The Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

Device Description

The All Flow Pulmonary Function Filter, manufactured by Alliance Tech Medical, Inc., is a see barrier type, bi-directional filter fabricated from a plastic resin that is a filtering medium. The customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.

The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from a white opaque of miller the and the machine housings are fabricated from the same plastic but with different colors. The colored end fits the machine and the white opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.

AI/ML Overview

The provided text is a 510(k) submission for the "All Flow Pulmonary Function Filter" and details its performance against certain criteria. It is not a study involving AI or human readers, but rather a submission for a medical device. Therefore, many of the requested points related to AI studies (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from context of predicate devices/standards)	Reported Device Performance (All Flow Pulmonary Function Filter)
Bacterial Filtration Efficiency (BFE)	Implied to be high (as predicates are effective). Specific quantitative criteria not explicitly stated as a target, but the context of "reducing cross-contamination" and meeting standards implies high efficiency.	> 99.99% (at an increased challenge)
Viral Filtration Efficiency (VFE)	Implied to be high (as predicates are effective). Specific quantitative criteria not explicitly stated as a target, but the context of "reducing cross-contamination" and meeting standards implies high efficiency.	> 99.99% (at an increased challenge)
Airflow Resistance	Meets recommendations of American Thoracic Society's Standardization of Spirometry. Specific quantitative criteria are implied by the standard but not explicitly listed in the document.	Average of 2.625 cm H₂O½SLPM at 720 L (approx. 0.23 cm H2O/L/sec). The document states this "meets the recommendations of the American Thoracic Society's Standardization of Spirometry."
Filter Dead Space	Not explicitly stated as an acceptance criterion in this document, but characteristics like this are typically considered in device design for pulmonary function testing.	Approximately 35 mL

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

Sample Size: Not specified. The document states "Data provided in this submission indicate that the basic functional characteristics..." but does not detail the sample size for the BFE, VFE, or airflow resistance testing.
Data Provenance: Not specified. The country of origin of the testing data is not mentioned, nor whether the tests were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a submission for a non-AI medical device (a filter), not a study involving expert assessment of data for ground truth. The "ground truth" here is the physical performance of the device as measured by scientific testing, not subjective expert evaluation of medical images or conditions.

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

Not applicable. There was no human adjudication required for the performance testing of this filter device.

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

Not applicable. This document is not an MRMC comparative effectiveness study and does not involve AI assistance for human readers.

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

Not applicable. This document is about a physical medical device (a filter), not an algorithm or AI.

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

The "ground truth" for the device's performance is established through objective, laboratory-based physical and microbiological testing. Specifically:

BFE/VFE: Determined by challenging the filter with known bacterial/viral concentrations and measuring the reduction.
Airflow resistance: Measured using standardized instrumentation against known flow rates.
Filter dead space: Measured physically.

The ultimate "ground truth" for substantial equivalence is the comparison of these objective performance metrics to those of legally marketed predicate devices and established medical standards (like the American Thoracic Society's recommendations).

8. The sample size for the training set

Not applicable. This is a submission for a physical medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for this type of device submission.

Summary

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K043/48

Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter 510(k) Submission

4.0 510(k) SUMMARY

DEC 1 3 2004

In accordance with 21 CFR section 807.92, Alliance Tech Medical, Inc. is submitting the following 510(k) summary:

4.1 Submitter Information:

Alliance Tech Medical, Inc. Company Representative: John Silva, Exec. V.P. 5305 Mission Circle Granbury, TX 76049 USA FDA Registration No .: 3004476631 Owner / Operator No.: 9060999

4.2 Preparer of Submission and Contact for Information:

Solutions MDI, Inc.

Gus Bock, Managing Director 40310 Calle de Suenos Murrieta, CA 92562 Telephone: (909) 698-1505 / Fax: (909) 677-3261

Keith Lowrey, Partner & Consultant (contact for correspondence and information) 611 South Schoolhouse Creek Rd. Grants Pass, OR 97526 Telephone: (541) 476-1628 / Cell: (541-601-3695

4.3 Name of Device:

Proprietary Name:	All Flow Pulmonary Function Filter.
Common Name:	Disposable bacterial/viral filter.
Classification Name:	Breathing circuit bacterial filter, [21 CFR 868.5260(a)].
Regulation Number:	21 CFR 868.5260(a) for Breathing circuit bacterial filters
Product Code:	73 CAH
Class:	Class II (performance standards)

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Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter 510(k) Submission

4.4 Substantial Equivalence:

This submission establishes the substantial equivalence of the Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter to five predicate devices:

The Main Flow Bacterial/Viral PF Filter, K961914, SE letter: 08/14/96. (1)
(2) The SpiroSafe Disposable PF Filter, K973314, SE letter: 11/21/97. (3) The KOKO Disposable PF Filter II, K934475, SE letter: 10/21/93. The MicroGard Disposable PF Filter, (4) K934272, SE letter: 11/24/93. The MultiSPIRO Disposable PF Filter, K951410, SE letter: 04/24/95. (5)

4.5 Description of the Device:

The All Flow Pulmonary Function Filter, manufactured by Alliance Tech Medical, Inc., resin that is a see barrier type, bi-directional filter fabricated from a plastic fittering modiment the customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.

