(264 days)
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Et™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable.
The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
The SuperNO2VA Et™ Device is a nasal mask with a sampling port for the nasal portion and a sampling "hood" for over the mouth.
The subject device is similar to an anesthesia or oxygen mask with gas sampling port. Instead of covering the full face the SuperNO2VA Et™ Device design is to allow the clinician to have access to the oral cavity during a procedure but still be able to provide air, oxygen or anesthesia gases to the patient while also sampling expired gases from the nasal or oral areas.
The design incorporates the standard 15 mm male circuit connector, luer fitting for the gas sampling line and a slip-fit port for pressure monitoring or oxygen if the mask is used with a manual resuscitator or hyperinflation bag.
The mask is not considered a long-term use device as it would only be used from pre- to postoperative care. This would be similar to the standard anesthesia mask.
It is not for use in long-term ventilation conditions or the treatment of sleep apnea.
Here's a breakdown of the acceptance criteria and study information for the SuperNO2VA Et™ Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than explicitly stating pre-defined acceptance criteria for each tested parameter. However, we can infer some criteria from the comparative testing and performance values presented. The "Proposed SuperNO2VA EtTM Device" column shows the reported performance.
| Feature | Acceptance Criteria (Inferred from Predicate/Equivalence) | Reported Device Performance (SuperNO2VA Et™ Device) |
|---|---|---|
| Mechanical Performance | ||
| Internal Volume (Nasal mask only) | Comparable to K163277 (Medium – 53 ml, Large – 87 ml) | Medium – 53 ml, Large - 87 ml |
| Pressure to maintain a seal | Comparable to K163277 (Up to 30 cmH2O) | Up to 30 cmH2O |
| Resistance to flow | Comparable to K163277 (0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm) & Medline (30 lpm – 0.13 cmH2O, 60 lpm – 0.25 cmH2O, 90 lpm – 0.51 cmH2O) | 0.46 cmH2O @ 50 lpm, 1.8 cmH2O @ 100 lpm |
| Leak rate under pressure | Comparable to K163277 (0.8 Lpm @ 20 cmH2O) | 0.8 Lpm @ 20 cmH2O |
| Dead space (Nasal mask only) | Comparable to K163277 (Medium – 53 ml, Large – 87 ml) | Medium – 53 ml, Large – 87 ml |
| Pressure / Leakage (General) | Maintain pressure > 20 cmH2O with 10 lbs. force, Leakage < 2 Lpm | Can maintain pressure of > 20 cmH2O with 10 lbs. force, Leakage < 2 Lpm |
| Pressure Drop Acceptance | < 5 cmH2O @ 60 Lpm (from predicate RMD SuperNO2VA) | 30 lpm – 0.13 cmH2O, 60 lpm – 0.38 cmH2O, 90 lpm – 1.15 cmH2O |
| Biocompatibility | ISO 10993-1 compliance for externally communicating tissue, surface contact (skin/mucosal), limited duration (<24 hours) | ISO 10993-1 compliant, externally communicating tissue, surface contact (skin/mucosal), limited duration (<24 hours). Testing included: Cytotoxicity, Sensitization, Irritation. |
| O2 / CO2 Performance | Comparable to K011050 (Oridion - Capnostream) for nasal and oral sampling. Also comparable to Exempt Medline Anesthesia mask for both nasal/oral sampling under positive pressure. Note: The exact delta for "comparable" isn't quantified. | Nasal Sampling (Adult, CO2 1%, O2 Flow 1 lpm): Ave. - 1.00% Nasal Sampling (Adult, CO2 1%, O2 Flow 5 lpm): Ave. - 4.93% Nasal Sampling (Adult, CO2 5%, O2 Flow 1 lpm): Ave. - 0.94% Nasal Sampling (Adult, CO2 5%, O2 Flow 5 lpm): Ave. - 4.92% Oral Sampling (Adult, CO2 1%, O2 Flow 1 lpm): Ave. - 0.98% Oral Sampling (Adult, CO2 1%, O2 Flow 5 lpm): Ave. - 4.95% Oral Sampling (Adult, CO2 5%, O2 Flow 1 lpm): Ave. - 0.90% Oral Sampling (Adult, CO2 5%, O2 Flow 5 lpm): Ave. - 4.46% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each test in terms of number of physical devices or runs, but it refers to "testing" and provides average values. For the O2/CO2 performance, the values are "Ave." suggesting multiple measurements were taken for each condition (Adult/Pediatric, CO2%, O2 Flow).
