(237 days)
Not Found
No
The device description focuses on a pneumatic system for gas delivery with mechanical and pressure-based safety features. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to provide analgesia (pain relief) by delivering a mixture of N2O/O2 to a patient, which is a therapeutic effect.
No
The Nitronox Plus is described as an analgesia system used to deliver a mixture of nitrous oxide and oxygen gases. Its "Intended Use / Indications for Use" section states it is "intended to provide a mixture of N20/02, on demand," and the "Device Description" elaborates on its function as a delivery system. There is no mention of diagnostic capabilities, such as detecting, identifying, or monitoring a disease or condition.
No
The device description clearly outlines a pneumatic system with physical components like regulators, gauges, hoses, and a demand valve, indicating it is a hardware device that delivers gas.
Based on the provided information, the Nitronox Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Nitronox Plus Function: The Nitronox Plus is a device that delivers a mixture of gases (nitrous oxide and oxygen) directly to a patient for pain relief (analgesia). It is used on the patient ("in vivo") and does not involve testing bodily specimens.
The description clearly states its purpose is to provide a gas mixture for inhalation by a conscious, spontaneously breathing patient. This is a therapeutic or supportive medical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
Product codes
BZR
Device Description
The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. The device is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates. It is only for use in a healthcare setting by healthcare professionals. The Nitronox Plus is available in three models which differ only in adjustability and maximum ratio of nitrous oxide that can be delivered. The Nitronox Plus features a 0-70% N2O adjustable model, 0-50% N2O adjustable model, and 50% N2O/50% O2 fixed model.
The Nitronox Plus is a pneumatic system. Oxygen and nitrous oxide are supplied to the device through flexible hoses. Inlet gas is regulated and equalized through the use of an oxygen piloted dual diaphragm regulator. The inlet pressure of both gases and the mixed gas pressure are displayed on the front panel of the device through the use of pressure gauges. The device is designed to function with a medical breathing circuit and face mask or mouthpiece accessory.
Delivery of mixed gas starts with a patient's demand; upon inhalation through a face mask or mouthpiece, a demand valve opens and supplies mixed gas to the patient through the connected Medical Breathing Circuit. In adjustable models, the healthcare professional is able to set the desired concentration through the use of a control knob on the front panel. Mixed gas is supplied through the breathing circuit until inhalation ceases.
The Nitronox Plus contains several safety features. Pneumatically powered alarms for both gas inlets alert the user when either gas supply begins to deplete. The device will also maintain delivery of the set concentration with depleting oxygen pressure. Once the oxygen pressure drops below a certain threshold, the device will allow ambient air to be delivered through an Emergency Air Intake valve. The device also features a key lock to control the nitrous oxide gas supply, allowing healthcare professionals to prevent unauthorized use of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gas is to be inhaled through the mouth and nose region.
Indicated Patient Age Range
Adult and pediatric patients. Not intended to be used with infants or neonates.
Intended User / Care Setting
To be used by healthcare professionals in a healthcare setting.
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)
The results of performance testing demonstrate that the Nitronox Plus meets all design input requirements, including functional, operational, and performance requirements. Performance testing was conducted to verify performance characteristics, safety features, capabilities compared to the predicate device, and biocompatibility; validate reprocessing activities; and ensure usability of the device to meet patient needs when used as intended. The results of the performance testing support the conclusion that the subject device is substantially equivalent to the predicate device.
Risk management processes were applied throughout product development. Results of the comprehensive risk analysis conclude that the benefits associated with the design modifications for new and enhanced safety systems exceed any residual risk. The remaining risks are acceptable when weighed against the benefits provided to patients when using the device. None of the residual risks outweigh the benefits of using the Nitronox Plus system for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nitronox Pre-Set 50/50 Nitrous Oxide/Oxygen Gas Mixer (K760766)
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 22, 2021
Parker Hannifin % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K202480
Trade/Device Name: Nitronox Plus Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing gas mixer Regulatory Class: Class II Product Code: BZR Dated: August 26, 2020 Received: August 28, 2020
Dear Dave Yungvirt:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202480
Device Name Nitronox Plus
Indications for Use (Describe)
The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
| 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)
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3
న్. 510(k) Summary
Parker Hannifin Nitronox Plus (per 21CFR 807.92)
5.1. Submitter/510(k) Holder
| Parker Hannifin Corporation
Precision Fluidics Division
245 Township Line Road
Hatfield, Pennsylvania 19440
Phone: 215-723-4000 | Contact: Andrew Ellinger,
Product Development Engineer
Contact Phone: 215-660-8175
Contact Email: andrew.ellinger@parker.com
Date Prepared: May 1, 2020 |
| --------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
5.2. Device Name
| Proprietary Name: | Nitronox Plus |
|---|---|
| Common Name: | Breathing gas mixer |
| Classification Name: | Mixer, breathing gases, anesthesia inhalation |
| Classification Regulation: | 21 CFR 868.5330 |
| Classification Panel: | Anesthesiology |
| Product Code: | BZR |
| Device Class: | Class II |
5.3. Predicate Device
Nitronox Pre-Set 50/50 Nitrous Oxide/Oxygen Gas Mixer (K760766)
5.4. Device Description
The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. The device is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates. It is only for use in a healthcare setting by healthcare professionals. The Nitronox Plus is available in three models which differ only in adjustability and maximum ratio of nitrous oxide that can be delivered. The Nitronox Plus features a 0-70% N2O adjustable model, 0-50% N2O adjustable model, and 50% N2O/50% O2 fixed model.
