(459 days)
Not Found
No
The device description and performance studies focus on the physical design and gas delivery/sampling capabilities of a procedural mask, with no mention of AI or ML technologies.
No
The device is a procedural mask that facilitates oxygen delivery, CO2 monitoring, and scope access, but it does not directly treat a disease or condition.
No
The device is a procedural mask used for delivering oxygen and sampling exhaled CO2, which are monitoring functions, not diagnostic. It is used in conjunction with "FDA cleared capnographs," which are typically diagnostic devices, but the mask itself is not.
No
The device description clearly indicates it is a physical procedural mask with a membrane, designed for insertion of oral scopes and delivery of oxygen. It is a hardware device.
Based on the provided information, the Oxy2Pro device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used on a patient for delivering oxygen, monitoring exhaled gases, and providing access for oral scopes. This is a direct interaction with the patient's respiratory system.
- Device Description: The description focuses on the physical design of a mask for patient use.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVDs are typically used to test blood, urine, tissue, or other samples in a laboratory setting to diagnose or monitor conditions.
- Performance Studies: The performance studies evaluate the device's ability to deliver oxygen and sample exhaled CO2 from the patient, not to analyze samples in vitro.
The Oxy2Pro is a medical device used for respiratory support and monitoring in vivo (within the living body).
N/A
Intended Use / Indications for Use
Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs.
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
adult patients
Intended User / Care Setting
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)
Performance Testing: Accredited third-party testing was completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device.
Test conditions: Respiratory Rate: 12, Tidal Volume: 500, Inspiratory:Expiratory Ratio: 1:1, Baseline true EtCO2 5%.
The results demonstrated that the Oxy2Pro mask was not statistically significantly less than the predicate for FiO2 or EtCO2 at the tested flow rates, meeting the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Oxy2Pro | Predicate (K172365) | |||
|---|---|---|---|---|
| Oxygen Flow Rate | FiO2 | ETCO2 | FiO2 | ETCO2 |
| 5 l/min | 53.3% | 6.13% | N/A | N/A |
| 8 l/min | 64.0% | 4.87% | 52.3% | 4.03% |
| 10 l/min | 64.7% | 4.70% | 48.3% | 4.17% |
| 12 l/min | 67.3% | 3.77% | 54.7% | 3.30% |
| 15 l/min | 72.3% | 3.70% | 52.0% | 3.53% |
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).
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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.
November 21, 2023
Southmedic Inc. Tish Whitehead Vice President of Regulatory Affairs & New Product Development 50 Alliance Blvd. Barrie, Ontario L4M 5K3 Canada
Re: K222511
Trade/Device Name: Oxy2Pro Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: September 29, 2023 Received: September 29, 2023
Dear Tish Whitehead:
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.
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"
1
(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 OS 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.
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 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.
2
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,
Bradley Q. Quinn -S
Bradley Quinn Assistant 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
3
Indications for Use
510(k) Number (if known) K222511
Device Name Oxy2Pro
Indications for Use (Describe)
Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.
| 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) |
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Image /page/4/Picture/0 description: The image shows the logo for Southmedic. The text "Southmedic" is written in a dark blue sans-serif font. To the right of the text is a blue heartbeat line with an arrow at the end, and the number 1983 is written below the line.
510(k) Summary
| Company: | Southmedic Inc. |
|---|---|
| 50 Alliance Blvd. | |
| Barrie, Ontario, Canada | |
| L4M 5K3 | |
| Official Contact: | Tish Whitehead |
| P: (705) 720-1902 | |
| F: (705) 728-6537 | |
| Date Prepared: | 11/20/2023 |
| Trade Name: | Oxy2Pro |
| Common Name: | Gas sampling oxygen mask |
| Classification: | Product Code: CCK |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | |
| Class II per 21 CFR 868.1400 | |
| Anesthesiology | |
| Predicate Device: | Panoramic Oxygen Mask (POM) – K172365 |
| POM Medical, LLC | |
| Device Description: | The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs. |
| Intended Use: | The Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, or tubes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for non-intubated, adult patients who are breathing spontaneously. |
Image /page/4/Picture/3 description: The image shows a graphic with the text "Our Passion" at the top. Below that is a stylized image of the earth. To the right of the earth image is the text "Innovative Manufacturing & Distribution, Profitably". Below the earth image is the text "Exceptional Customer Service & Quality".