Example of Filter Part No. 5551000 with patient and machine housing components separated:

Image /page/1/Picture/9 description: The image shows a dark, low-lit scene with two primary objects. On the left, there's a cylindrical object with an angled top, possibly made of cardboard or a similar material. To the right and slightly above, there's a round, reflective object, which could be a mirror or a metallic disc, catching the dim light and creating a bright spot in the image.

Opaque white colored patient housing

White colored machine housing

0012

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Because spirometers can have different sensor diameters, the All Flow Pulmonary Function Filter is available in six different sizes and colors that correlate with their respective part numbers. The following chart lists the size and color of each model:

ATM PF Filter Part No.	Color combination(patient housing / machine housing)	I.D / O.D (mm)
5551000	Opaque white / solid white	26.3 / 30.0
5552000	Opaque white / solid red	40.0 / 40.0
5553000	Opaque white / solid orange	45.0 / 48.5
5554000	Opaque white / solid blue	30 /34
5555000	Opaque white / solid green	30 / 33.5
5556000	Opaque white / solid yellow	25.7 / 28.3

Filter Chart

4.6 Intended Use of the Device:

The ATM All Flow Pulmonary Function Filter is designed as a disposable and singleuse bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic purposes.

4.7 Technological Characteristics in Comparison to the Predicates:

The All Flow Pulmonary Function Filter is substantial equivalent to the five predicate devices with respect to the following design characteristics and functions:

The devices are intended for use in reducing the possible cross contamination 1. of spirometers and pulmonary function testing instruments from bacterial and/or viral pathogens by droplets, particulates, and/or aerosols.
1. The devices function as a barrier type, bi-directional filter, which is within a sealed double port assembly, with one port contacting the patient's mouth and the other port to be attached to the spirometers or pulmonary function-testing instrument.
1. The device housing components are fabricated from the same or similar plastic resin materials used in the predicate devices. The filter media is the same as or similar to that used in the predicate devices. These materials have long and extensive use in medical device applications.
1. The devices have been demonstrated to function effectively in reducing high challenge numbers of bacterial and viral contaminates.
ട്. The devices provide air filtration while minimizing airflow resistance through the filter assemblies in the pulmonary test equipment.
1. The devices meet the recommendations of the American Thoracic Society's Standardization of Spirometry.

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4.8 Conclusions drawn from the Non-Clinical Tests:

Data provided in this submission indicate that the basic functional characteristics of the All Flow Pulmonary Function Filter are substantially equivalent to those of the predicate devices.

Bacterial Filtration Efficiency (BFE) testing demonstrated the All Flow 1. Pulmonary Function Filter, at an increased challenge, to be %BFE = > 99.99%.
Viral Filtration Efficiency (VFE) testing demonstrated the All Flow Pulmonary Function Filter, at an increased challenge, to be %VFE = > 99.99%.
Airflow resistance testing demonstrated the device to an average of 2.625 cm 2. H₂O½SLPM at 720 L. (Ref. 760 mm HGA 70 °F), which is approximately 0.23 cm H2O/L/sec.
Filter dead space was demonstrated to be approximately 35 mL. ന്
The device meets the recommendations of the American Thoracic Society's র . Standardization of Spirometry.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a bird in flight, composed of three curved lines.

Public Health Service

DEC 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alliance Tech Medical, Incorporated C/O Mr. Keith Lowrey Solutions MDI, Incorporated 611 South Schoolhouse Creek Road Grants Pass, Oregon 97526

Re: K043148

Trade/Device Name: All Flow Pulmonary Function Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: November 11, 2004 Received: November 16, 2004

Dear Mr. Lowrey:

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 Federal Register.

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Page 2 - Mr. Lowrey

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.

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 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 regulation (21 CFR Part 801), please contact 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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chris

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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Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter 510(k) Submission

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: ·

All Flow Pulmonary Function Filter

-. '

Indications for Use:

(PLEASE NO NOT WRITE: BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CRDH, Office of Device Evaluation (ODE)

Cree Syekom

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

510(k) Number

Prescription Use (per 21 CFR 801.109)

OR Over-the-Counter Use (Optional Format 1-2-96)

00299

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).