(181 days)
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No
The summary describes a physical water filter and its performance characteristics, with no mention of software, algorithms, or AI/ML concepts.
No.
The device is a water filter for hemodialysis applications, designed to remove impurities like bacteria, endotoxins, and particulate matter from water, not to treat a patient's medical condition directly.
No
This device is described as a water filter for hemodialysis applications, intended to remove bacteria, endotoxin, and particulate matter. It performs a filtration function, which is not characteristic of a diagnostic device that detects or identifies diseases or conditions. The performance studies listed (Pressure Drop vs. Flow Rate, Endotoxin Rejection, Minimum and Maximum Water Flow Rates and Extractables testing) relate to its filtration efficacy, not diagnostic capability.
No
The device description clearly outlines physical components like a polysulfone membrane and polycarbonate housing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter water for hemodialysis applications. This is a process that prepares water for use in a medical procedure, not a test performed in vitro (outside the body) on a biological sample to diagnose a condition.
- Device Description: The device is a filter designed to remove contaminants from water. This aligns with a water purification or preparation device, not an IVD which typically involves reagents, assays, or analytical methods for testing biological samples.
- 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 specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
The device's function is to prepare a necessary component (water) for a medical procedure (hemodialysis), not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The FiberFlo™ Capsule Water Filter is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.
Product codes (comma separated list FDA assigned to the subject device)
78 FIP
Device Description
The FiberFlo™ Hollow Fiber Capsule Water Filters consist of encapsulated microporous polysulfone membrane in a polycarbonate housing with multiple endcap connections to filter endotoxins, bacteria and particulates from water.
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)
The following performance testing was conducted to support substantial equivalence as a water filter for its intended use: Pressure Drop vs. Flow Rate, Endotoxin Rejection, Minimum and Maximum Water Flow Rates and Extractables testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
FiberIllo™ Hollow Fiber Water Filters
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.
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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).
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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.
0
MINNTECH MAR-03-99 WED 11:27 AM
FAX NO. 6125533387
387 K983/P.036
3/8/99
. . . .
510(k) SUMMARY
1. Submitter Information:
| Name: | Fibercor®, Division of Minntech Corporation | |
|---|---|---|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 | |
| Contact Person: | Mark Murphy | |
| Date Prepared: | September 4, 1998 |
2. Device Name:
| Proprietary name: | Fiberllo™ Hollow Fiber Capsule Water Filters |
|---|---|
| Common name: | Capsule Filters |
| Classification name: | Water Purification Subsystem per 21 CFR 876.5665 |
3. Predicato Devicc:
FiberIllo™ Hollow Fiber Water Filters
Devicc Description: 4.
The FiberFlo™ Hollow Fiber Capsule Water Filters consist of encapsulated microporous polysulfone membrane in a polycarbonate housing with multiple endcap connections to filter endotoxins, bacteria and particulates from water.
ડ. Indications for Use:
| Device | Indications |
|---|---|
| Fibercor®FiberFlo™™ | |
| Hollow Fiber Capsule | |
| Water Filters | The FiberFlo™ series of Hollow Fiber Capsule Water |
| Filters is intended to filter bacteria, endotoxin and | |
| particulate matter from water used for hemodialysis | |
| applications. | |
| Fibercor® FiberFlo™ | |
| Hollow Fiber Water | |
| Filters | The FiberFlo™ Cartridge series of Hollow Fiber Water |
| Filters is designed to filter bacteria, endotoxin and | |
| particulate matter from water used by medical devices. |
1
6. Technological Characteristics:
A comparison of the FiberFlo™ Hollow Fiber Capsule Water Filters and predicate
| Characteristic | FiberFlo™ Hollow Fiber Capsule Water Filters | FiberFlo™ Hollow Fiber Water Filters |
|---|---|---|
| Case Material | Polycarbonate | Polypropylene |
| Potting Material | Polyurethane | Polyurethane |
| Microporous Membrane | Polysulfone | Polysulfone |
| Membrane Porosity | 50, 100 and 200 micron | 50, 100 and 200 micron |
| Sanitizable | Yes | Yes |
| Water System location | Product water supply lines | Product water supply lines |
7. Performance Testing:
The following performance testing was conducted to support substantial equivalence as a water filter for its intended use: Pressure Drop vs. Flow Rate, Endotoxin Rejection, Minimum and Maximum Water Flow Rates and Extractables testing.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 1999
Mr. Mark Murphy Regulatory Affairs Associate MINNTECH® Corporation 14605 28th Avenue North Minneapolis. MN 55447
Re: K983126
FiberFlo™ Capsule Water Filter Dated: December 7, 1998 Received: December 8, 1998 Regulatory Class: II 21 CFR 876.5665/Procode: 78 FIP
Dear Mr. Murphy:
We have reviewed vour 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 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). 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 (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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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/dsma/dsmamain.html".
Sincerely yours,
CART Daniel S. Stadler, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/15 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract design that resembles an eagle or bird-like figure.
3
Indications for Usc
510(k) Number (if known): K983126
FiberFloTM Capsule Water Filter Device Name:
Indications for Use:
The FiberFlo™ Capsule Water Filter is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-the -counter-use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983126/8⁰⁰¹