(90 days)
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Not Found
No
The summary describes a heated humidifier for a CPAP system, focusing on increasing air humidity. There are no mentions of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is intended to relieve symptoms (dry nose and throat), which is a therapeutic function.
No
The device is described as a heated humidifier for a CPAP system, designed to increase air humidity and relieve symptoms of dry nose and throat. It does not perform any diagnostic function.
No
The device description is not available, but the intended use clearly describes a "Heated Humidifier" which is a hardware component used with a CPAP system. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to increase the humidity of air from a CPAP system to relieve symptoms of a dry nose and throat. This is a therapeutic function, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not interact with bodily samples for diagnostic purposes.
The device is a humidifier, which is an accessory to a CPAP system used for respiratory therapy.
N/A
Intended Use / Indications for Use
HumidCare Heated Humidifier is for use with Apex Medical Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.
Product codes (comma separated list FDA assigned to the subject device)
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
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)
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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.
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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.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Chang Management Representative/Director of President Office Apex Medical Corporation No. 9, Min Sheng Street, Tucheng City Taipei County 236, TAIWAN, R.O.C.
DEC - 6 2006
Re: K062664
Trade/Device Name: HumidCare Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 7, 2006 Received: November 9, 2006
Dear Mr. Chang:
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.
1
Page 2 - Mr. Chang
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 legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0120. 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,
Clu C
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
2
Indications for Use
510(k) Number (if known): 062664
HumidCare Heated Humidifier Device Name:
HumidCare Heated Humidifier is for use with Apex Medical Indications for Use:
Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the
CPAP thereby relieving the symptoms of a dry nose and throat that some people may
experience.
Prescription Use _ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qul
1 Sen-Cin of Anesthesiology, General Hospital, n Control, Dental Devic
KOLLEGE
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