Dialysate prior to entering the dialyser
Water prior to its use for preparation of dialysate
Water prior to use for regenerating dialysers.
DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).

Device Description

DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device's performance, organized according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DialGuard™ filter are primarily focused on its ability to reduce endotoxin levels. The performance is reported in the context of meeting or exceeding relevant standards.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Endotoxin Removal (Water for Dialysate)	Quantitative: Endotoxin levels in water for dialysate should be reduced to < 5.0 EU/mL (AAMI standard). The implied acceptance criterion from the performance claims is to achieve significantly lower.	Quantitative: "Experimental data indicates that DialGuard™ will consistently reduce endotoxin levels to ≤ 0.05 EU/mL." This significantly exceeds the AAMI standard.
Endotoxin Removal (Dialysate)	Qualitative/Implied: To reduce endotoxin from dialysate. (Note: "Currently, there are no standards set for dialysate"). The implied acceptance criterion from the performance claims is to achieve very low endotoxin levels.	Quantitative: "Experimental data indicates that DialGuard™ will consistently reduce endotoxin levels to ≤ 0.05 EU/mL." This is applied to dialysate as well.
Flow Rate	Sufficient to maintain proper operation. (Specific numerical criteria not explicitly stated, but implied as a functional requirement).	"Flow Rate Pressure Studies" were conducted, implying acceptable performance. No specific values are provided in the summary.
Pressure	Within acceptable operating ranges. (Specific numerical criteria not explicitly stated, but implied as a functional requirement).	"Flow Rate Pressure Studies" were conducted, implying acceptable performance. No specific values are provided in the summary.
Maintenance of Dialysate Composition	Not negatively impact conductivity and ion composition.	"Conductivity and Ion Composition testing" was performed, implying acceptable performance. No specific values for maintenance of composition are provided.
Leachables	No harmful or significant leachables.	"leachables testing" was conducted, implying acceptable performance. No specific details on leachables are provided.
Biocompatibility	Biocompatible with the intended use.	"Biocompatibility Testing" was conducted, implying acceptable performance. No specific details on biocompatibility are provided.
Sanitizable	Must be sanitizable.	Reported as "yes" for DialGuard™.

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

Sample Size: The document does not explicitly state the specific sample size for the "test set" used in the endotoxin reduction studies, flow rate, pressure, conductivity, ion composition, leachables, or biocompatibility tests. It only states that "Experimental data indicates..."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the context of a 510(k) summary, these would typically be internal testing conducted by the manufacturer (Clarigen, Inc.) to support the submission.

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

This information is not provided in the document. The studies described are laboratory-based performance tests (e.g., endotoxin reduction, flow rate, leachables) rather than studies that would typically require expert consensus for "ground truth" in the way a diagnostic imaging study would. The ground truth for these tests is established by objective measurements against known standards or controls.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for studies where human readers or experts are interpreting results (e.g., medical images). The studies described here are direct performance measurements of a filter.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI applications involving human interpretation (e.g., radiology AI), not for a device like an endotoxin filter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this concept is not applicable to the DialGuard™ filter. The device itself is a physical filter, not an algorithm. The "performance" being evaluated is its physical and chemical effectiveness in reducing endotoxin and maintaining dialysate properties.

7. The Type of Ground Truth Used

The ground truth used for relevant tests would be:

Endotoxin Removal: Quantified endotoxin levels using standard assay methods (e.g., Limulus Amebocyte Lysate (LAL) test) in controlled experiments, with reference to established benchmarks like the AAMI standard for water for dialysate.
Flow Rate/Pressure: Direct physical measurements.
Conductivity/Ion Composition: Direct chemical measurements using calibrated instruments.
Leachables: Chemical analysis (analytical chemistry techniques).
Biocompatibility: Standardized in vitro and/or in vivo biocompatibility testing methods against recognized standards.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this type of device. The DialGuard™ filter is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The "training set" concept relates to data used to train an AI model.

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

This information is not provided and is not applicable for the same reason as point 8. There is no AI training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the word "CLARIGEN" in bold, black letters. To the left of the word is a black graphic that resembles a crescent moon with two circles attached to the bottom. In the upper right corner of the image, the letters "AUG" are visible.

AUG 1 4 2000

510(k) SUMMARY

Submitter Information: 1.

Name:

Clarigen, Incorporated

5922 Farnsworth Court, Carlsbad, California 92008 Address:

Contact Person: Edit Hegyi, M.D., Ph.D.

760-929-4996 Phone Number:

Fax Number: 760-929-2279

November 05, 1999 Date Prepared:

Clarigen, Inc. 5922 Farnsworth Court Carlsbad, CA 92008 Phone 619. 929 4996 619. 929 2279 Fax Email clarigen@earthlink.net

170

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2. Device Name

Proprietary name: Common name: Classification name: Product Code:

DialGuard™ Filter for the removal of endotoxin from dialysate and water Water Purification Subsystem per 21 CFR 876.5665 78 FIP

3. Predicate Device

RenaGuard™ Dialysate Filter 510(k) Number K945136

Device Description 4.

5. Indications for Use

Device	Indications for Use
DialGuard™	DialGuard™ is intended to be used toremove endotoxin from dialysate,water used to prepare dialysate, andwater used to regenerate dialysers.
RenaGuard™	RenaGuard™ is intended to be used toremove bacteria and endotoxin fromdialysate

6. Technological Characteristics

	DialGuardTM	RenaGuardTM
Case Material	polysulfone	polycarbonate
Sanitizable	yes	yes
Position on Dialyzer	Prior to artificial kidney	Prior to artificial kidney
Materials	agarose based affinity resin	hollow fiber membrane

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7. Safety and Effectiveness

The following testing was conducted to support substantial equivalence as a filter to remove endotoxin from dialysate and water for dialysate:

Flow Rate Pressure Studies Endotoxin Removal from water and dialysate

The maintenance of Dialysate Composition through the use of:

Conductivity and Ion Composition testing leachables testing Biocompatibility Testing.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2000

Edit Hegyi, M.D., Ph.D. Vice President Research and Development Clarigen, Inc. 5922 Farnsworth Court Carlsbad, CA 92008

Re: K993806

DialGuard™ Endotoxin Removal Device for treatment of dialysate and dialysis water Dated: June 23, 2000 Received: June 26, 2000 Regulatory Class; II 21 CFR §876.5665/Procode: 78 FIP

Dear Dr. Hegyi:

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 teach review devilles 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 finding in 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 Rearly and Clark Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practive 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 regulation (FLT) in the coonply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements on region in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you micht have under sections 531 through 542 of the Act for devices under Radiation Cantrol 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 predication 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 witco diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 and "Misbranding by reference to premarket notification" (21CFR 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 (80) 638-2041 or (301) 443-557 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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K993806

Page 1 of 1

Statement of Indications for Use

The DialGuard™ device is intended to be used for the reduction of endotoxin from:

1. Dialysate prior to entering the dialyser
1. Water prior to its use for preparation of dialysate
1. Water prior to use for regenerating dialysers.

DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Dyson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number

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.