FLOWREST
Device Facts
| Record ID | K103316 |
|---|---|
| Device Name | FLOWREST |
| Applicant | Vapotherm, Inc. |
| Product Code | BTT · Anesthesiology |
| Decision Date | Feb 8, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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, subacute and hospital settings.
Device Story
Flowrest delivers warmed, humidified high-flow respiratory gases (15-35 L/min) to spontaneously breathing patients. System comprises main unit with blower, heater, and humidifier; dual-lumen breathing circuit; and nasal cannula. Blower draws room air, heats it, and splits flow: inner lumen passes through humidification chamber for patient delivery; outer lumen provides insulation to minimize condensation. Used in home, subacute, or hospital settings; operated by patients, clinicians, or technicians. Software controls fan speed, temperature, and ramp-up settings. Clinicians/distributors access usage data and configure prescriptions via USB port. Device provides therapy to improve patient comfort and respiratory support.
Clinical Evidence
Bench testing only. Device performance verified against standards including ISO 10993 (biocompatibility), IEC 60601-1 (safety), EN 60601-1-2 (EMC), and ISO 8185 (respiratory humidifiers). No clinical data presented.
Technological Characteristics
Integrated non-invasive high-flow system. Components: blower, air heater, heated humidifier, dual-lumen circuit, cannula. Materials: distilled water reservoir, heated plate. Connectivity: USB port for clinical/service configuration. Software-controlled temperature and flow (15-35 L/min). Standards: ISO 10993, IEC 60601-1, EN 60601-1-2, EN 60601-1-4, ISO 8185, ISO 14971. IPX1 drip-proof rating.
Indications for Use
Indicated for spontaneously breathing patients requiring warmed, humidified high-flow respiratory gases in homecare, subacute, or hospital settings.
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
- Fisher Paykel Airvo Series Humidifier (K092846)
Submission Summary (Full Text)
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K103316
## 510(k) SUMMARY
# Vapotherm Flowrest®
FEB - 8 20il
# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, Maryland 21666
Phone: (410) 604 - 0808 extension 209 Facsimile: (410) 604 - 3978
Contact Person: Gregory A. Whitney
Date Prepared: November 1, 2010
# Name of Device and Name/Address of Sponsor:
Flowrest®
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, Maryland 21666
# Common or Usual Name:
Humidifier, respiratory gas, (direct patient interface)
# Classification Name:
Respiratory gas humidifier. Anesthesiology Panel 868.5450 Class II
# Product Code:
втт 868.5450
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#### Predicate Device:
| # | Manufacturer | Trade Name | 510(k) |
|---|-----------------------------|-------------------------|---------|
| 1 | Fisher Paykel<br>Healthcare | Airvo Series Humidifier | K092846 |
### Intended Use / 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, subacute and hospital settings.
#### Technological Characteristics:
The Flowrest® is an integrated non-invasive high flow device incorporating a blower, an air flow heater, a heated humidifier, and a dual lumen breathing circuit and cannula. Please refer to the accompanying diagram below. Filtered room air is drawn in through a blower, where it passes a heater. The heated air is split between the inner lumen and outer lumen of the dual lumen breathing circuit. The heated air in the inner lumen passes through a heated humidifier and is delivered to the patient through a cannula. The heated air in the outer lumen passes through the entire length of the breathing circuit and serves to insulate the humidified patient air, thus minimizing condensation and rainout.
The Flowrest® is comprised of two functional, vet integrated components. One is a motorized fan assembly that provides the physician prescribed high flows of heated breathing and insulating gases between 15 and 35 liters per minute. The fan speed is directly related to flow rate and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second component of the Flowrest® is a heated humidifier. The water is contained in the humidification chamber positioned on a heater plate at the front of the unit. The chamber connects directly to the blower assembly. Air flow from the device passes through the heated humidification chamber, is warmed and humidified and after passing through the breathing circuit, is delivered to the patient through a cannula. The second flow of warm air through the outside lumen of the delivery tube bypasses the humidification chamber through the top of the humidifier chamber. Ambient temperature is monitored in order to reduce humidified patient air condensation. Temperature controls are controlled by software.
