PERFORMANCE WATER TREATMENT SYSTEM by PERFORMANCE WATER SYSTEMS, LLC

The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

Device Description

The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

Pretreatment components can include a tap water retroutinem, blending valve, sediment filtration, boosting Systems, water softeners, and all the carbon roll of reconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse oonditionsachine to ensure its safe and trouble free operation. The blending valve ensures that the operation: The proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis systhine has adequate water pressure and volume so it can produce the desired amount of water. The i sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications.

After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria.

The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Performance Water Treatment System:

The provided document (K033648) is a 510(k) Summary of Safety and Effectiveness for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical studies with strict acceptance criteria often seen with novel high-risk devices.

Therefore, many of the typical elements you'd expect for acceptance criteria and a study design proving a device meets those criteria (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance metrics, training set details) are not present in this type of document for this class of device.

The "study" here is essentially a non-clinical performance data assessment to show compliance with a recognized standard.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from AAMI RD62-2001)	Reported Device Performance
Produces product water in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation (AAMI RD62-2001) for water used in hemodialysis.	The Performance Water Treatment System produces product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001.

Explanation: The acceptance criterion is the mandate to meet the specific AAMI standard for water quality in hemodialysis. The reported device performance is a statement that the device does indeed comply with this standard. The K033648 document does not provide specific numerical values for various water parameters (e.g., conductivity, levels of specific contaminants) that would typically be detailed within AAMI RD62-2001. Instead, it makes a general claim of compliance.

Details Pertaining to the "Study" Proving Compliance:

The document does not describe a traditional clinical or performance study with the detailed elements requested. Instead, it refers to "Non-Clinical Performance Data."

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. This would typically involve testing water samples produced by the system.
- Data Provenance: Not specified, but likely obtained through laboratory testing of the system's output water. The document does not indicate country of origin or whether it was retrospective/prospective. Given it's pre-market, it would inherently be prospective testing for the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" here is objective measurement against established water quality standards (AAMI RD62-2001), not subjective expert interpretation.
- Qualifications of Experts: N/A.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is not a study requiring human interpretation or adjudication. Compliance is based on analytical measurements.
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:
- MRMC Study: No. This is a water purification system, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: The "standalone performance" is the system's ability to produce compliant water on its own without human intervention (beyond operation and maintenance). The statement of compliance with AAMI RD62-2001 serves as the evidence of this. There is no algorithm in the sense of AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Established objective physical and chemical water quality standards as defined by AAMI RD62-2001. These standards specify maximum allowable concentrations for various contaminants (e.g., chemical, microbiological, endotoxin).
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI algorithm.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.

Summary of Approach in K033648:

The K033648 submission for the Performance Water Treatment System primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Better Water, Inc. Water Purification System for Hemodialysis, K#920186/C).

The "study" or evidence to support the claim of safety and effectiveness, in this context, is the non-clinical performance data showing that the product water produced by the device complies with the AAMI RD62-2001 standard. For water purification systems in this class, meeting recognized standards is the primary method of demonstrating performance and safety, as opposed to complex clinical trials or AI performance evaluations involving human readers.

The document states: "Both the predicate device systems and the Performance Water Treatment System utilize reverse osmosis technology as the primary means of purification, and all utilize an R.O. which has 510(k) clearance from the FDA." This further reinforces the substantial equivalence argument based on similar technology and intended use, along with demonstrating compliance to critical water quality standards.

