(331 days)
The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.
Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen mixture to provide pain relief, on demand, to a conscious, spontaneously breathing, patient.
The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient.
A selection knob is used to select desired N20/02 gas mixture. The adjustable range is from 25% O2 (NJO 75%) to 100% O2 (N3O 0%), with the minimum of 25% oxygen output to eliminate the possibility of delivering a hypoxic mixture.
The Oxygen Enrichment Function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.
The built-in pneumatically powered alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut off should oxygen input falls below 35 PSI.
The main accessories for the proposed device are a disposable Patient Circuit and a Mouth Piece or a universal Face Mask.
The provided text describes the regulatory clearance of a medical device, the Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System, and its substantial equivalence to a predicate device, the Equinox® Relieve (K113687). However, the document does not contain the typical comprehensive study report details that would allow for a complete answer to all parts of your request. This document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, it relies on demonstrating equivalence to a predicate device and adherence to relevant standards. The "performance" reported is primarily comparative.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (Equinox® Advantage) |
|---|---|---|
| Intended Use | Administer adjustable N2O/O2, on demand, to a conscious, spontaneously breathing patient (comparable to predicate's 50/50% N2O/O2, on demand, to a conscious, spontaneously breathing patient) | Administers adjustable mixture of N2O/O2, on demand, to a conscious, spontaneously breathing patient. (Meets) |
| Environments of Use | Pre-hospital and in-hospital use (equivalent to predicate) | Pre-hospital and in-hospital environment. (Meets) |
| Patient Population | Conscious, spontaneous breathing patients requiring pain relief (equivalent to predicate) | Conscious, spontaneous breathing patients requiring pain relief. (Meets) |
| Contra-Indications | Same as predicate | Same as predicate. (Meets) |
| Gas input and regulating | 50-70 PSI Oxygen and Nitrous Oxide regulated by internal regulators (equivalent to predicate) | 50-70 PSI Oxygen and Nitrous Oxide regulated by internal regulators. (Meets) |
| Gas mixing | Oxygen and Nitrous Oxide equalized and mixed (predicate was 1:1 ratio, proposed is variable ratios) | Oxygen and Nitrous Oxide equalized and mixed at variable ratios. (Meets, with modification) |
| Gas delivery | Proportional to patient's demand (equivalent to predicate) | Proportional to patient's demand. (Meets) |
| Monitoring and alarms | Audible/Visual alarms activated if N2O or O2 input below 40 PSI (equivalent to predicate) | Audible/Visual alarms activated if N2O or O2 input below 40 PSI. (Meets) |
| Safety features (O2 supply failure) | Protection circuit shuts off device in event of O2 supply failure (equivalent to predicate) | Protection circuit shuts off the device in the event of O2 supply failure. (Meets) |
| Safety features (N2O supply failure) | Predicate: Shuts off device. Proposed: Continues with higher O2 output / 100% O2 if no N2O input, as per ISO 11195:1995 Sec.12.4. | Continues to operate with higher oxygen output; delivers 100% oxygen if no N2O input. (Meets ISO 11195:1995 Sec.12.4) |
| Input pressure | 50 to 70 PSI (equivalent to predicate) | 50 to 70 PSI. (Meets) |
| Output mixture concentration | Predicate: Preset 50/50% (V/V) O2 / N2O. Proposed: Adjustable 25%-100% Oxygen. | Adjustable Oxygen: 25%-100%. (Meets, with new feature) |
| Oxygen Enrichment | Not available on predicate. Proposed: 30 L/min oxygen. | 30 L/min oxygen. (New feature, meets ISO 80601-2-13:2011 Sec. 201.101.8) |
| Output failure shutoff | Predicate: Shut off if O2 much lower than N2O. Proposed: Removed function; minimum 25% oxygen setting prevents hypoxic mixture. | "Output failure shutoff" function removed; minimum 25% oxygen setting prevents delivering a hypoxic mixture. (Meets ISO 11195:1995 Sec.11.1) |
| Inspiratory Resistance | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Expiratory Resistance | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Volume-time waveforms | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Pressure-time waveforms | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Flow-time waveforms | Equivalent to predicate | Equivalent to predicate. (Meets) |
| "Low Oxygen supply" alarm characteristics | Equivalent to predicate | Equivalent to predicate. (Meets) |
| "Low Nitrous Oxide supply" alarm characteristics | Equivalent to predicate | Equivalent to predicate. (Meets) |
| "Oxygen Failure Shutoff" characteristic | Equivalent to predicate | Equivalent to predicate. (Meets) |
| Oxygen concentration (at 50% setting) | Equivalent to predicate (when predicate is 50%) | Equivalent to predicate. (Meets) |
| Nitrous Oxide concentration (at 50% setting) | Equivalent to predicate (when predicate is 50%) | Equivalent to predicate. (Meets) |
| Electrical Safety & Essential Performance | Compliance with ISO 11195 and other applicable standards | Bench testing performed as per ISO 11195 and other applicable standards. (Meets) |
2. Sample size used for the test set and the data provenance
The document describes "comparative performance testing" and "bench testing." These are laboratory-based tests comparing the proposed device against the predicate and against standards. It does not involve human subjects or patient data in the sense of a clinical trial. Therefore, specific "sample sizes" of a test set derived from patient data are not applicable here.
