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K Number
K103316
Device Name
FLOWREST
Manufacturer
VAPOTHERM, INC.
Date Cleared
2011-02-08

(90 days)

Product Code
BTT
Regulation Number
868.5450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Description
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. 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, yet 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.
More Information

K092846

Not Found

No
The description focuses on mechanical and software control of flow rate and temperature based on ambient conditions, without mentioning any learning or adaptive algorithms.

Yes
The device is intended for treating patients and delivers warmed, humidified, high-flow respiratory gases, which is a therapeutic intervention.

No
The device delivers warmed, humidified high-flow breathing gases for treatment, not for diagnosis.

No

The device description clearly outlines multiple hardware components including a blower, heater, humidifier, breathing circuit, and cannula. While software controls some functions, it is an integral part of a physical medical device.

Based on the provided information, the Flowrest® is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the Flowrest® is for "treating spontaneously breathing patients who require warmed and humidified high-flow respiratory gases." This describes a therapeutic intervention delivered directly to the patient, not a test performed on a sample taken from the body.
  • Device Description: The description details a system for delivering heated and humidified air to the patient's respiratory tract. It involves a blower, heater, humidifier, and breathing circuit. This is consistent with a respiratory support device, not a diagnostic test.
  • Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information. There is no mention of reagents, assays, or any form of in vitro analysis.

Therefore, the Flowrest® is a medical device used for respiratory therapy, not an IVD.

N/A

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.

Product codes (comma separated list FDA assigned to the subject device)

BTT

Device Description

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. 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.

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.

  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.
  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.

Controls, Indicators & Connections:
LEFT VIEW

  1. Insulated delivery tube
  2. Canister handle
  3. USB port (for clinical/service use only)

RIGHT VIEW
4. Canister
5. Heater plate
6. Power cord inlet

MAIN UNIT CONTROL PANEL

  1. On/Off
  2. Decrease/Down
  3. Increase/Up
  4. Enter/Select
  5. Liquid crystal display screen

Patient Interface:
The Flowrest® connects to the patient by a delivery tube, a headset and a cannula.
Delivery Tube:

  1. Twist-lock connector
  2. Swivel connector

Breathelite Cannula:

  1. nasal cannula
  2. left/right adapter
  3. Cannula Delivery Tube
  4. Pliable Connector
  5. Double Strap Fastener

Breathelite™ CANNULA SIDE VIEW:

  1. velcro fastener
  2. head strap
  3. neck strap
  4. Cannula Delivery Tube
  5. Tube Support

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Respiratory tract

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Homecare, subacute and hospital settings.

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)

The Flowrest® meets the requirements of the following standards:

  1. ISO 10993-3:2003 Biological Evaluation of Medical Devices Part 3:-Tests for genotoxicity, carcinogenicity & reproductive toxicity
  2. ISO 10993-5:2009 Biological evaluation of Medical Devices - Part 5: Tests for cytotoxicity
  3. ISO 10993-10:2010 Biological evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
  4. IEC 60601-1-1:2009 General Requirement for Safety Exceptions: 1) Section 5, Does not contain equipment to produce hazardous radiation 2) Section 6, Not to be used with anesthetic mixtures
  5. EN 60601-1-2:2007 Medical Electrical Equipment, Part 1: General requirements for safety 2:Collateral standard: Electromagnetic Compatibility - Requirements and Test
  6. EN 60601-1-4:2000 Medical Electrical Equipment - Part 1: General Requirements for Collateral Standard: Programmable Electrical Medical Systems
  7. IEC 529: IPX1 Drip Proof
  8. ISO 8185:2007 Respiratory tract humidifiers for medical use - Particular requirements for respiratory 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 Analytical Methods Number 0500 Particulates not otherwise regulated
  12. EPA Compendium Method TO-15 Determination of VOCs in Air by GC/MS
  13. ISO 13495:2003 Medical Devices Quality Management Systems

In all instances, the Flowrest® functioned as intended and the results observed were as expected.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K092846

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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

1

Predicate Device:

#ManufacturerTrade Name510(k)
1Fisher Paykel
HealthcareAirvo Series HumidifierK092846

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.

2

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.

3

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.
    1. 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.
    1. The distributor/clinician/service center have access to the amount of time that a patient is continually using the Flowrest®.
    1. 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.
    1. 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.

4

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

5

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
    1. Canister handle
    1. 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.
    1. Heater plate
  • દ. Power cord inlet

6

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
    1. Decrease/Down
    1. Increase/Up
    1. Enter/Select
    1. Liquid crystal display screen

7

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
    1. Swivel connector

8

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).

    1. Cannula Delivery Tube
    1. Pliable Connector
    1. 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).

    1. Cannula Delivery Tube
    1. Tube Support

9

Performance Data

The Flowrest® meets the requirements of the following standards:

NumberStandard TitleDescription
1ISO 10993-3:2003Biological Evaluation of Medical Devices Part 3:
-Tests for genotoxicity, carcinogenicity &
reproductive toxicity
2ISO 10993-5:2009Biological evaluation of Medical Devices - Part
5: Tests for cytotoxicity
3ISO 10993-10:2010Biological evaluation of Medical Devices - Part
10: Tests for irritation and skin sensitization
4IEC 60601-1-
1:2009General Requirement for Safety
Exceptions: 1) Section 5, Does not contain
equipment to produce hazardous radiation 2)
Section 6, Not to be used with anesthetic
mixtures
5EN 60601-1-2:2007Medical Electrical Equipment, Part 1: General
requirements for safety 2:Collateral standard:
Electromagnetic Compatibility - Requirements
and Test
6EN 60601-1-4:2000Medical Electrical Equipment - Part 1: General
Requirements for Collateral Standard:
Programmable Electrical Medical Systems
7IEC 529: IPX1Drip Proof
8ISO 8185:2007Respiratory tract humidifiers for medical use -
Particular requirements for respiratory
humidification systems, Section 51.101
9ISO 14971:2007Medical Devices - Risk Analysis
10EU Waste DisposalDirective 2003/12/EC
11NIOSH Manual of
Analytical MethodsNumber 0500 Particulates not otherwise
regulated
12EPA Compendium
Method TO-15Determination of VOCs in Air by GC/MS
13ISO 13495:2003
Medical DevicesQuality Management Systems

In all instances, the Flowrest® functioned as intended and the results observed were as expected.

10

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.

11

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

12

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

13

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