Minntech Corporation's RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in an approved dialyzer reprocessing program.

Device Description

The RenaClear™ Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to an institutions approved dialyzer reprocessing program. The stand-alone countertop system is equipped with two header cleaners that attach to the blood ports of a dialyzer. The header cleaners have a retractable, rotating, directional needle jet that will inject a water/air mixture into the dialyzer header and blood pathway. Simultaneously the dialyzer dialysate compartment and the exterior of the dialyzer fibers will be pressurized water to achieve reverse ultrafiltration.

The operator, through the use of a membrane switch front panel, controls the RenaClear™ Dialyzer Cleaning System. Operators have the following cycle choices: Dialyzer clean, system clean, system sanatize and system rinse.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RENACLEAR™ DIALYZER CLEANING SYSTEM based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety of the RenaClear™ Dialyzer Cleaning System	The device is stated to be safe.
Equivalent performance to the predicate device (Renatron® II Dialyzer Reprocessing System pre-clean cycle)	Functionality testing showed equivalent performance to the predicate device.
Material compatibility with chemicals used in the system as specified in the labeling	All materials were tested for compatibility with the chemicals used.
Effectiveness in facilitating the cleaning of blood and other debris from multiple-use hollow fiber dialyzers	The device is stated to be effective when used in accordance with labeling.
Substantial equivalence to legally marketed predicate devices	The FDA determined the device is substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only states that "Minntech Corporation has performed functional testing."

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The provided information does not mention using experts to establish ground truth or their qualifications. The evaluation appears to be based on functional testing and material compatibility.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method for a test set. This type of detail is typically relevant for studies involving human interpretation or subjective assessment, which doesn't seem to be the primary focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size for human reader improvement with or without AI assistance. This type of study is not relevant for a device focused on mechanical cleaning.

6. Standalone (Algorithm Only) Performance Study

The provided text does not describe a standalone (algorithm only) performance study. The device is a physical cleaning system, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for this device's evaluation appears to be based on:

Functional performance criteria: Showing the system performs its intended cleaning function.
Material compatibility testing: Verifying that the materials used are suitable for the chemicals involved.
Comparison to a predicate device: Demonstrating that its performance is equivalent to an already approved device.

There is no mention of expert consensus, pathology, or outcomes data as a ground truth for cleaning efficacy in the provided summary.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. This concept is typically relevant for machine learning or AI models, which is not the nature of this device.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the establishment of its ground truth is not applicable to this device description.

Summary

{0}------------------------------------------------

RENACLEAR™ DIALYZER CLEANING SYSTEM

510(k) Summary of Safety and Effectiveness

Manufacturer:	Minntech Corporation
Address:	14605 28th Avenue NorthMpls, MN 55447USA
Official Contact:	Robert JohnsonVice President, Regulatory Affairs and Quality Assurance

Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the RenaClear™ Dialyzer Cleaning System to other dialyzer pre-cleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States.

1. Device Description

1. Intended Use
  Minntech Corporation's RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in a dialyzer reprocessing program.

3. Comparison to Another Device in Commercial Distribution Within the United States

The RenaClear™ Dialyzer Cleaning System is equivalent to other dialyzer precleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States. The Renatron® II Dialyzer Reprocessing System

{1}------------------------------------------------

(K904210) pre-clean cycle is intended to pre-clean multiple-use dialyzers prior to testing and sterilization.

Summary 4.
- Minntech Corporation has performed functional testing to show the 4.1 RenaClear™ Dialyzer Cleaning System is safe and has equivalent performance with respect to the predicate device.
- 4.2 All materials have been tested for material compatability with the chemicals used in the system as specified in the labeling.
న. Summary of Substantial Equivalence

Minntech Corporation has provided the above information within the 510(k) to support the claim that the RenaClear™ Dialyzer Cleaning System is safe and effective when used in accordance with the device labeling.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized image of a human figure embracing a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. Richard M. Ormsbee Regulatory Affairs Associate Minntech Corporation 14605 28th Avenue, N. Minneapolis, MN 55447

Re: K991851 RenaClear™ Dialyzer Cleaning System Dated: May 27, 1999 Received: June 1, 1999 Regulatory Class: II 21 CFR §876,5820/Procode: 78 LIF

Dear Mr. Ormsbee:

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 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 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 Requlations. 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 assumplions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 requlation (21 CFR Part 801 and additionally 809.10 for in viro diagnostic devices), piease 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,

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

{3}------------------------------------------------

Indications for Use

510(k) Number (if Known):

*K991851

Device Name:

RenaClear™ Dialyzer Cleaning System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per21 CFR 801.109)
OR
Over-the Counter-use
(Optional Format 1-1-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991851

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.