AG Industries filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility, etc.

Device Description

Room air is drawn into the compressor of a respiratory device through the bacterial intake filter. From the compress, the air passes through the Compressor Filter, if one is installed on the machine and proceeds to the sieve beds. The sieve beds condition the air by removing nitrogen from the air stream, which results in higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AG Industries Compressor & Bacteria Filters:

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are implied by the performance of the legally marketed predicate devices, and the "reported device performance" is that of the AG Industries filters. The key performance metric explicitly stated for comparison is Bacterial Filtration Efficiency (BFE) and Air Flow Resistance. Other features like material and connection type are also compared.

Feature	Predicate Device (Acceptance Criteria)	AG Industries Device (Reported Performance)
AG1038831
Filtration Efficiency	99.999% BFE	99.9+% BFE
Air Flow Resistance	3.0 cm H2O @ 100 scfh	1.3 cm H20 @ 10 Lpm
LL205
Filtration Efficiency	99.999% BFE	99.99+% BFE
Air Flow Resistance	4.0 cm H2O @ 100 scfh	.78 cm H20 @ 10 Lpm
LL201
Filtration Efficiency	99.999% BFE	99.999+% BFE
Air Flow Resistance	4.0 cm H2O @ 100 scfh	12.02 cm H20 @ 85 Lpm
LL202
Filtration Efficiency	99.999% BFE	99.9+% BFE
Air Flow Resistance	4.0 cm H2O @ 100 scfh	.39 cm H20 @ 10 Lpm
HCF100
Filtration Efficiency	99.999% BFE	99.999+% BFE
Air Flow Resistance	3.0 cm H2O @ 100 scfh	.33 cm H20 @ 10.5 Lpm
BF910 (Platinum)
Filtration Efficiency	99.999% BFE	99.99+% BFE
Air Flow Resistance	18 in H2O (Platinum 10)	.4 cm H20 @ 5 Lpm
BF900 (Non-Platinum)
Filtration Efficiency	99.999% BFE	99.999+% BFE
Air Flow Resistance	7 in H2O (Non-Platinum)	1.6 cm H20 @ 84.9 LPM (Non-Platinum)
BF950 (Platinum & Non-Platinum)
Filtration Efficiency	99.999% BFE	99.999+% BFE
Air Flow Resistance	18 in H2O (Platinum 10) / 7 in H2O (non-Platinum)	.45 cm H2O @ 10.3 LPM
BF200C
Filtration Efficiency	99.999% BFE	99.999+% BFE
BF100
Filtration Efficiency	99.999% BFE	99.999+% BFE
BF500
Filtration Efficiency	99.97% BFE	99.999+% BFE
BF600
Filtration Efficiency	99.999% BFE	99.999+% BFE

Note on Acceptance Criteria: The submission implicitly uses the predicate device's performance as the acceptance criteria for "substantial equivalence." The AG Industries devices are expected to meet or exceed these values for key performance indicators like filtration efficiency and demonstrate comparable (or better) airflow resistance. For some models, the AG Industries device states a slightly lower BFE (e.g., 99.9+% vs 99.999%), but the overall conclusion of "substantial equivalence" suggests these differences were deemed acceptable by the FDA for the intended use. The air flow resistance is presented with different units (scfh vs Lpm) and flow rates sometimes, making direct numerical comparison difficult without conversion, but the goal is to show comparable or better (lower) resistance.

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

The document does not explicitly state the sample size used for the performance tests (Bacterial Filtration Efficiency, Dioctyl Phthalate (DOP) Aerosol Test) or biocompatibility tests (ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, MEM Elution Test, Material Mediated Rabbit Pyrogen Test).

The data provenance is not specified (e.g., country of origin, retrospective/prospective). It is implied that these are laboratory tests conducted to demonstrate the performance characteristics of the manufactured filters.

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

This type of information is not applicable to this submission. The "ground truth" for filter performance is established through standardized laboratory testing methods (e.g., BFE, DOP aerosol tests) rather than expert human interpretation of results. Biocompatibility tests also follow established protocols.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance assessment relies on standardized test methods and quantitative measurements, not on expert adjudication of outcomes.