- Data Provenance: The document explicitly states "Bench Testing" and refers to the device's internal performance tests. This implies a controlled laboratory environment. There is no information provided regarding country of origin of the data or whether it was retrospective or prospective in a clinical setting. It solely refers to non-clinical (bench) testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of experts being used to establish a "ground truth" for the test set. The testing described is bench testing against specified parameters or compared to predicate device performance under simulated conditions. This type of engineering performance evaluation typically does not involve human expert adjudication of results but rather objective measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was bench testing based on objective measurements and comparisons to predicate device specifications, not a study requiring human adjudication (like image interpretation or clinical outcomes).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a 510(k) submission for a medical device (a nasal mask with gas sampling), which is typically supported by bench testing and comparison to predicate devices, not MRMC studies. MRMC studies are generally relevant for AI/radiology devices where human interpretation is a key component.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. The SuperNO2VA Et™ Device is a physical medical device (a mask) with technical specifications, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the testing described is primarily based on objective physical measurements and engineering specifications, which are then compared to the performance of legally marketed predicate devices and established standards (e.g., ISO 10993-1). For the O2/CO2 performance, the "ground truth" would be the known CO2 concentrations and O2 flow rates created in the simulated breathing setup.
8. Sample Size for the Training Set
Not applicable. As stated, this is a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Revolutionary Medical Devices, Inc. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K173147
Trade/Device Name: SuperNO2VA EtTM Device Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, BSJ Dated: May 23, 2018 Received: May 24, 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);
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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 comprehensive regulatory information about medical devices and radiation-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.
Todd D. Courtney -S
Tina Kiang, Ph.D. for Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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See PRA Statement on last page.
Expiration Date: 06/30/2020
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173147
Device Name
SuperNO2VA Et™ Device
Indications for Use (Describe)
The SuperNO2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Ef™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable.
The SuperNO2VA Ef™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary Page 1 of 9 20-Jun-18
| Revolutionary Medical Devices, Inc.4090 E. Bujia Primera | ||||
|---|---|---|---|---|
| Tucson, AZ 85718 | Tel - (520)-844-3729 | |||
| Official Contact: | David M. Kane - President and CEO | |||
| Proprietary or Trade Name: SuperNO2VA EtTM Device | ||||
| Common/Usual Name: | Nasal anesthesia face mask with gas sampling | |||
| Classification Code/Name: | CCK - analyzer, gas, carbon-dioxide, gaseous-phase21CFR 868.1400, Class 2 | |||
| Device: | SuperNO2VA EtTM Device | |||
| Predicate Devices: | Primary - K011050 - Oridion Microstream (CapnoLine) - CCKSecondary - K163277 - RMD - SuperNO2VATM Device - BSJ | |||
| Reference Devices: | Class 510(k) exempt - Medline - Anesthesia Face MaskK133806 - Monitor Mask - M1 |
Device Description:
The SuperNO2VA Et™ Device is a nasal mask with a sampling port for the nasal portion and a sampling "hood" for over the mouth.
The subject device is similar to an anesthesia or oxygen mask with gas sampling port. Instead of covering the full face the SuperNO2VA Et™ Device design is to allow the clinician to have access to the oral cavity during a procedure but still be able to provide air, oxygen or anesthesia gases to the patient while also sampling expired gases from the nasal or oral areas.
The design incorporates the standard 15 mm male circuit connector, luer fitting for the gas sampling line and a slip-fit port for pressure monitoring or oxygen if the mask is used with a manual resuscitator or hyperinflation bag.
The mask is not considered a long-term use device as it would only be used from pre- to postoperative care. This would be similar to the standard anesthesia mask.
It is not for use in long-term ventilation conditions or the treatment of sleep apnea.
Indications for Use:
The SuperNQ2VA Et™ Device is a nasal mask that creates a seal when positioned over a patient's nose to direct anesthesia gas, air, and / or oxygen to the upper airway during the continuum of anesthesia care.
It has a means for sampling expired gases from the patient's exhaled breath from the oral / nasal areas.
The SuperNO2VA Et™ Device is intended for short-term (<24 hours) use on adult patients (>30 kg.). It is a single patient use, disposable.