The Nitronox Plus is a pneumatic system. Oxygen and nitrous oxide are supplied to the device through flexible hoses. Inlet gas is regulated and equalized through the use of an oxygen piloted dual diaphragm regulator. The inlet pressure of both gases and the mixed gas pressure are displayed on the front panel of the device through the use of pressure gauges. The device is designed to function with a medical breathing circuit and face mask or mouthpiece accessory.
4
Delivery of mixed gas starts with a patient's demand; upon inhalation through a face mask or mouthpiece, a demand valve opens and supplies mixed gas to the patient through the connected Medical Breathing Circuit. In adjustable models, the healthcare professional is able to set the desired concentration through the use of a control knob on the front panel. Mixed gas is supplied through the breathing circuit until inhalation ceases.
The Nitronox Plus contains several safety features. Pneumatically powered alarms for both gas inlets alert the user when either gas supply begins to deplete. The device will also maintain delivery of the set concentration with depleting oxygen pressure. Once the oxygen pressure drops below a certain threshold, the device will allow ambient air to be delivered through an Emergency Air Intake valve. The device also features a key lock to control the nitrous oxide gas supply, allowing healthcare professionals to prevent unauthorized use of the device.
5.5. Indications for Use
The Nitronox Plus is intended to provide a mixture of N20/O2, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
The Indications for Use statement for the Nitronox Plus is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device. Modifications made to enhance gas delivery functionality do not significantly change the key functional technology and operational characteristics of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are intended to deliver mixtures of N20/02, on demand, to a conscious, spontaneously breathing patient.
Summary of Technological Characteristics Compared to the Predicate Device 5.6.
The Nitronox Plus (subject device) is a redesigned version of the Nitronox HD originally cleared by FDA under submission K760766 (predicate device). The key technological characteristics of the Nitronox Plus are based on well-established technology that uses springs, diaphragms, valves, orifices, and other pneumatic mechanisms to regulate the pressure and flow of gases. The subject device is similar to the predicate device regarding:
- Force-balancing system consisting of diaphragms, springs, and poppet valves ●
- Gas mixing through tapered valve stems and orifices ●
- Pneumatic "whistle" alarms
- Bourdon tube gauges ●
- Demand valve to only deliver gas upon patient inhalation
5
The major technological differences between the subject device and predicate device include:
- Adjustable mixture ratio .
- . Low inlet pressure alarms
- Emergency air intake valve .
