(255 days)
Not Found
No
The device description and performance studies focus on the mechanical and gas delivery/sampling functions of a bite block, with no mention of data analysis, algorithms, or learning capabilities.
No
The device is a bite block that provides oxygen delivery and expired gas sampling. It is not intended to treat a disease or condition, but rather to facilitate monitoring and supplemental oxygen during procedures.
No.
Explanation: The device is a bite block with integrated oxygen delivery and expired gas sampling. It is intended for monitoring CO2 levels, not for diagnosing a medical condition.
No
The device description clearly states that AIM is a "single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing." This describes a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- AIM's Function: AIM is a bite block that facilitates the delivery of oxygen and the sampling of exhaled gases (CO2) directly from the patient's airway. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for delivering supplemental oxygen and monitoring CO2 during procedures. This is a direct interaction with the patient's respiratory system, not an analysis of a biological sample.
Therefore, based on the provided information, AIM falls under the category of a medical device used for respiratory support and monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CCK, MNK, CAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharynx
Indicated Patient Age Range
18 years and older; >/= 18 y.o.
Intended User / Care Setting
Not Found
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)
Performance Tests (FiO2, EtCO2) including CO2 waveforms: Comparison to predicate. All AIM samples passed the non-clinical tests, and all samples passed the performance tests at least as well as the predicate device.
Mechanical Tests (Bite Force Finite Element Analysis, Dislodgement Force, Axial Separation Force): Minimal deformation, Comparison to predicate, ISO 80369-2
Accelerated aging: Comparison of pre and post-aging, ISO 80369-2, ISO 594-2, ISO 11607-1
Ship Testing: ISTA 3A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
FiO2: AIM maintained FiO2 equivalent to the predicate device in all simulated conditions.
EtCO2: AIM indicated EtCO2 is equivalent to the predicate device in all simulated conditions.
CO2 Waveforms: AIM captured CO2 waveforms as well as or better than the predicated device in all simulated conditions.
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.
Not Found
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
§ 868.1400 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
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 16192
Coastal Hwy
Lewes, DE 19958 |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Tariq Chaudhry
Email: tacmd1@gmail.com
Phone: 813.843.4408 |
| Submission Correspondent: | Paul Dryden, ProMedic, LLC
Paul.Dryden@promedic.cc |
| Proprietary or Trade Name:
Common/Usual Name:
Classification Name: | AIM
Bite block with gas sampling and oxygen delivery
21 CFR §862.1345 - CCK - Analyzer, Gas, Carbon-
Dioxide, Gaseous- Phase
21 CFR §876.1500 - MNK – Endoscopic Bite Block
21 CFR §868.5340 - CAT - Cannula, Nasal, Oxygen |
| Predicate Device:
Common/Usual Name:
Classification Name: | Dualguard™ (K140473)
Endoscopic bite block and nasal oxygen cannula with
CO2 monitoring accessory
21 CFR §862.1345 - CCK - Analyzer, Gas, Carbon-
Dioxide, Gaseous- Phase |
1. 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.
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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 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. | DualGuard™ is intended for use in Adult
patients who require supplemental oxygen
delivery and CO2 monitoring during
endoscopy procedures and recovery.
The complete device with bite block is to
be used during endoscopy procedures. The
DualGuard™ Bite Block is to be removed
after endoscopy, leaving the O2
delivering/CO2 sampling cannula in place
for the patient recovery period. | AIM is not indicated for use during
procedures that are expected to require deep
sedation.
AIM specifies patients greater than 18 years
old whereas the DualGuard specifies adult
patients.
These differences do not result in a new
intended use. |
| Environments of Use | Locations where procedures are performed
in which the patient requires supplemental
oxygen and monitoring of exhaled gases.
Hospitals, Sub-acute facilities, Clinics,
Physician offices, MRI, Patient Transport
(ambulances, etc.) | Locations where endoscopy procedures are
performed in which the patient requires
supplemental oxygen and monitoring of
exhaled gases. | Similar |
| Duration of Use | Single patient, disposable | Single patient, disposable | Same |
| Mode of Operation | AIM is a biteblock that includes
methods to deliver oxygen and
sample expired gases in the oral
cavity. | DualGuard delivers oxygen through a
nasal/oral cannula and samples CO2
nasally and orally. | Similar: Both devices are placed in the
mouth and serve as bite blocks that deliver
oxygen and monitor CO2 in the oral cavity.
AIM does not include an integrated nasal
cannula. |
| 12-Dec-2024 | | | |
| | Subject Device: AIM | Predicate Device: DualGuard™ K140473 | Comparison |
| Biocompatibility | Surface contact, skin and mucosal.
Externally communicating, tissue.
Limited use (/= 18 y.o. | Adult | Similar |
| Connectable to
capnograph? | Yes | Yes | Same |
| Expired gas sampling
location | Oral - multiple ports | Nasal and Oral | Similar |
| Design | Bite block with attached oxygen delivery
tubing which delivers oxygen to the back of
the mouth. Multiple sampling ports which are
connected to a gas sampling line which is
attached a capnograph | Oval shape inserted into the mouth with a
central opening for insertion of instruments.
Includes sampling nasal cannula and oxygen
delivery tubing. It has an elastic head band | Both design include means for delivering
oxygen and sampling CO2 and method of
securement. |
| Location of use | Inserted on either the left or right side of the
mouth | Inserted in the center of the mouth | The differences do not raise a different
question of safety and effectiveness. |
| Mechanism for securement | AIM inserted into mouth and secured with
tape | Secured with an elastic band around the
head | Each has a means of securing from potential
dislodgement |
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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-determined
Acceptance Criteria |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Biocompatibility | ISO 10993-5:2009
ISO 10993-23:2021
ISO 10993-10:2021
ISO 18562-2:2017
ISO 18562-3:2017 |
| Performance Tests (FiO2, EtCO2)
including CO2 waveforms | Comparison to predicate |
| Mechanical Tests (Bite Force Finite
Element Analysis, Dislodgement Force,
Axial Separation Force) | Minimal deformation
Comparison to predicate
ISO 80369-2 |
| Accelerated aging | Comparison of pre and post-aging
ISO 80369-2
ISO 594-2
ISO 11607-1 |
| Ship Testing | ISTA 3A |
5. Conclusion
The testing and comparison to the predicate support a decision of substantial equivalence.