(94 days)
Air Safety Model 2800 PFT filter (K051712)
Not Found
No
The device description and performance studies focus on the physical filtration properties of an electrostatic filter, with no mention of AI or ML.
No
The device is described as a filter for pulmonary function testing equipment, designed to prevent contamination, not to provide therapy to a patient.
No
This device is a filter used with pulmonary function testing equipment to prevent contamination. It does not perform any diagnostic function itself.
No
The device description clearly states it is a "standard electrostatic filter" and describes physical components (patient end piece, biteblock shape, mouthpiece shape). The performance studies focus on physical properties like filtration efficiency, resistance to flow, and burst strength, which are characteristic of a hardware device.
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 between the patient's exhaled air and pulmonary function testing equipment. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The description confirms it's an electrostatic filter for preventing contamination of the equipment. It doesn't mention analyzing any biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information about a patient's health condition.
The device's function is purely to protect the testing equipment from contamination, which is a supportive role in the diagnostic process (pulmonary function testing itself is a diagnostic procedure), but the filter itself is not performing a diagnostic test.
N/A
Intended Use / Indications for Use
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient's exhaled air and the testing equipment. Single patient use, disposable. Duraton of use 107 challenge.
- Viral Filtration efficiency (VFE) 99.9939% per MIL-M-36954C. X174 o bacteriophage of approximately 2.9 micron size, > 106 challenge.
- Dead space
- Housing burst strength
- Age testing
Key results:
- Resistance to flow @ 1, 5, 14 l/sec per ATS standard for spirometry: 0.56 cmH2O @ 1 l/sec, 0.74 cmH2O @ 5 l/sec, 1.47 cmH2O @ 14 l/sec
- Bacterial Filtration Efficiency (BFE): 99.9998%
- Viral Filtration Efficiency (VFE): 99.9939%
- Weight (gm): 30 grams
- Internal volume/Dead space: 70 ml – Ergo, 68 ml - BiteOn
- Housing Burst Pressure: > 120 cm H2O
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial Filtration Efficiency (BFE): 99.9998%
- Viral Filtration Efficiency (VFE): 99.9939%
- Resistance to flow @ 1 l/sec: 0.56 cmH2O
- Resistance to flow @ 5 l/sec: 0.74 cmH2O
- Resistance to flow @ 14 l/sec: 1.47 cmH2O
- Weight: 30 grams
- Internal volume/Dead space (Ergo): 70 ml
- Internal volume/Dead space (BiteOn): 68 ml
- Housing Burst Pressure: > 120 cm H2O
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.
Air Safety Model 2800 PFT filter (K051712)
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
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
Medical Respiratory Devices S.L. Mr. Paul Dryden President, PreMedic, Inc. Avda. de las Americas 4, Nave A7 Coslada (Madrid) 28823 SPAIN
Re: K142303
Trade/Device Name: NeumoFilt Ergo and NeumoFilt BiteOn Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: October 21, 2014 Received: October 22, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. Dryden
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142303
Device Name NeumoFilt Ergo
Indications for Use (Describe)
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient's exhaled air and the testing equipment. Single patient use, disposable. Duraton of use 120 cm H2O | Not reported |
| Performance | None under section 514 | None under section 514 |
| Biocompatibility | Tested per ISO 10993
Cytotoxicity
Sensitization
Irritation | Not reported |
Technology – The MRD NeumoFilt is an electrostatic media that is equivalent in performance and the fundamental principle of operation as the predicate.
Discussion - There are no differences in technology between the proposed device and the predicate Air Safety Model 2800 PFT filter - K051712.
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510(k) Summary Page 3 of 4 8-Nov-14
Environment of Use - Hospitals, Sub-acute facilities, clinics and physician offices. Discussion - The environment of use is substantially equivalent to the predicate Air Safety Model 2800 PFT filter – K051712.
Patient Population - There are no patient specific limitations. Discussion - This is identical to the predicate Air Safety Model 2800 PFT filter - K051712.
Performance Specifications - The performance specifications are substantially equivalent to the predicates - Air Safety Model 2800 PFT filter - K051712.
Non-clinical Testing - We performed a number of non-clinical tests to demonstrate the safety and efficacy of the MRD NeumoFilt. These tests included:
Materials – The materials have been evaluated and tested in accordance with ISO 10993-1 and G95-1. Based upon ISO 10993-1 and G95-1 the NeumoFilt filter would be considered as:
- Externally communicating (indirect gas pathway) ●
- Tissue contact ●
- Limited duration ( 107 challenge.
- Viral Filtration efficiency (VFE) 99.9939% per MIL-M-36954C. X174 о bacteriophage of approximately 2.9 micron size, > 106 challenge.
- Dead space ●
- Housing burst strength ●
- Age testing
Discussion of Differences and Similarities -
As the above table and rationale present there are no major differences between the proposed NeumoFilt and the predicate. Each filter is operates on the same filtration technology that is placed between two houses. They each connect to PFT testing equipment. The predicate may be used with a separate mouthpiece to make it easier for the user whereas the proposed Ergo design the patient end-fitting is shaped like a mouthpiece thus not requiring a separate piece. Their physical
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510(k) Summary Page 4 of 4 8-Nov-14
size, design, dimensions are very similar and not considered significantly different as demonstrated by the comparative performance testing. The slight differences in BFE / VFE, weight, and Dead Space do not raise any new safety concern and thus can be considered substantially equivalent.
Substantial Equivalence Conclusion - The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.