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).

AI/ML Overview

The provided text is a 510(k) Summary for the SafeBreath Filter Mouthpiece (K190022). It primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing related to biocompatibility and filtration efficiency.

However, the provided text does not describe a study involving an AI/Machine Learning device that utilizes a test set, expert ground truth, multi-reader multi-case studies, or addresses improved human reader performance with AI assistance. The device in question is a physical filter mouthpiece, not a software algorithm.

Therefore, many of the requested criteria related to AI/ML device performance evaluation cannot be answered from the provided document. I will extract the information that is present concerning the device's acceptance criteria and the studies conducted.

Here's an analysis based only on the provided text for the SafeBreath Filter Mouthpiece:

1. A table of acceptance criteria and the reported device performance

Performance Test	Purpose	Acceptance Criteria	Reported Device Performance
ISO10993-5 In-vitro cytotoxicity	(Implied: To assess cytotoxicity)	Results less than Grade 2	Grade 0 - Non cytotoxic
ISO10993-10:2010 Skin Sensitization 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 SafeBreath filtered mouthpiece.	Score 2 or less	Score 0 - Non irritant
Public Health England Report 19/018 (Filtration Efficiencies)	To evaluate Filtration Efficiencies Against Bacterial and Viral Aerosol Challenges of Aged 4-year-old SafeBreath mouthpieces at 11 litres/min at a relative humidity of 95%.	Not applicable (criteria implicit in the purpose of proving efficiency)	Bacterial efficacy: 98.50%Viral efficacy: 99.40%

2. Sample size used for the test set and the data provenance

Biocompatibility Tests: The exact sample sizes for the in-vitro cytotoxicity study are not specified. For the in-vivo studies:
- Skin Sensitization (Guinea Pigs): Sample size not explicitly stated, but standard animal study protocols would involve a sufficient group size.
- Intracutaneous Reactivity (New Zealand White Rabbits): Sample size not explicitly stated, but the test involved "single administration at five sites" in rabbits, implying multiple rabbits.
Filtration Efficiency Test (Public Health England Report 19/018): The sample size for the filters tested is not explicitly stated, but it refers to "Aged 4 year old SafeBreath mouthpieces."
Data Provenance: The studies appear to be laboratory-based performance tests, likely conducted in a controlled environment by specific testing organizations (e.g., Public Health England). The data provenance is not described in terms of "country of origin" from a clinical dataset or whether it's retrospective/prospective, as these are material/device performance tests not clinical data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the provided document. The "ground truth" for this device is established through objective laboratory testing against established standards (ISO 10993 for biocompatibility) and direct measurement for filtration efficiency, not through expert interpretation of data like in an AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. As these are objective laboratory tests, there is no need for expert adjudication of results in the way it's done for clinical image interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This device is a physical filter, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation was performed or is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance claims are based on:
- Biocompatibility Standards: Compliance with ISO 10993 series through laboratory tests measuring specific biological responses (cytotoxicity, sensitization, irritation).
- Direct Measurement: For filtration efficiency, the ground truth is the directly measured percentage of bacterial and viral particles filtered under controlled laboratory conditions.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not a machine learning device.

9. How the ground truth for the training set was established

This question is not applicable. There is no "training set" for this physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.

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 (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

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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:	+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

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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 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 - K190022MDDiagnostics -SafeBreathbacterial viral filter	Predicate device -K973314SpiroSafe filter -MicroDirect Inc	Comparison
Intended use	Intended as a bacterial/viralfilter. Intended for use in acarbon monoxide breathexhalation test whenconnected to carbonmonoxide measuring device.	Intended as abacterial/viral filter.Intended for use in apulmonary function testwhen connected topulmonary measuringdevice.	Similar

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Indications forUse	To filter possible bacteriaand viruses from the patientexhalation for use withcarbon monoxide monitors.	To filter possiblebacteria and virusesfrom the patientexhalation whenperforming pulmonaryfunction testing.	Similar
Environmentsused	Healthcare	Healthcare	Same
Human Factor	Patient places thebacterial/viral filter deviceinto their mouth and exhalesinto carbon monoxidemeasuring device.	Patient places thebacterial/viral filterdevice into their mouthand exhales intopulmonary measuringdevice.	Same - patient has toplace subject andpredicate into theirmouth to perform test
Patient breathsamplingsystem	Bacterial viral filtermouthpiece - whenconnected to carbonmonoxide measuring device.	Bacterial viral filtermouthpiece - whenconnected to pulmonarymeasuring device.	Same
Componentparts	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
ISO10993-5In-vitro cytotoxicity		Results less thanGrade 2	Grade 0 - Noncytotoxic
ISO10993-10:2010Skin SenstizationStudy in Guinea Pigs(Maximization Test)	To assess skinsensitization potentialof polar and non polarextracts of the testitem SafeBreathfiltered mouthpiece inGuinea pigs byMaximization test.	Score 2 or less	Score 0 - Nonsensitizing
ISO10993 - 10:2010IntracutaneousReactivity in NewZealand White Rabbits(Irritation)	To assess the possibleirritation likely to arisefrom intracutaneousinjection of polar andnon polar extracts ofthe test item	Score 2 or less	Score 0 - Non irritant

Biocompatibility Evaluation

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	SafeBreath filteredmouthpiece followingsingle administration atfive site in NewZealand White rabbits
Public Health EnglandReport 19/018	To evaluation FiltrationEfficiencies AgainstBacterial and ViralAerosol Challenges ofAged 4 year oldSafeBreathmouthpieces at 11litres min-1 at a relativehumidity 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.

Regulation Number and Section

§ 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).