(230 days)
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.
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.
This document describes the safety and effectiveness of Air Safety HEPA and Non-HEPA Filters. However, it does not fit the typical format of a study designed to prove a device meets acceptance criteria, especially in the context of an AI/ML powered device. This is a 510(k) premarket notification for traditional medical devices (filters), and therefore, many of the requested categories are not applicable.
Here's an attempt to answer the questions based on the provided text, with clear indications where the information is not available or not relevant to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a pass/fail format with direct device performance comparison in a single table, as might be found in a study for an AI/ML device. Instead, it lists technical characteristics and performance standards that the device meets.
However, based on the General Technical Characteristics table, we can infer performance criteria and compare them to the device's reported performance:
| Attribute/Performance Standard | Acceptance Criteria (Inferred from Predicate/Standards) | Reported Device Performance (Air Safety Filters) |
|---|---|---|
| Dead Space (ml) | Comparable to predicate / within acceptable range for intended use | 45 to 84 ml (various models), 209 mm for Model 3000/04 |
| Resistance to flow | < 3.4 cm H2O @ 60 Lpm (Likely a standard for breathing circuits) | < 3.4 cm H2O @ 60 Lpm |
| HEPA Filtration Efficiency (for listed HEPA models) | Specified by standards (e.g., DOE-3025-99, DOE-3020-97, ASTM D2986 - DOP for > 99.97% of 0.3 micron DOP particle @ 60 Lpm) | 99.99999% (Models 6500/01, 6888/01, 8222/01, 8444/01) Model 3000/04 - 99.9999% |
| Bacterial Filtration Efficiency (BFE) - Nelson (for listed HEPA models) | Standard requirement for bacterial filters (implied by predicate and testing) | 99.99975% (Models 6500/01, 6888/01, 8222/01, 8444/01) Model 3000/04 - 99.9999% |
| Viral Filtration Efficiency (VFE) - Nelson (for listed HEPA models) | Standard requirement for viral filters (implied by predicate and testing) | 99.99996% (Models 6500/01, 6888/01, 8222/01, 8444/01) |
| Bacterial Filtration Efficiency (BFE) - Nelson (for Non-HEPA Model 4000/01) | Standard requirement for bacterial filters (implied) | 99.99996% |
| Viral Filtration Efficiency (VFE) - Nelson (for Non-HEPA Model 4000/01) | Standard requirement for viral filters (implied) | 99.99925% |
| Filtration Performance (General) | According to EN 13328 Salt for Breathing System filtration performance. | "Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance." (Implied compliance) |
| DOP Test Performance (for HEPA) | > 99.97% of 0.3 micron DOP particle @ 60 Lpm | > 99.97% of 0.3 micron DOP particle @ 60 Lpm |
| Standard 15/22 mm connectors | Required for compatibility | Yes |
| Gas sampling port | Optional | Optional |
| Single patient use up to 24 hours | Yes | Yes |
| ISO 5356-1 Conical 15/22 | Compliance with standard | Yes |
| ISO 594-2 Luer Fittings | Compliance with standard | Yes |
Summary of "Study" to Prove Device Meets Criteria:
The document details the device characteristics and states that the devices were tested to specific performance standards. This is not a "study" in the clinical trial sense but rather a series of engineering and laboratory performance tests.
- Testing Methodologies:
- Filtration Performance: Tested according to EN 13328 Salt for Breathing System filtration performance.
- HEPA Performance (Specific models): Tested in accordance with DOE-3025-99, DOE-3020-97, and ASTM D2986 - DOP.
- Electrostatic (non-HEPA) Filtration (BFE and VFE): Tested by Nelson Laboratories.
- Conclusion: The submission concludes that "The data within the submission demonstrates that the proposed devices when compared to the legally marketed predicate devices are safe and effective and substantially equivalent." This implies that the performance characteristics met or exceeded those of the predicate devices and applicable standards.
Information Not Applicable / Not Provided for this Device Type:
The following requested information is primarily relevant for AI/ML-powered diagnostic or predictive devices, or those requiring clinical studies with human assessors. The provided document concerns a physical filter, for which these criteria are generally not applicable or not detailed in this type of 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not provided in this context. For physical filters, testing typically involves laboratory samples of the filters themselves, not patient data in the sense of AI/ML. The number of filter units tested for each specific performance claim (e.g., BFE, VFE, resistance) is not specified. Data provenance like "country of origin" for test data is not a typical requirement for device performance testing in this manner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. "Ground truth" established by experts (like radiologists for an image analysis AI) is not relevant for a breathing circuit filter. Performance is measured objectively through standardized laboratory tests (e.g., particle counts, pressure measurements).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions, typically for establishing ground truth in clinical datasets. This is not relevant for the objective performance testing of a physical filter.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical filter, not an AI/ML-powered diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for a filter's performance is derived from standardized physical and biological challenge tests (e.g., aerosolized particles, bacterial/viral suspensions) and measurements, not clinical expert consensus or pathology.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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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 - K013089Non-HEPA – K013122Smiths Filter – K002201NPB 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.
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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, inspiredand / or expired gases. | Same |
| Intended for extended or single patient use upto 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 orventilator | Yes |
| Design | |
| Gas sampling port | Optional |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 84 ml209 mm for Model 3000/04 |
| Resistance to flow | < 3.4 cm H2O @ 60 Lpm |
| 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 | |
| Materials | |
| Housing polystyrene | Yes |
| Filter media - HEPA | Paper fiber |
| Filter Media - Electrostatic - non-HЕРА | Polypropylene |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| DOE 3025-99, DOE 3020-97 and ASTMD2986 - DOP | > 99.97% of 0.3 micron DOP particle @60 Lpm |
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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.
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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
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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
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Indications for Use
| Page 1 of 1 | |
|---|---|
| 510(k) Number: | K033008 (To be assigned) |
| Device Name: | Air Safety HEPA filtersModel 3000/04Models – 6500/01, 6888/01, 8222/01, 8444/01Non-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
§ 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).