(23 days)
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No
The summary does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA), which is a therapeutic purpose.
No
The device is intended to provide continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea, not for diagnosis.
No
The intended use clearly describes a device providing continuous positive airway pressure (CPAP), which is a hardware-based therapy requiring a physical device to deliver air pressure. The summary does not mention any software-only function related to this therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA). This is a therapeutic device that directly interacts with the patient's airway to treat a condition.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
- Anatomical Site: The anatomical site is the airway, which is where the device delivers the therapy, not where a sample is taken for analysis.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).
Product codes (comma separated list FDA assigned to the subject device)
BZD
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
airway
Indicated Patient Age Range
adult
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): 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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§ 868.5905 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 a logo with a circular border containing text, surrounding a stylized symbol. The text around the border appears to be "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol consisting of three curved lines, resembling a stylized bird or a swooping shape. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
Mr. Alan Chang Quality Assurance Director Apex Medical Corporation 9. Min Sheng Street Tu-Cheng. Taipei County, 236 TAIWAN, R.O.C.
Re: K041828
Trade/Device Name: Apex Medical CPAP Model 9S-003 Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 1, 2004 Received: July 7, 2004
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.
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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 mour that I D. Fine has or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not I vartal 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 110(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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chin 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
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Indications for Use
510(k) Number (if known): __
CPAP 9S-003 Device Name:
Indications for Use:
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use ___ x _______________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (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)
Page 1 of 1
Ouen Sylevan
(Division Sign-OK Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number: