The Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer.

Device Description

The Vapotherm Aerosol Adapter AAA-2 is an accessory that is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT® 2.0, cleared under K203357, and the Aerogen Aeroneb® Solo Nebulizer System, cleared under K133360, and more recently with K143719. which is intended to aerosolize solutions for inhalation. The AAA-2 facilitates the connection between the noted devices, and therefore aerosolization use is dictated by the Aerogen Aeroneb Solo Nebulizer System labeling.

AI/ML Overview

The provided text describes the Vapotherm Aerosol Adapter AAA-2 (subject device) and its equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specific numerical results of a study that directly proves the device meets those criteria in a tabular format as requested.

Instead, the document outlines the types of non-clinical performance testing conducted and generally states that the device passed these tests or demonstrated similar performance to the predicate device.

Here's an attempt to extract and infer the information based solely on the provided text, while noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing descriptions)	Reported Device Performance (as stated or inferred)
Delivery of aerosolized solution confirmed (utilizing laser)	Confirmed delivery with nasal cannula and trach adapter.
Achievable flow rates (8, 20, 45 L/min with various cannula sizes)	Set flows were achieved.
Occlusion detection and alarm (at various L/min for different cannulas)	Passed occlusion testing (implied by "Occlusion testing with associated alarm included running..." without negative result).
Maximum rain-out of 5 mL not exceeded	System passed; maximum of 5 mL of rain-out was not exceeded in worst-case orientation.
Physical connections integrity under varying conditions	All connection points challenged and implied to be sufficient. 22mm female port compliant to ISO 5356-1.
No component/material degradation during continuous use	No signs of component or material degradation.
Similar aerosolization performance (particle size, respirable dose) to predicate	Demonstrated similar performance for both AAA-2 and Aeroneb Solo Adapter with Aeroneb Solo Nebulizer System, and did not interfere with expected performance.
Acceptable biocompatibility risk	Determined to possess acceptable biocompatibility risk.
Usability/Human Factors: no identified potential use errors, close calls, or difficulties with critical tasks.	Results support a substantial equivalence determination (implied successful).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any of the individual tests. The text describes "testing" and "running" the device but doesn't quantify the number of units or repetitions.
Data Provenance: Not explicitly stated. The tests were performed by Vapotherm Inc. or a contracted lab. It's bench testing, not clinical data, so country of origin of data (patients) is not applicable. This is retrospective bench testing on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. This document describes physical and performance bench testing of a medical device accessory, not an AI or diagnostic system that requires expert consensus for ground truth. Biocompatibility and performance standards (like ISO 10993-1, ISO 18562-1, ISO 5356-1) serve as the "ground truth" or accepted standards that the device performance is measured against.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, especially in AI studies, to establish ground truth. As this is bench testing against established engineering and material standards, such methods are not used. The device's performance is either within the specified limits or it is not.

5. 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

This section is not applicable. This document describes an accessory product (an adapter for a nebulizer) and its bench testing, not an AI system, diagnostic tool, or a product that interacts with human readers/interpretations. Therefore, an MRMC study and AI-assisted human reader improvement are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a hardware accessory; it does not involve any algorithm or AI component.

7. The type of ground truth used

The ground truth for the various tests described is based on:

Established engineering specifications and performance limits for flow rates, rain-out, connection integrity.
International standards for medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, ISO 18562-1 for breathing gas pathways, ISO 5356-1 for connections).
The performance of the predicate device (Aeroneb Solo Adapter) for aerosolization comparison.

8. The sample size for the training set

This section is not applicable. The device is a hardware accessory and does not involve AI/machine learning, so there is no training set.

9. How the ground truth for the training set was established

This section is not applicable. As there is no training set for an AI/ML algorithm, the establishment of ground truth for such a set is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains 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 words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.

Vapotherm Inc. Michael Webb VP of Regulatory Affairs 100 Domain Drive Exeter, New Hampshire 03833

Re: K220869

Trade/Device Name: Vapotherm Aerosol Adapter AAA-2 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: September 29, 2022 Received: September 30, 2022

Dear Michael Webb:

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/cfpmp/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 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

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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 Lee 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) K220869

Device Name Vapotherm Aerosol Adapter AAA-2

Indications for Use (Describe)

The Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer.

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)

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Image /page/3/Picture/0 description: The image shows the Vapotherm logo. The logo consists of a blue sphere with white lines on the left and the word "VAPOTHERM" in blue on the right. The sphere has a design of three curved lines that converge at the bottom. The word "VAPOTHERM" is in a sans-serif font, and there is a registered trademark symbol after the word.

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SECTION 5: 510(k) SUMMARY Date: 26-October-2022 Company: Vapotherm, Inc. 100 Domain Drive Exeter, NH 03833 Official Contact: Michael J. Webb - Vice President of Regulatory Affairs Tel - (844) 381-8276 Proprietary or Trade Name: AAA-2 Common/Usual Name: Nebulizer, Accessory to Classification Name: 21 CFR 868.5630, Class II Product Code: CAF Predicate Device: K133360 Aerogen Limited, Aeroneb Solo Adapter (Primary) Reference Device Predicate: K162753 Instrumentation Industries, Inc., RTC 26-C Inline Aerosol Adapter

Device Description:

Indications for Use:

The Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer.

