The FiberFlo™ series of Hollow Fiber Capsule Water Filters is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (FiberFlo™ Hollow Fiber Capsule Water Filters) and does not describe a study involving AI or machine learning. Therefore, most of the requested information regarding acceptance criteria, device performance, and study design relevant to AI models cannot be extracted.

However, I can provide the limited information available regarding the device's performance testing and general characteristics.

Information Extracted from the Document (Non-AI Device):

The document describes a conventional water filter, not an AI-powered device. Therefore, the questions related to AI acceptance criteria, sample sizes for AI training/test sets, ground truth establishment by experts, and MRMC studies are not applicable.

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

The document mentions performance testing but does not explicitly state numerical acceptance criteria or detailed quantitative results for each test. It broadly states that the testing was "to support substantial equivalence."

Characteristic / Test	Acceptance Criteria (Not explicitly stated as numerical values in document)	Reported Device Performance (Summary)
Intended Use	Filter bacteria, endotoxin, and particulate matter from water for hemodialysis applications.	Considered "substantially equivalent" to predicate devices for its intended use based on performance testing.
Pressure Drop vs. Flow Rate	(Not specified)	Testing conducted to support substantial equivalence.
Endotoxin Rejection	(Not specified)	Testing conducted to support substantial equivalence.
Minimum and Maximum Water Flow Rates	(Not specified)	Testing conducted to support substantial equivalence.
Extractables Testing	(Not specified)	Testing conducted to support substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable, as this is a physical device, not an AI model evaluated on a data set. The performance testing would involve physical units of the filter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth for a physical filter's performance is established through laboratory measurements and established testing protocols, not expert consensus on data.

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

Not applicable.

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.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this physical device, the "ground truth" would be objective measurements from laboratory tests according to recognized standards (e.g., bacterial retention challenge tests, endotoxin assays, flow rate measurements).

8. The sample size for the training set:

Not applicable.

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

Not applicable.

Summary

{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.

ડ. Indications for Use:

Device	Indications
Fibercor®FiberFlo™™Hollow Fiber CapsuleWater Filters	The FiberFlo™ series of Hollow Fiber Capsule WaterFilters is intended to filter bacteria, endotoxin andparticulate matter from water used for hemodialysisapplications.
Fibercor® FiberFlo™Hollow Fiber WaterFilters	The FiberFlo™ Cartridge series of Hollow Fiber WaterFilters is designed to filter bacteria, endotoxin andparticulate 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)

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

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.