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510(k) Summary Page 2 of 9 20-Jun-18
The SuperNO2VA Et™ Device is contraindicated for use in long-term ventilation conditions and treatment of sleep apnea.
To be used under clinical supervision with adequate alarms and safety systems for monitoring and treatment of ventilatory failure.
Patient Population: Adult patients (>30 kg)
Environment of Use: Hospital, Sub-acute
Substantial Equivalence Discussion: Table 1 below compares the key features of the proposed SuperNO2VA Et™ Device mask with the identified primary and secondary predicates and reference devices to demonstrate that the proposed device can be found to be substantially equivalent.
Indications for Use – SuperNO2VA Et™ Device combines indications for use from the predicates, namely expired gas sampling - oral and nasal, with the secondary predicate SuperNO2VA, K163277, which provides a seal to delivery of gases.
Discussion - The proposed indications are a combination of the predicate and reference devices and there are no differences in the indications which raise new concerns of safety and effectiveness when compared to the predicates.
Technology and construction - SuperNO2VA Et™ Device is a nasal mask with a means, a "hood" to also sample expired exhaled from the mouth.
Like the predicate and reference devices they all sample exhaled gases via a port which is a conduit for the samples gases to be delivered to the monitor.
Discussion - The difference is the combination of a nasal mask and the "hood" over the mouth. The predicate uses nasal cannula and an additional sampling means for the mouth. However, the comparison performance testing has demonstrated equivalence.
The difference of delivering gases is similar to the secondary predicate SuperNO2VA, K163277, which provides a seal to delivery of gases. Delivery of gases under pressure to only the nasal area only is consistent with the secondary predicate and thus does not raise different concerns of safety or effectiveness than the predicates.
Environment of Use - The environment of use is similar to the predicates and reference devices. Discussion - The subject device does not include the pre-hospital setting.
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510(k) Summary Page 3 of 9
20-Jun-18
Table 1 – Comparison to Predicate and Reference Devices
| Feature | Proposed | Primary Predicate | Secondary Predicate | Reference | Reference | ||
|---|---|---|---|---|---|---|---|
| SuperNO2VA Et™ | K011050 | K163277 | Exempt | K133806 | |||
| Device | Oridion - Capnostream | RMD SuperNO2VA | Medline Anesthesia | Monitor Mask - M1 | |||
| Oral / Nasal Cannula | Mask | mask | |||||
| Product | CCK | CCK | CCK | ||||
| Classification | 868.1400 | 868.1400 | 868.1400 | ||||
| BSI | BSI | BSI | |||||
| 868.5550 (Secondary) | 868.5550 | 868.5550 | |||||
| Indications for | The SuperNO2VA Et™ Device | Is used whenever the | The SuperNO2VA™ Device | Positioned over a | The M1 Capnagraphy Mask | ||
| Use | is a nasal mask that creates a | physician needs to | is a mask that creates a seal | patient's nose or mouth | is a single-use device | ||
| seal when positioned over a | measure the CO2 in a | when positioned over a | to direct anesthetic | intended for delivering | |||
| patient's nose to direct | patient's breathing in a | patient's nose and mouth, or | gases to the upper | supplemental oxygen and | |||
| anesthesia gas, air, and / or | non-intubated patient. | nose only, to direct anesthesia | airway. | monitoring exhaled carbon | |||
| oxygen to the upper airway | gas, air, and / or oxygen to the | dioxide in non-intubated | |||||
