Who is the manufacturer of Panoramic Oxygen Mask (POM)?

Pom Medical, LLC filed the 510(k) submission for Panoramic Oxygen Mask (POM) (K172365).

What is the FDA product code for Panoramic Oxygen Mask (POM)?

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

What is the regulatory pathway for Panoramic Oxygen Mask (POM)?

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

What are the predicate devices for Panoramic Oxygen Mask (POM)?

Monitored Mask, M1 Capnography mask (K133806).

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

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.

Panoramic Oxygen Mask (POM)

K172365 · Pom Medical, LLC · CCK · Apr 19, 2018 · Anesthesiology

Device Facts

Record ID	K172365
Device Name	Panoramic Oxygen Mask (POM)
Applicant	Pom Medical, LLC
Product Code	CCK · Anesthesiology
Decision Date	Apr 19, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

The Panoramic Oxygen Mask (POM) is a multi-port, single-patient disposable mask for non-intubated, spontaneously breathing patients. It delivers supplemental oxygen via standard tubing and enables monitoring of exhaled gases (e.g., EtCO2) via a gas sampling line connected to a capnography monitor. The mask features integrated oral and nasal membranes (slit access ports) allowing clinicians to insert scopes, probes, or tubes while maintaining oxygen delivery and gas sampling. Used in hospitals, clinics, and pre-hospital settings. The device benefits patients by allowing airway access or diagnostic procedures without interrupting oxygen therapy or gas monitoring. Healthcare providers use the mask to facilitate clinical procedures while maintaining patient respiratory support and monitoring.

Clinical Evidence

Bench testing only. Comparative performance testing evaluated EtCO2 accuracy, respiration rate, and FiO2 across various simulated patient settings (BPM 12-20, Tidal Volume 300-500ml, CO2 concentrations 1-5%, O2 flow 1-12 Lpm) for both adult and pediatric sizes. Results demonstrated performance comparable to the predicate device. Biocompatibility testing (ISO 10993-5, -10, -11) and mechanical/aging/shelf-life testing were performed.

Technological Characteristics

Multi-port mask with oral/nasal membranes for instrument access. Materials: biocompatible, limited contact (<24 hours). Sensing: Luer slip fit for gas sampling. Connectivity: standard oxygen tubing and gas sampling line. Sterilization: not specified. Dimensions: Adult (198 ml) and Child (93 ml) internal volumes. Features one-way valves to prevent rebreathing.

Indications for Use

Indicated for non-intubated, spontaneously breathing patients >30 kg requiring supplemental oxygen, expired gas monitoring, and/or airway access via scopes, probes, or tubes.

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

Monitored Mask, M1 Capnography mask (K133806)