Patient Population:

The AAA-2 shares the same intended patient populations as the Vapotherm HVT 2.0 which are spontaneously breathing adult and pediatric patients (5 kg and up), and the Aeroneb Solo Adapter which includes pediatric patients (29 days or older) as well as adult patients.

Environment of Use:

Hospital, sub-acute facility

Contraindications:

None

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Image /page/4/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a blue circle on the left with white lines forming a stylized "V" shape inside. To the right of the circle is the word "VAPOTHERM" in blue, with a registered trademark symbol next to it. The logo is clean and modern, with a focus on the company name.

Image /page/4/Picture/1 description: The image shows the logo for Hi-VNI Technology. The logo is blue and green, with the words "Hi-VNI" in large, bold letters. The word "TECHNOLOGY" is in smaller letters below the main text. A green swoosh design is underneath the "Hi-VNI" text, adding a dynamic element to the logo. The logo appears clean and professional.

Substantial Equivalence:

The AAA-2 is substantially equivalent to the predicate device, K133360 Aeroneb Solo Adapter. The reference predicate device K162753 RTC 26-C Inline Aerosol Adapter, also supports substantial equivalence.

A Benefit-Risk Assessment was completed and concluded that when assessing the minor differences between the subject and predicate device, there is no decrease in the expected benefit or increase in potential risk with the subject device. This assessment supports the conclusion that the minor differences in technological characteristics between the subject device AAA-2 and predicate Aeroneb Solo Adapter do not raise new questions of safety and effectiveness. Additionally, this assessment when considered with the Performance Testing-Bench, supports that the AAA-2 is "as safe and effective" and performs as well as the predicate device. The probable benefit to health from of the use of the AAA-2 outweighs any potential risk of injury or illness from such use.

The tables below present the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness. Performance data support a substantial equivalence determination.

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Image /page/5/Picture/0 description: The image contains the logo for Vapotherm. The logo consists of a blue sphere with white lines forming a "V" shape inside of it. To the right of the sphere is the word "VAPOTHERM" in blue, with a registered trademark symbol next to it.

Image /page/5/Picture/1 description: The image is a logo for Hi-VNI Technology. The logo is blue and green. The words "Hi-VNI" are in blue, with a green swoosh underneath. The word "TECHNOLOGY" is in smaller blue letters below the swoosh. The logo is simple and modern.

Table 5.1: Primary Predicate Device Comparison Table and Discussion
Characteristic	Primary Predicate:Aerogen Aeroneb SoloAdapter (K133360)	Subject Device:Vapotherm Aerosol AdapterAAA-2
Indications forUse	The Aeroneb® Solo Adapter isan accessory specific to theAeroneb® Solo Nebulizer. Itfacilitates intermittent andcontinuous nebulization andoptional supply of supplementalOxygen to pediatric (29 days orolder) and adult patients inhospital use environments via amouthpiece or aerosol mask. Ifsupplemental oxygen is used, forpediatric patients under 18 yearsof age, a maximum flow rate of2 LPM should be used. Note:The mouthpiece should not beused for children under 5 yearsof age.	SIMILAR TEXT, SAMEINTENDED USEThe Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connectionbetween Vapotherm High VelocityTherapy HVT®2.0 and the AerogenSolo Nebulizer.Both are aerosol adapters used with theAeroneb Solo Nebulizer System, thatallow connection to a larger breathingcircuit.Because the subject device is onlyindicated for use with the Aeroneb Soloand HVT 2.0, it carries the sameintended patient populations as the twoparent devices which are pediatric andadult patients.The pediatric use is limited to 29 daysor older and 5kg and up, again,consistent with the parent devices.
Intended Use	To allow use of the AeronebSolo Nebulizer System withsupplemental oxygen.	SAMETo allow use of the Aeroneb SoloNebulizer System with the VapothermHVT 2.0, which delivers supplementaloxygen.
PatientPopulation	Pediatric (29 days or older) andadult patients	SIMILARPediatric (29 days or older) and adultpatients.Pediatric Patients 5kg and up and adultpatients.The subject device is only for use withthe Aerogen Solo Nebulizer and HVT2.0 and therefore is subject to theircleared patient populations, whichwould be pediatric patients 5 kg and upand 29 days or older, as well as adultpatients.
Environment ofUse	Hospital	SIMILARHospital, sub-acute facilityEnvironments are similar clinicalenvironments. Sub-acute facility isincluded given the HVT 2.0 clearanceand is not a significant difference.
Table 5.1: Primary Predicate Device Comparison Table and Discussion
Characteristic	Primary Predicate:Aerogen Aeroneb SoloAdapter (K133360)	Subject Device:Vapotherm Aerosol AdapterAAA-2
Type & Durationof Use	Single patient use for up to 28 days	SIMILARSingle patient use for up to 30 daysAAA-2 30 day use is consistent withthe HVT 2.0 device it is used with.
Prescriptive	Rx Only	SAMERx Only
Patient Interface –for parent device	Mouthpiece, aerosol mask, nasalcannula, or via ventilator	SIMILARNasal cannula or TA-22Both share the same patient interface ofnasal cannula or via trach access.
Patient contactingmaterials	Externally communicating,tissue, prolonged duration	SAMEExternally communicating, tissue,prolonged durationBoth devices are comprised ofpolymers; Same ISO 10993-1classification
Sterility	Non-sterile	SAMENon-sterile
OperatingPrinciple	Function is to allow access to abreathing circuit for the purposeof the introduction of theaerosolized solution usingAeroneb Solo Nebulizer System.	SAMEFunction is to allow access to abreathing circuit for the purpose of theintroduction of the aerosolized solutionusing Aeroneb Solo Nebulizer System.Both are passive adapters that facilitatethe connection of the Aeroneb SoloNebulizer with a larger breathingcircuit that delivers supplementaloxygen.
CompatibleDevice	Breathing circuit, multiple, notspecifiedAerogen Aeroneb SOLONebulizer	SAMEVapotherm HVT 2.0Aerogen Aeroneb SOLO NebulizerAerogen Solo Adapter IFU showsmultiple different configurations forattaching the adapter to variousbreathing circuits. The Subject Deviceis more specific to HVT 2.0

