(25 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The description is solely for a physical CPAP mask.
Yes
The device is intended for the "treatment of adult obstructive sleep apnea," which is a therapeutic purpose.
No
Explanation: The device is a Nasal CPAP Mask intended for treatment, not diagnosis, of obstructive sleep apnea.
No
The device description explicitly states "iMask TM Nasal CPAP Mask", indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a nasal CPAP mask. Its intended use is to deliver positive airway pressure for the treatment of obstructive sleep apnea. It interacts directly with the patient's airway to facilitate breathing, not to analyze biological samples.
The description clearly indicates a medical device used for therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea.
Product codes
BZD
Device Description
iMask™ Nasal CPAP Mask
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
adult
Intended User / Care Setting
Environment of Use: The mask is intended for single patient use, or multiple patient use with proper high level disinfection. The mask may be reprocessed per the high level disinfection procedure, by clinical institutions only.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus-like symbol consists of three curved lines that converge at the bottom.
JUL - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Dielmann Vice President, RA/QA Vital Signs Colorado, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112
Re: K051559
Trade/Device Name: iMask™ Nasal CPAP Mask Regulation Number: 21 CFR 868. 5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 7, 2005 Received: June 15, 2005
Dear Mr. Dielmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ea your entermined 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 the Fouchar F USA). You may, therefore, market the device, subject to the general approvisions 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 (1 Nr.), it may be back of Federal Regulations, Title 2 i, Parts 800 to 898. In your device can or routlish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Dielmann
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 mean that I DA nas made a acteriand regulations administered by other Federal agencies. of the Act of ally I ederal backed and squirements, including, but not limited to: registration 1 od inust comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), laceling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality sjockers (Sections (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) This letter will anow you to began finding of substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific at no for pliance 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 may obtain other general and Consumer Assistance at its toll-free Diviber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chu Lin, Ph.D.
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: | K |
|---|---|
| Device Name: | iMask TM Nasal CPAP Mask |
| Indications For Use: | This device is intended to be used with positive airway pressure devices operating at or above 4cmH 2 O for the treatment of adult obstructive sleep apnea. |
| Environment of Use: | The mask is intended for single patient use, or multiple patient use with proper high level disinfection. The mask may be reprocessed per the high level disinfection procedure, by clinical institutions only. |
| Prescription Use (per 21 CFR 801 Subpart D) | X AND/OR Over-The-Counter Use ________ |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number. | K051559 |
SECTION 8 Page 1 of 1
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