gallon systems). The fill valve controller will not reactivate unless the water level is below the float level.
System Floats (Distribution Tank)	The distribution tank is equipped with a low-level float that lights a warning light if the bicarbonate in the tank drops below 25 gallons. If the distribution tank is allowed to go empty an audible alarm will sound.	The distribution tank is equipped with a low-level float that lights a warning light if the bicarbonate in the tank drops below 25 gallons. If the distribution tank is allowed to go empty an audible alarm will sound.
Pumps (Mix Pump)	½ hp Totally Enclosed Fan Cooled (TEFC) motor	½ hp Totally Enclosed Fan Cooled (TEFC) motor
Pumps (Distribution Pump)	1/9 hp TEFC motor	1/8 hp TEFC motor
Tank Material	Polyethylene	Polyethylene

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a device submission for substantial equivalence based on design and technical specifications, not a performance study on a test dataset. The "test set" would effectively be the device itself being compared to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth, in the context of device performance, typically refers to a gold standard used to evaluate the accuracy of a diagnostic or analytical device. This submission is for a mixing and dispensing system where "ground truth" would not be established by experts in the same way.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used in studies where there's disagreement among reviewers establishing ground truth, which is not relevant for this type of device submission.

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

This is not applicable. An MRMC study pertains to the evaluation of diagnostic performance, often with AI assistance for human readers. This device is a bicarbonate mixing and dispensing system, not an AI-powered diagnostic tool.

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

This is not applicable. This question relates to the performance of an algorithm independently of human involvement, which is relevant for AI or diagnostic software. The USFilter Bicarb System is a physical medical device.

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

This is not applicable. As discussed above, "ground truth" in the typical sense of a performance study is not relevant for demonstrating substantial equivalence for this device. The "ground truth" for this submission is the accepted safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. Training sets are used for machine learning algorithms, which are not involved in this device or its submission.

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

This is not applicable for the reasons mentioned in point 8.

Summary

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3

AUG 27 2004

510(k) Summary

USFilter/lonpure, Inc. in accordance with the requirements of 21 CFR§807.92 is submitting this summary of 510(k)-safety and effectiveness information.

Submitter's Identification USFilter/lonpure, Inc. 725 Wooten Road Colorado Springs, CO 80915 719-570-9600

Date Summary Prepared 26 March 2003 , (Rev.4 - 02 August 2004)

Official Correspondent/Contact 2

Douglas L. Rufenacht 725 Wooten Road Colorado Springs, CO 80915 719-550-2055

Name of the Device 3

USFilter Bicarbonate Mixing and Dispensing (Bicarb) System

Substantial Equivalence 4

MAR COR Services, Inc. MAR COR Services Bicarb System K003560

Device Description 5

The consistent mixing and delivery of bicarbonate solution for use in hemodialysis

6 Intended Use

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Comparison to Substantial Equivalence Devices 7

The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System unit contains the same fundamental scientific technology as the substantial equivalent device. Please reference the following Chart of Comparison:

Specifications andTechnical Information	USFilterBICARB50SYS &BICARB100SYS		MAR CORMCB 210-50 & MCB 210-100
Indications for Use:	The USFilter Bicarbonate Mixingand Dispensing (Bicarb) Systemis intended to be used in aHemodialysis facility to allow safeand effective delivery ofconcentrates as well as centralmixing and delivery of sodiumbicarbonate solution necessaryfor a hemodialysis treatment.		The Bicarb Mixing and DistributionSystem (Bicarb System) designedand manufactured by Mar CorServices is, safe, reliable and easyto use. This system will reduce stafftime by providing consistent bicarbmixing, and through systemcleaning and disinfection.
Utility Requirements
Water Feed:	RO or DI water produced to AAMIstandards for Hemodialysis		RO or DI water produced to AAMIstandards for Hemodialysis
Electricalrequirements:	115 VAC, Single Phase, 20 AMP		115 VAC, Single Phase, 20 AMP
Drain:	1" Minimum		1" Minimum
Physical Dimensions	50	100	50	100
Length:	70"	83"	85"	85"
Depth:	27"	35"	32"	32"
Height:	60"	60"	57"	61"
Operating Weight:	1800 LBS	2500 LBS	1300 LBS	2050 LBS
Dimensional/Operating Room
Width:	6' 10"		6' 10"
Depth:	3' 3"		3' 3"
Height:	6" 0"		6" 0"
Installation Piping
Feedwater:	½" schedule 80 PVC		½" schedule 80 PVC
Loop Distribution:	¾" schedule 80 PVC		¾" schedule 80 PVC
Loop Return:	¾" schedule 80 PVC		¾" schedule 80 PVC
Drain:	1" schedule 80 PVC		1" schedule 80 PVC
System Floats
Mix Tank Float:	The mix tank is equipped with ahigh level float that will close thefill valve if the water in the tankexceeds 100 gallons (50 gallonsfor 50 gallon systems). The fillvalve controller will not reactivateunless the water level is belowthe float level.		The mix tank is equipped with ahigh level float that will close the fillvalve if the water in the tankexceeds 100 gallons (50 gallons for50 gallon systems). The fill valvecontroller will not reactivate unlessthe water level is below the floatlevel.
Distribution TankFloat:	The distribution tank is equippedwith a low-level float that lights awarning light if the bicarbonate inthe tank drops below 25 gallons.If the distribution tank is allowedto go empty an audible alarm willsound.		The distribution tank is equippedwith a low-level float that lights awarning light if the bicarbonate inthe tank drops below 25 gallons. Ifthe distribution tank is allowed to goempty an audible alarm will sound.
Pumps
Mix Pump:	½ hp Totally Enclosed FanCooled (TEFC) motor		½ hp Totally Enclosed Fan Cooled(TEFC) motor
Distribution Pump:	1/9 hp TEFC motor		1/8 hp TEFC motor
Tank Material:	Polyethylene		Polyethylene

