Palladium High Flow Therapy System

K191010 · Vapotherm, Inc. · BTT · Oct 10, 2019 · Anesthesiology

Device Facts

• Record ID: K191010
• Device Name: Palladium High Flow Therapy System
• Applicant: Vapotherm, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Oct 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

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 Story

Palladium High Flow Therapy System delivers warmed, humidified respiratory gases to spontaneously breathing patients; pediatric and adult (≥3.5 kg). Device uses internal blower for air source; integrates with external oxygen. Humidification achieved via semi-permeable small-bore tubing technology. Portable, AC or battery-powered; used in hospital, sub-acute, or homecare settings. Operated by clinicians or patients/caregivers. User interface allows adjustment of flow rate, temperature, and oxygen fraction. Software-controlled alarms monitor temperature, flow, and system integrity. Output provides respiratory support; benefits include improved patient comfort and gas delivery efficiency. Healthcare providers use output to manage respiratory therapy; device performance verified via bench testing against predicate standards.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included oxygen accuracy, temperature accuracy, humidification output (per ISO 80601-2-74:2017), flow rate accuracy, surface temperature, continuous use lifespan, and nurse call compatibility. Biocompatibility testing performed per ISO 10993-1 and ISO 18562 series. Electrical safety and EMC testing per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Portable respiratory gas humidifier; AC/battery powered. Uses internal blower and semi-permeable small-bore tubing for humidification. Flexible Kapton circuit heater element. Flow range 5-40 L/min; temperature range 33°C-38°C. Software-controlled with audible/visual alarms. Biocompatibility per ISO 10993/18562. Electrical safety per IEC 60601-1/1-2. RFID immunity per AIM 7351731.

Indications for Use

Indicated for spontaneously breathing adult and pediatric patients weighing at least 3.5 kg requiring warmed and humidified high-flow respiratory gases in hospital, sub-acute, or homecare settings. Contraindicated in situations where humidification is contraindicated or in patients with occluded or damaged nares.

Regulatory Classification

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.

Predicate Devices

• Vapotherm Flowrest (K103316)

Reference Devices

• Vapotherm Precision Flow (K072845)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"> <span style="font-size: larger;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="white-space: nowrap;"> <span style="font-size: larger;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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.<br>100 Domain Drive<br>Exeter, NH 03833 |
| Official Contact: | Richelle Helman –Vice President of Regulatory and Quality<br>Tel – 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 II<br>Product Code: BTT |
| Predicate Device:<br>Reference Device: | K103316 - Vapotherm Flowrest®<br>K072845 - Vapotherm Precision Flow® |

#### 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.

#### 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:<br>Flowrest® (K103316) | Subject Device:<br>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 - K103316<br>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. |
| Patient Population | Neonate, pediatric, adult | SIMILAR – K103316<br>Pediatric, adult |
| Environment of Use | Homecare, sub-acute and hospital settings | SAME - K103316<br>Hospital, sub-acute and homecare settings |
| Duration of Use | Disposable can be used for up to 30 days single patient use. | SAME - K103316<br>Disposable can be used for up to 30 days single patient use. |
| Prescriptive | Rx Only | SAME - K103316<br>Rx Only |
| Patient Interfaces | Nasal cannula | SAME - K103316<br>Nasal cannula |
| Flow Range | 15 to 35 liters per minute | SIMILAR – K103316<br>5 to 40 liters per minute |
| Patient contacting materials | Externally communicating, tissue, prolonged duration | SAME - K103316<br>Externally communicating, tissue, prolonged duration |
| Temperature Setting | 31C to 38C | SIMILAR - K103316<br>33C to 38C |
| Heater | Flat heater element that contacts disposable patient circuit – Heatron Platen heater | SAME - K103316<br>Flat heater element that contacts disposable patient circuit – Flexible Kapton circuit heater element |
| Temperature Cutout | Software controlled; Alarms at 43 °C | SIMILAR – K103316<br>Software controlled; Alarms at 41 °C |
| Temperature Accuracy | ± 2 °C | SAME - K103316<br>± 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 - K103316<br>Audible and visual for temperature, low oxygen fraction, blocked tube, water out, disposable |
| Characteristic | Predicate:<br>Flowrest® (K103316) | Subject Device:<br>Palladium High Flow Therapy<br>System |
| | | water path not present, loss of<br>power and loss of flow |
| User interface | User set point adjustment via menu<br>system on display for flow rate,<br>temperature and time | SIMILAR - K103316<br>User set point adjustment via menu<br>system on display for flow rate,<br>temperature and oxygen fraction |
| Control | Software control | SAME - K103316<br>Software control |
| Modes of<br>operation | Run Mode – unit is either on and<br>running or is completely off | SIMILAR - K103316<br>Sleep, Standby and Run Modes<br>Sleep: Display is in sleep mode, no<br>gas flow<br>Stand-by: Input parameters can be<br>adjusted, no gas flow<br>Run: Warming to set point<br>temperature, gas flow<br>Unit operating at set point, gas<br>flow |
| Gas input | Medical gases<br>Air / oxygen | SAME - K103316<br>Medical gases<br>Air / oxygen |
| Humidification | Via a semi-permeable flat membrane | SIMILAR - K103316<br>Via semi-permeable small-bore<br>tubing |
| Power<br>Requirements | 100-240 VAC, 50-60 Hz<br>No backup battery | SIMILAR - K103316<br>100-240 VAC, 50-60 Hz<br>Lithium Ion 2600mAh, 7.26V,<br>19Wh backup battery |
| Connectors | Adapter allows connection to an<br>oxygen source. | SIMILAR - K103316<br>Oxygen inlet on unit allows<br>connection 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 – [phone] – 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.