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 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 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System. It is a regulatory document and does not contain details about a study to prove acceptance criteria or device performance in the way typically associated with AI/ML devices.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a common regulatory pathway for medical devices. This involves demonstrating that the new device is as safe and effective as a legally marketed device.

Therefore, many of the requested sections (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and are not present in the provided text.

However, I can extract the acceptance criteria as implied by the substantial equivalence comparison and the device's reported characteristics.

Here's the information that can be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a device like the Equinox Relieve®, "acceptance criteria" are generally derived from the specifications and performance of legally marketed predicate devices, along with relevant safety standards. The "reported device performance" is the device's design specifications and claimed capabilities that are compared to these in the context of substantial equivalence.

Characteristic	Acceptance Criteria (Implied from Predicates)	Reported Device Performance (Equinox Relieve®)
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.
Environments of Use	Emergency settings (Predicate K883833) / Pre-hospital and in-hospital environment (Predicate K991195)	Pre-hospital use and in-hospital environment (ER, Labor and Delivery etc.)
Patient Population	Spontaneous breathing patients requiring pain relief (Predicate K883833) / Spontaneous breathing patients (Predicate K991195)	Spontaneous breathing patients requiring relief from moderate to severe pain due to trauma, childbirth etc.
Operating Principles	Pneumatic, demand flow system.	Pneumatic, demand flow system.
Input Gas	O2 and N2O (Predicate K883833) / O2 (Predicate K991195 - Note: Predicate K991195 is for ventilatory support, not N2O mixing)	O2 and N2O.
Input Pressure	40 - 65 PSI (Predicate K883833) / 45 to 70 PSI (Predicate K991195)	50 to 70 PSI.
Built-in Mixer	Yes (Predicate K883833)	Yes.
Output Mixture Concentration	Preset 50/50% (V/V) N2O /O2 (Predicate K883833)	Preset 50/50% (V/V) N2O /O2.
Displays (Alarms)	Low input visual alarms for both O2 and N2O gases / O2 and N2O Mixture pressure gauge (Predicate K883833)	Low input visual alarms for both O2 and N2O gases (O2 and N2O).
Safety Features	Preset 50/50% N2O /O2; Activated only by patient inspiratory effort; CGA connection to prevent misconnection of gas supply; Audible alarm; Oxygen Fail Safe: Shut off mixer output if O2 pressure drops. (Predicate K883833)	Preset 50/50% N2O /O2; Activated only by patient inspiratory effort; CGA connection to prevent misconnection of gas supply; Audible & visual alarms; Oxygen Fail Safe: Shut off mixer output if O2 pressure drops; Input Gas Fail Safe: Shut off the device if supply of either N2O or O2 dropped below 35 PSI.
Alarms	Audible alarm triggered if N2O supply is depleted (Predicate K883833) / Audible/Visual (Green) alarms if O2 supply is below 40 PSI (Predicate K991195)	Audible/Visual (Red indicator) alarms if N2O input is below 40 PSI; Audible/Visual (Green indicator) alarms if O2 input is below 40 PSI; Audible alarm if device is shut off due to low O2 output.
Patient Support Mode	Demand valve.	Demand valve.
Demand Valve Function	Realized by extended handheld supply valve (Predicate K883833) / Built-in (Predicate K991195)	Built-in.
Peak Flow on Demand (L/min)	140 (Predicate K883833) / 120 minimum (Predicate K991195)	120 minimum.
Materials in Gas Pathway	Compatible with O2 & N2O (Implied from K883833)	Compatible with O2 & N2O.

Study Proving Acceptance Criteria:

The document describes a "comparative table" which is the primary evidence used to demonstrate substantial equivalence, rather than a stand-alone clinical study with explicit acceptance criteria and statistical analysis. The "study" here is essentially the comparison of the proposed device's specifications and features against those of the predicate devices. The conclusion presented is: "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. This is not a study involving patient data or a test set in the conventional sense. The "test set" is the proposed device's design specifications.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The ground truth, in the context of substantial equivalence, is established by the performance and safety characteristics of the legally marketed predicate devices, which have already undergone regulatory review. There is no mention of external experts establishing a ground truth for a test set for this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication process is described for a test set. The FDA's review process serves as the adjudication for the substantial equivalence claim.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is common for diagnostic imaging AI, but not for a physical device like a gas mixing and delivery system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical device, not an algorithm. Its operation is standalone in the sense that it functions automatically based on patient inspiratory effort, but this isn't analogous to "standalone algorithm performance" as typically discussed in AI/ML medical devices.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices (Nitronox® K883833 and CAREvent ALS+ K991195). The substantial equivalence pathway relies on demonstrating that the new device is "as safe and effective" as these known devices, based on their design, indications, and performance characteristics.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that uses a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/ML device.

Summary

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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

Page 5.1

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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.)

Page 5.2

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

Comparative table:

. : .

Characteristic	ProposedEquinox Relieve®	PredicateK883833 Nitronox®	PredicateK991195 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
Environmentsof use	Pre-hospital use and in-hospital environment	Emergency settings	Pre-hospital and in-hospital environment
Patientpopulation	Spontaneous breathing patients requiring pain relief	Spontaneous breathing patients requiring pain relief	Non-breathing patients requiring ventilatory support;Spontaneous breathing patients
Operatingprinciples	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,preferably 50 -55 PSI	45 to 70 PSI
Built-in Mixer	Yes	Yes	N/A
Output mixtureconcentration	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 N2Ogases (O2 and N2O)	O2 and N2O Mixture pressure gauge	Airway pressure gauge;Low input visual alarm
Safety features	- Preset 50/50% N2O /O2;- Activated only by patientinspiratory effort;- CGA connection to preventmisconnection of gas supply- Audible & visual alarms- Oxygen Fail Safe: Shut offmixer output if O2 pressuredrops- Input Gas Fail Safe: Shut offthe device if supply of eitherN2O or O2 dropped below 35PSI	- Preset 50/50% N2O /O2;- Activated only by patientinspiratory effort;- CGA connection to preventmisconnection of gas supply- Audible alarm;- Oxygen Fail Safe: Shut offmixer output if O2 pressuredrops	- Demand valve activated onlyby patient inspiratory effort;- CGA connection to preventmisconnection of gas supply;- Audible & visual alarm- Air way Pressure-relief
Alarms	- Audible/Visual (Redindicator) alarms if N2O inputis below 40 PSI;- Audible/Visual (Greenindicator) alarms if O2 input isbelow 40 PSI- Audible alarm if device isshut off due to low O2 output	- Audible alarm triggered ifN2O supply is depleted	- Audible/Visual (Green)alarms if O2 supply is below40 PSI;- Maximum Pressure-relief- 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;- Disposable patient circuit with 30 mm Scavenging port;- Oxygen supply hose;- Nitrous Oxide supply hose	- Adult PVC Face Mask;- Supply Valve & Supply Valve Hose;- Oxygen supply hose;- Nitrous Oxide Cylinder	- Universal PVC Face Mask;- Disposable patient circuit with 30 mm Scavenging port;- 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 (800) 638-2041 or (301) 796-7100 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:

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

Page 4.2

Regulation Number and Section

§ 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).