The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.

Device Description

The Endoscopy Oxygen Mask is a multi-port mask that serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.

AI/ML Overview

The provided document describes the Endoscopy Oxygen Mask (K220533) and its substantial equivalence to a predicate device, the Panoramic Oxygen Mask (POM) (K172365). The acceptance criteria for the new device are primarily demonstrated through comparative non-clinical testing against the predicate device, showing similar performance in key aspects.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for each performance metric. Instead, it relies on demonstrating similarity or equivalence to the legally marketed predicate device (K172365) through non-clinical comparative testing. The performance is reported in terms of this similarity.

Acceptance Criteria (Inferred from Comparison to Predicate)	Reported Device Performance (Endoscopy Oxygen Mask)
Indications for Use: Single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes for non-intubated, spontaneously breathing patients > 30 kg.	Similar to predicate.
Patient Population: Non-intubated spontaneously breathing patients (Adults to Children).	Similar to predicate. (Note: Subject device tested for Adults, whereas predicate was for Adults to Children).
Environment of Use: Locations where procedures are performed where the patient requires supplemental oxygen, monitoring exhaled gases, and scope access (Hospital, sub-acute, clinic, physician offices, pre-hospital).	Similar to predicate.
Duration of Use: Single patient, disposable, < 24 hours.	Similar to predicate.
Mode of Operation: O2 delivery through standard oxygen supply tubing and simultaneous exhaled gas monitoring via a gas sampling line connected from mask to capnography or oxygen only delivery. Slit access ports for introduction of a scope.	Similar to predicate.
Gas Sampling Connection: Luer slip fit.	Similar to predicate.
Profile: Over the nose / mouth.	Similar to predicate.
Face Strap: Yes.	Similar to predicate.
Entrainment Vents: One-way valves to prevent rebreathing.	Similar to predicate.
%CO2 accuracy and Respiration rate: Tested at different simulated patient settings for breath rate, Tidal Volume at different CO2 concentrations with waveforms with similar performance to predicate.	Performed similarly to the predicate, with the proposed device performing better, but no claim made other than equivalence.
Biocompatibility: External Communicating (indirect), Tissue contact; Surface Communicating (direct), Skin contact; Limited duration of use (< 24 hours) as per ISO 10993-5, ISO 10993-10, ISO 18562-2.	Similar to predicate. Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, and particulate matter testing performed.
Shelf-life: Equivalent to predicate's shelf-life.	1 year accelerated age testing (Predicate had 3 years real-time). Implies similarity in shelf-life characteristics.
FiO2 results: Similar across the range of tests.	Similar across the range of tests. The differences did not have a pre-defined clinical criteria and are reported as relative performance for clinician guidance.
Internal Volume: No adverse impact on comparative performance.	Subject device has a larger internal volume (314 ml for adult vs. predicate's 198 ml for adult), but this difference does not impact comparative performance and provides more access.

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

The document does not specify a "sample size" in terms of number of patients or clinical samples because it describes non-clinical comparative performance testing using simulated patient settings. Therefore, there is no data provenance in terms of country of origin or retrospective/prospective study design as this was not a clinical study.

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

This information is not applicable. The study was non-clinical and did not involve human experts establishing ground truth for a test set. Performance metrics were based on simulated parameters and physical measurements.

4. Adjudication method for the test set

This information is not applicable as there was no test set requiring expert adjudication.

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 information is not applicable. This device is an Oxygen Mask with Gas Sampling, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable. This is a medical device, not an algorithm. The performance testing was for the device itself in simulated environments.

7. The type of ground truth used

For %CO2 accuracy and Respiration rate, the "ground truth" was established by simulated patient settings at different breath rates, tidal volumes, and known CO2 concentrations.

For Biocompatibility, the "ground truth" was established by standards such as ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 18562-2.

8. The sample size for the training set

This information is not applicable. There was no "training set" as this is not a machine learning or AI-based device.

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

This information is not applicable as there was no training set.

Summary

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November 16, 2022

Engineered Medical Systems Inc. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bav Point Dr NE Saint Petersburg, Florida 33704

Re: K220533

Trade/Device Name: Endoscopy Oxygen Mask Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: October 17, 2022 Received: October 17, 2022

Dear Paul 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. 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.