Summary

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K033648
Page 1 of 3

AUG - 9 2004

510(k) Summary of Safety and Effectiveness

Submitter:	Performance Water Systems, LLC13601 South Kenton Ave.Crestwood, IL 60445
Establishment Registration Number:	9058752
Phone:	(708) 396-0136
Fax:	(708) 396-0137
Date Prepared:	Oct. 31, 2003
Contact Person:	Robert Downey
Device Names:	Trade Name:	Performance Water Treatment System
	Common Name:	Complete Water TreatmentSystem with pre-treatmentand product waterdistribution
	Classification Name:	Water purification system forHemodialysis(21 CFR 876.5665)Class II Critical MedicalDevice
	Product Code:	78 FIP
Predicate Device:		Better Water, Inc. Water Purification Systemfor Hemodialysis, K#920186/C

Device Description:

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K033648
Page 2 of 3

Pretreatment components can include a tap water l retroutinem, blending valve, sediment filtration, boosting Systems, water softeners, and all the carbon roll of reconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse oonditionsachine to ensure its safe and trouble free operation. The blending valve ensures that the operation: The proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis systhine has adequate water pressure and volume so it can produce the desired amount of water. The i sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications.

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K033648

Page 3 of 3

The Performance Water Treatment System is Intended Use: intended to be used to remove organic and intendou to beaminants from a tap water supply to illute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.

Predicate Device: The Performance Water Treatment System and its components are substantially equivalent to the Better Water, Inc. Water Purification System for Hemodialysis, K#920186/C. Both the predicate device systems and the Performance Water Treatment System utilize reverse osmosis technology as the primary means of purification, and all utilize an R.O. which has 510(k) clearance from the FDA.

Non-Clinical Performance Data:

The Performance Water Treatment System produces i product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Mr. Robert P. Downey Manager Performance Water Systems, LLC 13601 South Kenton Avenue CRESTWOOD IL 60445

Re: K033648

Trade/Device Name: Performance Water Treatment System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: August 1, 2004 Received: August 3, 2004

Dear Mr. Downey:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(x) premantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have delemined the actress to redicate devices marketed in interstate for use stated in the enclosure) it regally manced prodited Device Ameridae, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Days commerce prior to May 28, 1970, the chacinent and select one of the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the greats for annual registration, listing of
general controls provisions of the Act include requirements for any and general controls provisions of the Act morade requirements of the manufactures and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (see above) into crime regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affectives it may be subject to additional controls. Extraing mg Solo to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts of Register found in the Code of rederal Regulations, Four device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA Stssualles of a substitution with other requirements of the Act
that FDA has made a determination that your device of and orders . You must that FDA has made a delemination that your cerres by other Federal agencies. You must or any Federal statutes and regulations administed to: registration and listing comply with all the Act 5 requirencents, medaling practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicable, the electronic (2) CFR Part 807); labeling (21 CFR Pair 800); good namb f
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 OFR Public of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-105

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l'are ?

This letter will allow you to begin marketing your device as described in your Section 10(k)
10 alers and the supportion for the finding of substantial equivalence of a leg This letter will allow you to begin marketing your device of your device of your device to a le;ally
premarket notification The FDA finding of substantial equivalence and t prematication - The FDA linding of substantial Quivalence or your device and thus, permits your device
marketed predicate device results in a classification for your device a to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and on the security of the following numbers, based on the regulation If you desire specific advice for your device on our laooling ough 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 advice, please contact the Additionally, for questions on the promotion and administration, "Misbranding
Office of Compliance at (30) 594-4639. Also, please note this regulation of ther general Office of Compliance at (301) Systems (21CFR Part 807.97) you may obtain. Other general
by reference to premarket notification" (21CFR Part be obtained from the Division of by reference to premarket nothication (21C/A 1 are 0077) your drom the Division of Small
information on your responsibilities under the Act may be obtained from the Division information on your responsibilities under the Asstance at its toll-free number (800) 638-2041 or
Manufacturers, International and Chisantes Asstance at its toll-free number Manufacturers, International and Consumer Assistance at to con and Constitutional (1978)
(301) 443-6597 or at its Internet address http://www.fda.gov/odrh/dsmaldsmamin.itml.

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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K023648

Page / of /

510(k) Number (if known): المثال Hot Assigned

K033648

Device Name: Performance Water Treatment System

Indications for Use:

NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _V (Per 21 CFR 801.109)

David A. Legum

(Division Sign-Off) Division of Reproductive, and Radiological De 510(k) Number

Regulation Number and Section

§ 876.5665 Water purification system for hemodialysis.

(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.