The HydroPure "Acute" Portable Exchange Deionization (PEDI) System consists of two each small carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be placed on the back of a dialysis machine or on a handcart for single patient dialysis.

The HydroPure "Central" PEDI System consists of two or more carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be installed in a central location for multiple patient dialysis.

The HydroPure "Back-up" PEDI System consists of two or more mixed bed DI tanks as a component in a "back-up" condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions that an RO could not lower to safe levels.

All three PEDI systems with appropriate pre & post-filtration and components is intended for use with a hemodialysis system to remove organic and inorganic substances from water that is used to dilute dialysis concentrates to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.

Device Description

The HydroPure systems purify potable feed water through deionization. Deionization is used to remove 99.99+% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The systems require adequate pretreatment and post-treatment. Deionizers are designed for the hemodialysis application to treat RO or carbon filtered potable water. Inappropriate use can result in the formation of Nitrosamines in the effluent of the deionizer.

The purpose of the pretreatment section of the system is to condition the feed water supplying the deionizers. Conditioning the feed water will include: pressure reducing valves to regulate system pressure, check valves to prevent back-flow of the treated water into the potable water source, cartridge filters to reduce particulates and sediment, carbon filtration tanks to remove chloramines and sample ports after each carbon tank to check feed water conductivity and for any chlorine/chloramine residual.

The purpose of the post-treatment section of the system is to remove bacteria and endotoxins or lower them to acceptable levels as required by the AAMI standards. The post-treatment section of the system will include: submicron/ultrafilters after the deionizers. sample ports to check for microbial contamination and to test for comprehensive AAMI analysis, a 200K ohm quality control light at mid tank and a temperature compensated audible visual resistivity alarm set at one megohm or greater for final water quality. A remote alarm will be installed if the deionization system is not located in the patient treatment area. A distribution section of a system is necessary to deliver product water that meets ANSI/AAMI standards to the points of use. During use, continual monitoring of the effluent through the use of the temperature compensated audible and visual resistivity alarm is required. Routine monitoring of the mid tank quality indicator is also required on intervals during the day, at least before and after each patient treatment.

Should final water quality fall at or below 1 megohm, the alarm will sound and light up red and all patient treatments must be discontinued. The deionization tanks must be replaced as per Appendix C of the operating manual prior to resuming any patient treatment.

Depending upon the PEDI system size and feed water quality of 10grains TDS, HydroPure systems produce typically 250 gallons per deionization tank exchange at a flow-rate of up to 0.75gpm, to 3,600 gallons per deionization tank exchange at a flowrate of up to 15gpm.

HydroPure's water purification systems will produce product water that meets the requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment For Hemodialysis Applications.

AI/ML Overview

The provided text describes a 510(k) submission for water purification systems for hemodialysis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive performance studies with specific acceptance criteria in the manner typically seen for novel diagnostic or treatment devices.

Therefore, the information required for this request related to acceptance criteria, test set details, expert involvement, and ground truth establishment is not explicitly present or applicable in the provided 510(k) summary. The submission focuses on device description and intended use, and then asserts (and the FDA confirms) substantial equivalence to a predicate device based on regulatory standards.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary acceptance criterion mentioned for the device's performance is that it "will produce product water that meets the requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment For Hemodialysis Applications." Specific numerical thresholds are mentioned within the device description for monitoring:
- Temperature compensated audible visual resistivity alarm set at one megohm or greater for final water quality.
- If final water quality falls at or below 1 megohm, the alarm will sound and patient treatments must be discontinued.
Reported Device Performance:
- "Deionization is used to remove 99.99+% of ions from water."
- "HydroPure systems produce typically 250 gallons per deionization tank exchange at a flow-rate of up to 0.75gpm, to 3,600 gallons per deionization tank exchange at a flowrate of up to 15gpm." (This is dependent on PEDI system size and feed water quality of 10 grains TDS).

