(133 days)
Not Found
No
The summary describes a standard CPAP device with a heated humidifier and does not mention any AI or ML capabilities. The performance studies focus on safety, EMC, vapor/particle analysis, and firmware validation, without any indication of AI/ML model training or testing.
Yes
The device is intended to treat obstructive sleep apnea (OSA) by providing continuous positive airway pressure (CPAP), which is a form of therapy.
No
This device is intended to treat obstructive sleep apnea by providing continuous positive airway pressure (CPAP), not to diagnose it.
No
The device description explicitly mentions a "built-in heated humidifier" and refers to "Safety and EMC" testing according to standards for electrical medical equipment (IEC 60601-1 & IEC 60601-1-2), indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device provides continuous positive airway pressure to the airway, which is a direct interaction with the patient's body, not an analysis of a specimen.
- The intended use and device description clearly state its purpose is to treat obstructive sleep apnea by providing air pressure. This is a therapeutic function, not a diagnostic one based on analyzing biological samples.
The information provided describes a medical device used for treatment, not for in vitro diagnostic testing.
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) for adult patients in the home environment.
Product codes
BZD
Device Description
9S-007XXX series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA) in home care environment. A built-in heated humidifier of 9S-007xxx series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.
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 patients
Intended User / Care Setting
home environment.
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)
APEX MEDICAL XT Auto CPAP MODEL 9S-005200 (K083656), APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664)
Reference Device(s)
Not Found
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).
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
Apex Medical Corp.
iCH CPAP 9S-007XXX
Special 510(k) Premarket Notification Section E - 510(k) Summary (Rev.004)
MAY 1 6 2012
510(k) Summary- iCH CPAP 9S-007XXX series
Date Prepared: December 30, 2011
k 120035
Applicant name: Apex Medical Corp. Contact Person Alan Chang 9, Min Sheng St. Tu-Cheng, Taipei County, Taiwan, R.O.C. Address: Phone number: 886-2-22683100 Fax numbers: 886-2-222686525 Device name Trade name: Apex medical iCH CPAP 9S-007XXX series Common name: CPAP Classification name: Non-continuous ventilator Class II in accordance with 21 CFR 868.5905 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Classification Regulation Number: 868.5905 Medical Specialty: Anesthesiology Product Code: 73 BZD Device Class: II Predicate Device APEX MEDICAL XT Auto CPAP MODEL 9S-005200 (K083656) APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664) Reason for New Device Submission
1
Indications for Use:
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA) for adult patients in the home environment.
Device Description:
9S-007XXX series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA) in home care environment. A built-in heated humidifier of 9S-007xxx series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device(s)
-
Similar intended use
- A Similar operating principle
-
Similar technology
- A Similar manufacturing process
Design verification tests were performed on the new device with the predicate device(s) as a result of the risk analysis and product requirements. The verified items are as following:
- (1) Safety and EMC: according to XT Auto CPAP (K083656) testing procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1 & IEC 60601-1-2.
- (2) Vapor/particle analysis: according to XT Auto CPAP (K083656) testing procedure and EPA PM2.5 as well as EPA TO-15.
- (3) Firmware validation activities: according to XT Auto CPAP (K083656) firmware validation procedures and "Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
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Above tests were verified to meet the required acceptance criteria. We have determined that the new device has the same safety and effectiveness features. In summary, the device described in this submission is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three swooping lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Alan Chang Senior Quality Director Apex Medical Corporation No. 9 Minsheng Street Tucheng City Taipei County 236, Taiwan ROC
MAY 1 6 2012
Re: K120035
Trade/Device Name: iCH CPAP 9S-007XXX Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 17, 2012 Received: April 23, 2012
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. Please note: CDRH does ' not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
th for
Anthony D. Watson, B.S., M.S., M.B.A. 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): Device Name: iCH CPAP 9S-007XXX Indications for Use:
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).
| Prescription Use | x |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR Over-The-Counter Use | |
| (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)
L. Schutter
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
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510(k) Number: K120035