The Palladium High Flow Therapy System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult and pediatric patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings.

Device Description

The Palladium High Flow Therapy System is designed to heat and humidify respiratory gases and deliver high flow respiratory therapy via a small-bore nasal cannula to spontaneously breathing pediatric and adult patients within hospital, sub-acute and homecare settings.

Palladium is portable, self-contained, AC driven or battery powered with high flow therapy driven by an internal blower room air source and supplied with external oxygen or other gas sources, which is the same as the predicate Vapotherm Flowrest® device.

Palladium utilizes similar semi-permeable small-bore tubing technology for humidification and integrity of a closed, single-use water path disposable as the reference Vapotherm Precision Flow® device.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Palladium High Flow Therapy System". It details the device's indications for use, its comparison to predicate devices, and non-clinical performance testing. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed quantitative results for the Palladium system's performance.

Based on the provided text, a table of acceptance criteria and reported device performance, and details about a specific study proving the device meets these criteria, is not fully available in the requested format. The document describes several non-clinical tests (biocompatibility, electrical safety, software, and bench/performance testing) and states that the "results demonstrated that the device performance was met after conditioning and was substantially equivalent to the predicate device." However, it does not provide the specific numeric acceptance criteria or the measured performance values for the Palladium device in a clear, quantifiable manner for each test.

Here's a breakdown of what can be extracted based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes general categories of performance testing and states that the outcomes met expectations or demonstrated substantial equivalence. Specific measurable acceptance criteria values and the actual results of the Palladium device (e.g., "Oxygen accuracy: ±X%" and "Measured: Y%") are not provided.

Test Category	Acceptance Criteria (as described generally)	Reported Device Performance (as described generally)
Biocompatibility	Compliance with ISO 10993-1, ISO 18562-1, -2, -3, -4, ISO 10993-5, ISO 10993-10; appropriate biocompatibility profile for "externally communicating, tissue contacting, permanent duration of use" materials.	"Testing of the patient-contacting parts of the Palladium High Flow Therapy System demonstrates an appropriate biocompatibility profile for the device."
Electrical Safety and EMC	Compliance with IEC 60601-1:2005 Ed.3+A1:2012, IEC 60601-1-2: 2014 Ed.4, and AIM 7351731:2017 (RFID immunity). Specifics include basic safety, essential performance, emissions, and immunity.	"The testing demonstrated the appropriate electrical safety and electromagnetic compatibility (EMC) profile for the device."
Software V&V	Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" classified as "moderate" level of concern.	"Software verification and validation testing were conducted and documentation was provided as recommended... The software for this device was considered as a 'moderate' level of concern."
Bench/Performance Testing	`Oxygen accuracy`: Not explicitly stated but implied to meet predicate performance.`Temperature accuracy`: Expected to be ±2 °C (from comparison table).`Humidification system output`: Compliance with ISO 80601-2-74:2017.`Flow rate accuracy`: Not explicitly stated but implied to meet predicate performance.`Patient contacting surface temperature`: Not explicitly stated but implied to meet safety standards.`Continuous use (Use Lifespan)`: Not explicitly stated but implied to demonstrate safe operation over time.`Operating environment`: Not explicitly stated but implied to meet specified environmental conditions.`Nurse call compatibility`: Not explicitly stated but implied to work with nurse call systems.	"The results demonstrated that the device performance was met after conditioning and was substantially equivalent to the predicate device."Regarding temperature accuracy, the comparison table states "Temperature Accuracy: SAME - K103316 ± 2 °C" for the subject device, indicating this was the acceptance criteria and presumably met. For other performance metrics, only a general statement of meeting performance and substantial equivalence is given.

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

Sample Size: Not specified for any of the non-clinical tests.
Data Provenance: The tests are non-clinical (bench testing, lab-based safety, and performance evaluations), therefore no patient data or geographical provenance is applicable in the context of the supplied text. The company (Vapotherm, Inc.) is based in Exeter, NH, USA. The testing would have been conducted in a controlled lab environment.