Related Devices

K220533 — Endoscopy Oxygen Mask · Engineered Medical Systems, Inc. · Nov 16, 2022
K222511 — Oxy2Pro · Southmedic, Inc. · Nov 21, 2023
K131339 — CAPNOMASK · Mediplus , Ltd. · Nov 25, 2013
K133806 — M1 CAPNOGRAPHY MASK · Monitor Mask, Inc. · Dec 31, 2013
K971229 — CAPNOXYGEN MASK · Medsys, Inc. · Sep 23, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". April 19, 2018 POM Medical, LLC % Paul Dryden Consultant ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704 Re: K172365 Trade/Device Name: Panoramic Oxygen Mask (POM) Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 17, 2018 Received: March 20, 2018 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use ### K172365 Device Name ### Panoramic Oxvgen Mask (POM) Indications for Use (Describe) 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, 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 respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ ### 510(k) Summary Page 1 of 7 19-Apr-18 | Company: | POM Medical, LLC 1230 Madera Rd., Suite 5, Box 101 Simi Valley, CA 92065 | |----------------------------|----------------------------------------------------------------------------------------------| | Official Contact: | Jeff Voss, VP Operations Tel - (855) 766-0202 | | Proprietary or Trade Name: | Panoramic Oxygen Mask (POM) | | Common/Usual Name: | Gas sampling oxygen mask | | Classification Name: | 21 CFR 868.1400 Procode – CCK Analyzer, gas, carbon-dioxide, gaseous phase Class II | | Predicate Device: | K133806 – Monitored Mask, M1 Capnography mask CapnoVue Scope | ### Device Description: The Panoramic Oxygen Mask (POM) 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. The design of the POM's oral or nasal membranes allow access of a scope and are soft and pliable to help maintain the oxygen concentration to the patient while having scopes, etc. inserted through these oral or nasal membranes. ### 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. ### Patient Population: For non-intubated, spontaneously breathing patients greater than 30 kg. ### 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. ### Contraindications: None. {4}------------------------------------------------ ## 510(k) Summary ### K172365 ## Page 2 of 7 19-Apr-18 ## Predicate Device Comparison - Table 1 - Comparison to the Predicate | Attributes | Proposed POM Panoramic Oxygen Mask | Predicate Monitor Mask – K133806 M1 Capnography mask (Scope) | Comments | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 30kg. | The M1 Capnography Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female luer ports for gas sample line attachment are included. | Both provide - supplemental oxygen - monitoring of exhaled gases Subject device provides - access port(s) for scopes ( CapnoVue Scope model) | | Patient Population | non-intubated spontaneously breathing patients | non-intubated spontaneously breathing patients Child and adult | Similar | | Environment of Use | Locations where procedures are performed where the patient requires supplemental oxygen, monitoring exhaled gases, and scope access | Locations where procedures are performed where the patient requires supplemental oxygen, monitoring exhaled gases | Scope access for the subject device | | | Hospital, sub-acute, clinic, physician offices, pre-hospital | Hospital, sub-acute, clinic, physician offices, pre-hospital | | | Duration of Use | Single patient, disposable | Single patient, disposable | Similar | | Prescriptive | 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 are provided in the CapnoVue Scope model | | Attributes | Proposed POM Panoramic Oxygen Mask | Predicate Monitor Mask – K133806 M1 Capnography mask (Scope) | Comments | | 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 lock | Similar Both connector type accommodate standard gas sampling luer fittings | | Sizes | Child Adult | Child Adult | Similar | | Profile | Over the nose / mouth | Over the nose / mouth | Similar | | Face strap | Yes | Yes | Similar | | Performance | | | | | Internal volume | Child - 93 ml Adult - 198 ml | Child - 73 ml Adult - 159 ml | The difference in internal volume does not affect performance of oxygen delivery or monitoring of exhaled gases | | Access Ports and Maximum instrument size | Oral port – 60 mm ID / 20 mm OD Nasal – 36 mm ID / 12 mm OD | Not available | Access port allows introduction of instruments while delivering supplemental oxygen and sampling expired gases | | Entrainment Vents | One-way valves to prevent rebreathing | Open vents allowing room entrainment | Without the one-way valves the exhaled gas monitoring performance is reduced. For the intended use the designs are similar. There are oxygen masks marketed as non- rebreathing mask with one-way valves to prevent rebreathing. (Teleflex Non- rebreathing mask) This does not raise different questions of safety or effectiveness. | | Attributes | Proposed POM Panoramic Oxygen Mask | Predicate Monitor Mask – K133806 M1 Capnography mask (Scope) | Comments | | %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. | | Biocompatibility | External Communicating (indirect) Tissue contact And Surface Communicating (direct) Skin contact Limited duration of use (< 24 hours) Testing included Cytotoxicity (ISO 10993-5:2009) Sensitization (ISO 10993-10:2010) Intracutaneous / Irritation (ISO 10993- 10:2010) Acute Systemic Toxicity (ISO 10993- 11:2017) | External Communicating (indirect) Tissue contact And Surface Communicating (direct) Skin contact Limited duration of use (< 24 hours) | Similar | | Storage | -20° to + 50°C | Not specified | Testing supports the claim | | Shelf-life | 3 years real-time aging and shelf-life | | | | Effects of Aging | No effects of aging on performance | | | {5}------------------------------------------------ 510(k) Summary ### K172365 ## Page 3 of 7 19-Apr-18 {6}------------------------------------------------ 510(k) Summary ### K172365 # Page 4 of 7 19-Apr-18 {7}------------------------------------------------ ### Substantial Equivalence Discussion The POM is viewed as substantially equivalent to the predicate device (K133806 - M1 Capnography mask) based on the following discussions: ### 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 The differences of the