(459 days)
The 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.
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.
Here's a breakdown of the acceptance criteria and study information for the Oxy2Pro device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the acceptance criteria for the Oxy2Pro mask was that its performance for FiO2 (fraction of inspired oxygen) and EtCO2 (end-tidal carbon dioxide) should not be statistically significantly less than the predicate device (K172365) at the tested flow rates.
The study results demonstrate the following:
| Oxygen Flow Rate | Oxy2Pro FiO2 | Oxy2Pro EtCO2 | Predicate (K172365) FiO2 | Predicate (K172365) 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% |
The document concludes 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."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a number of masks or subjects. The document mentions "testing was completed under simulated conditions at various flow rates." This implies a series of measurements were taken at different flow rates, but the number of devices tested or repetitions of each test is not specified.
- Data Provenance: The testing was "completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device." It was performed by an "Accredited third-party testing" organization. The location of this organization and whether the data is retrospective or prospective is not specified. Given the context of a 510(k) submission, it is likely prospective testing specifically conducted for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This information is not relevant or applicable to the type of performance testing described. The "ground truth" (or reference standard) in this context is the measured FiO2 and EtCO2 values under controlled simulated conditions, using calibrated equipment. It does not involve expert interpretation or consensus.
4. Adjudication Method for the Test Set
N/A. As the testing involved objective measurements under simulated conditions, there was no need for an adjudication method by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This type of study is typically performed for AI/image analysis devices where human readers provide interpretations. The Oxy2Pro is a medical device for oxygen delivery and CO2 sampling, and its performance is evaluated objectively through physical measurements, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. This concept is for software algorithms. The Oxy2Pro is a physical device; its performance is standalone in the sense that it functions physically to deliver oxygen and sample gas.
7. Type of Ground Truth Used
The ground truth used was simulated conditions with true baseline EtCO2 at 5%. This implies a controlled environment where the actual concentration of inspired oxygen and exhaled CO2 was known and measured with high precision using reference instruments.
8. Sample Size for the Training Set
N/A. The Oxy2Pro is a physical medical device, not an AI or machine learning algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, this question is not applicable.
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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"
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(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.
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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
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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
Image /page/4/Picture/5 description: The image shows the word "Deloitte." in a bold, sans-serif font. The word is black, and there is a small gray dot to the right of the word. The background is white.
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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 forUse | The Oxy2Pro is a single patient,disposable procedural mask withaccess for the insertion of oral scopes,probes, or tubes, delivery ofsupplemental oxygen and monitoringbreathing by providing a means tosample exhaled CO2. It is for non-intubated, adult patients who arebreathing spontaneously. | The Panoramic Oxygen Mask (POM)is a single patient, disposable deviceintended for delivering supplementaloxygen and monitoring expired gasesfrom the patient, with ports to allowthe clinician to insert scopes, probes,or tubes. It is for non-intubated,spontaneously breathing patientsgreater than 30kg. | Same |
| PatientPopulation | Non-intubated, adult patients who arebreathing spontaneously. | Non-intubated spontaneouslybreathing patients.Greater than 30 kg | Similar; the predicate device isavailable in adult and pediatric sizes.This comparison is only made to theadult size. |
| Environments ofUse | Locations where procedures areperformed where the patient requiressupplemental oxygen, monitoring ofexhaled gases and scope access.Hospital, sub-acute, clinic, physicianoffices, pre-hospital | Locations where procedures areperformed where the patient requiressupplemental oxygen, monitoring ofexhaled gases and scope access.Hospital, sub-acute, clinic, physicianoffices, pre-hospital | Same |
| Duration of Use | Single patient, disposable | Single patient, disposable | Same |
| Prescriptive | Yes | Yes | Same |
