(77 days)
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway. As a HEPA particulate filter for the inlet air to be supplied to the patient from the ventilator.
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for the NPB Achieva or LP 10 ventilators, which is in the gas flow pathway. Screw-in cartridge to fit the inlet air filter port of the ventilator housing.
The Air Safety HEPA Model 3500 Filter is an inlet filter designed to remove particles of 0.3 micron size or larger from entering ventilators, specifically the NPB Achieva and LP 10 models. It is a HEPA grade particulate filter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resistance to flow | ≤ 0.9 cm H2O @ 40 Lpm | ≤ 0.9 cm H2O @ 40 Lpm |
| ≤ 1.25 cm H2O @ 60 Lpm | ≤ 1.25 cm H2O @ 60 Lpm | |
| HEPA – particulate filtration efficiency (retention) | ≥ 99.97% of 0.3 micron DOP particle at 60 Lpm | > 99.97% of 0.3 micron DOP particle at 60 Lpm |
| ≥ 99.97% of 0.3 micron DOP particle at 100 Lpm | > 99.97% of 0.3 micron DOP particle at 100 Lpm |
2. Sample size used for the test set and the data provenance:
The document describes performance testing based on "standard DOP aerosol testing methods" and references specific standards (DOE 3025-99, DOE 3020-97, and ASTM D2986 - DOP). However, it does not specify the sample size for the test set used to generate the reported performance data. The data provenance is implied to be from internal testing conducted by Air Safety Ltd. in England. It's a prospective testing for the device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a physical filter, and its performance (filtration efficiency and resistance to flow) is assessed through objective laboratory testing using recognized standards. Therefore, the concept of "experts establishing ground truth" in the way it applies to image analysis or clinical diagnoses is not relevant in this context. The ground truth is the result of the objective measurements obtained through the specified test methods.
4. Adjudication method for the test set:
Not applicable. As described above, the performance is determined by objective, standardized measurements, not through expert judgment or consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation is involved. This device's performance is quantifiable through laboratory testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the performance testing of the HEPA filter can be considered a standalone assessment. The filtration efficiency and resistance to flow are measured attributes of the device itself, independent of human interaction in its primary function (filtering air).
7. The type of ground truth used:
The ground truth used for this device's performance assessment is based on objective measurements obtained through standardized laboratory protocols. Specifically, it involves:
- DOP aerosol testing for particulate filtration efficiency (retention).
- Measurement of resistance to flow at specified flow rates.
These are established engineering and scientific methods to quantify the physical properties of filters.
8. The sample size for the training set:
Not applicable. This device is a physical product, not an algorithmic model 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 this type of device.
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Premarket Notification - K040712
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 2 1-June-04
| Official Contact: | Steve Brown - Quality Manager |
|---|---|
| Proprietary or Trade Name: | Air Safety HEPA Model 3500 Filter |
| Common/Usual Name: | Inlet filter |
| Classification Name: | Accessory to a Continuous Ventilator (Respirator), MOD |
| Predicate Devices: | NPB Achieva ventilator - K990177EMS filter - K013089 |
| Device Description |
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator.
It is a HEPA grade particulate filter for the NPB Achieva or LP 10 ventilators, which is in the gas flow pathway.
HEPA particulate filtration testing was performed via standard DOP aerosol testing methods. There are no Bacterial or Viral filtration efficiency (BFE / VFE) claims made or required for this filter.
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter Intended Use -removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway. It is changed during periodic maintenance of the ventilator.
Environment of Use -- Where the NPB Achieva and LP 10 ventilators are used, i.e., Home, Hospital, Sub-acute Institutions, Emergency services
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 1-June-04
| General Technical Characteristics | |
|---|---|
| Attribute | Air Safety |
| Indications for use – As a HEPA particulatefilter for the inlet air to be supplied to thepatient from the ventilator. | Same |
| Intended for disposable, extended use –preventive maintenance | Yes |
| Prescription | Yes |
| Specific equipment | Only for use with the NPB Achieva and LP 10ventilators |
| Intended Environment of Use | As specified by the ventilator |
| Design | |
| Screw-in cartridge to fit the inlet air filter portof the ventilator housing | Yes |
| Dead Space (ml) | Not applicable as it is not in the patient circuit |
| Resistance to flow | ≤ 0.9 cm H2O @ 40 Lpm≤ 1.25 cm H2O @ 60 Lpm |
| HEPA – particulate filtration efficiency(retention) | ≥ 99.97%of 0.3 micron DOP particle at 60 Lpm> 99.97%of 0.3 micron DOP particle at 100 Lpm |
| Materials | |
| Housing K-resin | Yes |
| Filter media - HEPA | Paper fiber |
| Performance Standards | |
| None under Section 514 | Yes |
| DOE 3025- 99, DOE 3020-97 andASTM D2986 - DOP | Yes ≥ 99.97% of 0.3 micron DOP particleat 60 Lpm and 100 Lpm |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed device when compared to the predicate device is safe and effective and is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines above two wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004-
Air Safety Ltd. C/O Mr. Paul Dryden ProMedic Inc. 6329 W. Waterview Ct. McCordsville, IN 46055
Rc: K040712
Trade/Device Name: Air Safety HEPA Model 3500 Regulation Number: 21 CFR 868.5895 Regulation Name: Accessory to Continuous Ventilator (Respirator) Regulatory Class: Class II Product Code: MOD Dated: March 17, 2004 Received: March 18, 2004
Dcar Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to re would your end 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, of to do research Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provide for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh 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 mean that 127 may and statutes and regulations administered by other Federal agencies. or the Act of arry I business on the Act's requirements, including, but not limited to: registration
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Page 2 - Mr. Paul Dryden
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 607), laceling systems-(QS) regulation (21 CFR Part 820); and if requirences as set form in the quarty of the 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) This letter will anon you to begin made 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), If you desire specific at 100 for your as at (301) 594-4646. 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chris Liu, Ph.D.
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: | K040712 (To be assigned) |
|---|---|
| Device Name: | Air Safety HEPA filters - Model 3500/01 |
Intended Use:
Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator.
It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway.
Prescription Use XX (Per CFR 801.109)
Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Amy Siliom
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K040712
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).