Equinox Advantage

K173205 · O-Two Medical Technologies, Inc. · BZR · Aug 29, 2018 · Anesthesiology

Device Facts

• Record ID: K173205
• Device Name: Equinox Advantage
• Applicant: O-Two Medical Technologies, Inc.
• Product Code: BZR · Anesthesiology
• Decision Date: Aug 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable, pneumatically powered device for on-demand delivery of adjustable Nitrous Oxide/Oxygen analgesic gas mixtures. Inputs: N2O and O2 cylinders via pressure regulators. Operation: User selects O2 concentration (25-100%) via knob; gas delivery triggered by patient inspiratory effort. Includes Oxygen Enrichment function (30 L/min 100% O2) for circuit flushing. Used in pre-hospital (ambulance) and in-hospital (ER, Labor and Delivery) settings by clinicians. Features integrated pneumatic alarm system (audible/visual) for low input pressure (<40 PSI) and automatic shut-off if O2 input falls below 35 PSI. Output: Analgesic gas mixture to patient via face mask or mouthpiece. Benefits: Provides adjustable pain relief while preventing hypoxic mixtures; enhances patient safety through fail-safe mechanisms.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate (K113687) evaluated inspiratory/expiratory resistance, volume-time, pressure-time, and flow-time waveforms, alarm characteristics, and gas concentration accuracy. Additional bench testing conducted per ISO 11195 and standards for electrical safety and essential performance.

Technological Characteristics

Pneumatically powered gas mixer. Materials: Brass (nickel-plated), anodized aluminum, stainless steel, ABS, PC/ABS, polycarbonate, silicone, polypropylene, PVC, polyurethane. Connectivity: None. Dimensions/Form: Portable. Standards: ISO 11195:1995, ISO 80601-2-13:2011. Sensing: Pressure sensors for gas inputs. Actuation: Demand valve triggered by patient inspiratory effort.

Indications for Use

Indicated for conscious, spontaneously breathing patients requiring pain relief. Contraindicated in patients with hypersensitivity to medication, head injuries with impaired consciousness, maxillofacial injuries, pneumothorax (artificial, traumatic, or spontaneous), air embolism, middle ear occlusion/infection, decompression sickness, or abdominal distension/intestinal obstruction.

Regulatory Classification

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.

Predicate Devices

• Equinox® Relieve (K113687)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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: [phone] |

| 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 <ul><li>Manufactured by O-Two Medical Technologies Inc.</li><li>510(k) number K113687</li></ul> |

#### 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 | Proposed<br>Equinox® Advantage | Predicate K113687<br>Equinox® Relieve | Substantial<br>Equivalence |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | Administer an adjustable mixture of<br>N2O/O2, on demand, to a conscious,<br>spontaneously breathing patient | Administer 50/50% N2O/O2 mixture, on<br>demand, to a conscious, spontaneously<br>breathing patient | Equivalent |
| Environments<br>of use | Pre-hospital use and in-hospital<br>environment | Pre-hospital use and in-hospital<br>environment | Yes |
| Patient<br>population | Conscious, spontaneous breathing<br>patients requiring pain relief | Conscious, spontaneous breathing<br>patients requiring pain relief | Yes |
| Contra-<br>Indications | Hypersensitivity to the medication Head injuries with impaired<br>consciousness Maxillofacial injuries Artificial, traumatic or spontaneous<br>pneumothorax Air embolism Middle ear occlusion, ear infection Decompression sickness Abdominal distension / intestinal<br>obstruction | Hypersensitivity to the medication Head injuries with impaired<br>consciousness Maxillofacial injuries Artificial, traumatic or spontaneous<br>pneumothorax Air embolism Middle ear occlusion, ear infection Decompression sickness Abdominal distension / intestinal<br>obstruction | Yes |

## Comparative table - Intended use:

# Comparative table - Operating principle:

| Characteristic | Proposed<br>Equinox® Advantage | Predicate K113687<br>Equinox® Relieve | Substantial<br>Equivalence |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Gas input and<br>regulating | 50- 70 PSI Oxygen and Nitrous Oxide<br>regulated by internal regulators | 50- 70 PSI Oxygen and Nitrous Oxide<br>stabilized by internal regulators | Yes |
| Gas mixing | Oxygen and Nitrous Oxide are<br>equalized and mixed at variable ratios | Oxygen and Nitrous Oxide are<br>equalized and mixed at 1:1 ratio | Similar-<br>(mixing ratio is<br>adjustable) |
| Gas delivery | Gas mixture delivery is proportional to<br>patient's demand. | Gas mixture delivery is proportional to<br>patient's demand. | Yes |
| Monitoring<br>and alarms | The input pressure from each gas input<br>is measured by pressure sensors and<br>Audible/Visual alarms activated should:<br>- N2O input is below 40 PSI;<br>- O2 input is below 40 PSI | The input pressure from each gas input<br>is measured by pressure sensors and<br>Audible/Visual alarms activated should:<br>- N2O input is below 40 PSI;<br>- O2 input is below 40 PSI | Yes |
| Safety features | In the event of O2 supply failure,<br>1.<br>the protection circuit will shut off<br>the device: | 1.<br>In the event of O2 supply failure,<br>the protection circuit will shut off<br>the device: | Yes |
| | 2.<br>In the event of N2O supply failure,<br>Oxygen will be supplied as per ISO<br>11195:1995 Sec.12.4 | 2.<br>In the event of N2O supply failure,<br>the protection circuit will shut off<br>the device | Similar-<br>(Modification<br>made as per ISO<br>11195 Sec.12.4) |