| Mode ofOperation | Oxygen delivery through standardoxygen supply tubing andsimultaneous exhaled gas monitoringvia a gas sampling line connectedfrom mask to capnography or oxygenonly delivery. Slit access membrane | Oxygen delivery through standardoxygen supply tubing andsimultaneous exhaled gas monitoringvia a gas sampling line connectedfrom mask to capnography or oxygen | Similar; Oxy2Pro does not feature auniversal size inlet but it achieves thesame performance through the diffusersleeve and insert without the need foradditional adaptors. |
| Description | Subject Device | Predicate Device (K172365) | Comments |
| allowing for introduction of a scope.Oxygen and sampling tube areconnected to mask via a rotatableelbow positioned in front of the face. | only delivery. Slit access portsallowing for introduction of a scope.Universal size inlet allows for removalor insertion of high or mediumconcentration adaptor, located to theside of the front of the mask. Thesampling line is connected on theopposite side. | ||
| Componentswhich may besupplied orpackaged withthe mask | Standard oxygen tubing (connected tomask) with universal connectorGas sampling line | Standard oxygen tubing with universalconnectorGas sampling lineOxygen rebreather bag | Similar; Oxy2Pro does not feature auniversal size inlet with a rebreatherbag but it achieves the sameperformance through the diffusersleeve and insert without the need foradditional adaptors. |
| Gas samplingconnections | Male Luer and Female Luer | Luer slip fit | Similar; Southmedic shall offer both afemale and male luer sampling line toaccommodate different capnographyequipment. |
| Sizes | Adult | Adult | Oxy2Pro is only available in adultsize; comparison only made to adultpredicate. |
| 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 ODNasal – 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 litersHigh 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 |
| % CO2Accuracy | Testing was completed undersimulated conditions with truebaseline EtCO2 at 5%, at various flowrates. | Testing was completed undersimulated conditions with truebaseline EtCO2 at 5%, at various flowrates. | Same; Oxy2Pro was not significantlyless than the predicate. |
| Materials | Mask: Clear PolyvinylchlorideElbow and Sleeve: AcrylicInsert: Polypropylene | Mask: Clear Polyvinylchloride | Similar |
| Biocompatibility | Surface contacting for a limitedduration (<24 hours). Gas pathwaycontacting for a limited duration (<24hours).Testing includes:Cytotoxicity (ISO 10993-5:2009)Sensitization (ISO 10993-10:2010Intracutaneous/Irritation (ISO 10993-10:2010)Emissions of particulate matter (ISO18562-2:2017)Emissions of volatile compounds(VOCs) (ISO 18562-3:2017) | Externally communicating: Tissuecontact, surface communicating, andskin contact for a limited duration ofuse (<24 hours).Testing included:Cytotoxicity (ISO 10993-5:2009)Sensitization (ISO 10993-10:2010Intracutaneous/Irritation (ISO 10993-10:2010)Acute Systemic Toxicity (ISO 10993-11:2017) | Similar; devices have a similarbiological categorization. Differencesin testing endpoints may be attributedto the application of ISO 10993-1 andISO 18562. |
| Storage | Standard warehouse conditions | -20° to +50°C | Similar |
| DeviceClassification | Class IIProduct code - CCK | Class IIProduct code - CCK | Same |
Our Passion
Image /page/5/Picture/5 description: The image shows a logo with a globe and text. The globe is a light blue color and has a wireframe design. To the right of the globe, the text reads "Innovative Manufacturing & Distribution, Profitably". Below the globe, the text reads "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
Image /page/5/Picture/8 description: The image is a logo for "Canada's Best Managed Companies". To the left of the text is a grey maple leaf. Below the text "Best Managed Companies" is the text "Platinum member".
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Image /page/6/Picture/0 description: The image shows the logo for Southmedic. The logo has the word "Southmedic" in a dark blue sans-serif font. To the right of the word is a teal-colored line that resembles a heart rate monitor, and the year "1983" is printed in a small font below the line.
Our Passion
Image /page/6/Picture/3 description: The image shows a light blue globe with the continents outlined. To the right of the globe, the text "Innovative Manufacturing & Distribution, Profitably" is displayed. Below the globe, the text "Exceptional Customer Service & Quality" is written in a curved manner.
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
Image /page/6/Picture/6 description: The image is a logo for "Canada's Best Managed Companies". The logo features a stylized maple leaf on the left, with the text "CANADA'S" vertically aligned along the leaf's edge. To the right of the leaf, the words "BEST MANAGED COMPANIES" are stacked in bold, sans-serif font. Below this, the words "Platinum member" are written in a smaller, regular font.
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Image /page/7/Picture/0 description: The image shows the logo for Southmedic. The text "Southmedic" is in a dark blue sans-serif font. To the right of the text is a teal-colored heartbeat line that ends in an arrow, with the number "1983" below the line.
Our Passion
Image /page/7/Picture/3 description: The image shows a logo with a world map in light blue. The text "Innovative Manufacturing & Distribution, Profitably" is on the right side of the map. The text "Exceptional Customer Service & Quality" is at the bottom of the map.
Image /page/7/Picture/6 description: The image shows a logo for "Canada's Best Managed Companies". To the left of the text is a grey maple leaf. Below the text "Best Managed Companies" is the text "Platinum member".
