(133 days)
No
The summary describes a standard CPAP device with auto-adjusting pressure based on sensors, which is a common feature in non-AI/ML CPAP devices and is explicitly referenced to a predicate device (K032480) that predates widespread AI/ML in medical devices. There is no mention of AI, ML, or related concepts in the text.
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 described as providing continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA), which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "CPAP Model" and describes physical components like "pressure and flow sensor on the circuit," indicating it is a hardware device with integrated software, not a software-only medical 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 provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA). This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on delivering air pressure to treat a condition, not on analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances in the body for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to provide a physical therapy (air pressure) to manage a diagnosed condition.
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
73 BZD
Device Description
XT Auto CPAP Model 9S-005200 is intended to be used to delivery continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) for adult patients in the home environment. It is a modification of CPAP XT I MODEL 9S-005 (K070609) & RT2120 (K022650). It shares the same construction with XT-I but adds pressure and flow sensor on the circuit and has same downloading function as RT2120. As for the function of auto CPAP, it refers to the predicate Resmed Autoset Spirit (K032480).
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
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)
Design verification tests were performed on the new device with the predicate device(s) as a result of the risk analysis and product requirements. All 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
APEX MEDICAL XT1 CPAP MODEL 9S-005 (K070609), APEX MEDICAL CPAP RT 21XX (K022650), ResMed AutoSet Spirit CPAP (K032480)
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.
CPAP 9S-005200
、「
510(k) Summary- XT Auto CPAP 9S005200
Date Prepared: 8th December, 2008
| Applicant name: | Apex Medical Corp. | APR 22 2009 |
|---|---|---|
| Contact Person | Alan Chang | |
| Address: | 9, Min Sheng St. Tu-Cheng, Taipei County, Taiwan, R.O.C. | |
| Phone number: | 886-2-22683100 | |
| Fax numbers: | 886-2-222686525 | |
| Device name | Trade name: Apex medical XT Auto CPAP 9S-005200 | |
| Common name: CPAP | ||
| Classification name: | ||
| Non-continuous ventilator Class II in accordance with 21 CFR | ||
| 868.5905 | ||
| Classification | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | |
| Regulation Number: 868.5905 | ||
| Medical Specialty: Anesthesiology | ||
| Product Code: 73 BZD | ||
| Device Class: II | ||
| Predicate Device | APEX MEDICAL XT1 CPAP MODEL 9S-005 (K070609) | |
| APEX MEDICAL CPAP RT 21XX | (K022650) | |
| ResMed AutoSet Spirit CPAP | (K032480) | |
| Reason for | ||
| Submission | New Device |
E-I
1
Indications for Use:
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).
Device Description:
XT Auto CPAP Model 9S-005200 is intended to be used to delivery continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) for adult patients in the home environment. It is a modification of CPAP XT I MODEL 9S-005 (K070609) & RT2120 (K022650). It shares the same construction with XT-I but adds pressure and flow sensor on the circuit and has same downloading function as RT2120. As for the function of auto CPAP, it refers to the predicate Resmed Autoset Spirit (K032480).
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device(s)
- 公 Similar intended use
- A Similar operating principle
- A Similar technology
-
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. All 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is in black and white.
Public Health Service
APR 2 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Chang Director of President Office Apex Medical Corporation Number 9 Minsheng Street Tucheng City, Taipei County CHINA (TAIWAN) 236
Re: K083656
Trade/Device Name: XT Auto CPAP 9S-005200 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 6, 2009 Received: April 8, 2009
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 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.
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.
3
Page 2- Mr. Chang
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
Susan Runor
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
XT Auto CPAP 9S-005200 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).
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)
Susan Roger
Jision Sign-Off) ് ; ;Islon Sign-On)
Jivision of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number:
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