(77 days)
Not Found
No
The device is a simple particulate filter and the description contains no mention of AI, ML, or related concepts.
No.
Explanation: The device is a replacement part (inlet filter) for a ventilator, which itself is a therapeutic device, but the filter's function is to remove particles from the air entering the ventilator, not to directly provide therapy to a patient.
No
The device is described as an Inlet Filter that removes particles from entering a ventilator, acting as a replacement part in the gas flow pathway. Its function is to filter, not to diagnose.
No
The device description clearly states it is a physical filter (a screw-in cartridge) and describes physical performance testing (particulate filtration efficiency and resistance to flow), indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter air entering a ventilator, which is a life support device used for breathing assistance. This is a mechanical function related to the operation of the ventilator and the delivery of air to a patient.
- Device Description: The description reinforces its function as a particulate filter within the ventilator's gas pathway.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information for diagnosis, monitoring, or treatment decisions based on the analysis of these samples.
- Using reagents or other materials to perform tests on biological samples.
The device is a component of a medical device (a ventilator) and performs a physical function (filtration) rather than an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MOD
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.
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
Environment of Use -- Where the NPB Achieva and LP 10 ventilators are used, i.e., 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.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 868.5895 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).
0
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 - K990177 |
| EMS 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
1
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 particulate | |
| filter for the inlet air to be supplied to the | |
| patient 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 10 |
| ventilators | |
| Intended Environment of Use | As specified by the ventilator |
| Design | |
| Screw-in cartridge to fit the inlet air filter port | |
| of 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 and
ASTM D2986 - DOP | Yes ≥ 99.97% of 0.3 micron DOP particle
at 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.
2
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
3
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
4
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