Acceptance Criteria (from ANSI/AAMI RD62:2001 & device specific monitoring)	Reported Device Performance
Product water meets ANSI/AAMI RD62:2001 standards	Device produces water meeting ANSI/AAMI RD62:2001 requirements
Final water quality ≥ 1 Megohm (resistivity)	Temperature compensated audible visual resistivity alarm set at one megohm or greater.
Ion removal effectiveness	99.99+% of ions removed
System output capability (dependent on size/feed water)	250 - 3,600 gallons per deionization tank exchange at 0.75-15gpm

Regarding the study that proves the device meets the acceptance criteria:

The document does not describe a specific clinical or performance study in the traditional sense, with a detailed methodology, sample size, or expert involvement. Instead, it seems the proof of meeting the ANSI/AAMI standard is inherent in the device's design, monitoring features (resistivity alarm, mid-tank indicator), and the known performance characteristics of deionization technology when appropriately configured. The phrase "HydroPure's water purification systems will produce product water that meets the requirements..." suggests a declaration based on engineering design and expected performance, rather than results from a specific, independent study detailed in this summary.

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

Not explicitly provided. There is no mention of a specific test set, its sample size, or data provenance (country, retrospective/prospective). The submission relies on demonstrating substantial equivalence to a predicate device and adherence to an existing standard.

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

Not applicable/Not explicitly provided. There is no mention of experts establishing a ground truth for a test set in this context. The "ground truth" is defined by the ANSI/AAMI RD62:2001 standard.

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

Not applicable/None mentioned. Given the nature of the device (water purification system) and the regulatory submission type (510(k) for substantial equivalence), a multi-reader adjudication method for a test set like in a diagnostic imaging study is not relevant or described.

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

No. This device is a water purification system, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant.

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

Not applicable. This is not an algorithmic device. Its performance is intrinsic to its physical operation. The "standalone" performance here refers to the system's ability to purify water to the specified standard as a physical product.

7. The type of ground truth used

Established Standard: The ground truth for performance is the "requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment For Hemodialysis Applications." This standard likely details acceptable levels of organic and inorganic substances and microbial contaminants.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, no training set is involved.

Summary

{0}------------------------------------------------

KO22747 PAGE 1 OF 2

FEB 1 1 2003

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is provided as part of this Premarket Notification to comply with the provisions of the safe Medical Devices Act of 1990 requiring that either a summary be included in a submission or a statement that a summary is available upon request.

Submitter

Robert V. Price HydroPure Systems, Inc. 3319 Bartlett Blvd. Orlando, FL. 32811 TEL: (407) 428-9377 FAX: (407) 648-0817 July 23, 2002

Device Names

Trade Names

HydroPure "Acute" Portable Exchange Deionization (PEDI) System HydroPure "Central" PEDI System HydroPure "Back-up" PEDI System

Common or usual name

Deionization systems with pre & post treatment and product water distribution components.

Classification name

Water purification systems for hemodialysis (21CFR 876.5665)

Intended Use

HydroPure Deionization Systems with pre & post-treatment and product water distribution components are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrates to form dialysate, reprocessing of hemodialyzers and equipment rinse and disinfection.

{1}------------------------------------------------

K022747 PAGE 2 OF 2

Device Description

Predicate Device

The Hydropure PEDI Systems and pretreatment and product water distribution components are substantially equivalent to US Filter Corporation's water treatment system for dialysis which utilizes carbon and deionization cylinders to purify water for hemodialysis.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 11 2003

Mr. Robert V. Price President HydroPure Systems, Inc. 3319 Bartlett Blvd. ORLANDO FL 32811

Re: K022747

Trade/Device Name: HydroPure Systems, Inc. PEDI Water Purification Systems for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: December 11, 2002 Received: December 17, 2002

Dear Mr. Price:

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 (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.

{3}------------------------------------------------

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 Office of Compliance at one of the following numbers, based on the regulation 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 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" (21CFR Part 807.97) you may obtain. 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 vours.

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

Page 2

{4}------------------------------------------------

Page 1 of 1

510(k) Number K022747

HydroPure "Acute" Portable Exchange Deionization (PEDI) System Device Name: HydroPure "Central" PEDI System. HydroPure "Back-up" PEDI System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109) (Optional Format 3-10-98)

David A. Segner

and Rad 510(k) Nun

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.