(217 days)
No
The device is a simple adapter for connecting existing devices and the summary does not mention any AI/ML capabilities or related performance metrics.
No
The device is an adapter that facilitates the connection between two other medical devices (a high-velocity therapy device and a nebulizer system). Its function is to enable aerosolization, which is performed by the nebulizer, not the adapter itself. Therefore, it is not a therapeutic device but an accessory for therapeutic devices.
No
The device is an accessory that facilitates the connection between two other medical devices (a high velocity therapy system and a nebulizer) to enable aerosolization of solutions for inhalation. It does not perform any diagnostic function.
No
The device is described as an "accessory" and "adapter" that facilitates a physical connection between two other medical devices. The performance studies focus on physical characteristics, material biocompatibility, and flow dynamics, indicating a hardware component. There is no mention of software functionality.
Based on the provided text, the Vapotherm Aerosol Adapter AAA-2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to facilitate the connection between two medical devices (Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer) for the purpose of aerosolizing solutions for inhalation. This is a therapeutic/delivery function, not a diagnostic one.
- Device Description: The description reinforces its role as an accessory for connecting devices used in respiratory therapy.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the device's ability to facilitate the connection, maintain flow rates, prevent rain-out, and ensure proper aerosolization delivery. These are all related to the delivery of therapy, not diagnostic testing.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The Vapotherm Aerosol Adapter AAA-2's function is purely related to the delivery of aerosolized medication or solutions to a patient's respiratory system.
N/A
Intended Use / 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.
Product codes
CAF
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.
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
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.
Intended User / Care Setting
Hospital, sub-acute facility
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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:
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.
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 Solo | ||
| Adapter (K133360) | Subject Device: | |
| Vapotherm Aerosol Adapter | ||
| AAA-2 | ||
| Indications for | ||
| Use | The Aeroneb® Solo Adapter is | |
| an accessory specific to the | ||
| Aeroneb® Solo Nebulizer. It | ||
| facilitates intermittent and | ||
| continuous nebulization and | ||
| optional supply of supplemental | ||
| Oxygen to pediatric (29 days or | ||
| older) and adult patients in | ||
| hospital use environments via a | ||
| mouthpiece or aerosol mask. If | ||
| supplemental oxygen is used, for | ||
| pediatric patients under 18 years | ||
| of age, a maximum flow rate of | ||
| 2 LPM should be used. Note: | ||
| The mouthpiece should not be | ||
| used for children under 5 years | ||
| of age. | SIMILAR TEXT, SAME | |
| INTENDED 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. |
Both are aerosol adapters used with the
Aeroneb Solo Nebulizer System, that
allow connection to a larger breathing
circuit.
Because the subject device is only
indicated for use with the Aeroneb Solo
and HVT 2.0, it carries the same
intended patient populations as the two
parent devices which are pediatric and
adult patients.
The pediatric use is limited to 29 days
or older and 5kg and up, again,
consistent with the parent devices. |
| Intended Use | To allow use of the Aeroneb
Solo Nebulizer System with
supplemental oxygen. | SAME
To allow use of the Aeroneb Solo
Nebulizer System with the Vapotherm
HVT 2.0, which delivers supplemental
oxygen. |
| Patient
Population | Pediatric (29 days or older) and
adult patients | SIMILAR
Pediatric (29 days or older) and adult
patients.
Pediatric Patients 5kg and up and adult
patients.
The subject device is only for use with
the Aerogen Solo Nebulizer and HVT
2.0 and therefore is subject to their
cleared patient populations, which
would be pediatric patients 5 kg and up
and 29 days or older, as well as adult
patients. |
| Environment of
Use | Hospital | SIMILAR
Hospital, sub-acute facility
Environments are similar clinical
environments. Sub-acute facility is
included given the HVT 2.0 clearance
and is not a significant difference. |
| Table 5.1: Primary Predicate Device Comparison Table and Discussion | | |
| Characteristic | Primary Predicate:
Aerogen Aeroneb Solo
Adapter (K133360) | Subject Device:
Vapotherm Aerosol Adapter
AAA-2 |
| Type & Duration
of Use | Single patient use for up to 28 days | SIMILAR
Single patient use for up to 30 days
AAA-2 30 day use is consistent with
the HVT 2.0 device it is used with. |
| Prescriptive | Rx Only | SAME
Rx Only |
| Patient Interface –
for parent device | Mouthpiece, aerosol mask, nasal
cannula, or via ventilator | SIMILAR
Nasal cannula or TA-22
Both share the same patient interface of
nasal cannula or via trach access. |
| Patient contacting
materials | Externally communicating,
tissue, prolonged duration | SAME
Externally communicating, tissue,
prolonged duration
Both devices are comprised of
polymers; Same ISO 10993-1
classification |
| Sterility | Non-sterile | SAME
Non-sterile |
| Operating
Principle | Function is to allow access to a
breathing circuit for the purpose
of the introduction of the
aerosolized solution using
Aeroneb Solo Nebulizer System. | SAME
Function is to allow access to a
breathing circuit for the purpose of the
introduction of the aerosolized solution
using Aeroneb Solo Nebulizer System.
Both are passive adapters that facilitate
the connection of the Aeroneb Solo
Nebulizer with a larger breathing
circuit that delivers supplemental
oxygen. |
| Compatible
Device | Breathing circuit, multiple, not
specified
Aerogen Aeroneb SOLO
Nebulizer | SAME
Vapotherm HVT 2.0
Aerogen Aeroneb SOLO Nebulizer
Aerogen Solo Adapter IFU shows
multiple different configurations for
attaching the adapter to various
breathing circuits. The Subject Device
is 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
7
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.