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Image /page/8/Picture/0 description: The image shows the logo for Southmedic. The text "Southmedic" is in a dark blue sans-serif font. To the right of the text is a teal-colored heartbeat line that ends with an arrow and the number 1983.
Our Passion
Image /page/8/Picture/3 description: The image shows a world map with the text "Innovative Manufacturing & Distribution, Profitably" on the right side of the map. The map is light blue and has a grid of lines over it. Below the map, the text "Exceptional Customer Service & Quality" is written in a smaller font.
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
Image /page/8/Picture/6 description: The image is a logo for "Canada's Best Managed Companies Platinum Member". On the left side of the logo is a gray maple leaf, which is a symbol of Canada. To the right of the maple leaf is the text "BEST MANAGED COMPANIES" in bold, black letters. Below the text is the phrase "Platinum member" in a smaller, non-bold font.
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Image /page/9/Picture/0 description: The image shows the logo for Southmedic. The logo consists of the word "Southmedic" in a dark blue sans-serif font. To the right of the word is a teal-colored heartbeat line that ends in an arrow. Below the arrow is the number 1983.
Substantial Equivalence Discussion:
The Oxy2Pro Mask is considered substantially equivalent to the predicate Panoramic Oxygen Mask (POM), by POM Medical (510k holder, K172365) based on the following discussion. In making this determination, Southmedic followed the FDA's Guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (Document issued on: July 28, 2014) and the detailed flowchart provided in Appendix A. 510(k) Decision-Making Flowchart.
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. Both devices provide supplemental oxygen and monitoring of exhaled gases, with oral scope access and are to be used in similar environments of use.
The predicate is available in pediatric and adult sizes and features an additional nasal access port. The adult version of the predicate was used for comparison testing. Regardless of model, both sizes have the same intended use. The nasal access port in the predicate facilitates nasal scope/probe entry. This may lead to additional indications provided by the predicate, however, the intended use and indications per the predicate labeling does not differentiate between the nasal or oral option. Per the labeling, the Oxy2Pro and predicate device have the same intended use and the same environments of use when compared within the same indication. The difference of the predicate device having a nasal access port should not affect oxygen delivery and sampling performance.
Technology: The devices have similar sampling line luer and oxygen tubing technology, and feature oral access ports/membranes for scope entry. The oxygen tubing is connected to the oxygen source using a universal connector, and the sampling line is connected to the capnography equipment. The Oxy2Pro mask is made of a clear polyvinylchloride material which is the same material as the predicate.
Oxy2Pro's oxygen and sampling lines are connected to the mask via a rotatable elbow positioned at the front of the face. Oxygen is delivered through a diffuser sleeve and insert that directs the oxygen towards the nose and mouth. Carbon dioxide is sampled through this same diffuser.
The predicate device features a universal size inlet to allow for the removal or insertion of a high or medium concentration adaptor, which is located to the front of the mask. Oxygen is delivered through this adaptor. The sampling line is connected to the opposite side of the mask.
Image /page/9/Picture/8 description: The image shows a graphic with the text "Our Passion" at the top and a stylized globe in the center. The globe is light blue with white lines indicating continents. To the right of the globe, the text "Innovative Manufacturing & Distribution, Profitably" is displayed. At the bottom, the text "Exceptional Customer Service & Quality" is curved along the bottom edge of the graphic.
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
Deloitte.
BEST
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Image /page/10/Picture/0 description: The image shows the logo for Southmedic. The word "Southmedic" is written in a dark blue sans-serif font. To the right of the word is a teal-colored graphic that resembles a heart rate monitor. The year "1983" is written in small font to the right of the graphic.
The safety and performance of the Oxy2Pro and predicate device are similar, as shown in the testing summary below. The differences in technology do not affect device performance and safety with respect to oxygen delivery and EtCO2 sampling.
Testing summary:
Biocompatibilitv and Materials:
The Oxy>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.
Image /page/10/Picture/11 description: The image shows a logo with a globe and text. The text at the top reads "Our Passion". The text on the right side of the globe reads "Innovative Manufacturing & Distribution, Profitably". The text at the bottom of the globe reads "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 ISO 13485 www.southmedic.com
Image /page/10/Picture/13 description: The image shows the word "Deloitte." in a bold, sans-serif font. The word is black, and there is a small gray circle to the right of the word. The background is white.
Platinum member
§ 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).