This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for single patient reuse in the home environment.

Device Description

The iCH CPAP with PVA 9S-007XXX Series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA). It is a modification of iCH CPAP 9S-007XXX (K120035) with the same algorithm of XT Auto with PVA 9S-005720 (K112079). It shares the same construction and auto adjustment algorithm with iCH CPAP 9S-007XXX but adds the identical Pressure Variation Algorithm with the predicate device XT Auto with PVA 9S-005720 (K112079). The Pressure Variation Algorithm provides a release pressure during expiration phase which is designed for patients who have difficulty exhaling against high CPAP pressure. It works by reducing the CPAP setting pressure in the normal breath status of expiratory phase from the treatment pressure in either CPAP or APAP mode.

A built-in heated humidifier of iCH CPAP with PVA 9S-007XXX Series are 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. The modified iCH CPAP series (with PVA) are from the iCH CPAP 9S-007XXX (K120035), but the algorithm for pressure variation algorithm(PVA) of the device comes from XT Auto with PVA (K112079).

The PVA Pressure Variation Alqorithm for the subject and predicated device (K112079) is an exhalation pressure relief function which is designed for patients who have difficulty exhaling against high CPAP pressure. Pressure can be reduced to three different levels (according to patient need) during the transition from Inspiration to Expiration phase. This reduced pressure level (depending on the PVA setting) will be maintained during Expiration phase and will return to the therapeutic pressure in the end of Expiration phase. In order to ensure the effectiveness of CPAP therapy, PVA will be automatically suspended if apneas are detected. After apneas disappear, PVA will re-start.

AI/ML Overview

The provided text describes a 510(k) summary for the iCH CPAP with PVA 9S-007XXX series, which is a modified version of an existing device. The summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study to prove acceptance criteria for a novel algorithm's performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory document. The focus here is on engineering verification and comparison to existing, cleared devices.

Here's an attempt to extract relevant information and note where the requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity for disease detection). Instead, it relies on design verification tests to ensure the modified device functions similarly and safely to the predicate devices. The "reported device performance" is framed as "equivalent" or "identical" to the predicate.

Device Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (vs. Predicate)
Intended User	Adult	Equivalent
Outlook & Construction	Be identical to Predicate 1 (K120035)	Identical to Predicate 1 (K120035)
Air Outlet	22mm	Equivalent (22mm)
User	Single-user, multi-use	Equivalent (Single-user, multi-use)
Operating Environment	Within +5 ~ 35 °C, 15 ~ 95% Non-condensing	Equivalent (+5 ~ 35 °C, 15 ~ 95% Non-condensing)
Pressure Range	4 ~ 20 cmH2O	Equivalent (4 ~ 20 cmH2O)
Pressure Increment	0.5 cmH2O	Equivalent (0.5 cmH2O)
Pressure Ramp Time	0~45 min, 5 minutes per step	Equivalent (0~45 min, 5 minutes per step)
Pressure Compensate	Yes	Equivalent (Yes)
Altitude Compensate	Yes	Equivalent (Yes)
Automatically Titrates Pressure in APAP mode	Yes (iCH Auto)	Identical (Yes, iCH Auto)
Expiration Pressure Release (PVA)	Yes, Three Constant Levels (1, 2, 3 cmH2O)	Identical to Predicate 2 (K112079) (Yes, Three Constant Levels (1, 2, 3 cmH2O))

Design Verification Tests Performed:

Safety and EMC: According to iCH CPAP 9S-007XXX series (K120035) verification procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1 & IEC 60601-1-2.
FDA Draft Reviewer Guidance for Ventilators (July 1995)
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
Side-by-side waveform testing: At various pressure and frequency levels with the predicate device(s).
Algorithm analysis (for PVA):
- Step function
- PVA waveform with different breathing frequencies and flow volumes
- PVA feature handling conditions of disordered breathing (apneas and hypopneas)
- PVA waveform upper and lower pressure control
- PVA pressure average and tolerance error
- Performance characteristics of PVA

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

This information is not provided in the document. The "test set" here refers to the engineering and algorithm verification tests, not a clinical trial with human subjects. The data provenance would be from internal testing, not patient data in the context of a clinical study.

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

This information is not provided. The ground truth for engineering tests is typically established by comparing the device's output to expected behavior based on specifications and predicate device performance, often using calibrated instruments.

4. Adjudication Method for the Test Set

This information is not provided. This refers to clinical adjudication, which is not described for these engineering/algorithm verification tests.

