EQUINOX RELIEVE

K113687 · O-Two Medical Technologies, Inc. · BZR · Apr 30, 2012 · Anesthesiology

Device Facts

• Record ID: K113687
• Device Name: EQUINOX RELIEVE
• Applicant: O-Two Medical Technologies, Inc.
• Product Code: BZR · Anesthesiology
• Decision Date: Apr 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.

Device Story

Equinox Relieve® is a portable, pneumatically powered gas mixing/delivery system. It connects to nitrous oxide and oxygen cylinders via pressure regulators. Device operation is triggered by patient inspiratory effort, delivering a fixed 50/50% N2O/O2 mixture on demand. Used in pre-hospital (ambulance) and in-hospital (ER, Labor and Delivery) settings by medical personnel. Features include a built-in mixer, visual/audible alarms for low input pressure (<40 PSI), and automatic shut-off if input pressure drops below 35 PSI or if internal malfunctions/hose ruptures occur. The system prevents hypoxic mixtures by design. Healthcare providers monitor the patient and the device's visual indicators; the output provides analgesic relief, improving patient comfort during painful procedures or trauma.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, design specifications, and comparison of technological characteristics to predicate devices.

Technological Characteristics

Pneumatic, demand-flow system. Materials compatible with O2 and N2O. Dimensions/form factor: portable. Energy source: pneumatic (gas pressure 50-70 PSI). Connectivity: none. Sterilization: not specified (disposable patient circuit/mask). Safety features: CGA gas-specific connections, mechanical fail-safe shut-off, audible/visual alarms for low pressure.

Indications for Use

Indicated for conscious, spontaneously breathing patients requiring relief from moderate to severe pain (e.g., trauma, childbirth). Contraindicated in patients with hypersensitivity to medication, head injuries with impaired consciousness, maxillofacial injuries, pneumothorax, 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

• Nitronox® (K883833)
• CAREvent ALS+ (K991195)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 - 510(k) Summary

Equinox Relieve®

# K113687

### Non-Confidential Summary of Safety and Effectiveness

O-Two Medical Technologies 7575 Kimbel St. Mississauga, Ontario L5S1C8 Canada Tel - 905-677-9410

Official Contact: David Zhang Application Date: 8-Dec-11 Equinox Relieve® Proprietary or Trade Name: Common/Usual Name: Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System Classification Name: · Breathing Gas Mixer (21 CFR 868.5330, product code: BZR) and Ventilator, emergency, powered (21 CFR 868.5925, product code: BTL) Device Class: Class II Classification Panel: Anesthesiology Predicate Devices: Nitronox® · Manufactured by Matrix Medica Inc. • 510(k) number K883833

CAREvent ALS+

- · Manufactured by O-Two Medical Technologies Inc.
- · 510(k) number K991195

#### Device Description:

The proposed Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture.

The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N20/02 gas mixture will only be activated by an

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Premarket Notification 510(k) Section 5 - 510(k) Summary

inspiratory effort by the patient. The out put of N20/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.

The gas specific built-in alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will automatically shut off should either nitrous oxide or oxygen input fall below 35 PSL

The device is also equipped with a secondary "fail safe" circuit that will activate an alarm and shut off the device should internal malfunction occur in the mixer or any internal hoses rupture or kink.

The main accessories for the proposed device are a disposable Patient Circuit and a universal Face Mask.

### Indications for Use;

The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%' 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.

### Patient Population:

Spontaneous breathing patients requiring relief from moderate to severe pain due to trauma, childbirth etc.

Contraindications:

- Hypersensitivity to the medication .
- 4 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 poeumothorax 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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### Premarket Notification 510(k) Section 5 - 510(k) Summary

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### Comparative table:

