(75 days)
No
The description focuses on the physical filtration mechanism and performance metrics related to filtration efficiency and airflow resistance. There is no mention of AI, ML, or any computational analysis of data.
No.
This device is a filter for a ventilator, intended for the filtration of exhaled gases to prevent the spread of bacteria and viruses, rather than directly treating a patient's medical condition.
No
This device is a filter designed to remove exhaled gases from a ventilator circuit. Its purpose is filtration and safety, not the diagnosis of a medical condition.
No
The device is a physical filter (HEPA filter) designed to be placed in a ventilator circuit, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Filtration of exhaled gases in the ventilator circuit." This is a mechanical function within a medical device (a ventilator circuit) to prevent the spread of pathogens.
- Device Description: The description focuses on the physical characteristics of the filter, its materials, and its filtration performance (BFE, VFE, DOP).
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This device's function is purely mechanical filtration within a breathing circuit.
N/A
Intended Use / Indications for Use
Filtration of exhaled gases in the ventilator circuit.
Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.
Cleaning method -- autoclaved -- 30 minutes with 3 minutes at 134°C.
Environment of Use --Hospital, Sub-acute Institutions
Product codes
CAH
Device Description
The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which The An Bareey Indust side of the PB 700 series and 7200 ventilators. It can be cleaned by steam ecomeets in the ennation are 1 year service life. It has standard 22 mm tubing connectors and it has a clear housing. It contains the Air Safety standard Multipleat media which has been HEPA tested for enting performance according to BS 3928 Sodium Flame for Air filters and in accordance to DOE 3202-97 and ASTM D2986 - DOP. In addition BFE and VFE testing has been performed by 1902 5202 77 and in the substantial equivalence to the predicate devices.
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)
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resistance to flow 99.97% of 0.3 micron DOP particle
Predicate Device(s)
Air Safety – Model 3000/04 – K033008, PB Omniflow Filter – K890362
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
C 050955
Air Safety Model 3000/06 Filter
Premarket Notification 510(k) Section 4 - Certifications and Summaries
JUN 2 9 2005
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 14-Apr-05
| Official Contact: | Steve Brown – Quality Manager |
|---|---|
| Proprietary or Trade Name: | Air Safety Model 3000/06 HEPA Filters |
| Common/Usual Name: | Bacterial / Viral Filters |
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH |
| Predicate Devices: | Air Safety – Model 3000/04 – K033008 |
| PB Omniflow Filter – K890362 | |
| Device Description |
The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which The An Bareey Indust side of the PB 700 series and 7200 ventilators. It can be cleaned by steam ecomeets in the ennation are 1 year service life. It has standard 22 mm tubing connectors and it has a clear housing. It contains the Air Safety standard Multipleat media which has been HEPA tested for enting performance according to BS 3928 Sodium Flame for Air filters and in accordance to DOE 3202-97 and ASTM D2986 - DOP. In addition BFE and VFE testing has been performed by 1902 5202 77 and in the substantial equivalence to the predicate devices.
Intended Use and Environments
Filtration of exhaled gases in the ventilator circuit.
Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the riousl 3000 to to be played. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.
Cleaning method - autoclaved - 30 minutes with 3 minutes at 134°C.
Environment of Use -- Hospital, Sub-acute Institutions
1
Section 4 - Certifications and Summaries
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2
14-Apr-05
| Attribute | Air Safety Model 3000/04 - K033008
PB - Omniflow - K890362 |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indications for use - To filter expired gases. | Same |
| Intended for extended use up to 15 days
continuous, reusable up to 100 times via
autoclave or 1 year service life | Yes |
| Prescription | Yes |
| Intended population | Any patient on a ventilator - PB 700 series and
7200 |
| Intended Environment of Use | Hospital, sub-acute institution |
| Placement in exhalation limb of circuit | Yes |
| Design | |
| Reusable housing and materials | Yes |
| Clean by autoclave | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | ~ 350 ml |
| Resistance to flow | 99.97% of 0.3 micron DOP particle |
General Technical Characteristics
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged around the seal's perimeter. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Mr. Paul Dryden President Air Safety Ltd. c/o ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055-9501
Re: K050953
Trade/Device Name: Air Safety Model 3000/06 HEPA Filters Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: April 14, 2005 Received: April 18, 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.
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
3
Mr. Paul Dryden
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) 276-0115. 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,
Jenia y. Michieoms
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
Indications for Use 4.3
Page 1 of 1
| 510(k) Number: | K050953 (To be assigned) |
|---|---|
| Device Name: | Air Safety Model 3000/06 HEPA Reusable filter |
Intended Use:
Filtration of exhaled gases in the ventilator circuit.
Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.
Cleaning method -- autoclaved -- 30 minutes with 3 minutes at 134°C.
Environment of Use --Hospital, Sub-acute Institutions
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per CFR 801.109) | |
| or | |
| Over-the-counter use |
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K0S0953 |
|---|---|
| ---------------- | --------- |