(15 days)
No
The summary describes a mechanical device for humidifying oxygen and does not mention any AI or ML components or functions.
Yes.
The device's intended use is to add moisture to breathing gases for administration to a patient, indicating a therapeutic purpose related to patient care.
No
Explanation: The provided text describes the HUMIDIFLOW™ as a device intended to add moisture to breathing gases for patients, specifically by humidifying oxygen. Its function is to transfer humidity to the patient gas, and it is designed to be installed on oxygen concentrators. There is no mention of the device collecting, analyzing, or interpreting biological signals or data to diagnose- The device functions as a humidifier.
No
The device description clearly states it is a physical device that attaches to oxygen concentrators and operates as a mass exchanger, indicating it is a hardware device.
Based on the provided information, the HUMIDIFLOW™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HUMIDIFLOW™ Function: The HUMIDIFLOW™ is described as a device that adds moisture to breathing gases for administration to a patient. It operates as a mass exchanger to transfer humidity from room air to the patient gas.
- No Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The device interacts with the breathing gases being delivered to the patient, not with samples taken from the patient's body.
Therefore, the HUMIDIFLOW™ falls under the category of a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.
Product codes
BTT
Device Description
The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance characteristics that could be affected by the installation of the HUMIDIFLOW™ were identified for the various oxygen concentrators for which HUMIDIFLOW™ would be installed. The device was also measured for humidity output. All testing indicates that the device is substantially equivalent to the predicate device. The conclusions that can be drawn from the non-clinical testing are that the HUMIDIFLOW™ humidifier performs substantially equivalent as the predicate bubbler humidifier. The HUMIDIFLOW™ is biocompatible and manufactured with the identical membrane and adhesive components that are already used in other products we supply for gas flow path applications for the Puritan Bennett 840 ventilator subject of premarket notification K053388. The Polyester shell and endcaps used in the construction of the HUMIDIFLOW™ is identical to the Polvester shell used for a filter capsule provided to Respironics for the Millenium concentrator which was the subject of premarket notification K043006. Porous Media has also performed additional biocompatibility testing to show the HUMIDIFLOW™ is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5450 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
510(k) Summary
APPLICANT
Porous Media Corporation 1350 Hammond Road St. Paul, MN 55110 Telephone: 651-653-2000 Fax: 651-653-2230 Contact: Keith Roberts Title: Technical Business Development
DATE
6/20/06
NAME HUMIDIFLOW™ Humidifier
CLASSIFICATION
Respiratory gas humidifier, 21 CFR 868.5450, Class II
PRODUCT CODE
BTT
DEVICE DESCRIPTION
The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.
PREDICATE DEVICE
The Porous Media HUMIDIFLOW™ is substantially equivalent to the Allegiance bubble humidifier (subject of premarket notification K991484) and Salter Labs' bubbler (part number REF 7600) which has been on the market prior to 1976.
PERFORMANCE TESTING
Performance characteristics that could be affected by the installation of the HUMIDIFLOW™ were identified for the various oxygen concentrators for which HUMIDIFLOW™ would be installed. The device was also measured for humidity output. All testing indicates that the device is substantially equivalent to the predicate device.
INTENDED USE
Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.
1
| | HUMIDIFLOW™ | Predicate Device (Salter Labs
REF 7600) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Intended Use | For gas humidification | For gas humidification |
| Method of operation | Transfer of moisture vapor
from atmospheric air to dry
oxygen stream via diffusion | Transfer of moisture vapor and
droplets to dry gas stream via
bubble-through operation |
| Materials of
construction | ProprietaryShell/End Caps:
Nylon
O-ring: Buna-N
Tubing: USP Class VI,
flexible vinyl
Fittings: Nylon
Membrane: [redacted] | N/A |
| Method of installation | Installs on the inlet side of
the air compressor and
oxygen outlet | Installs on the outlet oxygen
stream |
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
CONCLUSIONS DRAWN FROM NON-CLINICAL TESTING
The conclusions that can be drawn from the non-clinical testing are that the HUMIDIFLOW™ humidifier performs substantially equivalent as the predicate bubbler humidifier. The HUMIDIFLOW™ is biocompatible and manufactured with the identical membrane and adhesive components that are already used in other products we supply for gas flow path applications for the Puritan Bennett 840 ventilator subject of premarket notification K053388. The Polyester shell and endcaps used in the construction of the HUMIDIFLOW™ is identical to the Polvester shell used for a filter capsule provided to Respironics for the Millenium concentrator which was the subject of premarket notification K043006. Porous Media has also performed additional biocompatibility testing to show the HUMIDIFLOW™ is biocompatible.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters. The text is arranged in a circular fashion around the eagle.
NOV 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Porous Media Corporation C/O Mr. Neil E. Devine Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087
Re: K062091
Trade/Device Name: Humidflow TM Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: July 21, 2006 Received: July 24, 2006
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of August 8, 2006.
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premiance results and the results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), nlease contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte y. Michael Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): N / A
Device Name: Humidflow TM
Indications For Use: Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient.
Prescription Use (Part 21 CFR 801 Sybpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Guy Sullivan
Division Sig , General Hospital, sthesiolog Division of A Infection Control, Der
510(k) Number:__
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