Southmedic Incorporated Head Office: 50 Alliance Blvd., Barrie, Ontario, Canada L4M 5K3 1-705-726-9383 1-800-463-7146 Fax: 1-705-728-9537 www.southmedic.com ISO 13485
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Image /page/5/Picture/0 description: The image shows the word "Southmedic" in a bold, sans-serif font. To the right of the word is a teal-colored graphic that resembles a heart rate monitor. The year "1983" is printed in a small font below the heart rate monitor graphic.
Predicate Device Comparison:
Table 1: Predicate Device Comparison Table
| Description | Subject Device | Predicate Device (K172365) | Comments |
|---|---|---|---|
| Indications for | |||
| Use | The Oxy2Pro is a single patient, | ||
| disposable procedural mask with | |||
| access for the insertion of oral scopes, | |||
| probes, or tubes, delivery of | |||
| supplemental oxygen and monitoring | |||
| breathing by providing a means to | |||
| sample exhaled CO2. It is for non- | |||
| intubated, adult patients who are | |||
| breathing spontaneously. | 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. | Same | ||
| Patient | |||
| Population | Non-intubated, adult patients who are | ||
| breathing spontaneously. | Non-intubated spontaneously | ||
| breathing patients. | |||
| Greater than 30 kg | Similar; the predicate device is | ||
| available in adult and pediatric sizes. | |||
| This comparison is only made to the | |||
| adult size. | |||
| Environments of | |||
| Use | Locations where procedures are | ||
| performed where the patient requires | |||
| supplemental oxygen, monitoring of | |||
| 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 of
exhaled gases and scope access.
Hospital, sub-acute, clinic, physician
offices, pre-hospital | Same |
| Duration of Use | Single patient, disposable | Single patient, disposable | Same |
| Prescriptive | Yes | Yes | Same |
| Mode of
Operation | Oxygen 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 membrane | Oxygen delivery through standard
oxygen supply tubing and
simultaneous exhaled gas monitoring
via a gas sampling line connected
from mask to capnography or oxygen | Similar; Oxy2Pro does not feature a
universal size inlet but it achieves the
same performance through the diffuser
sleeve and insert without the need for
additional adaptors. |
| Description | Subject Device | Predicate Device (K172365) | Comments |
| | allowing for introduction of a scope.
Oxygen and sampling tube are
connected to mask via a rotatable
elbow positioned in front of the face. | only delivery. Slit access ports
allowing for introduction of a scope.
