(66 days)
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.
The EMS PFT Filter is a compact, 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.
Air Safety Model 2800 PFT Filter Acceptance Criteria and Study Findings
This document outlines the acceptance criteria for the Air Safety Model 2800 PFT Filter and the study that demonstrates its conformance.
1. Acceptance Criteria and Reported Device Performance
The Air Safety Model 2800 PFT Filter underwent testing to demonstrate substantial equivalence to the predicate device, the Engineered medical Systems - K013123. The acceptance criteria were based on the performance characteristics of this predicate device.
| Attribute | Acceptance Criteria (Predicate EMS K013123) | Reported Device Performance (Model 2800) |
|---|---|---|
| Intended use | Filter air between patient's exhaled air and PFT equipment | Meets criteria |
| Intended for single patient use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Any patient |
| Intended Environment of Use | Hospital, sub-acute | Hospital, sub-acute, physician office |
| Can be used with several different PFT machines | Yes | Yes |
| Compact housing | Yes | Yes |
| Various end-fittings | Yes | Yes |
| Dead Space (ml) | 75 ml | 75 ml |
| Resistance to flow at 720 lpm (ATS standard) | $0.7 cm H_2O$ | $0.7 cm H_2O$ |
| 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 |
| Housing material | Polystyrene | Polystyrene |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
The study demonstrates that the Air Safety Model 2800 PFT Filter meets all specified acceptance criteria, showing identical performance characteristics to the predicate device for all listed attributes.
2. Sample Size and Data Provenance
- Sample Size for the Test Set: Not explicitly stated for each specific test (BFE, VFE, flow resistance). However, the narrative indicates that "BFE and VFE testing has been performed by Nelson Laboratories to demonstrate substantial equivalence to the predicate device."
- Data Provenance: The data was generated by Nelson Laboratories, a third-party testing facility. The country of origin for the testing is not explicitly stated, but the submission is from Air Safety Ltd. in England. The study appears to be retrospective in the sense that it evaluates the performance of the manufactured device against pre-established criteria based on the predicate.
3. Number of Experts and Qualifications for Ground Truth
This type of device (PFT filter) does not typically involve expert human interpretation or "ground truth" in the diagnostic sense (e.g., image interpretation by radiologists). Instead, its performance is objectively measured against physical and biological metrics. Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging algorithms is not relevant here. The "ground truth" for this device's performance is derived from standardized testing protocols and the established performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on objective laboratory testing against defined performance metrics, not on human interpretation or adjudication of ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not applicable and therefore not performed. This device is a passive filter and does not involve human readers or AI in its operation. Its effectiveness is measured through physical and microbiological performance characteristics.
6. Standalone Performance Study
A standalone performance study was done for the device. The study involved BFE (Bacterial Filtration Efficiency) and VFE (Viral Filtration Efficiency) testing performed by Nelson Laboratories. This testing was conducted on the Air Safety Model 2800 PFT Filter independently of human interaction to objectively measure its filtration capabilities and other physical properties (e.g., dead space, resistance to flow). The results of these standalone tests were then compared directly to the established performance characteristics of the predicate device.
7. Type of Ground Truth Used
The ground truth used for evaluating the Air Safety Model 2800 PFT Filter was objective performance data from standardized laboratory testing. This includes:
- Bacterial and viral filtration efficiency percentages.
- Measured resistance to flow at specified rates (cm H2O).
- Measured dead space (ml).
- Material composition and physical dimensions.
This "ground truth" was established by comparing the results of the Model 2800's tests against the known, documented performance parameters of the legally marketed predicate device (EMS K013123), demonstrating substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical component, not a software algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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
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Section 4 - Certifications and Summaries
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 23-June-05
General Technical Characteristics
| Proposed deviceFilter – Model 2800 | Predicate EMS K013123 | |
|---|---|---|
| Attribute | ||
| Intended use | For use with pulmonary functiontesting equipment, to filter airbetween the patient's exhaled airand the testingequipment | For use with pulmonaryfunction testing equipment, tofilter air between the patient'sexhaled air and the testingequipment |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute, physicianoffice | Hospital, sub-acute |
| Can be used with severaldifferent 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 lpmper ATS standard forspirometry | $0.7 cm H_2O$ | $0.7 cm H_2O$ |
| 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.
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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 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.
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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 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
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| 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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510(k) Number.
§ 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).