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

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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 mediation-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,

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

K220533

Device Name

Endoscopy Oxygen Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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EMS

Date Prepared:	16-Nov-2022
Sponsor:	Engineered Medical Systems, Inc.2055 Executive Dr.Indianapolis, IN 46241Tel - 317-246-5500
Official Contact:	Tami Lefevers – senior QA/RA Manager
Proprietary or Trade Name:	Endoscopy Oxygen Mask
Common/Usual Name:	Oxygen mask with Gas sampling
Classification Name:	Product Code - CCK – Analyzer, gas, carbon-dioxide, gaseous phase
Predicate Device:	Panoramic Oxygen Mask (POM) - K172365
Common/Usual Name:	Oxygen mask with Gas sampling
Classification Name:	Product Code – CCK – Analyzer, gas, carbon-dioxide, gaseous phase

The Endoscopy Oxygen Mask is a multi-port mask that Device Description: serves several functions: A standard oxygen mask for when a patient requires supplemental oxygen; Sampling of exhaled gases for monitoring, typically end-tidal CO2; Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases.

Principle of Operation: The subject device allows for O2 delivery through standard oxygen supply tubing and simultaneous exhaled gas monitoring via a gas sampling line connected from mask to capnography. It may also be used for supplemental oxygen only delivery.

Slit access ports allowing for introduction of a scope, tubing, etc. by the healthcare professional.

Indications for Use: The Endoscopy Oxygen Mask is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for nonintubated, spontaneously breathing patients greater than 30 kg.

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K220533

510(k) Summary Page 2 of 5

Table 1 - Comparison of Subject vs. Predicate

	Predicate	Subject device	Comparison
	Panoramic Oxygen Mask (POM)	Endoscopy Oxygen Mask
	POM Medical, LLC	Engineered Medical Systems, Inc.
K#	K172365	TBD	N/A
Product Code	CCK	CCK	Similar
CFR	21 CFR 868.1400	21 CFR 868.1400	Similar
Classification	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Similar
Indications for Use	The Panoramic Oxygen Mask (POM) is a singlepatient, disposable device intended for deliveringsupplemental oxygen and monitoring expired gasesfrom the patient, with ports to allow the clinician toinsert scopes, probes, or tubes. It is for non-intubated,spontaneously breathing patients greater than 30 kg.	The Endoscopy Oxygen Mask is a single patient,disposable device intended for deliveringsupplemental oxygen and monitoring expired gasesfrom the patient, with ports to allow the clinician toinsert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greaterthan 30 kg.	Similar
Patient Population	Non-intubated spontaneously breathing patientsAdults to Children	Non-intubated spontaneously breathing patientsAdults to Children	Similar
Environment of Use	Locations where procedures are performed where thepatient requires supplemental oxygen, monitoringexhaled gases, and scope accessHospital, sub-acute, clinic, physicianoffices, pre-hospital	Locations where procedures are performed where thepatient requires supplemental oxygen, monitoringexhaled gases, and scope accessHospital, sub-acute, clinic, physicianoffices, pre-hospital	Similar
Duration of Use	Single patient, disposable, <24 hours	Single patient, disposable, <24 hours	Similar
Perspective	Yes	Yes	Similar
Mode of Operation	O2 delivery through standard oxygen supply tubingand simultaneous exhaled gas monitoring via a gassampling line connected from mask to capnography oroxygen only deliverySlit access ports allowing for introduction of a scope	O2 delivery through standard oxygen supply tubingand simultaneous exhaled gas monitoring via a gassampling line connected from mask to capnographyor oxygen only deliverySlit access ports allowing for introduction of a scope	Similar
	PredicatePanoramic Oxygen Mask (POM)POM Medical, LLC	Subject deviceEndoscopy Oxygen MaskEngineered Medical Systems, Inc.	Comparison
Components whichmay be supplied orpackaged with themask	Standard oxygen tubingGas sampling line	Standard oxygen tubingGas sampling line	Similar
Gas samplingconnection	Luer slip fit	Luer slip fit	Similar
Sizes	Child and Adult	Adult	Currently one size
Profile	Over the nose / mouth	Over the nose / mouth	Similar
Face strap	Yes	Yes	Similar
Performance
Internal volume	Child – 93 mlAdult - 198 ml	Adult - 314 ml	The difference in internalvolume does not impactcomparative performance
Entrainment Vents	One-way valves to prevent rebreathing	One-way valves to prevent rebreathing	Similar
%CO2 accuracy andRespiration rate	Testing was done at different simulated patient settingsfor breath rate, Tidal Volume at different CO2concentrations with waveformsThe results showed similar performance with theproposed device performing better, but no claim isbeing made on performance other than equivalence.	Testing was done at different simulated patientsettings for breath rate, Tidal Volume at differentCO2 concentrations with waveformsThe results showed similar performance with theproposed device performing better, but no claim isbeing made on performance other than equivalence.	Similarcomparative testing results
Biocompatibility	External Communicating (indirect), Tissue contactAndSurface Communicating (direct), Skin contactLimited duration of use (< 24 hours)ISO 10993-5ISO 10993-10ISO 18562-2	External Communicating (indirect), Tissue contactAndSurface Communicating (direct), Skin contactLimited duration of use (< 24 hours)	Similar
Shelf-life	3 years real-time aging and shelf-life	1 year accelerated age testing	Similar

