(15 days)
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.
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.
While the provided text describes the HUMIDIFLOW™ Humidifier and its substantial equivalence to predicate devices, it does not contain the detailed information required to fill out all the acceptance criteria and study details as requested. The summary focuses on technological characteristics and biocompatibility, not performance metrics directly tied to numerical acceptance criteria.
However, I can extract the available information and indicate where details are missing based on the prompt's requirements.
Here's a breakdown of what can be inferred and what is explicitly not available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "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."
This statement implies that some performance metrics related to "humidity output" were measured and compared. However, it does not provide specific numerical acceptance criteria (e.g., minimum humidity level, maximum humidity variability) or the reported device performance against those criteria. It only states that the device was found to be "substantially equivalent" to the predicate.
| Acceptance Criteria (e.g., specific humidity output range) | Reported Device Performance (e.g., measured humidity output) |
|---|---|
| Not specified in the document. The document only states that "Performance characteristics... were identified" and "measured for humidity output." | Not specified in the document. The document only states "All testing indicates that the device is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified.
- Data provenance: Not specified. (The testing was likely internal to Porous Media Corporation, but no details are given.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is generally relevant for studies involving subjective interpretation (e.g., medical imaging). For a device like a humidifier, "ground truth" would typically refer to objective measurements using calibrated equipment (e.g., hygrometers). The document does not describe the use of human experts to establish ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as there's no indication of human expert interpretation or a need for adjudication in the context of humidifier performance testing presented.
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
- MRMC study: Not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools, which the HUMIDIFLOW™ is not.
- Effect size of human readers: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The HUMIDIFLOW™ is a physical device, not an algorithm. Therefore, "standalone" performance testing would refer to the device's intrinsic mechanical and humidification performance. The document states that "The device was also measured for humidity output," indicating standalone testing, but no specific results are provided beyond the general claim of substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a humidifier, ground truth would be established through objective physical measurements of humidity, temperature, and potentially airflow using calibrated sensors and instrumentation. The document implies this type of measurement was done ("measured for humidity output") but doesn't detail the specific methods or equipment used to establish this "ground truth."
8. The sample size for the training set
This is not applicable as the HUMIDIFLOW™ is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical device.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence primarily through technological characteristics and biocompatibility, rather than detailed quantitative performance studies with specific acceptance criteria and outcome measurements typical for AI/ML devices or complex diagnostic tools.
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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.
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| HUMIDIFLOW™ | Predicate Device (Salter LabsREF 7600) | |
|---|---|---|
| Intended Use | For gas humidification | For gas humidification |
| Method of operation | Transfer of moisture vaporfrom atmospheric air to dryoxygen stream via diffusion | Transfer of moisture vapor anddroplets to dry gas stream viabubble-through operation |
| Materials ofconstruction | ProprietaryShell/End Caps:NylonO-ring: Buna-NTubing: USP Class VI,flexible vinylFittings: NylonMembrane: [redacted] | N/A |
| Method of installation | Installs on the inlet side ofthe air compressor andoxygen outlet | Installs on the outlet oxygenstream |
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.
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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
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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:__
Page 1 of
§ 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).