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

This is not applicable. This submission is for medical device filters, not an AI or imaging diagnostic device that would involve human readers or cases.

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

This is not applicable. This submission is for medical device filters, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these filters is based on standardized laboratory test results. Specifically:

Performance (Filtration Efficiency, Air Flow Resistance): Established by physical and microbiological testing methods (e.g., Bacterial Filtration Efficiency, Dioctyl Phthalate (DOP) Aerosol Test) that quantitatively measure the filter's ability to remove particulates and resist airflow under controlled conditions.
Biocompatibility: Established by adherence to ISO standards for evaluating biological effects of medical devices (e.g., ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, MEM Elution Test, Material Mediated Rabbit Pyrogen Test).

8. The Sample Size for the Training Set

This is not applicable. This submission is for medical device filters and does not involve AI or machine learning that would require a "training set."

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

This is not applicable for the same reason as point 8.

Summary

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KC091363

510(K) SUMMARY

FEB - 4 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 21 CFR §807.92.

510(k) number:

1. Submitter's Identification:

AG Industries 3637 Scarlet Oak Blvd. St Louis, MO 63122 USA Submitter Phone: (866) 222-8988 Submitter Fax: (970) 494-2052 Submitter Contact: Michael Amann Title: Vice-President Date Summary Prepared: 1-5-2009

2. Name of the Device:

Please reference the following table for Proprietary and Common names of the devices included in this submission.

Proprietary Name	Common Name
AG1038831	Compressor Filter
LL201	Compressor Filter
LL202	Compressor Filter
LL205	Compressor Filter
HCF100	Compressor Filter
BF910 (Platinum)	Compressor Filter
BF900 (Non-Platinum)	Compressor Filter
BF950 (Platinum and Non-Platinum)	Compressor Filter
BF200C	Bacterial Filter
BF100	Bacterial Filter
BF500	Bacterial Filter
BF600	Bacterial Filter

3. Predicate Device Information:

Comparison to Predicate Devices:

The above devices are compared to similar devices marketed by Porous Media which were cleared under K061426. The features of each are exhibited in the following tables.

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Feature	AG Industries	Porous MediaK061426
Model	AG1038831	DBF 32
Intended Use	The filters are intended to helpremove air-borne contaminants,including air borne bacteria andother particulate debris, from theair stream of a respiratory device.	Same
Filtration Efficiency	99.9+% BFE	99.999%BFE
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	1.3 cm H20 @ 10 Lpm	3.0 cm H2O @ 100 scfh
Maximum Flow Rate	100 LPM	Same
Connection	12.72 mm to fit machine	22 mm ISO male/female

Feature	AG Industries	Porous MediaK061426
Model	LL205	DBF 27
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.99+% BFE	99.999% BFE
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approved equivalent	Polystyrene or approved equivalent
Air Flow Resistance	.78 cm H20 @ 10 Lpm	4.0 cm H2O @ 100 scfh
Maximum Flow Rate	100 LPM	100 LPM
Connection	Male 22 mm ISO	Same

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

Feature	AG Industries	Porous MediaK061426
Model	LL201	DBF 24
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	12.02 cm H20 @ 85 Lpm	4.0 cm H2O @ 100 scfh
Maximum Flow Rate	100 LPM	Same
Connection	Male 22 mm ISO	Same

. . .

