SPIROSAFE FILTER

K973314 · Micro Direct, Inc. · CAH · Nov 21, 1997 · Anesthesiology

Device Facts

• Record ID: K973314
• Device Name: SPIROSAFE FILTER
• Applicant: Micro Direct, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing

Device Story

SpiroSafe Filter is a disposable bacterial/viral filter used during pulmonary function testing. It functions by filtering exhaled air from patients to prevent cross-contamination. The device consists of an impact polystyrene housing containing electrostat filter media. It is intended for use in clinical settings where a qualified clinician performs lung function measurements. The filter acts as a physical barrier to pathogens, protecting equipment and subsequent patients. It is a single-patient-use device.

Clinical Evidence

Bench testing only. Performance metrics provided: Bacterial efficiency >99%, viral efficiency >99%, and resistance to airflow of 1.5 cmH2O/L/Sec at 12 L/Sec.

Technological Characteristics

Housing: Impact Polystyrene. Filter Media: Electrostat synthetic electret. Single-patient-use disposable form factor. Mechanical filtration principle.

Indications for Use

Indicated for patients requiring lung function evaluations during pulmonary function testing.

Regulatory Classification

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.

Predicate Devices

• PDSI KoKo Filter (K914272)

Submission Summary (Full Text)

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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.<br>1485 Lisbon Street<br>Lewiston, ME 04240 | Tel - [phone] | Fax - [phone] |
|----------------------------------------------------------------|---------------------------------------------------------------------------|----------------------|
| 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 function<br>testing | |

### Indicated use:

1

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 | Intended<br>device | PDSI<br>KoKo Filter |
|------------------------------------------------------------------------------------------------|--------------------|---------------------|
| Use<br>Intended as a bacterial/viral filter<br>Intended for use during pulmonary function test | Yes<br>Yes | Yes<br>Yes |
| Design<br>Single patient use | Yes | Yes |

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Comparison to predicate devices (continued):

| Attribute | Intended<br>device | PDSI<br>KoKo Filter |
|-------------------------------------------------------------------------------------------------------------|----------------------|-----------------------|
| Materials<br>Housing - Impact Polystyrene<br>Filter Media | Yes<br>Electrostat | Yes<br>Filtrete |
| Performance<br>Bacterial Efficiency<br>Viral Efficiency<br>Resistance to Airflow (cmH2O/L/Sec. @ 12/L/Sec.) | >99%<br>>99%<br>>1.5 | 99.99%<br>99.98%<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

f

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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