Nitronox Scavenger Plus
Device Facts
| Record ID | K223452 |
|---|---|
| Device Name | Nitronox Scavenger Plus |
| Applicant | Parker Hannifin Corporation |
| Product Code | CBN · Anesthesiology |
| Decision Date | Mar 5, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5430 |
| Device Class | Class 2 |
Indications for Use
The Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
Device Story
Device connects patient exhalation line to vacuum source; controls vacuum flowrate for waste analgesic gas scavenging. Operated by licensed healthcare professional during conscious sedation. Uses control knob and reservoir bag to limit vacuum applied to breathing circuit; maintains pressure balance between manifold and vacuum source. Prevents excessive vacuum via under-pressure and over-pressure valves. Output is removal of waste gas from healthcare environment. Benefits patient by reducing exposure to waste analgesic gases.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical performance bench testing, including functional, operational, and safety feature verification.
Technological Characteristics
Gas scavenging apparatus; mechanical flow/pressure control. Features manifold, reservoir bag, under-pressure valve, and over-pressure valve. Dimensions/materials not specified. Connectivity: connects to external vacuum source. Complies with ISO 80601-2-13 (pressure limit < 3.0 cm H2O at 75 L/min flow).
Indications for Use
Indicated for use in dental or medical procedures in healthcare facilities to control vacuum flowrate for scavenging waste analgesic gas during conscious sedation. Not intended for general anesthesia.
Regulatory Classification
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.
Predicate Devices
- G. Dundas Passive Waste Gas Scavenger (K080039)
Submission Summary (Full Text)
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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
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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
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# 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<br>Features | Subject Device<br>Parker Hannifin Corporation's<br>Scavenger Plus | Predicate Device<br>G. Dundas Co. Inc.'s<br>Passive Waste Gas Scavenger<br>K080039 | Comments |
|----------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Classification | Class II | Class II | Same |
| Product Code | CBN | CBN | Same |
| Regulation<br>Number | $$868.5430$ | $$868.5430$ | Same |
| Regulation<br>Name | Gas Scavenging Apparatus | Gas Scavenging Apparatus | Same |
| Intended Use | The Scavenger Plus is intended to<br>control the vacuum flowrate for<br>scavenging of waste analgesic<br>gas. | The Passive Waste Gas<br>Scavenger is intended to be used<br>for the scavenging of waste<br>anesthetic gases from anesthesia<br>machines used during the<br>provision of general anesthesia to<br>adults and children. | Same. Both devices are<br>intended for scavenging of<br>waste gas. |
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Image /page/5/Picture/0 description: The image shows the logo for Parker Porter. The logo consists of the word "Parker" in white letters on a black background, with a horizontal line extending from the left side of the "P". A yellow vertical line separates "Parker" from "Porter", which is written in black letters on a white background. The logo is simple and modern, with a clear contrast between the black and white elements.
| Product<br>Features | Subject Device<br>Parker Hannifin Corporation's<br>Scavenger Plus | Predicate Device<br>G. Dundas Co. Inc.'s<br>Passive Waste Gas Scavenger<br>K080039 | Comments |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | The Scavenger Plus uses a<br>scavenging method that relies on<br>the gas in the manifold and<br>reservoir bag to create a system of<br>pressure between the entry side<br>and vacuum source. This pressure<br>balance allows for all of the gas<br>that enters the device manifold to<br>then be pulled through the device<br>to the connected vacuum source. | The Passive Waste Gas<br>Scavenger uses a scavenging<br>method that relies on the pressure<br>of the waste gas to transfer the<br>gas from the scavenger to the<br>vacuum source. | Similar. Both devices use a<br>scavenging method that<br>relies on control of<br>flow/pressure and a<br>connected vacuum source. |
| Functional<br>Characteristics | The waste gas enters the<br>Scavenger Plus through the<br>exhalation line of the connected<br>breathing circuit. The gas then<br>travels through the internal cavity<br>that connects the reservoir bag.<br>under-pressure valve, and over-<br>pressure valve. The gas remains<br>within the manifold and reservoir<br>bag. Gas is removed by the<br>connected vacuum source. | The inlet port is attached to the<br>ventilation system of the<br>anesthesia machine. During<br>operation, waste gases from the<br>patient are transferred into the<br>scavenger by the outlet pressure<br>supplied by the ventilator. The<br>gases will then travel through the<br>scavenger into a non-recirculating<br>exhaust system. | Similar. Waste gases from<br>the patient are transferred<br>into the scavenger and then<br>are removed from the<br>healthcare environment. |
| Pressure Limit | Under normal operating<br>conditions (75 L/min flow<br>through the inlet), the pressure<br>shall not exceed 3.0 cm H2O. | Under normal operating<br>conditions (75 L/min flow<br>through the inlet), the pressure<br>shall not exceed 3.0 cm H2O. | Same. Both devices meet<br>Section 201.103.1.1.1 of<br>ISO 80601-2-13, which<br>states that under normal<br>operating conditions (75<br>L/min flow through the<br>inlet), the pressure shall<br>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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Image /page/6/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 a white stylized "P" and the word "Parker" in white font. The right section is a white background with the word "Porter" in black font.
## 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.