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# Flowrest® Air-Vapor Flow-Path Diagram:
Image /page/2/Figure/3 description: This image shows a diagram of a humidity chamber assembly. The diagram includes labels for various components such as the air heater assembly, humidity chamber assembly, tube set patient circuit, and cannula. It also shows the flow of air and water vapor within the system, including the environment air inlet, blower-fan, filter, water reservoir, heaters, and gore membrane.
### Main Unit:
The main unit houses the blower fan, internal heater, heater plate, display, control panel, and all the electronics that control air flow and temperature. It contains no water and only dry gas pathways, so it requires no internal cleaning or disinfection.
### Disposable Components:
The canister assembly contains the distilled water reservoir, gas pathways and humidity cartridge. The insulated delivery tube convevs heated patient gas from the canister to the nasal cannula. Air from the internal heater passes between the insulated tube's inner and outer walls, and keeps the humidified gas from loosing heat and water.
### Software Features:
ne flowrest software is configured for four types of interface; the patient, the distributor, service, and clinicăl.
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The Flowrest® software control system functions are as follows:
- 1. The user may or may not be able to adjust the flow and/or temperature settings and the ramp up increase/decrease of the delivered gas, depending on the physician's prescription. A patient may have full access or limited access. The Durable Equipment Supplier has the capability to preset through a secure mode the prescription flow values, temperature values, and ramp up (gradual increase to the full setting value of flow and temperature) through a USB software communication port on the flowrest.
- 2. The Liquid Crystal Display (LCD) screen will notify the user of reminders when to replace flowrest disposable components, such as, the cannula with tube, delivery tube, water tank, head gear, filter cartridge, ultra fine filter, and pollen filter.
- 3. The distributor/clinician/service center have access to the amount of time that a patient is continually using the Flowrest®.
- 4. The service center can access the sum of the time periods during which the Flowrest® is powered on and is in Patient Mode (called "usage hours"). Usage hours primarily monitor the aging of parts, such as the heaters and blower. The service center can us the USB port to upgrade the software.
- Note: The patient, distributor, service center, and clinician can only interact with preset software functions and can not access the software code.
- 5. The Flowrest® provides the ability to operate the system convenient to a clinical technician who may be located in a room away from the device and desires to minimize direct manipulation of the device.
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# Use Case Overview:
Image /page/4/Figure/3 description: The image is a use case diagram that shows the interactions between different actors and the system. The actors include Patient, Secure Mode Actor, and Sleep Center Software. The use cases include Change Airflow, Display Device Hours, Change Temperature, Display Compliance Hours, Upload Usage Info, Upload Device Info, Update Firmware, Start Airflow, Stop Airflow, Log In To Secure Features, Change Airflow Setting Config, Change Temp Setting Config, and Reset Compliance Hours. The diagram shows how the actors interact with the system to perform different tasks.
- Note: The term "actor" is used to identify a distributor, service, or clinician
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# Controls, Indicators & Connections:
#### LEFT VIEW
Image /page/5/Figure/4 description: The image shows a medical device with three callouts labeled 1, 2, and 3. Callout 1 points to an insulated delivery tube connected to the device. Callout 2 points to a circular component on the side of the device. Callout 3 points to a rectangular feature on the base of the device.
- . 1. Insulated delivery tube
- 2. Canister handle
- 3. USB port (for clinical/service use only)
RIGHT VIEW
Image /page/5/Figure/9 description: The image shows a medical device with labels. The labels point to different parts of the device. The labels are numbered 4, 5, and 6.
- Canister 4.
- 5. Heater plate
- દ. Power cord inlet
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______________________________________________________________________________________________________________________________________________________________________________
#### 3.3 MAIN UNIT CONTROL PANEL
Image /page/6/Picture/3 description: The image shows a control panel with several buttons and a display screen. The control panel has five buttons labeled with the numbers 1 through 5. The buttons include a power button, an up and down arrow, and an enter button. The display screen is located above the buttons.
- 1. On/Off
- 2. Decrease/Down
- 3. Increase/Up
- 4. Enter/Select
- 5. Liquid crystal display screen
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# Patient Interface:
The Flowrest® connects to the patient by a delivery tube, a headset and a cannula.
