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.

AI/ML Overview

The document provided is a 510(k) Premarket Notification from the FDA for a medical device called the "Nitronox® Scavenger Plus." This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving its absolute safety and efficacy through extensive clinical trials.

The document discusses non-clinical performance data and states that clinical investigation was not required because safety and efficacy were supported by non-clinical testing. Therefore, the information typically associated with a study proving a device meets acceptance criteria for an AI/ML medical device (such as those involving test sets, training sets, expert adjudication, MRMC studies, and detailed ground truth establishment) is not present in this document.

The acceptance criteria described in the document relate to engineering and operational performance of a physical gas-scavenging apparatus, not an AI/ML algorithm.

Here's a breakdown of the relevant information provided, adapted to the questions where possible, and noting where information is absent due to the nature of the device and submission:

Acceptance Criteria and Reported Device Performance

The document describes performance criteria primarily related to pressure limits for gas scavenging.

Acceptance Criteria	Reported Device Performance	Comments
Under normal operating conditions (75 L/min flow through the inlet), the pressure shall not exceed 3.0 cm H2O. (This is a standard from ISO 80601-2-13, Section 201.103.1.1.1)	Under normal operating conditions (75 L/min flow through the inlet), the pressure did not exceed 3.0 cm H2O.	The device met this ISO standard.
Functional, operational, and performance characteristics (general)	The Scavenger Plus met all of the acceptance criteria for functional, operational, and performance characteristics.	Demonstrated through performance bench testing.

Study Details (as inferable from the document, with many points being N/A for this type of device/submission)

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This device is a physical gas scavenging apparatus, not an AI/ML algorithm that processes data. Testing was likely done on physical units of the device under controlled conditions. The number of samples/units tested is not specified but would be part of standard engineering verification.
- Data Provenance: Not applicable in the context of "data" for an AI model. This refers to bench testing performed on the physical device. The location of testing is not specified, but it would be part of the manufacturer's quality system. The testing would be "prospective" in the sense that it was conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical device's performance usually relates to engineering specifications and physical measurements, rather than expert interpretation of complex data (like medical images). Compliance with standards like ISO 80601-2-13 is verified directly through measurement.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human interpretation or subjective assessments. Performance testing for this device is based on objective measurements against engineering specifications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted device. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It's a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and objective physical measurements: The "ground truth" for this device's performance is whether its physical output (e.g., pressure) meets predefined engineering and regulatory standards (e.g., ISO 80601-2-13).
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.

In summary, the provided document details a 510(k) submission for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around bench testing demonstrating compliance with established engineering standards and functional specifications, rather than complex data-driven analyses characteristic of AI/ML device evaluations. The FDA determined that the non-clinical testing was sufficient to establish substantial equivalence to a predicate device, thus no clinical trials were deemed necessary.

Summary

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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

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
--	--	-----------------------------------------------------	--	--

ProductFeatures	Subject DeviceParker Hannifin Corporation'sScavenger Plus	Predicate DeviceG. Dundas Co. Inc.'sPassive Waste Gas ScavengerK080039	Comments
Classification	Class II	Class II	Same
Product Code	CBN	CBN	Same
RegulationNumber	$$868.5430$	$$868.5430$	Same
RegulationName	Gas Scavenging Apparatus	Gas Scavenging Apparatus	Same
Intended Use	The Scavenger Plus is intended tocontrol the vacuum flowrate forscavenging of waste analgesicgas.	The Passive Waste GasScavenger is intended to be usedfor the scavenging of wasteanesthetic gases from anesthesiamachines used during theprovision of general anesthesia toadults and children.	Same. Both devices areintended for scavenging ofwaste 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.

ProductFeatures	Subject DeviceParker Hannifin Corporation'sScavenger Plus	Predicate DeviceG. Dundas Co. Inc.'sPassive Waste Gas ScavengerK080039	Comments
Principle ofOperation	The Scavenger Plus uses ascavenging method that relies onthe gas in the manifold andreservoir bag to create a system ofpressure between the entry sideand vacuum source. This pressurebalance allows for all of the gasthat enters the device manifold tothen be pulled through the deviceto the connected vacuum source.	The Passive Waste GasScavenger uses a scavengingmethod that relies on the pressureof the waste gas to transfer thegas from the scavenger to thevacuum source.	Similar. Both devices use ascavenging method thatrelies on control offlow/pressure and aconnected vacuum source.
FunctionalCharacteristics	The waste gas enters theScavenger Plus through theexhalation line of the connectedbreathing circuit. The gas thentravels through the internal cavitythat connects the reservoir bag.under-pressure valve, and over-pressure valve. The gas remainswithin the manifold and reservoirbag. Gas is removed by theconnected vacuum source.	The inlet port is attached to theventilation system of theanesthesia machine. Duringoperation, waste gases from thepatient are transferred into thescavenger by the outlet pressuresupplied by the ventilator. Thegases will then travel through thescavenger into a non-recirculatingexhaust system.	Similar. Waste gases fromthe patient are transferredinto the scavenger and thenare removed from thehealthcare environment.
Pressure Limit	Under normal operatingconditions (75 L/min flowthrough the inlet), the pressureshall not exceed 3.0 cm H2O.	Under normal operatingconditions (75 L/min flowthrough the inlet), the pressureshall not exceed 3.0 cm H2O.	Same. Both devices meetSection 201.103.1.1.1 ofISO 80601-2-13, whichstates that under normaloperating conditions (75L/min flow through theinlet), the pressure shallnot 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.

Regulation Number and Section

§ 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).