(230 days)
No
The device description and performance studies focus solely on the physical filtration properties of the filters and do not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is a filter designed to remove particulates and microorganisms from inspired and expired gases, not to directly treat or cure a disease or condition in a patient.
No
The device is described as a HEPA/Non-HEPA filter for use with ventilators and anesthesia machines to filter inspired and/or expired gases. Its function is filtration, not diagnosis. The performance metrics provided relate to its filtration efficiency (e.g., BFE, VFE), not diagnostic accuracy.
No
The device description clearly indicates it is a physical filter made of pleated paper fiber, available in multiple sizes and shapes, and incorporates standard connectors. It is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to filter inspired and/or expired gases in respiratory circuits (ventilators, anesthesia machines, open flow systems). This is a mechanical function related to the delivery and removal of gases from the patient's respiratory system.
- Device Description: The description details the physical characteristics of the filters (materials, connectors, testing for filtration efficiency). It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical filtration capabilities of the device (resistance to flow, bacterial and viral filtration efficiency, particle filtration). These are measures of the device's mechanical function, not diagnostic performance.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of any tissue or organ for transplantation. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Anesthesia / Respiratory Filters
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model - HEPA filter 3000/04 - Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model - Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.
Product codes
CAH
Device Description
The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.
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 some with tidal volumes > 150 ml
Intended User / Care Setting
Home, Hospital, Sub-acute Institutions, Emergency services
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.)
HEPA - Models - 6500/01, 6888/01, 8222/01, 8444/01: 99.99999%
Model 3000/04: 99.9999%
Bacterial filtration - BFE - Nelson
HEPA - Models - 6500/01, 6888/01, 8222/01, 8444/01: 99.99975%
Model 3000/04: 99.9999%
Viral filtration - VFE - Nelson
Non-HEPA - Model 4000/01: 99.99996%
Bacterial filtration - BFE – Nelson
Non-HEPA - Model 4000/01: 99.99925%
Viral filtration - VFE - Nelson
DOE 3025-99, DOE 3020-97 and ASTM D2986 - DOP: > 99.97% of 0.3 micron DOP particle @ 60 Lpm
Predicate Device(s)
K013089, K013122, K002201, K964540, K984379
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
MAY 1 3 2004
Summary of Safety and Effectiveness
Air Safety Ltd. NFC House, Vickers Industrial Estate Mellishaw Lane Morecambe, Lancaster LA3 3EN England Non-Confidential Summary of Safety and Effectiveness Page 1 of 3 7-May-04
| Official Contact: | Steve Brown – Quality Manager |
|---|---|
| Proprietary or Trade Name: | Air Safety HEPA and non-HEPA Filters |
| Common/Usual Name: | Bacterial / Viral Filters |
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH |
| Predicate Devices: | Engineered Medical Systems – |
| HEPA - K013089 | |
| Non-HEPA – K013122 | |
| Smiths Filter – K002201 | |
| NPB D/X7 - K964540 and K984379 |
Device Description
The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.
Indications for Use and Environments
Indications for Use -
Anesthesia / Respiratory Filters
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model - HEPA filter 3000/04 - Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model - Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.
1
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 3 7-May-04
Environment of Use --
Home, Hospital, Sub-acute Institutions, Emergency services
General Technical Characteristics
| Attribute | Air Safety |
|---|---|
| Indications for use - To filter inlet, inspired | |
| and / or expired gases. | Same |
| Intended for extended or single patient use up | |
| to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient some with tidal volumes > 150 ml |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit or | |
| ventilator | Yes |
| Design | |
| Gas sampling port | Optional |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 84 ml |
| 209 mm for Model 3000/04 | |
| Resistance to flow | 99.97% of 0.3 micron DOP particle @ |
| 60 Lpm |
2
Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 7-May-04
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the The data within the backle and effective and substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Air Safety Ltd. C/O Mr. Paul Dryden ProMcdic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055
Re: K033008
Trade/Device Name: Air Safety HEPA and Non-HEPA Filters Regulation Number: 21 CFR 868.5620 Regulation Name: Filter, Bacterial, Breathing-Circuit Regulatory Class: Class II Product Code: CAH Dated: March 12, 2004 Received: March 15, 2004
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 for assession 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 -- Mr. Paul Dryden
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deeting your device as described in your Section 510(k) i his letter will anow you to begin manketing your unce of your device of your device to a legally premarket nothleadon: "The PDA mumg of Gastian 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 If you desire specific acrice for your 201) 594-4646. Also, please note the regulation entitled, Contact the Office of Compraise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/dsma/dsmamain.html.
Sincerely yours,
Syra Jurn
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
5
Indications for Use
| Page 1 of 1 | |
|---|---|
| 510(k) Number: | K033008 (To be assigned) |
| Device Name: | Air Safety HEPA filters |
| Model 3000/04 | |
| Models – 6500/01, 6888/01, 8222/01, 8444/01 | |
| Non-HEPA filters – Model – 4000/01 |
Indications for Use:
Ancsthesia / Respiratory Filters
Ancistiesia / Respiratory / Interia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Noder - Non 1121 111111111111111111111111111111111111111111111111111111111111111111111
| Prescription Use XX | |
|---|---|
| (Per CFR 801.109) |
or
| Over-the-counter use | |
|---|---|
| ---------------------- | -- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Am
(Division Sion-Off Division of Anesthesiology General Hospital. Infection Control, Dental Devices
510(k) Number: KC33658