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| Characteristic | Proposed<br>Equinox Relieve® | Predicate<br>K883833 Nitronox® | Predicate<br>K991195 CAREvent ALS+ |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Provide 50/50% N2O/O2 mixture, on demand, to a conscious, spontaneously breathing patient for the relief of pain | Provide 50/50% N2O/O2 mixture, on demand, to a conscious, spontaneously breathing patient for the relief of pain | Provide ventilatory support to non-breathing patient as well as "Demand Breathe" to spontaneously breathing patient |
| Environments<br>of use | Pre-hospital use and in-hospital environment | Emergency settings | Pre-hospital and in-hospital environment |
| Patient<br>population | Spontaneous breathing patients requiring pain relief | Spontaneous breathing patients requiring pain relief | Non-breathing patients requiring ventilatory support;<br>Spontaneous breathing patients |
| Operating<br>principles | Pneumatic, demand flow system | Pneumatic, demand flow system | Pneumatic, time/volume cycled, demand flow system |
| Input gas | O2 and N2O | O2 and N2O | O2 |
| Input pressure | 50 to 70 PSI | 40 - 65 PSI,<br>preferably 50 -55 PSI | 45 to 70 PSI |
| Built-in Mixer | Yes | Yes | N/A |
| Output mixture<br>concentration | Preset 50/50% (V/V) N2O /O2 | Preset 50/50% (V/V) N2O/O2 | O2 only |
| Displays | Low input visual alarms for both O2 and N2O<br>gases (O2 and N2O) | O2 and N2O Mixture pressure gauge | Airway pressure gauge;<br>Low input visual alarm |
| Safety features | - Preset 50/50% N2O /O2;<br>- Activated only by patient<br>inspiratory effort;<br>- CGA connection to prevent<br>misconnection of gas supply<br>- Audible & visual alarms<br>- Oxygen Fail Safe: Shut off<br>mixer output if O2 pressure<br>drops<br>- Input Gas Fail Safe: Shut off<br>the device if supply of either<br>N2O or O2 dropped below 35<br>PSI | - Preset 50/50% N2O /O2;<br>- Activated only by patient<br>inspiratory effort;<br>- CGA connection to prevent<br>misconnection of gas supply<br>- Audible alarm;<br>- Oxygen Fail Safe: Shut off<br>mixer output if O2 pressure<br>drops | - Demand valve activated only<br>by patient inspiratory effort;<br>- CGA connection to prevent<br>misconnection of gas supply;<br>- Audible & visual alarm<br>- Air way Pressure-relief |
| Alarms | - Audible/Visual (Red<br>indicator) alarms if N2O input<br>is below 40 PSI;<br>- Audible/Visual (Green<br>indicator) alarms if O2 input is<br>below 40 PSI<br>- Audible alarm if device is<br>shut off due to low O2 output | - Audible alarm triggered if<br>N2O supply is depleted | - Audible/Visual (Green)<br>alarms if O2 supply is below<br>40 PSI;<br>- Maximum Pressure-relief<br>- Audible alarm |
| Patient support mode | Demand valve | Demand valve | IMV, Demand valve |
| Demand Valve function | Built-in | Realized by extended handheld supply valve | Built-in |
| Peak Flow on Demand (L/min) | 120 minimum | 140 | 120 minimum |
| Materials in gas pathway | Compatible with O2 & N2O | Unknown | Compatible with O2 |
| Accessories | - Universal PVC Face Mask;<br>- Disposable patient circuit with 30 mm Scavenging port;<br>- Oxygen supply hose;<br>- Nitrous Oxide supply hose | - Adult PVC Face Mask;<br>- Supply Valve & Supply Valve Hose;<br>- Oxygen supply hose;<br>- Nitrous Oxide Cylinder | - Universal PVC Face Mask;<br>- Disposable patient circuit with 30 mm Scavenging port;<br>- Oxygen supply hose |

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Premarket Notification 510(k) Section 5 – 510(k) Summary

# Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate devices, K883833 and K991195.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. David Zhang Quality Assurance Manager O-Two Medical Technologies 7575 Kimbel Street Mississauga CANADA L5S 1C8

APR 3 0 2012

Re: K113687

Trade/Device Name: Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System

Regulation Number: 21 CFR 868.5330

Regulation Name: Breathing Gas Mixer

Regulatory Class: II

Product Code: BZR Dated: March 22, 2012 Received: April 2, 2012

Dear Mr. 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. 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.

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Page 2 - Mr. Zhang

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hn for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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## Indications for Use Statement

Page __ of _

510(k) Number:

K113687 (To be assigned)

Device Name:

Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System

Indications for Use:

The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.

Prescription Use_Y (21 CFR 801 Subpart C) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

and there

Copeurrence of CDRH, Office of Device Evaluation (ODE) 1 - Ox

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 113 687

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