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Image /page/6/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a blue circle with white lines inside, followed by the word "VAPOTHERM" in blue, with a registered trademark symbol next to it. The logo is simple and modern, and the colors are calming and professional.

Image /page/6/Picture/1 description: The image is a logo for Hi-VNI Technology. The logo is primarily blue, with the words "Hi-VNI" in a stylized font. A green swoosh underlines the "VNI" portion of the logo. Below the swoosh, the word "TECHNOLOGY" is written in a smaller, sans-serif font.

Non-clinical performance testing:

Biocompatibility / Materials -

Biocompatibility testing was conducted in accordance with FDA guidance, Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing

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Image /page/7/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a blue circle on the left with a white stylized "V" inside. To the right of the circle is the word "VAPOTHERM" in blue, with a registered trademark symbol after the word.

Image /page/7/Picture/1 description: The image shows the logo for Hi-VNI Technology. The logo is primarily blue, with a green swoosh underneath the "Hi" portion of the name. The word "Technology" is written in a smaller, sans-serif font below the main logo. A registered trademark symbol is present next to the "I" in "VNI".

within a risk management process" and ISO 18562-1 - Biocompatibility evaluation of breathing gas pathways in healthcare applications. The AAA-2 was determined to possess acceptable biocompatibility risk.

Bench / Performance Testing -

Testing was performed to assure that the proposed design does not raise new questions of safety and effectiveness based on the proposed device intended use. Testing included:

Aerosolized solution output testing was performed utilizing a 500mW green laser to confirm delivery, with a nasal cannula patient and trach adapter interface.

Achievable flow rate consisted of testing the AAA-2 with HVT 2.0 while varying flow rates set to 8, 20, and 45 L/min, with varying cannula sizes which included Infant, Pediatric Small, and Adult XL cannulas, to confirm the set flows were achieved.

Occlusion testing with associated alarm included running the AAA-2 with HVT 2.0 at varying flow rates of 3 and 8 L/min for the infant cannula, 3 and 20 L/min for the Pediatric Small, and 3 and 45 L/min for the Adult XL.

The testing described as 'Volume of liquid exiting the adapter outlet' is to demonstrate that excessive rain-out does not occur. The system passed as the maximum of 5 ml of rainout was not exceeded with the AAA-2 placed in a worst-case orientation.

The physical connections testing included challenging all connection points under varying flow rates and worst-case simulated conditions. The 22mm female port that accommodates the connection to the Aerogen Solo Nebulizer was also demonstrated to be compliant to ISO 5356-1.

Continuous use testing was performed while running the HVT 2.0 at varying flow rates and temperatures and there were no signs of component or material degradation.

Aerosolization performance comparison testing for commonly nebulized solutions was completed to demonstrate similar performance for both the AAA-2 Aerosol Adapter and the Aeroneb Solo Adapter when used with an Aeroneb Solo Nebulizer System. To determine particle size distributions and respirable dose of the nebulized solution, nebulized solution respules were collected using the Next Generation Cascade Impactor (NGI) and demonstrated that the use of HVT 2.0 with AAA-2 did not interfere with the expected performance of the Aeroneb Solo device.

Usability/Human Factors testing was performed with results analyzed to identify potential use errors, close calls, and difficulties associated with the critical tasks. The results of this testing supports a substantial equivalence determination.

Substantial Equivalence Conclusion

The performance testing demonstrates that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).