(265 days)
Not Found
No
The description focuses on the physical design and function of a mask for oxygen delivery and gas monitoring, with no mention of AI or ML capabilities.
No
The device delivers supplemental oxygen and monitors expired gases, which are supportive functions for a patient during a medical procedure, but it is not intended to treat or cure a disease or condition. Its primary function is to facilitate the delivery of oxygen and monitoring while allowing scope access.
Yes
Explanation: The device is described as "monitoring expired gases from the patient" and "Sampling of exhaled gases for monitoring, typically end-tidal CO2". This indicates it is used to obtain information about physiological states (respiratory function, CO2 levels) which is a diagnostic function.
No
The device description clearly outlines a physical, multi-port mask intended for delivering oxygen and monitoring gases, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Endoscopy Oxygen Mask is a device used directly on a patient to deliver oxygen, monitor expired gases (like CO2), and facilitate the insertion of medical instruments. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use clearly describes a device for delivering oxygen and monitoring gases from the patient, not for analyzing samples from the patient.
The device is a medical device used for patient care and monitoring during procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / 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 non-intubated, spontaneously breathing patients greater than 30 kg.
Product codes
CCK
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Non-intubated, spontaneously breathing patients greater than 30 kg.
Intended User / Care Setting
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
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)
Non-clinical comparative performance testing was performed that included:
- Internal volume
- Evaluation of ability to measure EtCO2 and Respiration Rate at various simulated patient settings typical of pediatric and adult users. The results showed similar performance with the proposed device performing better, but no claim is being made on performance other than equivalence.
- 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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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
1
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
2
Indications for Use
K220533
Device Name
Endoscopy Oxygen Mask
Indications for Use (Describe)
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.
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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FORM FDA 3881 (7/17) 443-6740 EF
Page 1 of 1
PSC Publishing Services (301)
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EMS
| Date Prepared: | 16-Nov-2022 |
|---|---|
| Sponsor: | Engineered Medical Systems, Inc. |
| 2055 Executive Dr. | |
| Indianapolis, IN 46241 | |
| Tel - 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 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. | 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. | Similar | ||
| Patient Population | Non-intubated spontaneously breathing patients | ||
| Adults to Children | Non-intubated spontaneously breathing patients | ||
| Adults to Children | Similar | ||
| 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 | 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 |
| Duration of Use | Single patient, disposable,