(728 days)
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None
No
The summary describes a humidifier, a device that typically does not incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets which would indicate the presence of such technology.
No
A therapeutic device is used to treat a disease or condition. This device is intended to add moisture and warm breathing gases, which is a supportive function rather than a direct treatment.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended to add moisture and to warm the breathing gases for administration to a patient." This describes a therapeutic or supportive function, not a diagnostic one. Diagnostic devices are used to identify or monitor medical conditions.
No
The intended use describes a device that adds moisture and warms breathing gases, which inherently requires hardware components to perform these functions. The summary does not mention any software-only aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "add moisture and to warm the breathing gases for administration to a patient." This describes a device that interacts directly with the patient's breathing system, not a device used to examine specimens taken from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device described is a therapeutic device used to condition breathing gases for patient comfort and potentially clinical benefit, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.
Product codes
73 BTT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 20
Mr. Ken Miller Pegasus Research Corporation 1714 South Lyon Street Santa Ana, CA 92705
K983783 Re: Heated Humidifier Regulatory Class: II (two) 73 BTT Product Code: Dated: September 19, 2000 September 20, 2000 Received:
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosi and we have determined the device is the device releived above and a indications for use stated in the Substantially equivalens (collected predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Intelstate Commerce prior of the devices that have been reclassified Medical Device Amendales, of the Federal Food, Drug, and in accordance with the provisions of the market the device, subject to the general controls provisions of the Act. The general controls the general concrols provisions of the manual registration, provisions of the ... o od manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device is class III (Premarket Approval), it may be subject to such controls) of Clabo III (Freman major regulations affecting your device add cronar concern the Code of Federal Regulations, Title 21, Parts 800 can be round in choise determination assumes compliance co oss. If babbeansed to the entire requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regaracter.
The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in abounpeasin. concerning your device in the Federal Register. Please note: this cesponse to your premarket notification submission does not affect any rebbense to your promave under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Ken Miller
This letter will allow you to begin marketing your device as described This letter will allow you co begin marketing your advace of substantial
in your 510(k) premarket notification. The Finding of substantial in your 510(K) premarket notification. I marketed predicate device equivalence of your device to a regardy
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 If you desire specific advice for your router for in vitro regulation (21 Crk Fart our and the Office of Compliance at diagnostic devices), preace contact constions on the promotion and (301) 594-4648. AdditIonally, for quoters' on 665 - of Compliance at
advertising of your device, please contact and the entitled advertising of your device, prease the regilation entitled, and to response of .
(101) 594–4639. Also, please, note the regilation entitled, and .97) .
"Misbranding by refere "Misbranding by reference on your responsibilities under the Act may Other general Information on your seall Manufacturers Assistance at its internet be obtained Irom the Drision of Email (193–6597, or at its internet correllee number (000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sincerely yours,
/.plm
James/E. Dillard III Diredtor Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510K NUMBER: K983783
DEVICE NAME: PATIENT-END HUMIDIFIER
INDICATIONS FOR USE:
The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devi
K983783
Prescription Use _X (Per CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________