Who is the manufacturer of Endoscopy Oxygen Mask?

Engineered Medical Systems, Inc. filed the 510(k) submission for Endoscopy Oxygen Mask (K220533).

What is the FDA product code for Endoscopy Oxygen Mask?

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Endoscopy Oxygen Mask?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Endoscopy Oxygen Mask?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Endoscopy Oxygen Mask

Q: What are the predicate devices for Endoscopy Oxygen Mask?

Panoramic Oxygen Mask (POM) (K172365).

K220533 · Engineered Medical Systems, Inc. · CCK · Nov 16, 2022 · Anesthesiology

Device Facts

Record ID	K220533
Device Name	Endoscopy Oxygen Mask
Applicant	Engineered Medical Systems, Inc.
Product Code	CCK · Anesthesiology
Decision Date	Nov 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Device is a multi-port, single-patient, disposable oxygen mask; used in hospital, sub-acute, clinic, and pre-hospital settings. Inputs: supplemental oxygen via standard tubing; exhaled gases via sampling line. Features slit access ports for clinician insertion of scopes, probes, or tubes during procedures. Principle of operation: delivers O2 while allowing simultaneous capnography monitoring and instrument access. Healthcare providers use the mask to maintain patient oxygenation and monitor respiratory status (EtCO2/respiration rate) during endoscopic procedures. Output: physical access for instruments and gas samples for external capnography monitors. Benefits: enables continuous monitoring and oxygen delivery during invasive procedures without requiring intubation.

Clinical Evidence

Bench testing only. Comparative performance testing evaluated internal volume, EtCO2 measurement accuracy, and respiration rate across various simulated patient settings (pediatric/adult) and CO2 concentrations. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity) and ISO 18562-2 (particulate matter). Results demonstrated performance equivalence to the predicate.

Technological Characteristics

Single-patient, disposable oxygen mask with luer-slip gas sampling connection and slit access ports. Features one-way entrainment valves to prevent rebreathing. Materials evaluated per ISO 10993-1 and ISO 18562-2. Device is non-powered, standalone, and intended for <24-hour use.

Indications for Use

Indicated for non-intubated, spontaneously breathing patients >30 kg requiring supplemental oxygen, expired gas monitoring, and endoscopic/probe access.

Regulatory Classification

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.

Predicate Devices

Panoramic Oxygen Mask (POM) (K172365)

Related Devices

K172365 — Panoramic Oxygen Mask (POM) · Pom Medical, LLC · Apr 19, 2018
K222511 — Oxy2Pro · Southmedic, Inc. · Nov 21, 2023
K971229 — CAPNOXYGEN MASK · Medsys, Inc. · Sep 23, 1997
K131339 — CAPNOMASK · Mediplus , Ltd. · Nov 25, 2013
K133806 — M1 CAPNOGRAPHY MASK · Monitor Mask, Inc. · Dec 31, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. " FORM FDA 3881 (7/17) 443-6740 EF Page 1 of 1 PSC Publishing Services (301) {3}------------------------------------------------ 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. {4}------------------------------------------------ ## 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, <24 hours | Single patient, disposable, <24 hours | Similar | | Perspective | Yes | Yes | Similar | | 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 allowing for introduction of a scope | 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 allowing for introduction of a scope | Similar | | | Predicate Panoramic Oxygen Mask (POM) POM Medical, LLC | Subject device Endoscopy Oxygen Mask Engineered Medical Systems, Inc. | Comparison | | Components which may be supplied or packaged with the mask | Standard oxygen tubing Gas sampling line | Standard oxygen tubing Gas sampling line | Similar | | Gas sampling connection | 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 ml Adult - 198 ml | Adult - 314 ml | The difference in internal volume does not impact comparative performance | | Entrainment Vents | One-way valves to prevent rebreathing | One-way valves to prevent rebreathing | Similar | | %CO2 accuracy and Respiration rate | Testing was done at different simulated patient settings for breath rate, Tidal Volume at different CO2 concentrations with waveforms The results showed similar performance with the proposed device performing better, but no claim is being made on performance other than equivalence. | Testing was done at different simulated patient settings for breath rate, Tidal Volume at different CO2 concentrations with waveforms The results showed similar performance with the proposed device performing better, but no claim is being made on performance other than equivalence. | Similar comparative testing results | | Biocompatibility | External Communicating (indirect), Tissue contact And Surface Communicating (direct), Skin contact Limited duration of use (< 24 hours) ISO 10993-5 ISO 10993-10 ISO 18562-2 | External Communicating (indirect), Tissue contact And Surface Communicating (direct), Skin contact Limited duration of use (< 24 hours) | Similar | | Shelf-life | 3 years real-time aging and shelf-life | 1 year accelerated age testing | Similar | {5}------------------------------------------------ ## 510(k) Summary Page 3 of 5 {6}------------------------------------------------ ### 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 {7}------------------------------------------------ ## 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.