AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

Device Description

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

Acceptance Criteria (Internal/Predetermined)	Reported Device Performance
Biocompatibility: Meet ISO 10993 standards (ISO 10993-5:2009, ISO 10993-23:2021, ISO 10993-10:2021, ISO 18562-2:2017, ISO 18562-3:2017) for surface contact, skin and mucosal, externally communicating tissue, limited use (<24hr).	Met the specified ISO standards for biocompatibility.
Performance Tests
* % Fraction of Inspired O2 (FiO2)	AIM maintained FiO2 equivalent to the predicate device in all simulated conditions (at several respiratory rates, tidal volumes, and oxygen flow rates).
* % End Tidal CO2 (EtCO2)	AIM indicated EtCO2 is equivalent to the predicate device in all simulated conditions (under two simulated conditions at multiple simulated EtCO2 values).
* CO2 Waveforms	AIM captured CO2 waveforms as well as or better than the predicated device in all simulated conditions (under several simulated respiratory conditions, oxygen flow rates, and simulated EtCO2 values).
Mechanical Tests:
* Bite Force Finite Element Analysis (FEA)	Minimal deformation observed.
* Dislodgement Force	Comparison to predicate (implies equivalence or better).
* Axial Separation Force (ISO 80369-2)	Comparison to predicate (implies equivalence or better) and compliance with ISO 80369-2.
Accelerated Aging: Comparison of pre and post-aging performance (ISO 80369-2, ISO 594-2, ISO 11607-1).	All samples passed the performance tests at least as well as the predicate device after accelerated aging. Compliance with ISO 80369-2, ISO 594-2, ISO 11607-1.
Ship Testing: ISTA 3A	Passed ISTA 3A.

Note: The primary acceptance criterion for many of the performance and mechanical tests is "Comparison to predicate," implying that the AIM device must perform equivalently or better than the legally marketed predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify the exact sample sizes (number of devices tested) for the performance, mechanical, or aging tests. It mentions "All AIM samples passed the non-clinical tests, and all samples passed the performance tests..." which suggests that all units tested within the sample passed, but the size of "all samples" is not quantiﬁed.
Data Provenance: The study appears to be retrospective in the sense that it's a submission for regulatory clearance based on historical testing. The data originates from simulated conditions (e.g., "simulated oxygen delivery," "simulated EtCO2 values," "simulated respiratory conditions"). The geographic origin of the data/testing is not explicitly stated, but as it's an FDA submission, the testing would typically be conducted under recognized standards, often implicitly in the US or by labs adhering to US-acceptable standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The acceptance criteria relate to physical performance (FiO2, EtCO2, mechanical properties) measured by instrumentation under simulated conditions, compared against a predicate device. There is no mention of human expert adjudication for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As noted above, the ground truth is based on physical measurements and comparisons to a predicate device, not human interpretation or consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is typically performed for AI-assisted diagnostic devices where human readers interpret medical images or data. The AIM device is a physical medical device for oxygen delivery and CO2 monitoring, not an AI diagnostic tool.

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

Yes, in a sense, the performance tests for FiO2, EtCO2, and CO2 waveforms were evaluative of the device's standalone performance under simulated conditions, without direct human intervention as part of the measurement process itself. The "algorithm" here refers to the physical design and function of the device rather than a computational algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (FiO2, EtCO2, CO2 Waveforms) was established by:

Instrumental measurement under simulated conditions: The values of FiO2 and EtCO2, and the characteristics of CO2 waveforms, were presumably measured by calibrated instruments under controlled, simulated physiological conditions.
Comparative equivalence to a legally marketed predicate device: The performance of the AIM device was directly compared to the performance of the DualGuard™ predicate device under the same simulated conditions. The predicate device's performance effectively served as a reference or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. The AIM device is a physical medical device, not an AI/ML model that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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December 16, 2024

Inventeur, LLC % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704

Re: K240937

Trade/Device Name: AIM Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, MNK, CAT Dated: November 19, 2024 Received: November 19, 2024

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 (the 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 available 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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Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep 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

Submission Number (if known)	K240937
Device Name	AIM
Indications for Use (Describe)	AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.
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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Page 1 of 4 12-Dec-2024

510k Sponsor:	Inventeur, LLC 16192Coastal HwyLewes, DE 19958
Official Contact:	Tariq ChaudhryEmail: tacmd1@gmail.comPhone: 813.843.4408
Submission Correspondent:	Paul Dryden, ProMedic, LLCPaul.Dryden@promedic.cc
Proprietary or Trade Name:Common/Usual Name:Classification Name:	AIMBite block with gas sampling and oxygen delivery21 CFR §862.1345 - CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous- Phase21 CFR §876.1500 - MNK – Endoscopic Bite Block21 CFR §868.5340 - CAT - Cannula, Nasal, Oxygen
Predicate Device:Common/Usual Name:Classification Name:	Dualguard™ (K140473)Endoscopic bite block and nasal oxygen cannula withCO2 monitoring accessory21 CFR §862.1345 - CCK - Analyzer, Gas, Carbon-Dioxide, Gaseous- Phase