subject device having access port(s) for scopes or instruments has been shown to not affect performance related to supplemental oxygen delivery and EtCO2 sampling. ### 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. - There are 2 sizes Child and adult mask . Discussion - The population is similar to the predicate Monitor Mask - K133806 - M1 Capnography mask. ### Technology – - Identical technology of utilizing a luer fitting to connect gas sampling lines, - This device modifies existing masks with ports for scope access. . Discussion - The technology is similar to the predicate Monitor Mask - K133806 - M1 Capnography mask. ### Differences - The subject device offers access ports for scopes while the mask sits on the patient face. This technological characteristic is a combination of supplemental O2 and CO2 sampling facilitated by cannulas, which still allows scopes to access the patient airway. While access ports are different technological characteristic, the risk is the inability to use scopes to access airway. Labeling is provided to ensure compatibility of scopes with this device for airway access. The differences between the predicate and the proposed device do not impact the performance of the device for supplemental oxygen delivery and EtCO2 sampling. These differences do not raise different questions of safety or effectiveness. ### Non-clinical performance 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 ### Biocompatibility / Materials - {8}------------------------------------------------ ### 510(k) Summary Page 6 of 7 19-Apr-18 The materials in patient / drug contact have been tested they are characterized as: - . External Communicating (Indirect gas pathway), Tissue / Bone / Dentin communicating, And - Surface Contact, Skin, - . Duration of Use - limited (< 24 hours) We performed the following tests with guidance from ISO 10993-1 and the results were acceptable. - Cytotoxicity ISO 10993-5:2009 . - Sensitization ISO 10993-10:2010 ● - . Irritation (for surface contact materials) - ISO 10993-10:2010 - Acute Systemic Toxicity ISO 10993-11:2017 . Discussion - The materials used in the subject device are familiar and standard materials utilized in devices for this intended use. ### Bench / Performance testing - We performed comparative performance testing the tests included: - Internal volume ● - . Evaluation of ability to measure EtCO2 and Respiration Rate are various simulated patient settings typical of pediatric and adult users. - Biocompatibility of Materials - Mechanical Drop test ● - . Effects of Aging on Performance - Environmental Testing / Shelf-life - ISO 594 Luer connector . Tables 2 and 3 presents a summary of the testing performed. | | | POM | | Predicate M1 | | |-----------------|-----------------------|-------------------|-------------------|--------------|----| | Adult | | EtCO2 | RR | EtCO2 | RR | | | | Closed / Inserted | Closed / Inserted | | | | Test conditions | BPM – 12, TV – 500 ml | | | | | | 5% CO2 | O2 Flow – 1 Lpm | 7.37% / 6.57% | 12/12 | 6.43% | 12 | | | O2 Flow – 8 Lpm | 5.17% / 4.78% | 12/12 | 2.50% | 12 | | 1% CO2 | O2 Flow – 1 Lpm | 1.40% | 12 | 1.20% | 12 | | | O2 Flow – 8 Lpm | 1.00% | 12 | 0.47% | 12 | | | BPM – 20, TV – 300 ml | | | | | | 5% CO2 | O2 Flow – 1 Lpm | 8.23% / 7.07% | 20/20 | 6.77% | 20 | | | O2 Flow – 8 Lpm | 6.17% / 4.40% | 20/20 | 3.37% | 20 | | 1% CO2 | O2 Flow – 1 Lpm | 1.63% | 20 | 1.27% | 20 | | | O2 Flow – 8 Lpm | 1.13% | 20 | 0.60% | 20 | | Internal Volume | | 198 ml | | 159 ml | | ### Table 2 - Summary of Comparative Testing - Adult Size | Table 3 – Summary of FiO2 Testing – Adult Size | | | | |------------------------------------------------|--|--|--| |------------------------------------------------|--|--|--| | | POM | |-----------------|-----------------------| | Adult | FiO2 | | Test conditions | | | | BPM - 12, TV - 400 ml | | | Closed | {9}------------------------------------------------ | | 510(k) Summary Page 7 of 7 19-Apr-18 | | |--------|--------------------------------------------|-------| | 4% CO2 | O2 Flow – 8 Lpm | 77.6% | | | O2 Flow – 10 Lpm | 83.4% | | | O2 Flow – 12 Lpm | 87.0% | ### Table 4 - Summary of Comparative Testing - Pediatric size | | | POM | | | | Predicate M1 | | |-----------------|-----------------------|----------------------------|-------------------------|---------------------------|-------|--------------|--| | Pediatric | | EtCO2 Closed / Inserted | RR Closed / Inserted | FiO2 Closed / Inserted | EtCO2 | RR | | | Test conditions | BPM - 12, TV – 500 ml | | | | | | | | 5% CO2 | O2 Flow – 1 Lpm | 6.40% / 6.13% | 12 / 12 | 25.0% / 24.33% | 6.17% | 12 | | | | O2 Flow – 8 Lpm | 3.40% / 3.17% | 12 / 12 | 48.67% / 49.0% | 4.07% | 12 | | | 1% CO2 | O2 Flow – 1 Lpm | 1.10% | 12 | | 1.07% | 12 | | | | O2 Flow - 8 Lpm | 0.73% | 12 | | 0.77% | 12 | | | | BPM - 20, TV – 300 ml | | | | | | | | 5% CO2 | O2 Flow - 1 Lpm | 6.40% / 6.23% | 20 / 20 | 23.67% / 24.67% | 6.03% | 20 | | | | O2 Flow – 8 Lpm | 3.10% / 2.23% | 20 / 20 | 56.0% / 56.33% | 3.97% | 20 | | | 1% CO2 | O2 Flow - 1 Lpm | 1.23% | 20 | | 1.17% | 20 | | | | O2 Flow – 8 Lpm | 0.70% | 20 | | 0.77% | 20 | | | Internal Volume | | 93 ml | | | 73 ml | | | The results demonstrated that the device is substantially equivalent. ### Discussion of Differences and Substantial Equivalence Conclusion - The differences in: - Access ports - While access ports are different technological characteristic, the risk is the o inability to use scopes to access airway. Labeling is provided to ensure compatibility of scopes with this device for airway access. - Access ports impact on monitoring is characterized O - Internal volume - While the internal volume of the mask is different the measured results show that o the difference does not influence the measured performance. - . One-way valves for non-rebreathing - There are standard oxygen masks which contain one-way valves to prevent o rebreathing. These differences do not raise different questions of safety or effectiveness. In conclusion, the comparison to the predicate for features, indications for use, population, and comparative testing across the range of oxygen flow, simulated patient conditions for both adult and pediatrics, 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.