For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.

Device Description

The PFT Filter is filter for use with PFT equipment and testing. It is intended to interface between the equipment and the patient during the test. It has a lightweight, compact housing with electrostatic filter media.

AI/ML Overview

The provided text describes a 510(k) summary for "The PFT Filter," a device intended for use with pulmonary function testing equipment to filter air between the patient and the equipment.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criteria (Predicate Device)	Reported Device Performance (The PFT Filter)
Indications for Use	For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment.	For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment.
Environments of use	Hospital, Sub-acute Institutions, Doctor's offices, Laboratories	Hospital, Sub-acute Institutions, Doctor's offices, Laboratories
Single patient use, single session, disposable	Yes	Yes
May be used on different PFT testing machines	Yes - not specified (for predicate EMS - PFT - K013123)	Yes
Filter media type	Electrostatic	Electrostatic
Internal volume	50 ml (for predicate PDS KoKo – K934475)	51 ml
Resistance to flow @ 60 Lpm	0.5 cm H2O	0.5 cm H2O
Resistance to flow @ 720 Lpm	0.7 cm H2O	0.7 cm H2O
Bubble test per ASTM F316-03	1.2 cm H2O @ 0.26 Lpm (Reference only)	1.0 cm H2O @ .26 Lpm
Bacterial Filtration Efficiency (BFE)	99.99+%	99.9+%
Viral Filtration Efficiency (VFE)	99.99+% (for predicate PDS - KoKo-K934475)	99.9+%
Weight	41 gm (for predicate PDS-KoKo – K934475)	46 gm
Duration of use	<24 hours or not specified	< 24 hours
Materials	Housing – polystyrene; Media - spun polypropylene (Identical to EMS – Filter– K013122, AM Systems – K063526)	Housing – polystyrene; Media - spun polypropylene

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

The document does not specify a distinct "test set" in the context of clinical data for performance evaluation in the way one might expect for an AI/CADe device. Instead, the performance claims are based on bench testing and comparison to predicate devices.

Sample Size: Not explicitly stated as a number of patient cases. The evaluation appears to involve measurements taken on device prototypes or production samples during specific tests. For example, "Resistance to flow" and "Bubble test" refer to physical measurements. Bacterial and Viral Filtration Efficiency would be tested on filter material samples.
Data Provenance: Not applicable in the sense of patient data. The data originates from laboratory and bench testing of the filter device. There is no information regarding country of origin or whether it's retrospective or prospective patient data, as it's not a clinical study.

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

This section is not applicable to this submission. The device is a physical filter, and its performance criteria (e.g., filtration efficiency, resistance to flow) are established through objective laboratory measurements and engineering standards, not through expert consensus on medical images or patient diagnoses.

4. Adjudication Method for the Test Set:

This is not applicable. There is no "test set" of cases requiring adjudication by medical experts, as the evaluation is based on objective physical and microbiological performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The PFT Filter is a physical accessory, and its performance is evaluated through bench testing.

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

This concept is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is relevant for AI/CADe devices. The PFT Filter is a passive mechanical device; it does not involve algorithms or human-in-the-loop performance in its primary function. Its "standalone performance" refers to its physical filtration capabilities without a human directly influencing its filtering action during a pulmonary function test.

7. The Type of Ground Truth Used:

The "ground truth" for the PFT Filter's performance metrics is based on objective laboratory measurements and established engineering standards (e.g., ASTM F316-03 for bubble test), as well as microbiological testing protocols (e.g., Nelson Labs per MIL-M-36954-1975 for filtration efficiency). The comparison is often made against the performance of legally marketed predicate devices which have already been deemed safe and effective.

8. The Sample Size for the Training Set:

This is not applicable. The PFT Filter is not an AI/ML device that requires a "training set" of data. Its design and performance are based on engineering principles and materials science, not on learning from data.

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

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

Summary

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510(k) Summary Page 1 of 2 28-Feb-09

Pulmonary Filtration Technologies, LLC755 A Buckley Rd.San Luis Obispo, CA 93401	MAR - 2 2005Tel - 800-837-6751Fax - 805-763-1303
Official Contact:	Richard J. White, President
Proprietary or Trade Name:	The PFT Filter
Common/Usual Name:	PFT filter
Classification Name:	Diagnostic spirometer (accessory)
Device:	The PFT Filter
Predicate Devices:	Engineered Medical Systems - PFT - K013123PDS KoKo -- K934475

Device Description:

Indications for Use:

Indications for Use --	For use with pulmonary function testing. To filter air betweenthe patient's exhaled air and the testing equipment.Single patient use, single session, disposable.
Environment of Use --	Hospital, Sub-acute Institutions, Doctor's offices, Laboratories
Contraindications --	None

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510(k) Summary Page 2 of 2 28-Feb-09

Attribute	Proposed	Predicates
	The PFT Filter
Indications for Use	For use with pulmonary functiontesting. To filter air between thepatients's exhaled air and thetesting equipment.	For use with pulmonary functiontesting. To filter air between thepatients's exhaled air and thetesting equipment.EMS - PFT - K013123
Environments of use	Hospital, Sub-acute Institutions,Doctor's offices, Laboratories	Hospital, Sub-acute Institutions,Doctor's offices, LaboratoriesEMS - PFT - K013123
Single patient use, singlesession, disposable	Yes	YesEMS - PFT - K013123
May be used on different PFTtesting machines	Yes	Yes - not specifiedEMS - PFT - K013123
Design and Performance Testing and Results
Filter media type	Electrostatic	ElectrostaticEMS - K013123,PDS KoKo - K934475
Internal volume	51 ml	50 mlPDS KoKo – K934475
Resistance to flow(Reported as an average)	0.5 cm H2O @ 60 Lpm0.7 cm H2O @ 720 Lpm	0.5 cm H2O @ 60 Lpm0.7 cm H2O @ 720 LpmEMS - K013123
Bubble test per ASTM F316-03	1.0 cm H2O @ .26 Lpm	1.2 cm H2O @ 0.26 LpmReference only
Bacterial Filtration Efficiency	99.9+%	99.99+%
Viral Filtration Efficiency	99.9+%	99.99+%PDS - KoKo-K934475
Per Nelson Labs (MIL-M-36954-1975)
Weight	46 gm	41 gmPDS-KoKo – K934475
Duration of use	< 24 hours	<24 hours or not specifiedEMS PFT K013123
Materials	Housing – polystyreneMedia - spun polypropylene	Identical – EMS – Filter–K013122Identical - AM Systems –K063526
Performance under Section 514	None	None

Differences Between Other Legally Marketed Predicate Devices

The is viewed as substantially equivalent to the following predicate devices – K934475 - PDS - KoKo and K013123 - Engineered Medical Systems - PFT Filter

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is a common symbol of the United States, and its presence on the seal signifies the department's role in protecting the health and well-being of the nation. The text around the eagle clearly identifies the organization.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Pulmonary Filtration Technologies, LLC C/o Mr. Paul Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

MAR - 2 2009

K083233 Re:

Trade/Device Name: The PFT Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: February 16, 2009 Received: February 18, 2009

Dear Mr. Dryden:

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. Dryden

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Sultte y. Micham Ons.

Ginette Y, Michaud, M.D. Acting 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 Statement

Page 1 of 1

K083233 510(k) Number:

Device Name: The PFT Filter

Indications for Use:

For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zra M. Z-

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

510(k) Number: KO83233

Page S1.16

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).