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# Comparative table- Materials

| Materials | Proposed<br>Equinox® Advantage | Predicate K113687<br>Equinox® Relieve | Substantial<br>Equivalence |
|---------------|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------|
| Metal parts | Brass-Nickel plated, Anodized<br>Aluminum, Stainless Steel | Brass-Nickel plated, Anodized<br>Aluminum, Stainless Steel | Yes |
| Plastic parts | ABS, PC / ABS blends, Polycarbonate,<br>Silicone, Polypropylene, PVC | ABS, PC / ABS blends, Polycarbonate,<br>Silicone, Polypropylene, PVC | Yes |
| Tubing | Polyurethane | Polyurethane | Yes |

# Comparative table- Safety features

| Characteristic | Proposed<br>Equinox® Advantage | Predicate K113687<br>Equinox® Relieve | Substantial<br>Equivalence |
|-----------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Safety features | - CGA gas specific connection to prevent<br>misconnection of gas supply; | - CGA gas specific connection to prevent<br>misconnection of gas supply; | Yes |
| | - Activated only by patient inspiratory<br>effort; | - Activated only by patient inspiratory<br>effort; | Yes |
| | - Audible & visual alarms; | - Audible & visual alarms; | Yes |
| | - Input Gas Fail Safe: Shut off the device<br>if supply of O2 dropped below 35 PSI | - Input Gas Fail Safe: Shut off the device<br>if supply of either N2O or O2 dropped<br>below 35 PSI | Similar-<br>(Modification<br>made as per ISO<br>11195 Sec.12.4) |

## Comparative table- Technological characteristics/specifications of performance

| Characteristic | Proposed<br>Equinox® Advantage | Predicate K113687<br>Equinox® Relieve | Substantial<br>Equivalence |
|---------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Input gas | O2 and N2O | O2 and N2O | Yes |
| Input pressure | 50 to 70 PSI | 50 to 70 PSI | Yes |
| Output mixture<br>concentration | Adjustable Oxygen: 25%-100% | Preset 50/50% (V/V) O2 / N2O | Equivalent-<br>(mixing ratio is<br>adjustable) |
| Oxygen<br>Enrichment | 30 L/min oxygen | Not available | New feature |
| Alarms | Low input audible and visual alarms<br>for both gases if either or both inputs<br>dropped below 40 PSI | Low input audible and visual alarms<br>for both gases if either or both inputs<br>dropped below 40 PSI | Yes |

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| Safety features | - Activated only by patient inspiratory effort;<br>- CGA connection to prevent misconnection of gas supply;<br>- Audible & visual alarms;<br>- Power Fail Safe: Shut off the device if supply of O2 drops below 35 PSI | - Activated only by patient inspiratory effort;<br>- CGA connection to prevent misconnection of gas supply;<br>- Audible & visual alarms;<br>-Power Fail Safe: Shut off the device if supply of O2 drops below 35 PSI<br>-Power Fail Safe: Shut off the device if supply of N2O drops below 35 PSI | Similar-<br>(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;<br>- Oxygen supply hose;<br>- Nitrous Oxide supply hose | - Disposable patient circuit with 30 mm Scavenging port and Universal PVC Face Mask;<br>- Oxygen supply hose;<br>- 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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| Mixing<br>system | Gas mixing<br>ratio | Fixed (Oxygen 50%) | Modified to adjustable mixing ratio<br>(Oxygen 25% - 100%) | ISO 11195:1995<br>Sec.3.1 |
|------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Delivery<br>system | Oxygen<br>enrichment | Not available | Oxygen enrichment (30 L/min)<br>added | ISO 80601-2-<br>13:2011 Sec.<br>201. 101.8 |
| Safety/<br>Warning<br>system | Output failure<br>shutoff | When O2 output pressure is<br>much lower than N2O, Shut<br>Off Sensor will shut off the<br>device to prevent delivering a<br>hypoxic mixture. | "Output failure shutoff" function<br>removed to enable adjustable mixing<br>ratio.<br>Minimum 25% oxygen setting<br>prevents delivering a hypoxic<br>mixture. | ISO 11195:1995<br>Sec.11.1 |
| | Power failure<br>shutoff-<br>Nitrous oxide | If the Nitrous Oxide input<br>pressure drops to 35 PSI, the<br>Demand Valve and the Mixer<br>will be shut off. | "Nitrous oxide failure shutoff"<br>function removed.<br>When Nitrous Oxide input drops to<br>35 PSI, with low pressure N2O<br>alarm on, the proposed device<br>continues to operate with higher<br>oxygen output. If there is no N2O<br>input, the device will deliver 100%<br>oxygen. | ISO 11195:1995<br>Sec. 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).