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

This information is not applicable. The documentation refers to non-clinical (bench) testing, software verification, and compliance with established standards. There is no mention of "ground truth" established by experts in the context of clinical expert review.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical data by multiple human readers, which is not described here.

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:

No MRMC study was conducted or mentioned in this document. This is a 510(k) submission for a respiratory gas humidifier, not an AI-assisted diagnostic device.

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

This is not applicable as the device is a physical medical device (humidifier), not an algorithm or AI system. Its performance is evaluated through engineering and physiological testing, not AI-centric standalone performance studies.

7. The type of ground truth used:

For the non-clinical performance and safety tests, the "ground truth" would be the objective measurements against pre-defined engineering specifications and internationally recognized standards (e.g., ISO, IEC). For example, temperature measurements against a calibrated reference, flow rate measurements, or chemical analysis for biocompatibility tests. It's based on technical standards and specifications, not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set:

Not applicable. This is not an AI/Machine Learning device that requires a training set.

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

Not applicable for the same reason as above.

Summary

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October 10, 2019

Vapotherm, Inc. % Dave Yungvirt Responsible Third Party Official Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K191010

Trade/Device Name: Palladium High Flow Therapy System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: August 13, 2019 Received: August 16, 2019

Dear Dave Yungvirt:

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.

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, Ph.D. Assistant Director DHT1C: Division of ENT, 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)

K191010

Device Name Palladium High Flow Therapy System

Indications for Use (Describe)

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 logo for Vapotherm. The logo consists of a blue sphere with white lines converging towards the center on the left side. To the right of the sphere, the word "VAPOTHERM" is written in blue, with a registered trademark symbol next to it.

Image /page/3/Picture/2 description: The image is a logo for Hi VNI Technology. The logo is blue and green. The word "Hi" is in large, bold, blue letters. The word "VNI" is in large, bold, blue letters and has a green swoosh underneath it. The word "TECHNOLOGY" is in smaller, blue letters below the swoosh.

SECTION 5: 510(k) SUMMARY

Date:	09-October-2019
Company:	Vapotherm, Inc.100 Domain DriveExeter, NH 03833
Official Contact:	Richelle Helman –Vice President of Regulatory and QualityTel – 603-658-0489
Proprietary or Trade Name:	Palladium High Flow Therapy System
Common/Usual Name:	Respiratory gas humidifier
Classification Name:	21 CFR 868.5450, Class IIProduct Code: BTT
Predicate Device:Reference Device:	K103316 - Vapotherm Flowrest®K072845 - Vapotherm Precision Flow®

Device Description:

Indications for Use:

The Palladium High Flow Therapy System is intended to deliver warmed and humidified highflow respiratory gases to spontaneously breathing adult and pediatric patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings.

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Image /page/4/Picture/0 description: The image contains the logo for Vapotherm. The logo consists of a blue circle with white lines inside, and the word "VAPOTHERM" in blue, sans-serif font. The registered trademark symbol is located to the right of the word "VAPOTHERM".

Image /page/4/Picture/2 description: The image contains the logo for Hi-VNI Technology. The logo is primarily blue, with the letters "Hi-VNI" in a bold, sans-serif font. A green swoosh underlines the letters, and the word "TECHNOLOGY" is written in a smaller font size below the swoosh. The logo has a clean and modern design.

Patient Population:

For pediatric and adult patients

Note: Vapotherm follows the definition of pediatric patients and pediatric subpopulations discussed in Guidance for Industry and Food and Drug Administration Staff "Providing Information about Pediatric Uses of Medical Devices".

Environment of Use:

Hospital, sub-acute and homecare settings

Contraindications:

Any situation in which humidification is contra-indicated (see American Association of Respiratory Care Clinical Practice Guidelines).

Specific to the nasal cannula: The system should not be used on patients with occluded or damage nares.

