(137 days)
Not Found
No
The description details a purely pneumatic and mechanical system with pre-set parameters and pressure-based alarms and shut-offs. There is no mention of any computational elements, learning algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient, primarily for analgesic purposes, which is a therapeutic intervention.
No
The device is used for delivering a mixture of nitrous oxide and oxygen for analgesic purposes, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical, pneumatically powered system with gas inputs, regulators, controls, alarms, and accessories like a patient circuit and face mask. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver a gas mixture (nitrous oxide and oxygen) to a patient for analgesia. This is a therapeutic and delivery function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device mixes and delivers gases based on patient inspiration and monitors gas pressures. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample handling, or analysis of biological markers.
Therefore, the Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a medical device for gas delivery and analgesia, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZR
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
Premarket Notification 510(k) Section 5 - 510(k) Summary
.
Comparative table:
. : .
"
| Characteristic | Proposed
Equinox Relieve® | Predicate
K883833 Nitronox® | Predicate
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
of use | Pre-hospital use and in-hospital environment | Emergency settings | Pre-hospital and in-hospital environment |
| Patient
population | Spontaneous breathing patients requiring pain relief | Spontaneous breathing patients requiring pain relief | Non-breathing patients requiring ventilatory support;
Spontaneous breathing patients |
| Operating
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,
preferably 50 -55 PSI | 45 to 70 PSI |
| Built-in Mixer | Yes | Yes | N/A |
| Output mixture
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
gases (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 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 | - 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 | - Demand valve activated only
by patient inspiratory effort; - CGA connection to prevent
misconnection of gas supply; - Audible & visual alarm
- Air way Pressure-relief |
| Alarms | - 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 | - Audible alarm triggered if
N2O supply is depleted | - Audible/Visual (Green)
alarms if O2 supply is below
40 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 |
3
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.
4
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.
5
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
6
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
Page 4.2