The AG Industries Breathing Filter Bacterial/Viral is a single use replacement filter intended for use in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce the passage of particulate that may carry airborne bacteria and/or viruses. When used with mechanical that may our and resuscitation devices, the replacement filter may be used in the hospital, home, or transport applications.

Device Description

The Breathing Filter is a replacement filter for use mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines. The product is composed of 3 main elements. These include a top housing, a bottom housing, and a filter element. The filter material is secured in the top and bottom housing using a sonic weld joint.

The top housing is made of plastic and has a clear polish finish and has a standard 22mm ID connection port.
The bottom housing is made of plastic and has a clear polish finish and has a standard 15mm ID/22mm OD connection port for universal usage.
The filter element is composed of electrostatic material, with a bonded scrim, on one side of the filter element only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AG Industries Breathing Filter Bacterial/Viral. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as the submission focuses on comparative analysis rather than new performance studies against specific acceptance criteria.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

Acceptance Criteria: Not explicitly stated as numerical performance metrics in this document. The "acceptance criteria" here is implicitly "demonstrating substantial equivalence" to the predicate device.
Reported Device Performance: The document states: "Performance testing has been completed on the AG Industries Breathing Filter Bacterial/Viral. The differences between the AG Industries Breathing Filter Bacterial/Viral specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness." However, no specific numerical performance data or results from this testing are provided in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Device specifications do not result in different performance than predicate	"Performance testing has been completed," and "differences... do not result in different performance or raise new questions regarding safety and effectiveness." (No specific numerical data provided)
Device does not raise new questions regarding safety and effectiveness compared to predicate	"The device... is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device." (No specific numerical data provided)

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

This information is not provided in the 510(k) summary. The document mentions "Performance testing has been completed," but does not detail the nature of these tests, the number of samples used, or data provenance. Since it's a device like a filter, the "test set" would likely refer to the number of filter units tested, not patient data.

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)

This is not applicable/not provided. For a physical device like a filter, "ground truth" would be established through laboratory measurements and standardized testing methods, not typically by human experts evaluating a "test set" in the way it applies to diagnostic algorithms.

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

This is not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. This document does not describe such a study.

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. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The AG Industries Breathing Filter Bacterial/Viral is a physical filter device, not an AI diagnostic tool.

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

This is not applicable. This is a physical filter device, not an algorithm.

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

As this is a physical device (filter), the "ground truth" for performance would be based on standardized laboratory test results for parameters such as bacterial/viral filtration efficiency, pressure drop, and airflow resistance. The document states "Performance testing has been completed," implying such testing, but it does not specify the exact nature of the ground truth or tests used beyond stating that performance testing occurred.

8. The sample size for the training set

This is not applicable. This is a physical device, not a machine learning model that requires a "training set."

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

This is not applicable. As above, no training set for a machine learning model.

Summary

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K052087

510(k) SUMMARY

DEC 1 4 2005

Submission Correspondent:	Emergo Group, Inc.
Address:	2454 McMullen Booth RoadSuite 427Clearwater, FL 33759
Phone:	(727) 797-4727
Fax:	(727) 797-4757
Contact:	Mr. Ian Gordon

Submission Sponsor:	AG Industries239 Seebold SpurFenton, MO 63026
Date Prepared:	October 17, 2005
Trade Name:	Breathing Filter Bacterial / Viral
Common Name:	Bacteria Filter
Classification:	CAH, Filter, Bacterial, Breathing-CircuitRegulation # 868.5260
Description:	The Breathing Filter is a replacement filter for use mechanicalventilators, anesthesia machines, manual resuscitation devices,and IPPB machines. The product is composed of 3 mainelements. These include a top housing, a bottom housing, and afilter element. The filter material is secured in the top and bottomhousing using a sonic weld joint.The top housing is made of plastic and has a clear polish finish and has a standard 22mm ID connection port.The bottom housing is made of plastic and has a clear polish finish and has a standard 15mm ID/22mm OD connection port for universal usage.The filter element is composed of electrostatic material, with a bonded scrim, on one side of the filter element only.
Intended Use:	The AG Industries Breathing Filter Bacterial/Viral is a single usereplacement filter intended for use in mechanical ventilators,anesthesia machines, manual resuscitation devices, and IPPBmachines to reduce the passage of particulate that may carryairborne bacteria and/or viruses. When used with mechanicalventilators, IPPB machines and resuscitation devices, thereplacement filter may be used in the hospital, home, or transportapplications.

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Predicate Devices: The predicate device referenced in this submission is:

Hudson Respiratory Care, Inc. – Hudson RCI Bacteria/Viral Filter - 510(k) # K961914

Safety and Effectiveness:

Performance testing has been completed on the AG Industries Breathing Filter Bacterial/Viral. The differences between the AG Industries Breathing Filter Bacterial/Viral specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness.

Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The differences between the AG Industries Breathing Filter Bacterial/Viral and the predicate device cited do not raise any different questions regarding safety and effectiveness. There are no significant differences in the technological characteristics or in the intended use of these devices.

The device, as designed and tested, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circle around the caduceus. The caduceus is depicted as a series of curved lines that resemble a human figure.

Public Health Service

DEC 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AG Industrics C/O Mr. Ian Gordon Emergo Group, Incorporated 2454 McMullen Booth Road Clearwater, Florida 33759

Re: K052087

Trade/Device Name: Breathing Filter Bacterial/Viral Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: December 5, 2005 Received: December 12, 2005

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 such 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 Eederal 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); good manufacturing practice and instills (s 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premaired 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), r you accure of the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You onay 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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 (if known): K052087

Device Name: Breathing Filter Bacterial / Viral

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)

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

Aun Sulin

General Hospital,
Control, Central Devices
K052587

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).