The USFilter MedRO - SPD is a single/acute care patient reverse osmosis unit intended to supply water that is used for hemodialysis treatments. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5:1992 and RD62:2001) and the CSA Water Treatment Equipment and Water Quality Requirements for Hemodialysis (CSA-Z364.2.2-03) when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.

Device Description

MedRO™-SPD is a reverse osmosis unit used to purify water in hemodialysis applications.

AI/ML Overview

The provided document describes the MedRO™-SPD, a water purification unit for hemodialysis, and its performance testing. However, it does not include information about a study proving the device meets acceptance criteria in the context of a medical AI device, as implied by the structure of the requested output.

Specifically, the document pertains to hardware validation and water quality testing of a physical device, not an AI algorithm. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text, highlighting the differences:

The document describes performance testing for a physical medical device (a reverse osmosis unit), not an AI algorithm. Thus, questions related to AI-specific terms like "test set," "training set," "ground truth experts," "MRMC study," and "standalone AI performance" are not applicable.

Here's an attempt to answer the questions based on the provided content, acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (AAMI Standards)	Reported Device Performance
AAMI quality water (chemical contaminants)	Unit was able to significantly reduce chemical contaminants to amounts below the FDA recognized standard and AAMI requirements.
Bacteria reduction (AAMI requirements)	Unit was able to reduce bacteria in the product water.
Endotoxin reduction (AAMI requirements - not FDA recognized at time of submittal)	Unit was able to reduce endotoxin in the product water.
Components installed according to design (IQ)	Passed (after correction of two discrepancies: electrical drawing and tubing material).
Unit operates according to design specifications (OQ)	Passed (tested for power failure response, operating sequences, switch/button/indicator functions, alarm conditions).
Unit operates as specified during failures (FAT)	Passed (tested for low quality alarm, low water pressure shutdown, accurate rejection/quality readings).
Alarms operational when preset requirements aren't met	Alarms were given forced conditions and were operational.
Product water meets AAMI RD5 quality water	Both systems are designed so the product water will meet AAMI RD5 quality water. (Verified through sampling).

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

Sample Size: For water quality testing (chemical, bacteria, endotoxin), "Two samples were drawn for the water testing to assure reproducibility of these results." Other tests (IQ, OQ, FAT) involved functional testing of the single unit.
Data Provenance: The testing was conducted on the MedRO™-SPD unit itself, installed to a potable water source. This is a prospective, in-house validation of the manufactured device.

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

This question is not applicable as the "ground truth" here refers to objective measurements against established engineering specifications and AAMI water quality standards, not expert interpretations of medical images or data. The "experts" would be the engineers performing the validation and laboratory technicians analyzing water samples according to standard protocols.

4. Adjudication method for the test set

Not applicable in the context of a physical device validation. Results were determined by direct measurement against pass/fail criteria (e.g., AAMI standards, functional test outcomes).

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 for a physical water purification device, not an AI system.

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

Not applicable. This is for a physical water purification device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" was based on:
- Engineering Design Specifications: For Installation Qualification (IQ), Operational Qualification (OQ), and Failure Analysis Test (FAT).
- ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5:1992 and RD62:2001): For chemical contaminants, bacteria, and endotoxin levels in the product water.

8. The sample size for the training set

Not applicable. This is for a physical water purification device, not an AI system. There is no "training set" in the AI sense. The device's design and manufacturing are based on established engineering principles and prior experience (e.g., the predicate device MedRO™ Reverse Osmosis System).

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

Not applicable. As noted above, there is no AI training set. The "ground truth" for the device's design and operation comes from engineering best practices, regulatory requirements, and industry standards like AAMI.

Summary

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SEP - 3 2003

030652
PAGE 1 OF 3

510(k) Summary

1. Submitter's Information

USFilter/lonpure Inc. 10 Technology Dr. Lowell, MA 01851 p) 978-614-7359 f) 978-441-6037 Robert Dudek, Regulatory Compliance Manager February 27, 2003

2. Device Information

Name: MedRO™-SPD Common Name: Single Patient Dialysis Reverse Osmosis Unit Classification: Water Purification Component for Hemodialysis

3. Predicate Device Information

MedRO™ Reverse Osmosis System (# K013677)

4. Device Description

MedRO™-SPD is a reverse osmosis unit used to purify water in hemodialysis applications.

5. Intended Use

The MedRO™-SPD is intended to be used as a component of a water purification system for Hemodialysis.