- Sample size for test set: Not applicable (bench testing, not patient data).
- Data provenance: Bench testing results, comparing the proposed device to the predicate device and relevant international standards (e.g., ISO 11195, ISO 80601-2-13). The country of origin for the test data is not specified but is presumably where the manufacturing and R&D for O-Two Medical Technologies Inc. takes place (Canada, as per the address). The testing is prospective for the purpose of demonstrating equivalence for the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For bench testing, ground truth is established by objective measurements against known physical and chemical standards and the specifications of the predicate device. Experts in this context would likely be engineers and testers.
4. Adjudication method for the test set
Not applicable. The testing described is objective, physical measurement and comparison, not expert adjudication of a diagnostic outcome.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical gas mixing and delivery system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human intervention. This concept is not applicable to a physical gas mixing and delivery system. Its "performance" is inherent in its mechanical and pneumatic operation.
7. The type of ground truth used
For the aspects involving comparison to the predicate device, the "ground truth" for equivalence was the performance and specifications of the legally marketed predicate device (Equinox® Relieve/K113687). For aspects related to safety and functionality specifications, the ground truth was defined by international standards such as ISO 11195:1995 and ISO 80601-2-13:2011.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
O-Two Medical Technologies Inc. David Zhang QA Manager 45A Armthorpe Road Brampton, Ontario L6T 5M4
Re: K173205
Trade/Device Name: Equinox Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR Dated: July 30, 2018 Received: August 1, 2018
Dear David Zhang:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4. Subpart A) for combination products; 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 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.
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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Indications for Use
510(k) Number (if known) K173205
Device Name
Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System
Indications for Use (Describe)
The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (k) Summary
| Submitter's Name & Address: O-Two Medical Technologies | |
|---|---|
| 45A Armthorpe Road | |
| Brampton, Ontario, L6T 5M4 | |
| Canada | |
| Tel: 905-792-6896 |
| Official Contact: | David Zhang |
|---|---|
| Date of Revision: | 2018-08-17 |
| Proprietary or Trade Name: | Equinox ® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System |
| Common/Usual Name: | Mixer, Breathing Gases, Anesthesia Inhalation |
| Classification Name: | Breathing Gas Mixer (21 CFR 868.5330, product code: BZR) |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
| Predicate Devices: | Equinox ® Relieve Manufactured by O-Two Medical Technologies Inc.510(k) number K113687 |
Device Description:
Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen mixture to provide pain relief, on demand, to a conscious, spontaneously breathing, patient.
The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient.
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A selection knob is used to select desired N20/02 gas mixture. The adjustable range is from 25% O2 (NJO 75%) to 100% O2 (N3O 0%), with the minimum of 25% oxygen output to eliminate the possibility of delivering a hypoxic mixture.
The Oxygen Enrichment Function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.
The built-in pneumatically powered alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut off should oxygen input falls below 35 PSI.
The main accessories for the proposed device are a disposable Patient Circuit and a Mouth Piece or a universal Face Mask.
Indications for Use:
The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.
Patient Population:
Conscious, spontaneous breathing patients requiring pain relief.
Contraindications:
- Hypersensitivity to the medication
- Head injuries with impaired consciousness ●
- Maxillofacial injuries ●
- Artificial, traumatic or spontaneous pneumothorax ●
- Air embolism ●
- Middle ear occlusion, ear infection ●
- Decompression sickness ●
- Abdominal distension / intestinal obstruction ●
NOTE: Nitrous Oxide/Oxygen (N20/02) mixtures must never be used in any condition where air is trapped in the body and expansion (up to 3x original size) would be dangerous. For example, it will exacerbate pneumothorax and increase pressure from any intracranial air. Air in any other cavities such as the sinuses, middle ear and gut may also expand.
Environment of Use:
Pre-hospital (ambulance) use and in-hospital use (ER. Labor and Delivery etc.)
