(187 days)
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No
The summary describes a reverse osmosis water purification system for hemodialysis and focuses on hardware validation and water quality testing. There is no mention of AI or ML.
No.
The device purifies water for hemodialysis treatments; it does not directly perform a therapeutic function on a patient. While essential for the therapy, the device itself is a water treatment system, not a therapeutic device.
No
Explanation: The device is a reverse osmosis unit used to purify water for hemodialysis treatments. It is not designed to diagnose medical conditions or diseases in patients. Instead, it processes water to meet quality standards for a medical procedure.
No
The device description and performance studies clearly indicate this is a physical reverse osmosis unit with hardware components, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD). Here's why:
- Intended Use: The intended use is to supply purified water for hemodialysis treatments. This is a process that supports a medical treatment, but it does not involve testing samples taken from the human body to provide diagnostic information.
- Device Description: The device is described as a reverse osmosis unit for purifying water. This aligns with its intended use of preparing water for a medical procedure, not for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is a water purification system used in the context of a medical treatment (hemodialysis), but it is not performing a diagnostic test itself.
N/A
Intended Use / Indications for Use
The MedRO™-SPD is intended to be used as a component of a water purification system for Hemodialysis.
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.
Product codes (comma separated list FDA assigned to the subject device)
78 FIP
Device Description
MedRO™-SPD is a reverse osmosis unit used to purify water in hemodialysis applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Installation Qualification (IQ): Performed to verify components were installed according to design specifications and drawings. Two discrepancies were noted and corrected (electrical drawing and P&ID tubing material). The unit passed the Installation Qualification, including hydrostatic testing and alarm operability.
- Operational Qualification (OQ): Performed to provide evidence that the unit operates according to design specifications. Tested for proper response to power failure, and verified output responses for all operating sequences, switches, buttons, indicators, and simulated alarm conditions.
- Failure Analysis Test (FAT): Performed to ensure the system operates as specified when introduced to failures. Tested with reject value set to 100% (to simulate low quality reading and force alarm) and water pressure below 15-psi. The unit passed, demonstrating correct alarm function and shutdown/restart behavior.
In addition, water samples were collected to test for AAMI quality water; bacteria and endotoxin requirements. The unit significantly reduced chemical contaminants to below FDA recognized standards and also reduced bacteria and endotoxin in product water.
Clinical Performance Data:
This unit is not required to have Clinical Test performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MedRO™ Reverse Osmosis System (# K013677)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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.
Nancy C. Brogdon
(Division Sign-Off (Division of Reproductive, Abdor Divisiand Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)