Substantial Equivalence:

The Palladium High Flow Therapy System is substantially equivalent to the predicate device, the Vapotherm Flowrest" (510(k) K103316). The table below presents the similarities and differences between the products for substantial equivalence purposes. The reference device, the Vapotherm Precision Flow" (510(k) K072485), is being used to support the effectiveness of the scientific methods for evaluating the effect of the different characteristics on safety and effectiveness. The key differences between the subject device and the predicate device being supported by the reference device are flow range and humidification exchange media. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.

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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 on the left and the word "VAPOTHERM" in blue on the right. The word "VAPOTHERM" is in a sans-serif font, and there is a registered trademark symbol after the word.

Image /page/5/Picture/2 description: The image shows the logo for Hi-VNI Technology. The logo is in blue and green. The words "Hi-VNI" are in blue, and the word "TECHNOLOGY" is in green. There is a green swoosh under the words "Hi-VNI".

Characteristic	Predicate:Flowrest® (K103316)	Subject Device:Palladium High Flow Therapy System
Indications for Use	The Flowrest® delivers warmed humidified high-flow breathing gases. The Flowrest® is intended for treating spontaneously breathing patients who require warmed and humidified high-flow respiratory gases within the homecare, sub-acute and hospital settings.	SAME - K103316The Palladium High Flow Therapy System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult and pediatric patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings.
Patient Population	Neonate, pediatric, adult	SIMILAR – K103316Pediatric, adult
Environment of Use	Homecare, sub-acute and hospital settings	SAME - K103316Hospital, sub-acute and homecare settings
Duration of Use	Disposable can be used for up to 30 days single patient use.	SAME - K103316Disposable can be used for up to 30 days single patient use.
Prescriptive	Rx Only	SAME - K103316Rx Only
Patient Interfaces	Nasal cannula	SAME - K103316Nasal cannula
Flow Range	15 to 35 liters per minute	SIMILAR – K1033165 to 40 liters per minute
Patient contacting materials	Externally communicating, tissue, prolonged duration	SAME - K103316Externally communicating, tissue, prolonged duration
Temperature Setting	31C to 38C	SIMILAR - K10331633C to 38C
Heater	Flat heater element that contacts disposable patient circuit – Heatron Platen heater	SAME - K103316Flat heater element that contacts disposable patient circuit – Flexible Kapton circuit heater element
Temperature Cutout	Software controlled; Alarms at 43 °C	SIMILAR – K103316Software controlled; Alarms at 41 °C
Temperature Accuracy	± 2 °C	SAME - K103316± 2 °C
Operating Principle	Gas delivery via a blower and humidification via semi-permeable polymer technology which allows for delivery of entrained, humidified gases at constant flow to the patient	SAME - K103316Gas delivery via a blower and humidification via semi-permeable polymer technology which allows for delivery of entrained, humidified gases at constant flow to the patient
Alarms	Visual for temperature, heater, fan and pressure sensor failure, water empty or canister assembly not in place	SIMILAR - K103316Audible and visual for temperature, low oxygen fraction, blocked tube, water out, disposable
Characteristic	Predicate:Flowrest® (K103316)	Subject Device:Palladium High Flow TherapySystem
		water path not present, loss ofpower and loss of flow
User interface	User set point adjustment via menusystem on display for flow rate,temperature and time	SIMILAR - K103316User set point adjustment via menusystem on display for flow rate,temperature and oxygen fraction
Control	Software control	SAME - K103316Software control
Modes ofoperation	Run Mode – unit is either on andrunning or is completely off	SIMILAR - K103316Sleep, Standby and Run ModesSleep: Display is in sleep mode, nogas flowStand-by: Input parameters can beadjusted, no gas flowRun: Warming to set pointtemperature, gas flowUnit operating at set point, gasflow
Gas input	Medical gasesAir / oxygen	SAME - K103316Medical gasesAir / oxygen
Humidification	Via a semi-permeable flat membrane	SIMILAR - K103316Via semi-permeable small-boretubing
PowerRequirements	100-240 VAC, 50-60 HzNo backup battery	SIMILAR - K103316100-240 VAC, 50-60 HzLithium Ion 2600mAh, 7.26V,19Wh backup battery
Connectors	Adapter allows connection to anoxygen source.	SIMILAR - K103316Oxygen inlet on unit allowsconnection to an oxygen source.

