To aid in the cleaning of the headers, header spaces, and header caps of multiple-use hemodialyzers prior to an approved reprocessing procedure for reusable hemodialyzers.

Device Description

The ASSIST Header Cleaner™ is a one-piece device used to assist with the manual cleaning of headers in reusable hemodialyzers. One end of the ASSIST unit is inserted and attached to the arterial blood port on the header cap. The other end of the ASSIST unit is connected to a supply of reverse osmosis water. Jets of RO water are sprayed inside of the header to break up and clear away any debris, including clotted blood, in the header space. The dialyzer is manually turned along its longitudinal axis during this process to allow the water jets to contact all side surfaces of the header. This operation is repeated on the venous end where, besides cleaning, the water is used to flush the blood/debris/water mixture from the arterial end of the dialyzer. The dialyzer is flipped again and the process is repeated for a second time at the arterial end to flush away any blood/debris/water mixture from the venous end of the dialyzer.

AI/ML Overview

This submission does not contain information typically found in a study for an AI/ML device. The "ASSIST Header Cleaner™" is a non-AI manual device designed to assist in cleaning hemodialyzer headers. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable.

Here's an analysis based on the provided text, addressing the relevant sections:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not specify quantitative acceptance criteria. Instead, it makes a general statement about the device's performance relative to existing technology.

Acceptance Criteria (Implied)	Reported Device Performance
Safe and effective	"Tests have been performed which demonstrate the ASSIST Header Cleaner™ is safe and effective."
Performs as intended	"performs as intended"
Does not adversely affect the hemodialyzer	"without adversely affecting the hemodialyzer being cleaned."
Materials compatible for intended use	"The materials used in the ASSIST Header Cleaner™ are compatible for its intended use."
As safe and effective as other dialyzer cleaning systems currently in use in the US	"When used as indicated in the Directions for Use, the ASSIST Header Cleaner™ is as safe and effective as other dialyzer cleaning systems currently in use in the United States."

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

The document states that "Tests have been performed," but does not provide any details regarding sample size, type of test set (e.g., dialyzers tested), or data provenance (e.g., country of origin, retrospective or prospective). Given the nature of the device (manual cleaning tool), the "test set" would likely refer to the number of hemodialyzers on which the cleaning performance was evaluated and the impact on the dialyzer's integrity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. For a non-AI device like this, "ground truth" would likely refer to objective measurements of cleanliness or dialyzer integrity, rather than expert interpretation of medical images.

4. Adjudication Method for the Test Set

No adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a manual medical device, not an AI/ML algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant. The comparison mentioned is between the new device and existing "dialyzer cleaning systems currently in use in the United States."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

Not Applicable. This is not an AI algorithm; it's a manual device. It can be considered a standalone device, as its function doesn't rely on human interpretation of its internal "decisions" or AI output, but its effectiveness is still predicated on human operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for testing. For a device cleaning hemodialyzers, the ground truth would likely involve:

Visual inspection: To confirm removal of visible debris/blood.
Quantitative measurements: Such as residual blood protein assays, or testing of dialyzer performance parameters (e.g., clearance, ultrafiltration coefficient) after cleaning and reprocessing to ensure no damage.
Material compatibility tests: To ensure the device does not leach harmful substances or damage the dialyzer materials.

8. The Sample Size for the Training Set

Not Applicable. This is a manual device, not an AI/ML model, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary

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Premarket Notification [510(k)] Summary

ASSIST Header Cleaner™

Submitter's Name:	Alcavis International
Address:	8 - 8 Metropolitan CourtGaithersburg, MD 20878
Phone number:	(301) 330-7597
Fax Number:	(301) 330-6432
Contact Name:	Mr. Gary J. MishkinVice President, Research and Development
Date Summary Prepared:	November 8, 2004
Device Trade Name:	ASSIST Header Cleaner™
Common Name:	Dialyzer Reprocessing System
Substantially Equivalent Device:	RenaClear® Dialyzer Cleaning System(K991851)

A. Device Description

B. Intended Use

In the clinical setting, to clean residual blood and other debris from the headers, header spaces and the insides of header caps of multiple-use hemodialyzers prior to an approved reprocessing process for hemodialyzers

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C. Comparison of Technological Characteristics to Substantial Equivalent Device:
The ASSIST Header Cleaner™ is a manual device which uses reverse osmosis water to clean hemodialyzers. The RenaClear® Dialyzer Cleaning System (K991851) is an automated, software controlled, electrically powered device which uses water, a disinfectant, and air pressure to clean both the headers and membrane fibers of hemodialyzers. Both devices are used to preclean reusable hemodialyzers before further processing and testing the hemodialyzers on dialyzer reprocessing machines.

D. Testing:

Tests have been performed which demonstrate the ASSIST Header Cleaner™ is safe and effective, and performs as intended without adversely affecting the hemodialyzer being cleaned. The materials used in the ASSIST Header Cleaner™ are compatible for its intended use.

E. Summary
When used as indicated in the Directions for Use, the ASSIST Header Cleaner™ is as safe and effective as other dialyzer cleaning systems currently in use in the United States.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a bird-like figure with three wing-like extensions.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Mr. Gary J. Mishkin Vice President, Research and Development ALCAVIS International 8-8 Metropolitan Court GAITHERSBURG MD 20878

Re: K043126

Trade/Device Name: Alcavis ASSIST Header Cleaner Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIF Dated: November 8, 2004 Received: November 12, 2004

Dear Mr. Mishkin:

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) I mis lotter with and hygaller of substantial equivalence of your device to a legally prematted 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 11 you about office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 :: 1 /> > 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/cdrb/dsmadsmamain.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

510(k) Number (if known): K043126

Device Name: ASSIST Header Cleaner™

Indications for Use:

To aid in the cleaning of the headers, header spaces, and header caps of multiple-use hemodialyzers prior to an approved reprocessing procedure for reusable hemodialyzers.

Prescription Use X (Part 21 CFR 801 Subpart D) Over the Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner

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

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.