(66 days)
Not Found
No
The device description and performance studies focus on the physical filtration capabilities of the device, with no mention of AI or ML.
No.
The device is a filter used for pulmonary function testing equipment to prevent contamination, not to treat a medical condition.
No
The device is described as a filter for pulmonary function testing equipment, designed to prevent contamination between the patient and the equipment. It does not analyze patient data or provide medical insights, which are characteristics of a diagnostic device.
No
The device description clearly describes a physical filter with specific material properties and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "filter air between the patient's exhaled air and the testing equipment" for pulmonary function testing. This is a physical barrier and filtration function, not a diagnostic test performed in vitro (outside the body) on a specimen.
- Device Description: The description focuses on the physical characteristics of the filter (electrostatic, deadspace, connectors) and its function (filtering air). It doesn't mention any reagents, assays, or analysis of biological samples.
- Performance Studies: The performance studies mentioned are BFE (Bacterial Filtration Efficiency) and VFE (Viral Filtration Efficiency), which are measures of the filter's ability to block particles, not diagnostic accuracy or analytical performance on a biological sample.
- Key Metrics: The key metrics are filtration percentages, not diagnostic metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a component used with diagnostic equipment (pulmonary function testing equipment), but it doesn't perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use.
Product codes
BZG
Device Description
The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace of 0.7 cm H2O at 720 lpm per ATS spirometry guidelines or 0.5 cm H2O @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
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
Any patient
Intended User / Care Setting
Hospital, Sub-acute Institutions, Physician Offices
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)
BFE and VFE testing has been performed by Nelson Laboratories to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration: 99.9999%
Viral filtration: 99.999+%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SEP - 1 2005 Air Safety Model 2800 PFT Filter
Section 4 - Certifications and Summaries
Summary of Safety and Effectiveness 4.1
Air Safety Ltd. NFC House, Vickers Industrial Estate Mellishaw Lane Morecambe, Lancs LA3 3EN England
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 23-June-05
| Official Contact: | Steve Brown - Quality Manager |
|---|---|
| Proprietary or Trade Name: | Air Safety Model 2800 PFT Filters |
| Common/Usual Name: | PFT Filter |
| Classification Name: | Diagnostic Spirometer Accessory, BZG |
| Predicate Devices: | Engineered medical Systems - K013123 |
| Device Description: |
The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace of 0.7 cm H2O at 720 lpm per ATS spirometry guidelines or 0.5 cm H2O @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
BFE and VFE testing has been performed by Nelson Laboratories to demonstrate substantial equivalence to the predicate device.
| Intended Use and Environments |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Indications for Use -- Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment.
Environment of Use -- Hospital, Sub-acute Institutions, Physician Offices
1
Section 4 - Certifications and Summaries
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 23-June-05
General Technical Characteristics
| | Proposed device
Filter – Model 2800 | Predicate EMS K013123 |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | | |
| Intended use | For use with pulmonary function
testing equipment, to filter air
between the patient's exhaled air
and the testing
equipment | For use with pulmonary
function testing equipment, to
filter air between the patient's
exhaled air and the testing
equipment |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute, physician
office | Hospital, sub-acute |
| Can be used with several
different PFT machines | Yes | Yes |
| Design Features | | |
| Compact housing | Yes | Yes |
| Various end-fittings | Yes | Yes |
| Dead Space (ml) | 75 ml | 75 ml |
| Resistance to flow at 720 lpm
per ATS standard for
spirometry | $0.7 cm H_2O$ | $0.7 cm H_2O$ |
| Resistance to flow at 60 lpm | $0.5 cm H_2O$ | $0.5 cm H_2O$ |
| Bacterial filtration | 99.9999% | 99.9999% |
| Viral filtration | 99.999+% | 99.999+% |
| Weight | 40 gm | 40 gm |
| Materials | | |
| Housing polystyrene | Yes | Yes |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
| Performance | | |
| None under Section 514 | Yes | Yes |
Differences between Other Legally Marketed Predicate Devices
The proposed device, Model 2800, is identical to the predicate. Air Safety manufactures the predicate for EMS, therefore there are no significant differences.
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 wavy lines representing the feathers. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2005
Air Safety Limited C/O Mr. Paul Dryden Regulatory Consultant Promedic, Incorporated 6329 W. Waterview Ct. McCordsville, Indiana 46055-9501
Re: K051712
Trade/Device Name: Model 2800 PFT Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: June 23, 2005 Received: June 27, 2005
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.
3
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 Office of Compliance at (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suette H. Michael D.M.D
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
4
| 4.3 | Indications for Use |
|---|---|
| ----- | --------------------- |
| Page 1 of 1 | |
|---|---|
| 510(k) Number: | K051712 |
| Device Name: | Air Safety Model 2800 PFT filter |
| Intended Use: | Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. |
| Single patient use | |
| Environment of Use: | Hospital, Sub-acute Institutions, Physician offices |
| Prescription Use XX (Per CFR 801.109) | or Over-the-counter use |
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Aun Sulion
(Division Sign-Off) (Division Sign-Off)
510(k) Number.