Delivery Tube
Image /page/7/Figure/5 description: The image shows a corrugated tube that is bent into a loop. The tube has two attachments on either end, labeled with the numbers 1 and 2. The attachment labeled 1 is a rectangular piece, while the attachment labeled 2 is a cylindrical piece with a nozzle.
- 1. Twist-lock connector
- 2. Swivel connector
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Image /page/8/Figure/11 description: This image shows a diagram of the Breathelite Cannula from a front view. The diagram includes a person's face with the cannula attached. There are labels and numbers pointing to different parts of the cannula, including the nasal cannula (1), left/right adapter (2), and other components (3, 4, 5).
- 3. Cannula Delivery Tube
- 4. Pliable Connector
- 5. Double Strap Fastener
# Breathelite™CANNULA SIDE VIEW
Image /page/8/Figure/7 description: The image shows a diagram of a CPAP mask and its components. The diagram labels five parts of the mask with numbers and corresponding descriptions. The labeled parts include the velcro fastener (1), head strap (2), neck strap (3), and other components (4, 5).
- 4. Cannula Delivery Tube
- 5. Tube Support
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# Performance Data
The Flowrest® meets the requirements of the following standards:
| Number | Standard Title | Description |
|--------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | ISO 10993-3:2003 | Biological Evaluation of Medical Devices Part 3:<br>-Tests for genotoxicity, carcinogenicity &<br>reproductive toxicity |
| 2 | ISO 10993-5:2009 | Biological evaluation of Medical Devices - Part<br>5: Tests for cytotoxicity |
| 3 | ISO 10993-10:2010 | Biological evaluation of Medical Devices - Part<br>10: Tests for irritation and skin sensitization |
| 4 | IEC 60601-1-<br>1:2009 | General Requirement for Safety<br>Exceptions: 1) Section 5, Does not contain<br>equipment to produce hazardous radiation 2)<br>Section 6, Not to be used with anesthetic<br>mixtures |
| 5 | EN 60601-1-2:2007 | Medical Electrical Equipment, Part 1: General<br>requirements for safety 2:Collateral standard:<br>Electromagnetic Compatibility - Requirements<br>and Test |
| 6 | EN 60601-1-4:2000 | Medical Electrical Equipment - Part 1: General<br>Requirements for Collateral Standard:<br>Programmable Electrical Medical Systems |
| 7 | IEC 529: IPX1 | Drip Proof |
| 8 | ISO 8185:2007 | Respiratory tract humidifiers for medical use -<br>Particular requirements for respiratory<br>humidification systems, Section 51.101 |
| 9 | ISO 14971:2007 | Medical Devices - Risk Analysis |
| 10 | EU Waste Disposal | Directive 2003/12/EC |
| 11 | NIOSH Manual of<br>Analytical Methods | Number 0500 Particulates not otherwise<br>regulated |
| 12 | EPA Compendium<br>Method TO-15 | Determination of VOCs in Air by GC/MS |
| 13 | ISO 13495:2003<br>Medical Devices | Quality Management Systems |
In all instances, the Flowrest® functioned as intended and the results observed were as expected.
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# Substantial Equivalence
The Flowrest® is as safe and effective as the predicate device, the Fisher Paykel Airvo™ Series Humidifier, 510(k) #K092846. The Flowrest® has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate device. The minor technological differences between the Flowrest® and its predicate device raise no new issues of safety or effectiveness. Thus, the Flowrest® is substantially equivalent.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is left-aligned. The background is plain white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gregory A. Whitney VP Regulatory Affairs Vapotherm, Incorporated 198 Log Canoe Circle Stevensville, Maryland 21666
Re: K103316
FEB - 8 201
Trade/Device Name: Flowrest® Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 5, 2010 Received: November 10, 2010
Dear Mr. Whitney:
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. 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. Register. Register
the country of the county of
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Page 2- Mr. Whitney
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
#### Enclosure
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#### Premarket Indication for Use Statement
510(k) Number (if known):
Device Name: Flowrest®
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, subacute and hospital settings.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
__ of ________________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Anesthesioloov Goneral Hospital Infection Control, Dental Devices
510(k) Number: 410 3316