| during the continuum of | Intended to conduct a | upper airway during the | spontaneously breathing | ||||
| anesthesia care. | sample of the patient's | continuum of anesthesia care. | patients. Standard oxygen | ||||
| It has a means for sampling | breathing from the patient | To be used under clinical | tubing and two female luer | ||||
| expired gases from the patient's | to the gas measurement | supervision with adequate | Port for expired gas | ports for gas sample line | |||
| exhaled breath from the oral / | device for measuring the | alarms and safety systems for | sampling | attachment are Included. | |||
| nasal areas. | percentage of CO2 in the | monitoring and treatment of | |||||
| To be used under clinical | patient's exhalation. | ventilatory failure. | |||||
| supervision with adequate | |||||||
| alarms and safety systems for | The SuperNO2VA™ Device | ||||||
| monitoring and treatment of | is intended for short-term | ||||||
| ventilatory failure. | (<24 hours) use on adult | ||||||
| The SuperNO2VA Et™ Device | patients (>30 kg.) It is a single | ||||||
| is intended for short-term (<24 | patient use, disposable. | ||||||
| hours) use on adult patients | |||||||
| (>30 kg.). It is a single patient | The SuperNO2VA™ Device | ||||||
| use, disposable. | is contraindicated for use in | ||||||
| The SuperNO2VA Et™ Device | long-term ventilation | ||||||
| is contraindicated for use in | conditions and treatment of | ||||||
| long-term ventilation | sleep apnea. | ||||||
| conditions and treatment of | |||||||
| sleep apnea. | |||||||
| Feature | ProposedSuperNO2VA EtTMDevice | Primary PredicateK011050Oridion - CapnostreamOral / Nasal Cannula | Secondary PredicateK163277RMD SuperNO2VAMask | ReferenceExemptMedline Anesthesiamask | ReferenceK133806Monitor Mask – M1 | ||
| PatientPopulation | Adult Patients > 30 kg | All patients | Adult Patients > 30 kg | All patients | All patients | ||
| Environment ofUse | HospitalSub-acute | HospitalSub-acutePre-hospital | HospitalSub-acute | HospitalSub-acutePre-hospital | HospitalSub-acutePre-hospital | ||
| Duration of Use | Single patient use,Disposable < 24 hours | Single patient use,disposable | Single patient use,Disposable < 24 hours | Single patient use,disposable | Single patient use,disposable | ||
| Technological Characteristics | |||||||
| Where expiredgas sampled | NasalOral | NasalOral | No sampling | No sampling | NasalOral | ||
| Where is gasdelivered | Nasal | Nasal | NasalOral | NasalOral | NasalOral | ||
| Technology fordirecting gasesunder pressure | Seal at nasal area | No seal | Seal at both nasal and oral | Seal at both nasal andoral | No seal | ||
| Technology forsampling expiredgases | Luer port in nasal maskOpen hood for oral portion | Open sampling in nasalareaOpen hood for oralportion | No sampling port | Luer port in mask | Luer port in mask | ||
| Provides a sealfor delivery ofgas | YesNasal only | No | YesNasal and Oral | YesNasal and Oral | No | ||
| Oxygen orpressuremonitoring port | Yes | No | Yes | No | Yes | ||
| Method ofsampling expiredgases | At nasal portion via a portAt oral via a hood | At nasal via a cannulaAt oral via a hood | Does not sample | At oral and nasal via aport | |||
| Patientconnector | 15 mm connector for deliveredgas source | No patient connector | 15 mm connector forconnecting delivered gases | 15 / 22 mm connectorfor delivered gas source | Oxygen tubing connectorfor delivered gas source | ||
| Feature | ProposedSuperNO2VA EtTMDevice | Primary PredicateK011050Oridion - CapnostreamOral / Nasal Cannula | Secondary PredicateK163277RMD SuperNO2VAMask | ReferenceExemptMedline Anesthesiamask | ReferenceK133806Monitor Mask – M1 | ||
| Performance Comparison | |||||||
