(75 days)
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
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.
This response describes the acceptance criteria and the study that indicates the device meets the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Air Safety Model 3000/06) |
|---|---|---|
| Indications for use | To filter expired gases. | Same |
| Extended use | Up to 15 days continuous, reusable up to 100 times via autoclave or 1 year service life | Yes (Matches predicate) |
| Prescription | Yes | Yes (Matches predicate) |
| Intended population | Any patient on a ventilator - PB 700 series and 7200 | Any patient on a ventilator - PB 700 series and 7200 |
| Intended Environment of Use | Hospital, sub-acute institution | Hospital, sub-acute institution |
| Placement in exhalation limb of circuit | Yes | Yes (Matches predicate) |
| Reusable housing and materials | Yes | Yes (Matches predicate) |
| Clean by autoclave | Yes | Yes (Matches predicate) |
| Standard 15/22 mm connectors | Yes | Yes (Matches predicate) |
| Dead Space (ml) | ~ 350 ml | ~ 350 ml |
| Resistance to flow | < 1.5 cm H₂O at 60 lpm and < 2.5 cm H₂O at 100 lpm | < 1.5 cm H₂O at 60 lpm and < 2.5 cm H₂O at 100 lpm |
| HEPA - Bacterial filtration (BFE) | 99.999% | 99.999% |
| HEPA - Viral filtration (VFE) | 99.999% | 99.999% |
| Housing material | Polycarbonate | Polycarbonate (Matches predicate) |
| Filter media | HEPA (Paper fiber) | Paper fiber (Matches predicate) |
| Performance Standards Met | ISO 5356-1 Conical 15/22; DOE 3202-97 and ASTM D2986 - DOP ( > 99.97% of 0.3 micron DOP particle) | Yes (Matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in terms of the number of devices or units tested for each performance characteristic. Instead, it refers to the performance of the predicate devices and implies that the Air Safety Model 3000/06 HEPA Filter matches these established performance characteristics.
The provenance of the data is primarily from Nelson Lab for the Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE) testing. The document also refers to testing performed according to BS 3928 Sodium Flame for Air filters and in accordance with DOE 3202-97 and ASTM D2986 - DOP. The context suggests these are retrospective references to established standards and predicate device performance, rather than a prospective, independently designed clinical trial specifically for the 3000/06 model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not specify the number or qualifications of experts used to establish a "ground truth" for a specific test set. The data presented is engineering and laboratory performance data (e.g., filtration efficiency, resistance to flow) measured against established industry standards and specifications, rather than clinical outcomes requiring expert consensus on a patient-level "ground truth."
4. Adjudication Method for the Test Set
Not applicable. The evaluation relies on direct measurements against predefined technical specifications and standards, not on subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic imaging devices where human readers interpret patient cases, and the AI's impact on their performance is evaluated. The Air Safety Model 3000/06 is a physical filter, not a diagnostic tool that involves human interpretation of cases.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The performance metrics listed (e.g., BFE, VFE, resistance to flow, dead space) are inherent properties of the device itself, measured independently of human interaction in typical clinical use. The "study" here refers to the laboratory testing conducted to ascertain these physical and filtration properties against established standards.
7. Type of Ground Truth Used
The "ground truth" for the performance claims is based on established engineering and laboratory standards and predicate device specifications. For example:
- Bacterial and Viral Filtration Efficiency: Determined by testing performed by Nelson Lab, likely against a standardized challenge (e.g., specific bacterial/viral aerosols) under controlled laboratory conditions.
- Resistance to Flow: Measured using standardized methodologies relevant to ventilator circuits (e.g., flow rates of 60 lpm and 100 lpm).
- HEPA testing: Performance according to BS 3928 Sodium Flame for Air filters and DOE 3202-97 and ASTM D2986 - DOP, which specify testing procedures and filtration efficiency requirements for particulate matter.
8. Sample Size for the Training Set
Not applicable. This device is a physical filter being evaluated against quantifiable performance metrics, not an AI model that requires a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{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 – K033008PB 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 - K033008PB - Omniflow - K890362 |
|---|---|
| Indications for use - To filter expired gases. | Same |
| Intended for extended use up to 15 dayscontinuous, reusable up to 100 times viaautoclave or 1 year service life | Yes |
| Prescription | Yes |
| Intended population | Any patient on a ventilator - PB 700 series and7200 |
| 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 | < 1.5 cm H₂O at 60 lpm and< 2.5 cm H₂O at 100 lpm |
| HEPA - Bacterial filtration - BFE - NelsonLab. | 99.999% |
| HEPA - Viral filtration - VFE - Nelson Lab. | 99.999% |
| Materials | |
| Housing polycarbonate | Yes |
| Filter media - HEPA | Paper fiber |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| DOE 3202-97 and ASTM D2986 - DOP | Yes > 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 |
|---|---|
| ---------------- | --------- |
§ 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).