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| Characteristic | ProposedEquinox® Advantage | Predicate K113687Equinox® Relieve | SubstantialEquivalence |
|---|---|---|---|
| Intended Use | Administer an adjustable mixture ofN2O/O2, on demand, to a conscious,spontaneously breathing patient | Administer 50/50% N2O/O2 mixture, ondemand, to a conscious, spontaneouslybreathing patient | Equivalent |
| Environmentsof use | Pre-hospital use and in-hospitalenvironment | Pre-hospital use and in-hospitalenvironment | Yes |
| Patientpopulation | Conscious, spontaneous breathingpatients requiring pain relief | Conscious, spontaneous breathingpatients requiring pain relief | Yes |
| Contra-Indications | Hypersensitivity to the medication Head injuries with impairedconsciousness Maxillofacial injuries Artificial, traumatic or spontaneouspneumothorax Air embolism Middle ear occlusion, ear infection Decompression sickness Abdominal distension / intestinalobstruction | Hypersensitivity to the medication Head injuries with impairedconsciousness Maxillofacial injuries Artificial, traumatic or spontaneouspneumothorax Air embolism Middle ear occlusion, ear infection Decompression sickness Abdominal distension / intestinalobstruction | Yes |
Comparative table - Intended use:
Comparative table - Operating principle:
| Characteristic | ProposedEquinox® Advantage | Predicate K113687Equinox® Relieve | SubstantialEquivalence |
|---|---|---|---|
| Gas input andregulating | 50- 70 PSI Oxygen and Nitrous Oxideregulated by internal regulators | 50- 70 PSI Oxygen and Nitrous Oxidestabilized by internal regulators | Yes |
| Gas mixing | Oxygen and Nitrous Oxide areequalized and mixed at variable ratios | Oxygen and Nitrous Oxide areequalized and mixed at 1:1 ratio | Similar-(mixing ratio isadjustable) |
| Gas delivery | Gas mixture delivery is proportional topatient's demand. | Gas mixture delivery is proportional topatient's demand. | Yes |
| Monitoringand alarms | The input pressure from each gas inputis measured by pressure sensors andAudible/Visual alarms activated should:- N2O input is below 40 PSI;- O2 input is below 40 PSI | The input pressure from each gas inputis measured by pressure sensors andAudible/Visual alarms activated should:- N2O input is below 40 PSI;- O2 input is below 40 PSI | Yes |
| Safety features | In the event of O2 supply failure,1.the protection circuit will shut offthe device: | 1.In the event of O2 supply failure,the protection circuit will shut offthe device: | Yes |
| 2.In the event of N2O supply failure,Oxygen will be supplied as per ISO11195:1995 Sec.12.4 | 2.In the event of N2O supply failure,the protection circuit will shut offthe device | Similar-(Modificationmade as per ISO11195 Sec.12.4) |
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Comparative table- Materials
| Materials | ProposedEquinox® Advantage | Predicate K113687Equinox® Relieve | SubstantialEquivalence |
|---|---|---|---|
| Metal parts | Brass-Nickel plated, AnodizedAluminum, Stainless Steel | Brass-Nickel plated, AnodizedAluminum, Stainless Steel | Yes |
| Plastic parts | ABS, PC / ABS blends, Polycarbonate,Silicone, Polypropylene, PVC | ABS, PC / ABS blends, Polycarbonate,Silicone, Polypropylene, PVC | Yes |
| Tubing | Polyurethane | Polyurethane | Yes |
Comparative table- Safety features
| Characteristic | ProposedEquinox® Advantage | Predicate K113687Equinox® Relieve | SubstantialEquivalence |
|---|---|---|---|
| Safety features | - CGA gas specific connection to preventmisconnection of gas supply; | - CGA gas specific connection to preventmisconnection of gas supply; | Yes |
| - Activated only by patient inspiratoryeffort; | - Activated only by patient inspiratoryeffort; | Yes | |
| - Audible & visual alarms; | - Audible & visual alarms; | Yes | |
| - Input Gas Fail Safe: Shut off the deviceif supply of O2 dropped below 35 PSI | - Input Gas Fail Safe: Shut off the deviceif supply of either N2O or O2 droppedbelow 35 PSI | Similar-(Modificationmade as per ISO11195 Sec.12.4) |
Comparative table- Technological characteristics/specifications of performance
| Characteristic | ProposedEquinox® Advantage | Predicate K113687Equinox® Relieve | SubstantialEquivalence |
|---|---|---|---|
| Input gas | O2 and N2O | O2 and N2O | Yes |
| Input pressure | 50 to 70 PSI | 50 to 70 PSI | Yes |
| Output mixtureconcentration | Adjustable Oxygen: 25%-100% | Preset 50/50% (V/V) O2 / N2O | Equivalent-(mixing ratio isadjustable) |
| OxygenEnrichment | 30 L/min oxygen | Not available | New feature |
| Alarms | Low input audible and visual alarmsfor both gases if either or both inputsdropped below 40 PSI | Low input audible and visual alarmsfor both gases if either or both inputsdropped below 40 PSI | Yes |
