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).

AI/ML Overview

The provided text is a 510(k) summary for the Apex Medical Corp. XT Auto CPAP 9S-005200. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria with reported performance metrics.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

Here's an analysis based on the information provided:

Acceptance Criteria and Reported Device Performance

The document states:
"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."

However, it does not explicitly list the specific acceptance criteria or the reported performance for each criterion. It only states that the tests met the criteria.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Study Details

Sample size used for the test set and the data provenance: Not specified. The document only mentions "design verification tests" without details on a test set size or data origin (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a CPAP machine, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm's performance. The "standalone" performance here would refer to the device's functional operation (e.g., pressure delivery, auto-adjustment features). The document indicates "design verification tests" were performed, implying functional validation, but no specific performance metrics are given.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
The sample size for the training set: Not applicable. This is a hardware device (CPAP), not an AI algorithm requiring a training set in the conventional sense.
How the ground truth for the training set was established: Not applicable.

Summary of Limited Information

The 510(k) summary for the XT Auto CPAP 9S-005200 focuses on establishing substantial equivalence to previously cleared predicate devices (APEX MEDICAL XT1 CPAP MODEL 9S-005, APEX MEDICAL CPAP RT 21XX, and ResMed AutoSet Spirit CPAP). The logic for equivalence is based on:

Similar intended use
Similar operating principle
Similar technology
Similar manufacturing process

The document states that "Design verification tests were performed on the new device... All tests were verified to meet the required acceptance criteria," but it does not provide specifics on these criteria, the study design, or the performance results. This type of submission typically demonstrates functional equivalence through engineering tests rather than clinical performance studies that would involve human subjects and ground truth establishment by experts for diagnostic accuracy.

Summary

{0}------------------------------------------------

K083656

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 CFR868.5905
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 forSubmission	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:

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:

Page 1 of 1

D-1

Regulation Number and Section

§ 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).