(331 days)
Not Found
No
The description focuses on pneumatic and mechanical controls for gas mixing and delivery, with no mention of AI or ML algorithms for decision-making, control, or analysis.
Yes.
The device is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen for pain relief, which is a therapeutic purpose.
No
The device is described as an analgesic gas mixing and delivery system for administering nitrous oxide and oxygen to provide pain relief. It does not gather information from the patient's body to identify or monitor a medical condition, disease, or injury.
No
The device description clearly outlines a physical, pneumatically powered device with input connections, control knobs, and a built-in alarm system, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is used to administer a gas mixture directly to a patient for pain relief. It does not involve the analysis of any biological specimens.
The device is a therapeutic device used for pain management, not a diagnostic device used for testing samples.
N/A
Intended Use / 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.
Product codes
BZR
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.
A selection knob is used to select desired N2O/O2 gas mixture. The adjustable range is from 25% O2 (N2O 75%) to 100% O2 (N2O 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: Pre-hospital (ambulance) use and in-hospital use (ER. Labor and Delivery etc.)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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.)
5
| Characteristic | Proposed
Equinox® Advantage | Predicate K113687
Equinox® Relieve | Substantial
Equivalence |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | Administer an adjustable mixture of
N2O/O2, on demand, to a conscious,
spontaneously breathing patient | Administer 50/50% N2O/O2 mixture, on
demand, to a conscious, spontaneously
breathing patient | Equivalent |
| Environments
of use | Pre-hospital use and in-hospital
environment | Pre-hospital use and in-hospital
environment | Yes |
| Patient
population | Conscious, spontaneous breathing
patients requiring pain relief | Conscious, spontaneous breathing
patients requiring pain relief | Yes |
| Contra-
Indications | 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 | 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 | Yes |
Comparative table - Intended use:
Comparative table - Operating principle:
| Characteristic | Proposed
Equinox® Advantage | Predicate K113687
Equinox® Relieve | Substantial
Equivalence |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Gas input and
regulating | 50- 70 PSI Oxygen and Nitrous Oxide
regulated by internal regulators | 50- 70 PSI Oxygen and Nitrous Oxide
stabilized by internal regulators | Yes |
| Gas mixing | Oxygen and Nitrous Oxide are
equalized and mixed at variable ratios | Oxygen and Nitrous Oxide are
equalized and mixed at 1:1 ratio | Similar-
(mixing ratio is
adjustable) |
| Gas delivery | Gas mixture delivery is proportional to
patient's demand. | Gas mixture delivery is proportional to
patient's demand. | Yes |
| Monitoring
and alarms | The input pressure from each gas input
is measured by pressure sensors and
Audible/Visual alarms activated should:
- N2O input is below 40 PSI;
- O2 input is below 40 PSI | The input pressure from each gas input
is measured by pressure sensors and
Audible/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,
the protection circuit will shut off
the device: | 1.
In the event of O2 supply failure,
the protection circuit will shut off
the device: | Yes |
| | 2.
In the event of N2O supply failure,
Oxygen will be supplied as per ISO
11195:1995 Sec.12.4 | 2.
In the event of N2O supply failure,
the protection circuit will shut off
the device | Similar-
(Modification
made as per ISO
11195 Sec.12.4) |
6
Comparative table- Materials
| Materials | Proposed
Equinox® Advantage | Predicate K113687
Equinox® Relieve | Substantial
Equivalence |
|---------------|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------|
| Metal parts | Brass-Nickel plated, Anodized
Aluminum, Stainless Steel | Brass-Nickel plated, Anodized
Aluminum, 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 | Proposed
Equinox® Advantage | Predicate K113687
Equinox® Relieve | Substantial
Equivalence |
|-----------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Safety features | - CGA gas specific connection to prevent
misconnection of gas supply; | - CGA gas specific connection to prevent
misconnection of gas supply; | Yes |
| | - Activated only by patient inspiratory
effort; | - Activated only by patient inspiratory
effort; | Yes |
| | - Audible & visual alarms; | - Audible & visual alarms; | Yes |
| | - Input Gas Fail Safe: Shut off the device
if supply of O2 dropped below 35 PSI | - Input Gas Fail Safe: Shut off the device
if supply of either N2O or O2 dropped
below 35 PSI | Similar-
(Modification
made as per ISO
11195 Sec.12.4) |
Comparative table- Technological characteristics/specifications of performance
| Characteristic | Proposed
Equinox® Advantage | Predicate K113687
Equinox® Relieve | Substantial
Equivalence |
|---------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Input gas | O2 and N2O | O2 and N2O | Yes |
| Input pressure | 50 to 70 PSI | 50 to 70 PSI | Yes |
| Output mixture
concentration | Adjustable Oxygen: 25%-100% | Preset 50/50% (V/V) O2 / N2O | Equivalent-
(mixing ratio is
adjustable) |
| Oxygen
Enrichment | 30 L/min oxygen | Not available | New feature |
| Alarms | Low input audible and visual alarms
for both gases if either or both inputs
dropped below 40 PSI | Low input audible and visual alarms
for both gases if either or both inputs
dropped below 40 PSI | Yes |
7
| 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 |
8
| Mixing
system | Gas mixing
ratio | Fixed (Oxygen 50%) | Modified to adjustable mixing ratio
(Oxygen 25% - 100%) | ISO 11195:1995
Sec.3.1 |
|------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Delivery
system | Oxygen
enrichment | Not available | Oxygen enrichment (30 L/min)
added | ISO 80601-2-
13:2011 Sec.
201. 101.8 |
| Safety/
Warning
system | Output failure
shutoff | When O2 output pressure is
much lower than N2O, Shut
Off Sensor will shut off the
device to prevent delivering a
hypoxic mixture. | "Output failure shutoff" function
removed to enable adjustable mixing
ratio.
Minimum 25% oxygen setting
prevents delivering a hypoxic
mixture. | ISO 11195:1995
Sec.11.1 |
| | Power failure
shutoff-
Nitrous oxide | If the Nitrous Oxide input
pressure drops to 35 PSI, the
Demand Valve and the Mixer
will be shut off. | "Nitrous oxide failure shutoff"
function removed.
When Nitrous Oxide input drops to
35 PSI, with low pressure N2O
alarm on, the proposed device
continues to operate with higher
oxygen output. If there is no N2O
input, the device will deliver 100%
oxygen. | ISO 11195:1995
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:
9
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).