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| Safety features | - Activated only by patient inspiratory effort;- CGA connection to prevent misconnection of gas supply;- Audible & visual alarms;- Power Fail Safe: Shut off the device if supply of O2 drops below 35 PSI | - Activated only by patient inspiratory effort;- CGA connection to prevent misconnection of gas supply;- Audible & visual alarms;-Power Fail Safe: Shut off the device if supply of O2 drops below 35 PSI-Power Fail Safe: Shut off the device if supply of N2O drops below 35 PSI | Similar-(Modification made as per ISO 11195 Sec.12.4) | |
|---|---|---|---|---|
| Patient support mode | Demand valve | Demand valve | Yes | |
| Peak Flow on Demand (L/min) | 120 minimum | 120 minimum | Yes | |
| Accessories | - Disposable patient circuit with 30 mm Scavenging port and Universal PVC Face Mask;- Oxygen supply hose;- Nitrous Oxide supply hose | - Disposable patient circuit with 30 mm Scavenging port and Universal PVC Face Mask;- Oxygen supply hose;- Nitrous Oxide supply hose | Yes |
Substantially equivalence to the predicate devices:
The proposed device (Equinox® Advantage) is equivalent to the predicate device in Intended use, Patient populations, Environment of use and Contra-indications.
It not only incorporates parts which are identical to the Equinox® Relieve/K113687, but also use the same materials as the Equinox® Relieve/K113687.
Furthermore, Equinox® Advantage uses the identical operating principle as the Equinox® Relieve.
Safety features and range of performance specifications of the Equinox® Advantage are also found equivalent to those on the Equinox® Relieve/K113687.
The proposed Equinox® Advantage is substantially equivalent to the predicate Equinox® Relieve/ K113687 with the following minor modifications:
| Modification | Equinox Relieve | The proposed | Standard |
|---|---|---|---|
| made | (K113687 | Equinox Advantage | compliance |
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| Mixingsystem | Gas mixingratio | Fixed (Oxygen 50%) | Modified to adjustable mixing ratio(Oxygen 25% - 100%) | ISO 11195:1995Sec.3.1 |
|---|---|---|---|---|
| Deliverysystem | Oxygenenrichment | Not available | Oxygen enrichment (30 L/min)added | ISO 80601-2-13:2011 Sec.201. 101.8 |
| Safety/Warningsystem | Output failureshutoff | When O2 output pressure ismuch lower than N2O, ShutOff Sensor will shut off thedevice to prevent delivering ahypoxic mixture. | "Output failure shutoff" functionremoved to enable adjustable mixingratio.Minimum 25% oxygen settingprevents delivering a hypoxicmixture. | ISO 11195:1995Sec.11.1 |
| Power failureshutoff-Nitrous oxide | If the Nitrous Oxide inputpressure drops to 35 PSI, theDemand Valve and the Mixerwill be shut off. | "Nitrous oxide failure shutoff"function removed.When Nitrous Oxide input drops to35 PSI, with low pressure N2Oalarm on, the proposed devicecontinues to operate with higheroxygen output. If there is no N2Oinput, the device will deliver 100%oxygen. | ISO 11195:1995Sec. 12.4 |
As all the modifications made, meet the requirements of the current technical standards with safety measures also in place to prevent from introducing new potential risks, there is not any significant differences that raise different questions of safety or effectiveness of the intended device as compared to the predicate devices.
Summary of Performance Testing:
A comparative performance testing was performed on Equinox® Advantage and Equinox® Relieve. The result of the test demonstrates substantial equivalence of the proposed to the predicate.
The summary of the test results follows:
- Both mixers delivered equivalent Inspiratory Resistance, Expiratory Resistance, volume-time, pressure-time and flow- time wave forms under the same ventilation mode;
- Both mixers showed equivalent "Low Oxygen supply" and "Low Nitrous Oxide supply" alarm characteristics;
- Both mixers showed equivalent "Oxygen Failure Shutoff" characteristic; -
- When Equinox® Advantage is set at 50% Oxygen mixing ratio, both units delivered equivalent Oxygen concentration and Nitrous Oxide concentration.
We have also performed bench testing as per ISO 11195 and other applicable standards with respect to Electrical Safety & Essential performance of the proposed device and its accessory.
Conclusion:
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The results of the above comparative performance testing as well as bench testing demonstrate that the proposed Equinox® Advantage is as safe, as effective and performs as well as the legally marketed predicate devices - Equinox® Relieve (K113687).
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).