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Discussion of Non-Clinical Test Performed for Determination of Substantial 8 Equivalence is as follows:

The USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is an existing device actively marketed by USFilter with a long performance record. This submission seeks to obtain approval so as to begin marketing this device as part of a water system for use in hemodialysis.

Discussion of Clinical Test Performed: 9

N/A

Biocompatibility Testing: 10

USFilter certifies that all materials utilized in the design, manufacture, and operation of the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System are utilized in the predicate device as well as used in other registered devices and systems currently sold by USFilter and registered with the Food and Drug Administration. The tables in appendix D provide the detailed break down of these materials as well as a documented review in accordance with Appendix C of FDA document G95-1. It is the contention of USFilter that as per the results of the review documented in appendix D no further testing is required.

11 Conclusions:

As was true for the MAR COR Services Bicarb System, the USFilter Bicarbonate Mixing and Dispensing (Bicarb) System is intended to provide consistent bicarbonate mixing and distribution for Hemodialysis applications.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2004

Mr. Douglas Rufenacht Validation Manager and Regulatory Compliance USFilter Process Water Systems High Purity Systems 725 Wooten Road COLORADO SPRINGS CO 80915

Re: K031502

KU31302
Trade/Device Name: USFilter Bicarbonate Mixing and Dispensing (Bicarb) System Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIN Dated: August 20, 2004 Received: August 23, 2004

Dear Mr. Rufenacht:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally interest date of the Medical Device Amendments, or to commerce prior to May 20, 1970, are eccordance with the provisions of the Federal Food, Drug, devices that have been roomstilled in quire approval of a premarket approval application (PMA). and Costhere 710 (110) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, uicierore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 a00 regulations affecting your device can be it may be subject to adultions, 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 Ficase be advised that I Drive issuation that your device complies with other requirements of the Act that I DA has made a active regulations administered by other Federal agencies. You must of any I ederal statutes and roginements, including, but not limited to: registration and listing comply with an the riot 5 requirements, as and 801); good manufacturing practice requirements as set (21 CFR Part 607), labornig (21 OF Reason), government (20); and if applicable, the clectronic forth in the quality bysteins (QD) rog to the Act); 21 CFR 1000-1050.

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l'are 2

This letter will allow you to begin marketing your device as described in your Section 10(k).
The station and the market of alling of edicantial equivalence of your device to This letter will allow you to begin marketing your device of your device of your device to a le;sally
premarket notification. The FDA finding of substanted of your device an premarket notification. The FDA inding of substantal Quivation or 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), phease
s on the secure of the comments of the following numbers, based on the reg If you desire specific advice for your device on our labourig region in and on the regulation
contact the Office of Compliance at one of the following numbers, based on the r number at the top of the 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 advectising of your device, please contact the Additionally, for questions on the promotion and are mote the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, planse note the regulation of t Office of Compliance at (301) Syland St. Also, production oveganization Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtain. Division o by reference to premarket notification (21CFA i are oo 1779 yoed firon the Division of Small
information on your responsibilities under the Act may be obtained from the (800) information on your responsibilities under Asstance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its today, main html. Manufacturers, International and Collishiner Fisistance a the re-ri-

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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Indication for Use

Prescription Use

Daniel A. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.