(300 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on water purification for hemodialysis.
Yes
The device is a water purification system used in hemodialysis applications, which is a therapeutic treatment.
No
Explanation: The device is a water purification system intended for use in hemodialysis applications by removing contaminants from water. Its purpose is to prepare water for medical procedures, not to diagnose a condition or disease in a patient.
No
The device description clearly states "Water Purification System," which is a hardware device. The intended use also describes a physical system for purifying water. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for purifying water used in hemodialysis applications. This is a process related to treating a patient's blood, not for testing a sample taken from the body to diagnose a condition.
- Device Description: It's described as a "Water Purification System," which aligns with its intended use in preparing water for a medical procedure.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This water purification system does not fit that description.
N/A
Intended Use / Indications for Use
The USFitter water punfication systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from the subcent can be dilute dialysis concentrate to form water used to cince broyous began for other Gialysate, and rinse and disinfection.
Product codes
78 FIP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Ardizzoni V.P. Quality and Regulatory Affairs U.S .- Filter Corporation 10Technology Drive Lowell, MA 01851
Re: K980182 US Filter Water Purification System Dated: August 26, 1998 Received: September 3, 1998 Regulatory Class: II 21 CFR 876.5665/Procode: 78 FIP
Dear Ms. Ardizzoni:
NOV 1 6 1998
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
K980182 510(k) Number (if known): Device Name: Water Purification System Indications For Use:
The USFitter water punfication systems discussed in this premarket notification are intended for use in hemodialysis applications. The water purification systems are used to remove organic and inorganic substances and microbial contaminants from the subcent can be dilute dialysis concentrate to form water used to cince broyous began for other Gialysate, and rinse and disinfection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980182/S⁰⁰²
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formst 1-2-96)