(264 days)
No
The device description and performance studies focus on the physical filtration capabilities of the mouthpiece and do not mention any computational or analytical functions that would suggest the use of AI/ML.
No.
The device's purpose is to filter the patient's exhaled breath to prevent cross-contamination of monitoring equipment, not to treat or diagnose a medical condition.
No
The device is described as a "filter mouthpiece" designed to "filter possible bacteria and viruses from the patient exhalation" for use with carbon monoxide monitors, primarily to "prevent cross contamination." Its function is to filter and protect the monitor, not to diagnose a patient's condition.
No
The device description clearly states it is a physical mouthpiece with a filter made of cardboard, indicating it is a hardware device, not software.
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 bacteria and viruses from exhaled breath before it reaches a carbon monoxide monitor. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on a sample.
- Device Description: The description focuses on the physical structure and filtering mechanism of the mouthpiece. It doesn't describe any reagents, assays, or analytical processes typically associated with IVDs.
- Performance Studies: The performance studies listed are primarily focused on biocompatibility (cytotoxicity, sensitization, irritation) and filtration efficiency. These are relevant for a medical device that contacts the patient and interacts with another device, but not for evaluating the analytical performance of a diagnostic test.
- Key Metrics: The key metrics are bacterial and viral filtration efficacy, which are measures of the device's ability to physically block particles, not diagnostic performance metrics like sensitivity or specificity.
In summary, the SafeBreath Filter mouthpiece is a medical device designed to prevent cross-contamination during breath monitoring, not a device that performs a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
To filter possible bacteria and viruses from the patient exhalation, for use with carbon monoxide monitors. For use by healthcare professionals only.
Product codes (comma separated list FDA assigned to the subject device)
CAH
Device Description
The SafeBreath Filter mouthpiece is a single patient contacting mouthpiece consisting of a 22mm diameter cardboard tube with a filter for the filtration of possible bacteria and viruses from the patient exhaled breath into the breath monitor device to prevent cross contamination.
The SafeBreath mouthpieces connect directly to the carbon monoxide monitors, such as CO Check Pro and CO Screen (K171129).
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
healthcare professionals / Healthcare
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)
Biocompatibility Evaluation and Performance Testing:
- ISO10993-5 In-vitro cytotoxicity:
- Purpose: Not explicitly stated beyond general cytotoxicity assessment.
- Acceptance Criteria: Results less than Grade 2
- Results: Grade 0 - Non cytotoxic
- ISO10993-10:2010 Skin Senstization Study in Guinea Pigs (Maximization Test):
- Purpose: To assess skin sensitization potential of polar and non polar extracts of the test item SafeBreath filtered mouthpiece in Guinea pigs by Maximization test.
- Acceptance Criteria: Score 2 or less
- Results: Score 0 - Non sensitizing
- ISO10993 - 10:2010 Intracutaneous Reactivity in New Zealand White Rabbits (Irritation):
- Purpose: To assess the possible irritation likely to arise from intracutaneous injection of polar and non polar extracts of the test item SafeBreath filtered mouthpiece following single administration at five site in New Zealand White rabbits.
- Acceptance Criteria: Score 2 or less
- Results: Score 0 - Non irritant
- Public Health England Report 19/018 (Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges):
- Purpose: To evaluation Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges of Aged 4 year old SafeBreath mouthpieces at 11 litres min-1 at a relative humidity of 95%.
- Acceptance Criteria: Not applicable
- Results: Bacterial efficacy: 98.50%, Viral efficacy: 99.40%
Overall Conclusion: The Performance data demonstrates that the subject device met the acceptance criteria found in the standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial efficacy: 98.50%
Viral efficacy: 99.40%
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.
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
§ 868.5260 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).
0
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September 25, 2019
MD Diagnostics Limited Glen Hillsley Regulatory Affairs 15 Hollingworth Court, Turkey Mill Maidstone, ME14 5pp Gb
Re: K190022
Trade/Device Name: SafeBreath Filter Mouthpiece Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: August 25, 2019 Received: August 30, 2019
Dear Glen Hillsley:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190022
Device Name Safebreath Filter Mouthpiece
Indications for Use (Describe)
To filter possible bacteria and viruses from the patient exhalation, for use with carbon monoxide monitors. For use by healthcare professionals only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K190022
MD Diagnostics Ltd. – SafeBreath Filter mouthpiece
Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared
MD Diagnostics Ltd. 15 Hollingworth Court, Turkey Mill, Maidstone, Kent. ME14 5PP GB
| Phone: | +44(0) 1622 682686 |
|---|---|
| Facsimile: | +44(0) 1622 681693 |
| Contact Person: | Glen Hillsley |
|---|---|
| Date Prepared: | December 2018 |
Subject Device details
| Proprietary/Trade name: | Safebreath Filter Mouthpiece |
|---|---|
| Common or Usual Name: | Filter, bacteria, breathing circuit |
| Classification Name: | Breathing circuit, bacterial filter (868.5260) |
| Device classification: | II |
| Product code: | CAH |
Classification Panel: General Hospital
Predicate Device details
Predicate 1: Device name / 510k: SpiroSafe filter (K973314) Manufacturer: Micro Direct Inc, Lewiston, Maine 04240
Further to a review of the MAUDE database – There is no record of any product problems or safety
4
issues relating to the use of the SpiroSafe filter. (Note: The SpiroSafe filter is for use on pulmonary equipment when a pulmonary function test is performed by the patient, it is not intended for use on ventilator or other breathing circuit systems).