Universal size inlet allows for removal
or insertion of high or medium
concentration adaptor, located to the
side of the front of the mask. The
sampling line is connected on the
opposite side. | |
| Components
which may be
supplied or
packaged with
the mask | Standard oxygen tubing (connected to
mask) with universal connector
Gas sampling line | Standard oxygen tubing with universal
connector
Gas sampling line
Oxygen rebreather bag | Similar; Oxy2Pro does not feature a
universal size inlet with a rebreather
bag but it achieves the same
performance through the diffuser
sleeve and insert without the need for
additional adaptors. |
| Gas sampling
connections | Male Luer and Female Luer | Luer slip fit | Similar; Southmedic shall offer both a
female and male luer sampling line to
accommodate different capnography
equipment. |
| Sizes | Adult | Adult | Oxy2Pro is only available in adult
size; comparison only made to adult
predicate. |
| Description | Subject Device | Predicate Device (K172365) | Comments |
| Profile | Over the nose/mouth | Over the nose/mouth; aluminum nose strip | Similar; Oxy₂Pro does not feature an aluminum nose strip but instead is shaped to sit on the nose. This difference does not impact performance. |
| Face Strap | Yes | Yes | Same |
| Internal Volume | Adult – 230 ml | Adult – 198 ml | Similar; Oxy₂Pro has a somewhat larger volume but it is not expected to affect the intended use. |
| Access Membranes/ Ports and Maximum Instrument size | Oral Access Membrane – 58 mm x 42 mm | Oral port – 60 mm ID / 20 mm OD
Nasal – 36 mm ID / 12 mm OD | Similar; Oxy₂Pro contains an oral access membrane to allow for the introduction of instruments while delivering oxygen and sampling expired gases. The absence of a nasal port does not impact the intended use. |
| Vents | Open ports allow room entrainment to prevent rebreathing | One-way valves to prevent rebreathing | Similar; the difference in methodology does not affect performance or intended use |
| Oxygen Flow Rates | Flow rates from 5 liters per minute to 15 liters per minute | Medium Concentration: 6-8 liters
High Concentration: 10-15 liters | Same; devices offer the same flow rate range |
| % FiO2 | Testing was completed under simulated conditions at various flow rates | Testing was completed under simulated conditions at various flow rates | Same; Oxy₂Pro was not significantly less than the predicate. |
| Description | Subject Device | Predicate Device (K172365) | Comments |
| % CO2
Accuracy | Testing was completed under
simulated conditions with true
baseline EtCO2 at 5%, at various flow
rates. | Testing was completed under
simulated conditions with true
baseline EtCO2 at 5%, at various flow
rates. | Same; Oxy2Pro was not significantly
less than the predicate. |
| Materials | Mask: Clear Polyvinylchloride
Elbow and Sleeve: Acrylic
Insert: Polypropylene | Mask: Clear Polyvinylchloride | Similar |
| Biocompatibility | Surface contacting for a limited
duration (Pro and predicate have similar biocompatibility categorizations. The Oxy>Pro has been assessed as a limited contact duration mask against the following requirements and endpoints: ISO 18562-2 Emissions of particulate matter: ISO 18562-3 Emissions of volatile compounds (VOCs); ISO 10993-5 Cytotoxicity; ISO 10993-10 Sensitization; ISO 10993-10:2010 Intracutaneous/Irritation. Differences in testing endpoints are attributed to the application of ISO 10993-1 and ISO 18562. The primary material for both devices is clear polyvinylchloride.
Performance Testing:
Accredited third-party testing was completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device.
| Oxy2Pro | Predicate (K172365) | |||
|---|---|---|---|---|
| Oxygen Flow Rate | FiO2 | ETCO2 | FiO2 | ETCO2 |
| 5 l/min | 53.3% | 6.13% | N/A | N/A |
| 8 l/min | 64.0% | 4.87% | 52.3% | 4.03% |
| 10 l/min | 64.7% | 4.70% | 48.3% | 4.17% |
| 12 l/min | 67.3% | 3.77% | 54.7% | 3.30% |
| 15 l/min | 72.3% | 3.70% | 52.0% | 3.53% |
Test conditions: Respiratory Rate: 12, Tidal Volume: 500, Inspiratory:Expiratory Ratio: 1:1, Baseline true EtCO2 5%. Acronyms: I/min is liters per minute, FiO2 is fraction of inspired oxygen, EtCO2 is end tidal carbon dioxide
The results demonstrated that the Oxy2Pro mask was not statistically significantly less than the predicate for FiO2 or EtCO2 at the tested flow rates, meeting the acceptance criteria.
In conclusion, substantial equivalence is demonstrated between the Oxy2Pro mask and the predicate device. The differences observed do not impact performance and safety per the intended use of supplemental oxygen delivery and EtCO2 sampling.
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Southmedic Incorporated Head Office: 50 Alliance Blvd., Barrie, Ontario, Canada L4M 5K3 1-705-726-9383 1-800-463-7146 Fax: 1-705-728-9537 ISO 13485 www.southmedic.com
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