| Internal volume | Nasal mask onlyMedium – 53 mlLarge - 87 ml | Not applicable | Nasal mask onlyMedium – 53 mlLarge - 87 ml | Full mask~ 158 ml | Not applicable | ||
| Pressure tomaintain a sealfor gas delivery | Up to 30 cmH2O | Not applicable | Up to 30 cmH2O | Not specified | Not applicable | ||
| Resistance toflow | 0.46 cmH2O @ 50 lpm1.8 cmH2O @ 100 lpm | Not applicable | 0.46 cmH2O @ 50 lpm1.8 cmH2O @ 100 lpm | 30 lpm – 0.13 cmH2O60 lpm – 0.25 cmH2O90 lpm – 0.51 cmH2O | Not tested | ||
| Leak rate underpressure | 0.8 Lpm @ 20 cmH2O | Not applicable | 0.8 Lpm @ 20 cmH2O | Not tested | Not tested | ||
| Biocompatibility | ISO 10993-1Externally communicatingTissueSurface ContactSkin / MucosalLimited duration (< 24hours) | ISO 10993-1Externallycommunicating TissueSurface ContactSkin / MucosalProlonged duration | ISO 10993-1Externally communicatingTissueSurface ContactSkin / MucosalLimited duration (< 24 hours) | ISO 10993-1Externallycommunicating TissueSurface ContactSkin / MucosalLimited duration | ISO 10993-1Externallycommunicating TissueSurface ContactSkin / MucosalProlonged duration | ||
| Performancetesting | Internal volumeResistance to flow throughthe connectorLeakage under simulatedseal conditions with amannequin faceConnector – 15 mm testing– pre- and post-agingDropEnvironmental – Operating | EtCO2 performance | Internal volumeResistance to flow throughthe connectorLeakage under simulated sealconditions with a mannequinfaceConnector – 15 mm testing –pre- and post-agingDropEnvironmental – Operating / | Resistance to flowthrough the connectorLeakage under simulatedseal conditions with amannequin faceConnector – 15 mmtesting | EtCO2 performance | ||
| Feature | ProposedSuperNO2VA EtTMDevice | Primary PredicateK011050Oridion - CapnostreamOral / Nasal Cannula | Secondary PredicateK163277RMD SuperNO2VAMask | ReferenceExemptMedline / VentlabAnesthesia mask | ReferenceK133806Monitor Mask – M1 | ||
| Dead space | Nasal mask onlyMedium – 53 mlLarge – 87 ml | – – N/A | Nasal mask onlyMedium – 53 mlLarge – 87 ml | Large – 158 ml(Nasal and Oral)Medium – | – – N/A | ||
| Pressure / Leak | Can maintain pressure of >20 cmH2O with 10 lbs. forceLeakage < 2 Lpm | Can maintain pressure of >20 cmH2O with 10 lbs. forceLeakage < 2 Lpm | Can maintain pressure of >20 cmH2O with 10 lbs. forceLeakage ave. 2.6 Lpm | ||||
| Pressure DropAcceptance< 5 cmH2O @60 Lpm | 30 lpm – 0.13 cmH2O60 lpm – 0.38 cmH2O90 lpm – 1.15 cmH2O | – – N/A | 30 lpm – 0.13 cmH2O60 lpm – 0.38 cmH2O90 lpm – 1.15 cmH2O | 30 lpm – 0.13 cmH2O60 lpm – 0.25 cmH2O90 lpm – 0.51 cmH2O | – – N/A |
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510(k) Summary
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510(k) Summary Page 6 of 9
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Table 2 – Comparative O2 / CO2 Performance Nasal and Oral Sampling
| Feature | ProposedSuperNO2VA EtTMNasal Sampling | K011050Oridion - CapnostreamNasal Sampling | ProposedSuperNO2VA EtTMOral Sampling | K011050Oridion - CapnostreamOral Sampling |
|---|---|---|---|---|
| Adult | ||||
| BPR = 12TV (ml) = 500 mlCO2% - 1%O2 Flow rate – 1 and 5 lpm | EtCO2 @ 1% and 1 LpmAve. - 1.00%EtCO2 @ 1% and 5 LpmAve. - 4.93% | EtCO2 @ 1% and 1 LpmAve. - 0.93%EtCO2 @ 1% and 5 LpmAve. - 0.88% | EtCO2 @ 1% and 1 LpmAve. - 0.98%EtCO2 @ 1% and 5 LpmAve. - 4.95 | EtCO2 @ 1% and 1 LpmAve. - 0.86%EtCO2 @ 1% and 5 LpmAve. - 4.19% |
| BPR = 12TV (ml) = 500 mlCO2% - 5%O2 Flow rate – 1 and 5 lpm | EtCO2 @ 5% and 1 LpmAve. - 0.94%EtCO2 @ 5% and 5 LpmAve. - 4.92% | EtCO2 @ 5% and 1 LpmAve. - 4.22%EtCO2 @ 5% and 5 LpmAve. - 4.07% | EtCO2 @ 5% and 1 LpmAve. - 0.90%EtCO2 @ 5% and 5 LpmAve. - 4.46% | EtCO2 @ 5% and 1 LpmAve. - 0.79%EtCO2 @ 5% and 5 LpmAve. - 3.59% |