1. Device Description

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

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510(k) Summary Page 2 of 4

12-Dec-2024

	Subject Device: AIM	Predicate Device: DualGuard™K140473	Comparison
Indications for use	AIM is a bite block intended for use inpatients 18 years and older who requiresupplemental oxygen and CO2 monitoringduring procedures where the patient isexpected to be minimally or moderatelysedated. AIM is not indicated for use duringprocedures that are expected to require deepsedation.	DualGuard™ is intended for use in Adultpatients who require supplemental oxygendelivery and CO2 monitoring duringendoscopy procedures and recovery.The complete device with bite block is tobe used during endoscopy procedures. TheDualGuard™ Bite Block is to be removedafter endoscopy, leaving the O2delivering/CO2 sampling cannula in placefor the patient recovery period.	AIM is not indicated for use duringprocedures that are expected to require deepsedation.AIM specifies patients greater than 18 yearsold whereas the DualGuard specifies adultpatients.These differences do not result in a newintended use.
Environments of Use	Locations where procedures are performedin which the patient requires supplementaloxygen and monitoring of exhaled gases.Hospitals, Sub-acute facilities, Clinics,Physician offices, MRI, Patient Transport(ambulances, etc.)	Locations where endoscopy procedures areperformed in which the patient requiressupplemental oxygen and monitoring ofexhaled gases.	Similar
Duration of Use	Single patient, disposable	Single patient, disposable	Same
Mode of Operation	AIM is a biteblock that includesmethods to deliver oxygen andsample expired gases in the oralcavity.	DualGuard delivers oxygen through anasal/oral cannula and samples CO2nasally and orally.	Similar: Both devices are placed in themouth and serve as bite blocks that deliveroxygen and monitor CO2 in the oral cavity.AIM does not include an integrated nasalcannula.
12-Dec-2024
	Subject Device: AIM	Predicate Device: DualGuard™ K140473	Comparison
Biocompatibility	Surface contact, skin and mucosal.Externally communicating, tissue.Limited use (<24hr)	Surface contact, skin and mucosal.Externally communicating, tissue.Limited use (<24hr)	Similar patient contact and duration of use
% Fraction of Inspired O2(FiO2)	Comparative testing of simulated oxygen delivery was completed at several respiratoryrates, tidal volumes, and oxygen flow rates.		AIM maintained FiO2 equivalent to thepredicate device in all simulated conditions.
% End Tidal CO2(EtCO2)	Comparative testing was completed under two simulated conditions at multiple simulatedEtCO2 values.		AIM indicated EtCO2 is equivalent to thepredicate device in all simulated conditions.
CO2 Waveforms	Comparative testing was completed under several simulated respiratory conditions,oxygen flow rates, and simulated EtCO2 values.		AIM captured CO2 waveforms as well asor better than the predicated device in allsimulated conditions
Target population	>/= 18 y.o.	Adult	Similar
Connectable tocapnograph?	Yes	Yes	Same
Expired gas samplinglocation	Oral - multiple ports	Nasal and Oral	Similar
Design	Bite block with attached oxygen deliverytubing which delivers oxygen to the back ofthe mouth. Multiple sampling ports which areconnected to a gas sampling line which isattached a capnograph	Oval shape inserted into the mouth with acentral opening for insertion of instruments.Includes sampling nasal cannula and oxygendelivery tubing. It has an elastic head band	Both design include means for deliveringoxygen and sampling CO2 and method ofsecurement.
Location of use	Inserted on either the left or right side of themouth	Inserted in the center of the mouth	The differences do not raise a differentquestion of safety and effectiveness.
Mechanism for securement	AIM inserted into mouth and secured withtape	Secured with an elastic band around thehead	Each has a means of securing from potentialdislodgement

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510(k) Summary Page 3 of 4

12-Dec-2024

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510(k) Summary Page 4 of 4 12-Dec-2024

3. Substantial Equivalence

AIM is considered substantially equivalent to the predicate DualGuard device based on the following discussion.

AIM has a similar intended use as the predicate device. AIM specifies patients greater than 18 years old whereas the DualGuard specifies adult patients. This difference does not affect the risk profile of the device.

DualGuard device supplies oxygen and samples CO2 through the nose and mouth, while AIM delivers oxygen and samples CO2 for capnography in the oropharynx. During testing, AIM delivered oxygen and sampled CO2 for capnography as effectively as the DualGuard device over a broad range of oxygen flow rates, simulated end-tidal CO2 levels, tidal volumes, and respiratory rates. Both devices are used with standard oxygen sources and capnography machines.

Neither device is life-supporting or life-sustaining.

AIM and DualGuard have similar intended use and technological characteristics. The differences between the two devices do not raise additional questions of safety and effectiveness.

4. Summary of Testing

AIM has been evaluated according to the standards listed in the table below. EtCO2 and FiO2 tests were performed at a range of respiratory rates, tidal volumes, and oxygen flow settings. All AIM samples passed the non-clinical tests, and all samples passed the performance tests at least as well as the predicate device.

Test	Standard / Pre-determinedAcceptance Criteria
Biocompatibility	ISO 10993-5:2009ISO 10993-23:2021ISO 10993-10:2021ISO 18562-2:2017ISO 18562-3:2017
Performance Tests (FiO2, EtCO2)including CO2 waveforms	Comparison to predicate
Mechanical Tests (Bite Force FiniteElement Analysis, Dislodgement Force,Axial Separation Force)	Minimal deformationComparison to predicateISO 80369-2
Accelerated aging	Comparison of pre and post-agingISO 80369-2ISO 594-2ISO 11607-1
Ship Testing	ISTA 3A

5. Conclusion

The testing and comparison to the predicate support a decision of substantial equivalence.

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).