(258 days)
Not Found
No
The summary describes a physical medical device (oxygen mask) with ports for monitoring and procedures. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is intended for delivering supplemental oxygen, monitoring expired gases, and allowing scope insertion, but it does not directly treat a disease or condition; it facilitates other therapeutic or diagnostic procedures.
No
The device is primarily for delivering oxygen and providing access for other medical instruments while monitoring exhaled gases. Monitoring exhaled gases (like EtCO2 and Respiration Rate) is a measurement function, which can be part of a diagnostic process, but the device itself does not perform a diagnosis. It provides data that a clinician might use to diagnose.
No
The device description clearly states it is a "single patient, disposable device" and a "multi-port mask," indicating it is a physical hardware device. The performance studies also focus on physical characteristics and performance of the mask itself (internal volume, EtCO2 measurement, mechanical tests, biocompatibility, etc.).
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. They are used to examine specimens outside of the body.
- Device Function: The Panoramic Oxygen Mask (POM) is a device that is applied to the patient's face. Its primary functions are delivering oxygen, monitoring expired gases (which are exhaled from the body), and providing access for medical instruments.
- No Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient. The monitoring of expired gases is done directly from the patient's breath, not from a collected sample.
Therefore, the POM falls under the category of a medical device used for patient support and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
CCK
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.
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 performance testing included:
- Internal volume
- Evaluation of ability to measure EtCO2 and Respiration Rate at various simulated patient settings typical of pediatric and adult users.
- Storage, Drop and Aging
- Biocompatibility
Bench / Performance testing 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
Key results:
- Demonstrated that the device is substantially equivalent to the predicate device in performance.
- The differences in internal volume of the mask do not influence the measured performance.
- The differences in access ports and one-way valves for non-rebreathing do not raise different questions of safety or effectiveness.
- Both devices provide representative measurement of EtCO2 and respiratory rate and their respective waveforms were similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- %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.
- Internal volume: Child - 93 ml; Adult - 198 ml (Predicate: Child - 73 ml; Adult - 159 ml). The difference in internal volume does not affect performance of oxygen delivery or monitoring of exhaled gases.
- FiO2 Testing (Adult Size, 4% CO2): O2 Flow – 8 Lpm: 77.6%; O2 Flow – 10 Lpm: 83.4%; O2 Flow – 12 Lpm: 87.0%.
Predicate Device(s)
K133806 – Monitored Mask, M1 Capnography mask
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).
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)
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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 (