(110 days)
Not Found
No
The device description and performance studies focus on mechanical control of vacuum flowrate using a knob and reservoir bag, with no mention of AI/ML terms or data-driven decision making.
No
The device is intended to control the vacuum flowrate for scavenging of waste analgesic gas, meaning it removes gas from the breathing circuit to the vacuum source. It does not treat or diagnose any medical condition, but rather manages waste gases from other equipment.
No
The device is described as controlling the vacuum flowrate for scavenging waste analgesic gas and removing waste gases, which are actions related to device operation and environmental control, not diagnosing a medical condition.
No
The device description clearly outlines physical components like a control knob and reservoir bag, indicating it is a hardware device with a mechanical function, 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 "control the vacuum flowrate for scavenging of waste analgesic gas." This is a function related to managing the environment around a patient during a medical procedure, not analyzing a sample taken from the human body.
- Device Description: The description details how the device connects to a breathing circuit and a vacuum source to remove waste gases. It does not mention any interaction with biological samples (blood, urine, tissue, etc.) or performing any diagnostic tests on such samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
- Using reagents or calibrators.
The device's function is purely related to managing waste gases during a medical procedure, which falls under the category of medical devices used for patient care and environmental control, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
Product codes (comma separated list FDA assigned to the subject device)
CBN
Device Description
The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient.
The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
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
healthcare professional / healthcare facility environment
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 test strategy for the Scavenger Plus included performance bench testing of the device characteristics, safety features, and control mechanism. The results of the testing demonstrated that the Scavenger Plus met all of the acceptance criteria for functional, operational, and performance characteristics and therefore there are no new questions of safety or efficacy related to the subject device.
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
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
March 5, 2023
Parker Hannifin Corporation Dylan Alu Regulatory Compliance Manager 245 Township Line Road Hatfield, Pennsylvania 19440
Re: K223452
Trade/Device Name: Nitronox Scavenger Plus Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-scavenging apparatus Regulatory Class: Class II Product Code: CBN Dated: February 1, 2023 Received: February 3, 2023
Dear Dylan Alu:
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
1
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 and Part 809); 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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, James J. Lee -S
James J. Lee, Ph.D. Director DHT1C: Division of 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) K223452
Device Name Nitronox® Scavenger Plus
Indications for Use (Describe)
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Parker Porter. The logo is divided into two sections. The left section is a black rectangle with the word "Parker" in white, bold letters. To the left of the word "Parker" is a white symbol that looks like a stylized "P". To the right of the black rectangle is the word "Porter" in black letters, separated from the word "Parker" by a thin yellow line.
SECTION 5
510K SUMMARY
5.1 Date of Submission
November 15, 2022
5.2 Sponsor
Parker Hannifin Corporation Precision Fluidics Division 245 Township Line Road Hatfield, PA 19440
Contact Person: Dylan Alu Phone: 215-660-8132 Email: Dylan.alu@parker.com
5.3 Subject Device
Name of Device: Nitronox® Scavenger Plus
Common or Usual Name: Scavenging apparatus
Classification Name: Gas scavenging apparatus
Regulatory Class: Class II, 21 CFR 868.5430
Product Code: CBN
5.4 Predicate Device
G. Dundas Passive Waste Gas Scavenger, K080039
This predicate has not been subject to a design-related recall.
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5.5 Device Description
The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient.
The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
5.6 Intended Use
The Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
5.7 Comparison of the Technological Characteristics with the Predicate Device
| Table 5-1: Proposed and Predicate Product Overview | ||||
|---|---|---|---|---|
| -- | -- | ----------------------------------------------------- | -- | -- |
| Product
Features | Subject Device
Parker Hannifin Corporation's
Scavenger Plus | Predicate Device
G. Dundas Co. Inc.'s
Passive Waste Gas Scavenger
K080039 | Comments |
|----------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Classification | Class II | Class II | Same |
| Product Code | CBN | CBN | Same |
| Regulation
Number | $$868.5430$ | $$868.5430$ | Same |
| Regulation
Name | Gas Scavenging Apparatus | Gas Scavenging Apparatus | Same |
| Intended Use | The Scavenger Plus is intended to
control the vacuum flowrate for
scavenging of waste analgesic
gas. | The Passive Waste Gas
Scavenger is intended to be used
for the scavenging of waste
anesthetic gases from anesthesia
machines used during the
provision of general anesthesia to
adults and children. | Same. Both devices are
intended for scavenging of
waste gas. |
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| Product
Features | Subject Device
Parker Hannifin Corporation's
Scavenger Plus | Predicate Device
G. Dundas Co. Inc.'s
Passive Waste Gas Scavenger
K080039 | Comments |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | The Scavenger Plus uses a
scavenging method that relies on
the gas in the manifold and
reservoir bag to create a system of
pressure between the entry side
and vacuum source. This pressure
balance allows for all of the gas
that enters the device manifold to
then be pulled through the device
to the connected vacuum source. | The Passive Waste Gas
Scavenger uses a scavenging
method that relies on the pressure
of the waste gas to transfer the
gas from the scavenger to the
vacuum source. | Similar. Both devices use a
scavenging method that
relies on control of
flow/pressure and a
connected vacuum source. |
| Functional
Characteristics | The waste gas enters the
Scavenger Plus through the
exhalation line of the connected
breathing circuit. The gas then
travels through the internal cavity
that connects the reservoir bag.
under-pressure valve, and over-
pressure valve. The gas remains
within the manifold and reservoir
bag. Gas is removed by the
connected vacuum source. | The inlet port is attached to the
ventilation system of the
anesthesia machine. During
operation, waste gases from the
patient are transferred into the
scavenger by the outlet pressure
supplied by the ventilator. The
gases will then travel through the
scavenger into a non-recirculating
exhaust system. | Similar. Waste gases from
the patient are transferred
into the scavenger and then
are removed from the
healthcare environment. |
| Pressure Limit | Under normal operating
conditions (75 L/min flow
through the inlet), the pressure
shall not exceed 3.0 cm H2O. | Under normal operating
conditions (75 L/min flow
through the inlet), the pressure
shall not exceed 3.0 cm H2O. | Same. Both devices meet
Section 201.103.1.1.1 of
ISO 80601-2-13, which
states that under normal
operating conditions (75
L/min flow through the
inlet), the pressure shall
not exceed 3.0 cm H2O. |
5.8 Non-clinical Performance Data
The test strategy for the Scavenger Plus included performance bench testing of the device characteristics, safety features, and control mechanism. The results of the testing demonstrated that the Scavenger Plus met all of the acceptance criteria for functional, operational, and performance characteristics and therefore there are no new questions of safety or efficacy related to the subject device.
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5.9 Clinical Data
The characteristics of the Scavenger Plus do not require clinical investigation due to safety and efficacy being supported by non-clinical testing performed. The verification and validation testing of the Scavenger Plus was found to be acceptable and supports the claims of substantial equivalence.
5.10 Substantial Equivalence Discussion
Both the subject device and predicate device have the same intended use, use environment and similar technological characteristics. Both devices are intended to be used to remove waste gas in a healthcare facility with an vacuum system. Both devices use valves to maintain the appropriate scavenging pressure to remove waste gas. Both devices have features for maintaining the scavenging pressure to ensure proper removal of waste gas. The main difference is that the subject device is used with analgesic gas, which has lower associated risks than the predicate device which uses anesthetic gas.
Conclusions 5.11
It has been shown in this 510(k) submission that the differences between the Scavenger Plus and the predicate device do not raise any new questions regarding safety and efficacy. The Scavenger Plus is determined to be substantially equivalent to the referenced predicate device.