6. Comparison to Predicate Device

The MedRO-SPD™ and the MedRO™ both provide the same function using the same technology. The fundamental difference is the MedRO-SPD™ is smaller in size to the MedRO™. Both systems are designed to remove contaminants from the water supply prior to use in hemodialysis treatment by using the method of Reverse Osmosis. Both units utilize RO membranes in a single pass multi-stage format; feed water is passed through a series of 3 membranes to purify the water. Both systems measure quality of water and provide alarms when preset requirements aren't met. Both systems are also designed so the product water will meet AAMI RD5 quality water.

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7. Non-clinical Performance Data

There were three hardware validations performed and product water samples drawn to test for AAMI water quality, bacteria, and endotoxin from the MedRO™-SPD unit.

The Installation Qualification (IQ) was performed to verify the components used to construct the MedRO™ unit were installed according to design specifications and drawings. The system was installed in accordance with the P&ID, Electrical Schematic, Bill of Material, and Operations & Maintenance Manual. There were two discrepancies noted and corrected. The first discrepancy was found on the electrical drawing, RX101-051, the transformer was not drawn correctly. The drawing has been revised and is now correct. The second discrepancy was found in the P&ID, RX101-003. The drawing indicated Polyethylene tubing which is not appropriate for medical use, the drawing has since been corrected to indicate polypropylene tubing. The tubing and vessels passed the hydrostatic testing that was performed. The unit was designed, assembled and installed with no deadlegs. The alarms were given forced conditions from the O&M Manual and were operational. The MedRO™-SPD unit passed the Installation Qualification.

The unit ran for 14 hours while performing the Operational Qualification (OQ). This was performed to provide evidence that the unit will operate according to design specifications. The unit was tested for proper response in the case of a power failure. Concluding that it will shut off during a power failure and require a manual re-start upon the power being restored. The unit was ran through all operating sequences that are specified in the O&M Manual and verified the output of the device responded and that those responses were correct. Switches, buttons and indicators were tested to verify the functions and displays are what were specified. Alarm conditions were simulated to verify that the unit would alarm for necessary conditions.

A Failure Analysis Test (FAT) was performed to ensure that when the system is introduced to failures that it operates as specified. The reject value was set to 100% (100% rejection is an unachievable limit which will force the system into alarm simulating a low quality reading) and the Low Quality Alarm did sound. The water pressure was set below the 15-psi requirement; the unit shut down and required manual re-start to restore power to the unit. The system was also tested to indicate accurate rejection, feed water quality, product water quality and current set points. The unit passed the Failure Analysis Test.

In addition to the above testing, water samples were collected to test the unit for AAMI quality water; bacteria and endotoxin requirements set by AAMI. At this time the FDA does not recognize the AAMI limit for endotoxin, but because the end user will test for endotoxin levels we felt it would be informative to provide this test also. The unit was installed to a potable water source with a 10" carbon filter preceding the unit (to protect the membranes from chlorine) and ran for 30 minutes prior to sampling. The unit was able to significantly reduce the chemical contaminants in water to amounts below the FDA recognized standard. The unit was also able to reduce bacteria and endotoxin in the product water.

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KO30652 PAGE 3 OF 3

8. Clinical Performance Data

This unit is not required to have Clinical Test performed.

9. Conclusions of Performance Data

The MedRO-SPD unit passed a battery of diagnostic tests including, three hardware validations, AAMI water analysis, bacteria and endotoxin testing. Two samples were drawn for the water testing to assure reproducibility of these results.

10. Additional Safety & Effectiveness

In addition to the testing conducted for this submittal, the USFilter service/installation facility follows procedure 11.030, Service Department Responsibility for Dialysis Installation and Start-up, in our QSR Manual (see #K980182). According to this procedure the unit must pass acceptable bacteria, endotoxin and chemical contaminant criteria prior to releasing the unit to the end user.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2003

Mr. Robert Dudek Regulatory Compliance Manager U.S. Filter/lonpure, Inc. 10 Technology Drive LOWELL MA 01851

Re: K030652

Trade/Device Name: Med-RO™-SPD (Single Patient Dialysis Reverse Osmosis) Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: June 4, 2003 Received: June 5, 2003

Dear Mr. Dudek:

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.

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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 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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Indications for Use

Nancy C. Brogdon

(Division Sign-Off (Division of Reproductive, Abdor Divisiand Radiological Device 510(k) Number

Prescription Use (Per 21 CFR 801.109)

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.