Device Description
The SafeBreath Filter mouthpiece is a single patient contacting mouthpiece consisting of a 22mm diameter cardboard tube with a filter for the filtration of possible bacteria and viruses from the patient exhaled breath into the breath monitor device to prevent cross contamination.
The SafeBreath mouthpieces connect directly to the carbon monoxide monitors, such as CO Check Pro and CO Screen (K171129).
Intended Use / Indications for Use
The Safebreath Filter Mouthpieces are indicated for:
To filter possible bacteria and viruses from the patient exhalation for use with carbon monoxide monitors. For use by healthcare professionals only.
The Intended use:
The SafeBreath cardboard, Filter Mouthpieces are intended to channel a breath sample from a patient onto the sensor of any carbon monoxide measuring device fitted with a 22m port, specifically with the carbon monoxide monitors (CO Check Pro & CO Screen) and are designed to prevent bacterial and viral contamination of monitor sensor housing. The filtered mouthpieces are intended for direct connection to a carbon monoxide monitor device.
The Mouthpieces are intended for single-patient use to be disposed of after use. It is not designed to be re-used or sterilised.
The Mouthpieces are supplied in a non-sterile condition in a dispenser box for ease of use and to protect the product during transport.
Technological Characteristics
Shown below is a comparison of the subject device versus the predicate device.
| ltem | Subject device - K190022
MD
Diagnostics -SafeBreath
bacterial viral filter | Predicate device -
K973314
SpiroSafe filter -Micro
Direct Inc | Comparison |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | Intended as a bacterial/viral
filter. Intended for use in a
carbon monoxide breath
exhalation test when
connected to carbon
monoxide measuring device. | Intended as a
bacterial/viral filter.
Intended for use in a
pulmonary function test
when connected to
pulmonary measuring
device. | Similar |
5
| Indications for
Use | To filter possible bacteria
and viruses from the patient
exhalation for use with
carbon monoxide monitors. | To filter possible
bacteria and viruses
from the patient
exhalation when
performing pulmonary
function testing. | Similar |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Environments
used | Healthcare | Healthcare | Same |
| Human Factor | Patient places the
bacterial/viral filter device
into their mouth and exhales
into carbon monoxide
measuring device. | Patient places the
bacterial/viral filter
device into their mouth
and exhales into
pulmonary measuring
device. | Same - patient has to
place subject and
predicate into their
mouth to perform test |
| Patient breath
sampling
system | Bacterial viral filter
mouthpiece - when
connected to carbon
monoxide measuring device. | Bacterial viral filter
mouthpiece - when
connected to pulmonary
measuring device. | Same |
| Component
parts | LDPE coated cardboard tube; Polypropylene enclosure filter base; Electrostatic Filter material | Impact polystyrene housing Electrostatic, filter material | Similar |
Performance Data
Shown below are the biocompatibility and performance testing that was performed to verify whether the subject device could meet the acceptance criteria found in the standards.
| Performance Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO10993-5 | |||
| In-vitro cytotoxicity | Results less than | ||
| Grade 2 | Grade 0 - Non | ||
| cytotoxic | |||
| ISO10993-10:2010 | |||
| Skin Senstization | |||
| Study in Guinea Pigs | |||
| (Maximization Test) | To assess skin | ||
| sensitization potential | |||
| of polar and non polar | |||
| extracts of the test | |||
| item SafeBreath | |||
| filtered mouthpiece in | |||
| Guinea pigs by | |||
| Maximization test. | Score 2 or less | Score 0 - Non | |
| sensitizing | |||
| ISO10993 - 10:2010 | |||
| Intracutaneous | |||
| Reactivity in New | |||
| Zealand White Rabbits | |||
| (Irritation) | To assess the possible | ||
| irritation likely to arise | |||
| from intracutaneous | |||
| injection of polar and | |||
| non polar extracts of | |||
| the test item | Score 2 or less | Score 0 - Non irritant |
Biocompatibility Evaluation
6
| | SafeBreath filtered
mouthpiece following
single administration at
five site in New
Zealand White rabbits | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------|
| Public Health England
Report 19/018 | To evaluation Filtration
Efficiencies Against
Bacterial and Viral
Aerosol Challenges of
Aged 4 year old
SafeBreath
mouthpieces at 11
litres min-1 at a relative
humidity of 95% | Not applicable | Bacterial efficacy:
98.50%
Viral efficacy:
99.40% |
The Performance data demonstrates that the subject device met the acceptance criteria found in the standards.
Conclusion
The conclusions drawn from the nonclinical test (discussed above) that demonstrate that the Safebreath Filter Mouthpiece device is as safe, as effective, and performs as well as or better than the predicate device.