| Pediatric | ||||
| BPR = 20TV (ml) = 300 mlCO2% - 1%O2 Flow rate – 1 and 5 lpm | EtCO2 @ 1% and 1 LpmAve. 0.91%EtCO2 @ 1% and 5 LpmAve. - 4.62% | EtCO2 @ 1% and 1 LpmAve. - 0.82%EtCO2 @ 1% and 5 LpmAve. - 4.02% | EtCO2 @ 1% and 1 LpmAve. 0.87%EtCO2 @ 1% and 5 LpmAve. - 4.67% | EtCO2 @ 1% and 1 LpmAve. - 0.77%EtCO2 @ 1% and 5 LpmAve. - 4.01% |
| BPR = 20TV (ml) = 300 mlCO2% - 5%O2 Flow rate – 1 and 5 lpm | EtCO2 @ 5% and 1 LpmAve. - 0.88%EtCO2 @ 5% and 5 LpmAve. - 4.60% | EtCO2 @ 5% and 1 LpmAve. -0.81EtCO2 @ 5% and 5 LpmAve - 3.96% | EtCO2 @ 5% and 1 LpmAve. 0.91%EtCO2 @ 5% and 5 LpmAve. 4.06% | EtCO2 @ 5% and 1 LpmAve. - 0.72%EtCO2 @ 5% and 5 LpmAve. 3.35% |
| Note: Testing of the Secondary Predicate for EtCO2 is not applicable as the device does not have this feature |
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510(k) Summary Page 8 of 9 20-Jun-18
| Feature | ProposedSuperNO2VA EtTMBoth Nasal / Oral Sampling | Reference - ExemptMedline Anesthesia maskBoth Nasal / Oral Sampling |
|---|---|---|
| Adult | ||
| BPR = 12 | EtCO2 @ 1% | EtCO2 @ 1% |
| TV (ml) = 500 ml | Ave. - 0.98% | Ave. - 0.97% |
| CO2% - 1% | ||
| Pressure - 20 cmH2O | ||
| BPR = 12 | EtCO2 @ 5% | EtCO2 @ 5% |
| TV (ml) = 500 ml | Ave. - 4.96% | Ave. - 4.90% |
| CO2% - 5% | ||
| Pressure - 20 cmH2O | ||
| Pediatric | ||
| BPR = 20 | EtCO2 @ 1% | EtCO2 @ 1% |
| TV (ml) = 300 ml | Ave. - 1.00% | Ave. - 0.95% |
| CO2% - 1% | ||
| Pressure - 20 cmH2O | ||
| BPR = 20 | EtCO2 @ 5% | EtCO2 @ 5% |
| TV (ml) = 300 ml | Ave. - 5.00% | Ave. - 4.62% |
| CO2% - 5% | ||
| Pressure - 20 cmH2O |
Table 3 - Comparative O2 / CO2 Performance under Positive Pressure
Note: Testing of the Secondary Predicate for EtCO2 is not applicable as the device does not have this feature
Non-Clinical Testing Summary -
Bench Testing
We performed testing which evaluated the design. These tests included:
- . Dead space / volume
- Pressure drop
- Pressure and leakage ●
- O2 / CO2 performance at various simulated settings including positive pressure, oral / nasal sampling only
- . Age and shelf-life
- . Drop testing
Biocompatibility
SuperNO2VATM based upon ISO 10993-1 is considered:
Surface Contact Mucosal membrane Limited Duration (< 24 hours) And Externally Communicating Tissue Limited Duration (< 24 hours)
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Testing would include:
- Cytotoxicity
- Sensitization .
- . Irritation
Discussion of Differences –
The differences are:
- . The subject device provides a means to delivered gases under pressure only to the nasal area and sample expired gases. The secondary predicate, SuperNO2VA, K163277 delivers gases under pressure to also, but does not sample expired gases under pressure. Therefore, the reference device, Medline mask which is a full-face mask and delivers gases under pressure and also samples expired gases was compared and comparative testing demonstrated that performance was substantially equivalent.
- . Technology of sampling expired gases is a combination of 2 devices.
- In the sealed nasal mask portion this is similar to the reference full face mask, o Medline.
- Via the oral hood is similar to the primary predicate, Oridion K011050 which O samples both via an oral hood and via nasal cannula.
- Comparative testing demonstrated that the performance of measuring expired gases o was substantially equivalent.
Substantial Equivalence Conclusion -
Based upon the presented information the sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed devices and predicates have been found to substantially equivalent and there are no different safety or effectiveness concerns raised.
§ 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).