The provided text describes the SpiroSafe Filter, a disposable bacterial/viral filter for pulmonary function testing. The study demonstrates the device's substantial equivalence to a predicate device (PDSI KoKo Filter - K914272) based on performance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Intended device Performance (SpiroSafe Filter)	Predicate Device Performance (PDSI KoKo Filter)
Bacterial Efficiency	>99%	99.99%
Viral Efficiency	>99%	99.98%
Resistance to Airflow	>1.5 cmH2O/L/Sec. @ 12/L/Sec.	0.9 cmH2O/L/Sec. @ 12/L/Sec.
Use as bacterial/viral filter	Yes	Yes
Use during pulmonary function test	Yes	Yes
Single patient use	Yes	Yes
Housing material - Impact Polystyrene	Yes	Yes
Filter Media	Electrostat	Filtrete

Note: While the text doesn't explicitly state "acceptance criteria", the comparison table to the predicate device implies that the performance characteristics of the predicate serve as the benchmark for substantial equivalence. The SpiroSafe Filter meets or exceeds the critical performance aspects (bacterial/viral efficiency) of the predicate. The resistance to airflow value for the predicate is 0.9, and the intended device is ">1.5", which seems to indicate the SpiroSafe filter exceeds the predicate in this metric; however, for resistance, lower is generally better. This could be a typo in the document or interpreted differently. Assuming the acceptance criteria aligns with being "comparable or better" than the predicate, the device broadly meets this.

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

The document does not specify the sample size used for the performance testing shown. It is simply presenting performance data.

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be a direct presentation of product specifications rather than a clinical study.

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

This information is not applicable. The device's performance is measured against technical specifications, not subject to expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-in-the-loop assessment or expert review for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a physical filter, and the evaluation is based on its physical and filtering properties, not on diagnostic accuracy requiring human reader interpretation.

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

Yes, in a sense, a "standalone" performance assessment was done. The performance metrics (bacterial efficiency, viral efficiency, resistance to airflow) are inherent to the device itself and do not involve human interaction beyond conducting the tests. The results presented are solely based on the device's intrinsic characteristics.

7. The Type of Ground Truth Used

The ground truth used is based on measured physical and performance characteristics (e.g., bacterial efficiency percentage, viral efficiency percentage, resistance to airflow in cmH2O/L/Sec.). This is analogous to laboratory testing/engineering specifications.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" in the context of this device. The evaluation is focused on the manufactured product's specifications rather than a machine learning model.

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

This information is not applicable as there is no mention of a "training set" or a machine learning context.

Summary

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KG73314

Image /page/0/Picture/1 description: The image shows the logo for Micro Direct. The word "Micro" is on the top line, and the word "Direct" is on the bottom line. The word "Micro" is in a smaller font than the word "Direct."

Nov 2 1 1997

Non-Confidential Summary of Safety and Effectiveness September 1, 1997

Micro Direct, Inc.1485 Lisbon StreetLewiston, ME 04240	Tel - (207) 786-7808	Fax - (207) 786-7280
Official contact:	David R. Staszak, President
Proprietary or Trade Name:	SpiroSafe Filter
Common/Usual Name:	Disposable bacterial/viral filter
Classification Name:	73 CAH - Filter, bacterial
Intended device:	Disposable bacterial/viral filter
Predicate devices:	PDSI KoKo Filter - K914272
Device description:	A disposable bacterial/viral filter used in pulmonary functiontesting

Indicated use:

The intended device filters possible bacteria and viruses from the patient exhalation when performing pulmonary function testing.

Targeted population:

Patients requiring lung function evaluations.

Environment of use:

Places where a qualified clinician desires to take lung function measurements .

Comparison to predicate devices:

Attribute	Intendeddevice	PDSIKoKo Filter
UseIntended as a bacterial/viral filterIntended for use during pulmonary function test	YesYes	YesYes
DesignSingle patient use	Yes	Yes

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Comparison to predicate devices (continued):

Attribute	Intendeddevice	PDSIKoKo Filter
MaterialsHousing - Impact PolystyreneFilter Media	YesElectrostat	YesFiltrete
PerformanceBacterial EfficiencyViral EfficiencyResistance to Airflow (cmH2O/L/Sec. @ 12/L/Sec.)	>99%>99%>1.5	99.99%99.98%9

Differences

The only difference is that the intended filter uses Electrostat filter media manufactured by Enhanced Filter The Smy and the PDSI KoKo filter uses Filtrete manufactured by 3M. Both are synthetic electret filter media.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 21 1997

Mr. David R. Staszak Micro Direct, Inc. 1485 Lisbon Street St. Lewiston, Maine 04240

K973314 Re : SpiroSafe Filter Regulatory Class: II (two) Product Code: 73 CAH September 1, 1997 Dated: Received: September 3, 1997

Dear Mr. Staszak:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David R. Staszak

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may oched golleral indomision of Small Manufacturers Assistance at ITES " toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number	K973314 (To be assigned)
Device Name:	SpiroSafe Filter
Indications for Use:	To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing
Targeted population:	Patients requiring lung function measurements
Environment of use:	Places where a qualified clinician desires to take these lung measurements

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ath. A. Ciorlowski.

973314

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

page 7

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).