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Image /page/6/Picture/0 description: The image shows the Vapotherm logo. The logo consists of a blue sphere 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 center. The word "VAPOTHERM" is in a sans-serif font, and there is a registered trademark symbol after the word.

Image /page/6/Picture/2 description: The image shows the logo for Hi-VNI Technology. The logo is primarily blue, with the text "Hi-VNI" in a bold, sans-serif font. A green swoosh-like graphic is underneath the text. Below the swoosh, the word "TECHNOLOGY" is written in a smaller, sans-serif font.

From the comparison form above, the subject device and predicate device have similar intended use, are both prescription use, and have the same operating principle, gas input and method of humidification. The subject device claims slightly different patient population and flow range but these are a subset of the predicate and reference devices. Therefore, these differences do not raise new questions of safety or effectiveness.

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". Biocompatibility of the gas pathway complies with ISO 18562-1 - Biocompatibility evaluation of breathing gas pathways in healthcare applications and the materials are considered permanent duration due to potential cumulative use. Therefore, the patient contacting materials in the humidified gas pathway are considered to be externally

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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 and the word "VAPOTHERM" in blue on the right. The circle contains three white 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.

Image /page/7/Picture/2 description: The image shows the logo for Hi-VNI Technology. The logo is primarily blue and green. The text "Hi-VNI" is in a bold, blue font, with a green swoosh underneath. The word "TECHNOLOGY" is in a smaller, blue font below the swoosh.

communicating, tissue contacting, permanent duration of use (> 30 days). Evaluation and testing were conducted in accordance with the following standards and guidance documents:

. ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of . medical devices - Part 1: Evaluation and testing within a risk management process" June 16. 2016
ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro ● cvtotoxicity
. ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
. ISO 18562-1: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
. ISO 18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
. ISO 18562-3: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
. ISO 18562-4: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

Testing of the patient-contacting parts of the Palladium High Flow Therapy System demonstrates an appropriate biocompatibility profile for the device.

Electrical Safety and EMC:

Electrical safety and electromagnetic compatibility (EMC) testing were conducted in accordance with IEC 60601-1:2005 Ed.3+A1:2012 and IEC 60601-1-2: 2014 Ed.4 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. Additionally, RFID immunity testing was completed in accordance with FDA recognized standard AIM 7351731:2017, Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility (EMC) profile for the device.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern.

Bench / Performance Testing -

Comparative performance testing included:

Oxygen accuracy .
Temperature accuracy
Humidification system output (ISO 80601-2-74:2017 Medical Electrical Equipment . Part 2-74: Particular requirements for Basic Safety and Essential Performance of

Take the Work out of Breathing

Vapotherm Inc. – 100 Domain Drive, Exeter, NH 03833 – (603) 658-0011 – www.vapotherm.com

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Image /page/8/Picture/0 description: The image shows the logo for Vapotherm. The logo consists of a blue sphere with white lines on the left and the word "VAPOTHERM" in blue on the right. The word "VAPOTHERM" is in a sans-serif font, and there is a registered trademark symbol after the word.

Image /page/8/Picture/2 description: The image shows the logo for Hi-VNI Technology. The logo is primarily blue and green. The text "Hi-VNI" is in a bold, blue font, with a green swoosh underneath. The word "TECHNOLOGY" is in a smaller, blue font and is located to the right of the swoosh.

Respiratory Humidifying Equipment)

. Flow rate accuracy
Patient contacting surface temperature ●
Continuous use (Use Lifespan) .
Operating environment ●
Nurse call compatibility ●

The results demonstrated that the device performance was met after conditioning and was substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

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

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).