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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Medical Corp. iCH CPAP 9S-007XXX device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly detail specific quantitative acceptance criteria or corresponding reported device performance values in a table format. Instead, it relies on a comparison to a predicate device and adherence to established regulatory standards and testing procedures.

The text states: "Above tests were verified to meet the required acceptance criteria." This indicates that the device did meet criteria, but the specific numerical values of these criteria are not provided in this summary.

Here's a generalized table based on the information available:

Type of Test/Criterion	Acceptance Criteria (General)	Reported Device Performance
Safety	Compliance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) and FDA reviewer guidance 638.pdf (related to safety for similar devices).	Met. "Above tests were verified to meet the required acceptance criteria."
EMC	Compliance with IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests).	Met. "Above tests were verified to meet the required acceptance criteria."
Vapor/Particle Analysis	Compliance with XT Auto CPAP (K083656) testing procedure and EPA PM2.5 (particulate matter 2.5 micrometers or less in diameter) as well as EPA TO-15 (a method for the determination of volatile organic compounds in ambient air).	Met. "Above tests were verified to meet the required acceptance criteria."
Firmware Validation	Compliance with 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." (This would involve testing for proper functionality, reliability, and security of the device's software.)	Met. "Above tests were verified to meet the required acceptance criteria."
Substantial Equivalence	Similarities to predicate device in intended use, operating principle, technology, and manufacturing process.	Met. Declared substantially equivalent to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document describes design verification tests performed on the new device, comparing it to predicate devices. However, it does not provide details on:

Sample size: No specific number of devices or test iterations is mentioned for any of the verification tests (safety, EMC, vapor/particle, firmware).
Data Provenance: The document doesn't specify the country of origin of the data or whether the data was retrospective or prospective. Given that these are design verification tests, they would be conducted in a controlled lab or manufacturing environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not describe the use of human experts to establish "ground truth" for the test set. The tests performed are engineering and regulatory compliance validations (e.g., electrical safety, electromagnetic compatibility, firmware functionality, particle emissions). These would be evaluated against pre-defined engineering specifications, regulatory standards, and established laboratory protocols, rather than expert consensus on diagnostic accuracy.

4. Adjudication Method for the Test Set

As the "test set" consists of engineering and regulatory compliance tests, there is no mention of an adjudication method (like 2+1 or 3+1). The "ground truth" here is objective compliance with specified standards or successful execution of pre-defined procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was performed or mentioned. This submission is for a CPAP device, which is a therapeutic device for sleep apnea, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable to this device or its submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm or AI system. It is a physical medical device (CPAP machine). Therefore, a standalone algorithm performance study is not applicable. The performance is assessed based on its physical and electrical characteristics as per the verification tests.

7. The Type of Ground Truth Used

For the design verification tests (safety, EMC, vapor/particle, firmware), the "ground truth" is based on:

Regulatory Standards: IEC 60601-1, IEC 60601-1-2.
Environmental Standards: EPA PM2.5, EPA TO-15.
FDA Guidance Documents: FDA reviewer guidance 638.pdf, "Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Predicate Device Testing Procedures: The testing procedures established and validated for the APEX MEDICAL XT Auto CPAP MODEL 9S-005200 (K083656) and APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664).

Essentially, the ground truth is compliance with established engineering, safety, and regulatory benchmarks.

8. The Sample Size for the Training Set

This device does not use machine learning or AI algorithms that require a "training set." Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, this question is not applicable.

Summary

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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

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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:

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.

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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.

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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 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

Page 1 of 1

D-1

510(k) Number: K120035

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).