ALL FLOW PULMONARY FUNCTION FILTER

• K Number: K043148
• Device Name: ALL FLOW PULMONARY FUNCTION FILTER
• Manufacturer: ALLIANCE TECH MEDICAL, INC.
• Date Cleared: 2004-12-13 ( 28 days)
• Product Code: CAH
• Regulation Number: 868.5260

Intended Use

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.

Predicate Devices

K961914, K973314, K934475, K934272, K951410

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical filter designed to prevent cross-contamination. The description focuses on its physical properties and filtration efficiency, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is a filter designed to prevent cross-contamination of spirometers and pulmonary function testing instruments, not to treat a patient's medical condition. It's indicated for diagnostic applications, not therapeutic ones.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The device is indicated for diagnostic applications."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical filter fabricated from plastic resin and filter media, designed to be a barrier. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use clearly states the device is for "reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments... from aerosols and particulates, which may be present in a patient's exhaled gas." While it's used in conjunction with diagnostic applications (pulmonary function testing), its primary function is a barrier to prevent contamination, not to perform a diagnostic test on a sample in vitro.
• Device Description: The description reinforces this by describing it as a "barrier type, bi-directional filter" designed to "protect both the patient and pulmonary function instruments from potential transmission of pathogens."
• Lack of IVD Characteristics: There is no mention of the device being used to analyze a biological sample (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's condition. IVDs are typically reagents, instruments, or systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

This device is a medical device used in a diagnostic setting, but it is not an IVD itself. It serves a protective function during the diagnostic procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

73 CAH

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 . Standardization of Spirometry.

Key Metrics

Bacterial Filtration Efficiency (BFE) = > 99.99%.
Viral Filtration Efficiency (VFE) = > 99.99%.
Airflow resistance = 2.625 cm H₂O½SLPM at 720 L. (approximately 0.23 cm H2O/L/sec.)
Filter dead space = approximately 35 mL.

Predicate Device(s)

K961914, K973314, K934475, K934272, K951410

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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: [phone] / Fax: [phone]

Keith Lowrey, Partner & Consultant (contact for correspondence and information) 611 South Schoolhouse Creek Rd. Grants Pass, OR 97526 Telephone: [phone] / 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.

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.

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.
• 2. 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.
• 3. 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.
• 4. 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.
• 6. 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 [phone]. 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 [phone] or [phone] 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:

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.

(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