- . Key lock feature
A summary comparison of the subject and predicate devices is provided below:
| Characteristic | Subject:
Nitronox Plus | Predicate:
Nitronox (K760766) | Comparison |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended Use | Provide a mixture of N2O/O2, on
demand, to a conscious,
spontaneously breathing patient. The
Nitronox Plus is designed for use
with adult and pediatric patients and
is not intended to be used with
infants or neonates. | Provide 50/50% N2O/O2 mixture, on
demand, to a conscious,
spontaneously breathing patient. | Similar |
| Target
Population | Adult and pediatric patients. Not
intended to be used with infants or
neonates | Spontaneous breathing patients
requiring pain relief. | Similar |
| Prescription or
Over-the-
Counter Use | Prescription Use | Prescription Use | Same |
| Anatomical Site | Gas is to be inhaled through the
mouth and nose region. | Gas is to be inhaled through the
mouth and nose region. | Same |
| Where used | To be used by healthcare
professionals in a healthcare setting. | Dentistry, Emergency Departments,
Ambulances, Obstetrics,
Physiotherapy. Nursing. Specialist
Procedures, and Podiatry. | Similar |
| Operating
principle | Pneumatic, demand flow system. | Pneumatic, demand flow system. | Same |
| Energy used | Compressed oxygen/nitrous oxide
gas. | Compressed oxygen/nitrous oxide
gas. | Same |
| Energy
delivered | Low pressure mixed gas. | Low pressure mixed gas. | Same |
| Gas input
pressure | 45-60 psi. | 45-60 psi. | Same |
| Gas regulation
mechanism | Oxygen Piloted Regulator with dual
diaphragms. | Oxygen Piloted Regulator with dual
diaphragms. | Same |
| Gas delivery | Proportional to patient's demand. | Proportional to patient's demand. | Same |
| Gas mixing | Oxygen and nitrous oxide are
equalized and mixed at variable
ratios. | Oxygen and nitrous oxide are
equalized and mixed at a fixed 50%
ratio. | Different |
| Alarms | Audible alarm sounds when:
- N2O input is below 35 psi;
- O2 input is below 35 psi. | Audible alarm is triggered if oxygen
mixture pressure rises above 40 psi. | Different |
| Security feature | Key Lock allows healthcare
provider to turn device ON/OFF; in
the "OFF" position device will not
deliver nitrous oxide gas; with the
key turned in the "ON" position,
mixed gas can be supplied. | None. | New Feature |
| Characteristic | Subject:
Nitronox Plus | Predicate:
Nitronox (K760766) | Comparison |
| Accessories | - Medical Breathing Circuit; - Face mask;
- Mouth Piece;
- Oxygen & nitrous oxide supply
hose; - Oxygen & nitrous oxide;
- E-stand mobile cart;
- Two Cylinder Cart;
- Wall arm mount; | - Medical Breathing Circuit;
- Face mask;
- Mouth Piece;
- Oxygen & nitrous oxide supply
hose; - Oxygen & nitrous oxide;
- E-stand mobile cart;
- Two Cylinder Cart;
- Wall arm mount; | Same |
| Pressure
regulation | Force-balanced system of
diaphragms/poppets/springs | Force-balanced system of
diaphragms/poppets/springs | Same |
| Gas mixing
mechanism | Adjustable dual stem/orifice | Factory set dual stem/orifice | Different |
| Demand
mechanism | Demand Valve | Demand Valve | Same |
| Gauge type | Bourdon Tube | Bourdon Tube | Same |
| Alarm type | Pneumatic whistle | Pneumatic whistle | Same |
| Safety Features | O2 Piloted System: Shut off mixer
output if O2 pressure drops. | O2 Piloted System: Shut off mixer
output if O2 pressure drops. | Same |
| | DISS fittings to prevent
misconnection of gas supply. | DISS fittings to prevent
misconnection of gas supply. | Same |
| | Activated only via patient
inspiratory effort (self-
administration principle). | Activated only via patient
inspiratory effort (self-
administration principle). | Same |
| | In the event of N2O supply failure,
100% O2 will be supplied. | In the event of N2O supply failure,
100% O2 will be supplied. | Same |
| | Dual diaphragms prevent reverse
gas flow between supplies. | Dual diaphragms prevent reverse
gas flow between supplies. | Same |
| | Audible alarm for low inlet pressure. | Audible alarm for increased mix
pressure. | Different |
| | Emergency Air Intake Valve, if O2
pressure is lost patient can breathe
ambient air. | None. | New Feature |
| | Key lock system prevents
unauthorized use of device. | None. | New Feature |
Side-by-Side Comparison of the Subject and Predicate Devices
6
Summary of Non-clinical Performance Testing as Basis for Substantial 5.7. Equivalence
The results of performance testing demonstrate that the Nitronox Plus meets all design input requirements, including functional, operational, and performance requirements. Performance testing was conducted to verify performance characteristics, safety features, capabilities compared to the predicate device, and biocompatibility; validate reprocessing activities; and ensure usability of the device to meet patient needs when used as intended. The results of the performance testing support the conclusion that the subject device is substantially equivalent to the predicate device.
Risk management processes were applied throughout product development. Results of the comprehensive risk analysis conclude that the benefits associated with the design modifications for new and enhanced safety systems exceed any residual risk. The remaining risks are acceptable when weighed against the benefits provided to patients when using the device. None of the residual risks outweigh the benefits of using the Nitronox Plus system for its intended use.
7
5.8. Conclusions
The indications for use, principles of operation, and technological characteristics of the subject device are similar to the predicate device. Differences between the subject and predicate devices are limited to minor differences in the technology used to adjust the mixture ratio, triggering conditions of audible alarms, and addition of the emergency air intake and key lock safety features. Performance testing supports the conclusion that the subject device is as safe and effective as the predicate device, and therefore the two devices are substantially equivalent.