Feature	AG Industries	Porous MediaK061426
Model	LL202	DBF 24
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.9+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	.39 cm H20 @ 10 Lpm	4.0 cm H2O @ 100 scfh
Maximum Flow Rate	100 LPM	Same
Connection	Male 22 mm ISO	Same

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Feature	AG Industries	Porous MediaK061426
Model	HCF100	DBF 32
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	.33 cm H20 @ 10.5 Lpm	3.0 cm H2O @ 100 scfh
Maximum Flow Rate	100 LPM	Same
Connection	22mm ISO Male/Female	Same

Feature	AG Industries	Porous MediaK061426
Model	BF910 (Platinum)	DBF 25
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.99+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	.4 cm H20 @ 5 Lpm	18 in H2O (Platinum 10)7 in H2O (non-Platinum)
Maximum Flow Rate	100 LPM	Same
Connection	3/8 " FNPT and 22mm OD	3/8 " FNPT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Feature	AG Industries	Porous MediaK061426
Model	BF900 (Non-Platinum)	DBF 25
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	1.6 cm H20 @ 84.9 LPM (Non-Platinum)	18 in H2O (Platinum 10)7 in H2O (non-Platinum)
Maximum Flow Rate	100 LPM	Same
Connection	3/8" FNPT and 22mm OD	3/8" FNPT

Feature	AG Industries	Porous MediaK061426
Model	BF950 ( Platinum & NonPlatinum)	DBF 25
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Styrene Butadiene or approvedequivalent	Polystyrene or approved equivalent
Air Flow Resistance	.45 cm H2O @ 10.3 LPM	18 in H2O (Platinum 10)7 in H2O (non-Platinum)
Maximum Flow Rate	100 LPM	Same
Connection	3/8" FNPT and 22mm OD	3/8" FNPT

{5}------------------------------------------------

Feature	AG Industries	Porous MediaK061426
Model	BF200C	DDF4711M03Y
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+% BFE	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Polypropylene or approvedequivalent	Polystyrene or approved equivalent
Connection	3/8" Hose Barb	3/8" Hose Barb

Feature	AG Industries	Porous MediaK061426
Model	BF100	DDF4711M03Y
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+%	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Polypropylene or approvedequivalent	Polystyrene or approved equivalent
Connection	3/16"- ¼" Stepped Bar	1/8" Hose Barb

Feature	AG Industries	Porous MediaK061426
Model	BF500	DDF4700M03Y
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+%	99.97%
Filter Material	Glass Microfiber	Same
Housing Material	Polypropylene or approvedequivalent	Polystyrene or approved equivalent
Connection	1/4" Straight Barb	Same

ﺮ

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Feature	AG Industries	Porous MediaK061426
Model	BF600	DDF4711M03Y
Intended Use	Same as AG1038831 Above	Same
Filtration Efficiency	99.999+%	99.999%
Filter Material	Glass Microfiber	Same
Housing Material	Polypropylene or approvedequivalent	Polystyrene or approved equivalent
Connection	1/8" Hose Barb	Same

The following tests were performed to support substantial equivalence:

. Bacterial Filtration Efficiency
Dioctyl Phthalate (DOP) Aerosol Test
. ISO Guinea Pig Maximization Test
. ISO Acute Systemic Injection Test
. MEM Elution Test
. Material Mediated Rabbit Pyrogen Test

The above tests confirmed that the performance of the subject filters is substantially equivalent to the predicate device(s). The Biocompatibility tests confirmed that the following filters BF500, BF200C, BF100 and BF600, which contain materials not in previously cleared devices, present no biocompatibility issues.

4. Device Description:

COMPRESSOR & BACTERIA FILTERS ( AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600):

5. Intended Use:

AG Industries filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate

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debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility, etc.

6. Discussion of Clinical Tests Performed:

Not applicable

7. Conclusions:

The subject devices have the same intended use and similar characteristics as the predicate devices. No new questions of safety or effectiveness are raised by differences in technology or materials. Thus, the AG Industies COMPRESSOR & BACTERIA FILTERS ( AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600) are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the figure. The text is in all caps and is separated by dots.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 4 2010

ndd AG Industries C/O Mr. Ian Gordon Senior Vice-President Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re: K091363

Trade/Device Name: Compressor & Bacteria Filters (AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600

Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: January 21, 2010 Received: January 22, 2010

Dear Mr. Gordon:

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.

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Page 2 - Mr. Gordon

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number :

Device Name: COMPRESSOR & BACTERIA FILTERS ( AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600):

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheiss

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO91363 510(k) Number:

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).