SafeBreath Filter Mouthpiece

K190022 · MD Diagnostics Limited · CAH · Sep 25, 2019 · Anesthesiology

Device Facts

• Record ID: K190022
• Device Name: SafeBreath Filter Mouthpiece
• Applicant: MD Diagnostics Limited
• Product Code: CAH · Anesthesiology
• Decision Date: Sep 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Indications for 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.

Device Story

Single-patient use mouthpiece; 22mm diameter cardboard tube with integrated electrostatic filter. Used by healthcare professionals in clinical settings to facilitate carbon monoxide breath testing. Patient exhales through mouthpiece into carbon monoxide monitor; filter captures bacteria and viruses to prevent cross-contamination of monitor sensor housing. Device is disposable; non-sterile. Benefits include protection of equipment and reduction of cross-contamination risk during diagnostic breath sampling.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity: Grade 0), ISO 10993-10 (sensitization: Score 0), and ISO 10993-10 (irritation: Score 0). Filtration efficiency testing performed by Public Health England demonstrated 98.50% bacterial efficacy and 99.40% viral efficacy at 11 L/min and 95% relative humidity.

Technological Characteristics

22mm diameter cardboard tube; polypropylene enclosure filter base; electrostatic filter material. Single-patient use; non-sterile. Mechanical filtration principle. No energy source. No software.

Indications for Use

Indicated for filtering bacteria and viruses from patient exhalation during use with carbon monoxide monitors. For use by healthcare professionals only.

Regulatory Classification

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.

Predicate Devices

• SpiroSafe filter (K973314)

Reference Devices

• CO Check Pro (K171129)
• CO Screen (K171129)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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: | [phone] |
|------------|--------------------|
| Facsimile: | [phone] |

| 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

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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<br>MD<br>Diagnostics -SafeBreath<br>bacterial viral filter | Predicate device -<br>K973314<br>SpiroSafe filter -Micro<br>Direct Inc | Comparison |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | Intended as a bacterial/viral<br>filter. Intended for use in a<br>carbon monoxide breath<br>exhalation test when<br>connected to carbon<br>monoxide measuring device. | Intended as a<br>bacterial/viral filter.<br>Intended for use in a<br>pulmonary function test<br>when connected to<br>pulmonary measuring<br>device. | Similar |

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| Indications for<br>Use | To filter possible bacteria<br>and viruses from the patient<br>exhalation for use with<br>carbon monoxide monitors. | To filter possible<br>bacteria and viruses<br>from the patient<br>exhalation when<br>performing pulmonary<br>function testing. | Similar |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Environments<br>used | Healthcare | Healthcare | Same |
| Human Factor | Patient places the<br>bacterial/viral filter device<br>into their mouth and exhales<br>into carbon monoxide<br>measuring device. | Patient places the<br>bacterial/viral filter<br>device into their mouth<br>and exhales into<br>pulmonary measuring<br>device. | Same - patient has to<br>place subject and<br>predicate into their<br>mouth to perform test |
| Patient breath<br>sampling<br>system | Bacterial viral filter<br>mouthpiece - when<br>connected to carbon<br>monoxide measuring device. | Bacterial viral filter<br>mouthpiece - when<br>connected to pulmonary<br>measuring device. | Same |
| Component<br>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<br>In-vitro cytotoxicity | | Results less than<br>Grade 2 | Grade 0 - Non<br>cytotoxic |
| ISO10993-10:2010<br>Skin Senstization<br>Study in Guinea Pigs<br>(Maximization Test) | To assess skin<br>sensitization potential<br>of polar and non polar<br>extracts of the test<br>item SafeBreath<br>filtered mouthpiece in<br>Guinea pigs by<br>Maximization test. | Score 2 or less | Score 0 - Non<br>sensitizing |
| ISO10993 - 10:2010<br>Intracutaneous<br>Reactivity in New<br>Zealand White Rabbits<br>(Irritation) | To assess the possible<br>irritation likely to arise<br>from intracutaneous<br>injection of polar and<br>non polar extracts of<br>the test item | Score 2 or less | Score 0 - Non irritant |

# Biocompatibility Evaluation

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| | SafeBreath filtered<br>mouthpiece following<br>single administration at<br>five site in New<br>Zealand White rabbits | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------|
| Public Health England<br>Report 19/018 | To evaluation Filtration<br>Efficiencies Against<br>Bacterial and Viral<br>Aerosol Challenges of<br>Aged 4 year old<br>SafeBreath<br>mouthpieces at 11<br>litres min-1 at a relative<br>humidity of 95% | Not applicable | Bacterial efficacy:<br>98.50%<br>Viral efficacy:<br>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.