(176 days)
No
The summary describes a physical filter for pulmonary function testing and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The primary function of this device is to filter air between a patient's exhaled breath and testing equipment, which is a protective and hygienic function for the equipment and subsequent users, not to directly treat a medical condition or restore health.
No
The device is described as a filter for use with pulmonary function testing equipment, designed to filter air between the patient's exhaled air and the testing equipment. Its purpose is to prevent cross-contamination by filtering bacteria and viruses, not to diagnose a medical condition.
No
The device description clearly describes a physical filter with specific dimensions, materials (electrostatic filter), and physical 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" during pulmonary function testing. This is a physical barrier and filtration function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description focuses on the physical characteristics of the filter (electrostatic, deadspace, resistance, connectors) and its filtration capabilities (bacterial and viral filtration). It does not describe a test that analyzes a biological sample to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing a biological sample (like blood, urine, or tissue), reagents, or a diagnostic assay.
The device is a component used with a diagnostic test (pulmonary function testing equipment), but it is not the diagnostic test itself. It serves a protective and hygienic function for the equipment and potentially the patient.
N/A
Intended Use / Indications for Use
For use with pulmonary function testing. 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 a compact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 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
Not Found
Intended User / Care Setting
Hospital, Sub-acute Institutions
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.)
Not Found
Predicate Device(s)
Pulmonary Data Services - KoKo – K934475
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
§ 868.1840 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
Premarket Notification 510(k)
Section 2 - Certifications and Summaries
MAR 1 4 2002
EMS PFT Filtcr
1013123
Engincered Medical Systems, Inc. 2055 Executive Dr. Indianapolis, IN 46241
Non-Confidential Summary of Safety and Effectiveness
Page i of 2 March 7, 2002
| EMS | Tel (317) 246-5500 |
|---|---|
| 2055 Executive Dr. | Fax (317) 246-5501 |
| Indianapolis, IN 46241 | |
| Official Contact: | Bonnic Holly - Quality Manager |
| Proprietary or Trade Name: | EMS Pulmonary Function Testing Filter |
| Common/Usual Name: | PFT filter |
| Classification Name: | Filter, Bacterial, Breathing Circuit |
| Predicate Devices: | Pulmonary Data Services - KoKo – K934475 |
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 and resistance of 07. cm H2O at 720 Ipm per ATS spirometry or 0.5 cm I-120 @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.
| Intended Use: | |
|---|---|
| Indicated Use -- | For use with pulmonary function testing. To filter |
| air between the patient's exhaled air and the testing | |
| equipment. Single patient use. | |
| Environment of Use -- | Hospital, Sub-acute Institutions |
1
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2
March 7, 2002
Comparison to Predicate Devices:
| | EMS Proposed device
Filter - Model # 5813 | Predicate PDS KoKo
K934475 |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Attribute | | |
| Intended use | For use with pulmonary function
testing. To filter
air between the patient's exhaled
air and the testing
equipment | Same |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute | Same |
| 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 | 60 ml |
| Resistance to flow at 720 lpm
per ATS standard for
spirometry | 0.7 cm H2O |