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510(k) Summary Page 3 of 5

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510(k) Summary Page 4 of 5

Difference Between Subject and Predicate

The differences are:

The FiO2 results are similar across the range of tests, any differences do not have a pre-● defined clinical criteria. Relative performance values are provided in the labeling as guides for the clinician during use. There is always additional monitoring being utilized, i.e., pulse oximeters for SpO2 and expired gas monitors which would be used by the clinician.
The larger internal volume of the subject mask provides larger access area to the clinician, while any differences in performance do not raise new safety or effectiveness concerns, thus the subject device can be found equivalent.

Substantial Equivalence Discussion

The Endoscopy Oxygen Mask is viewed as substantially equivalent to the predicate Panoramic Oxygen Mask (POM) - K172365.

Indications -

The intended use is to provide supplemental oxygen, monitor exhaled gases, and provide scope access is similar to the predicate.
Discussion - Both provide supplemental oxygen, monitoring of exhaled gases, and access port(s) for scopes.

Patient Population and environment of Use -

The intended population is non-intubated spontaneously breathing patients in locations ● where procedures are performed that the patient may require supplemental oxygen, monitoring of exhaled gases and scope access.
Discussion - The population is similar to the predicate Panoramic Oxygen Mask (POM) -K172365.

Technology -

Similar technology of utilizing a luer fitting to connect gas sampling lines and having ● ports for scope access
Discussion - The technology is similar to the predicate Panoramic Oxygen Mask (POM) -K172365

Non-clinical Testing -

We have performed non-clinical comparative performance testing that included:

Internal volume .
. Evaluation of ability to measure EtCO2 and Respiration Rate are various
simulated patient settings typical of pediatric and adult users ●
Storage, Drop and Aging ●
. Biocompatibility testing was conducted per International Standard Organization (ISO) 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process and included cytotoxicity testing (MEM elution), sensitization (guinea pig maximization), intracutaneous reactivity, acute systemic toxicity, and material mediated pyrogenicity testing. In addition, particulate matter testing was performed per ISO 18562-2 Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 2: Tests for emissions of particulate matter

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510(k) Summary Page 5 of 5

Substantial Equivalence Conclusion

The FiO2 results are similar across the range of tests, this performance does not have a predefined clinical criteria. These are reported relative performance values in the labeling as guides for the clinician during use. There is always additional monitoring being utilized, i.e., pulse oximeters for SpO2 and expired gas monitors which would be used by the clinician.

These differences do not raise new concerns of safety or effectiveness. The comparison to the predicate for features, indications for use, population, and comparative testing across the range of oxygen flow, simulated patient conditions, exposed to different CO2 levels demonstrated that both devices provide representative measurement of EtCO2 and respiratory rate and their respective waveforms were similar.

The results demonstrate equivalence in performance.

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).