(79 days)
Not Found
No
The device description and key metrics indicate a physical filter, and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a filter for patient exhalation during pulmonary function testing, with the purpose of filtering bacteria and viruses. Its function is to prevent contaminant spread, not to treat a medical condition or restore health.
No
A diagnostic device is used to identify a condition or disease. This device is a filter, used to prevent the spread of bacteria and viruses during a medical test, but it does not perform any diagnostic function itself.
No
The device description explicitly states it is a "disposable bacterial/viral filter," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a filter used during pulmonary function testing. Its purpose is to filter exhaled air to prevent the spread of bacteria and viruses. It does not analyze a sample taken from the patient's body to diagnose or monitor a condition.
- Intended Use: The intended use is to filter exhaled air, not to perform a diagnostic test on a biological sample.
Therefore, this device falls under the category of a medical device used in a clinical setting, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing
Product codes
73 CAH
Device Description
A disposable bacterial/viral filter used in pulmonary function testing
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
Environment of use: Places where a qualified clinician desires to take lung function measurements.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Efficiency >99%
Viral Efficiency >99%
Resistance to Airflow (cmH2O/L/Sec. @ 12/L/Sec.) >1.5
Predicate Device(s)
PDSI KoKo Filter - K914272
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Street
| Lewiston, 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 function | |
| 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
device | PDSI
KoKo Filter |
|------------------------------------------------------------------------------------------------|--------------------|---------------------|
| Use
Intended as a bacterial/viral filter
Intended for use during pulmonary function test | Yes
Yes | Yes
Yes |
| Design
Single patient use | Yes | Yes |
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1
Comparison to predicate devices (continued):
| Attribute | Intended
device | PDSI
KoKo Filter |
|-------------------------------------------------------------------------------------------------------------|----------------------|-----------------------|
| Materials
Housing - Impact Polystyrene
Filter Media | Yes
Electrostat | Yes
Filtrete |
| Performance
Bacterial Efficiency
Viral Efficiency
Resistance 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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2
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.
3
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
4
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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