5. 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (CPAP machine for treating OSA) or its regulatory submission, which focuses on device functionality and substantial equivalence. This device does not involve "human readers" interpreting medical images or data with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, an algorithmic analysis was performed for the Pressure Variation Algorithm (PVA). The document states:

"Algorithm analysis; by comparing the test items as below:
- a. Step function
- b. PVA waveform with different breathing frequencies and flow volumes
- c. PVA feature handling conditions of disordered breathing (apneas and hypopneas)
- d. PVA waveform upper and lower pressure control
- e. PVA pressure average and tolerance error
- f. Performance characteristics of PVA"

This constitutes a standalone (algorithm-only) assessment of the PVA's expected behavior. However, it's an engineering verification, not a clinical standalone performance study.

7. The Type of Ground Truth Used

For the engineering and algorithm analysis tests, the ground truth would be based on:

Specifications and engineering requirements: For characteristics like pressure range, increment, ramp time, etc.
Predicate device performance: The behavior of the previously cleared XT Auto with PVA (K112079) served as the reference for the PVA algorithm's expected output.
Physiological models/simulations: To test responses to different breathing frequencies, flow volumes, and disordered breathing conditions.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is a hardware device with an algorithm for pressure variation, not a machine learning model that requires a "training set" in the conventional sense of AI/ML software. The algorithm is stated to be "the same algorithm of XT Auto with PVA 9S-005720 (K112079)," implying it was previously developed and validated.

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

This information is not applicable/provided for the reasons mentioned in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, with three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 6,2014

Apex Medical Corporation Mr. Alan Chang Vice President No. 9, Minsheng Street Tucheng, New Taipei City 23679 TAIPEI

Re: K141522

Trade/Device Name: iCH CPAP with PVA 9S-007XXX Series Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, Non-Continuous (Respirator) Regulatory Class: II Product Code: BZD Dated: September 2, 2014 Received: September 4, 2014

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno, DDS, mA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141522

Device Name

iCH CPAP with PVA 9S-007XXX Series

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510(k) Summary- iCH CPAP with PVA 9S-007XXX series

Date Prepared:	September 2, 2014
Applicant name:	Apex Medical Corp.
Contact Person:	Alan Chang
Address:	No.9, Min Sheng St., Tu-Cheng, New Taipei City, 23679, Taiwan
Phone number:	886-2-22683100
Fax numbers:	886-2-22686525
Device name	Trade name: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series
	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 iCH CPAP 9S-007XXX series (K120035)
	APEX MEDICAL XT Auto CPAP with PVA 9S-005720 (K112079)
Reason for Submission	Modification of original APEX MEDICAL iCH CPAP 9S-007XXX series

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Indications for Use:

Device Description:

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Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device(s)

Same intended use
Same operating principle
A Same technology
A Same manufacturing process

DeviceCharacteristic	iCH CPAP withPVA 9S-007XXXseries(New Device)	Predicate1iCH CPAP9S-007XXX(K120035)	Predicate2XT Auto withPVA 9S005720(K112079)	Comment
Intended user	Adult	Adult	Adult	Equivalent
Outlook &Construction	Image: iCH CPAP with PVA 9S-007XXX series	Image: iCH CPAP 9S-007XXX	Image: XT Auto with PVA 9S005720	Subject isidentical toPredicate 1(K120035),
Air Outlet	22mm	22mm	22mm	Equivalent
User	Single-user,multi-use	Single-user,multi-use	Single-user,multi-use	Equivalent
OperatingEnvironment	+5 ~ 35 °C15 ~ 95%Non-condensing	+5 ~ 36 °C10 ~ 95%	+5 ~ 35 °C15 ~ 95%Non-condensing	Equivalent
PressureRange	4 ~ 20 cmH2O	4 ~ 20 cmH2O	4 ~ 20 cmH2O	Equivalent
PressureIncrement	0.5 cmH2O	0.5 cmH2O	0.5 cmH2O	Equivalent
Pressure RampTime	0~45 min, 5minutes per step	0~45 min, 5minutes per step	0~45 min, 5minutes per step	Equivalent
PressureCompensate	Yes	Yes	Yes	Equivalent
AltitudeCompensate	Yes	Yes	Yes	Equivalent
AutomaticallyTitratesPressure inAPAP mode	Yes (iCH Auto)	YES (iCH Auto)	Yes	Identical

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DeviceCharacteristic	iCH CPAP withPVA 9S-007XXXseries(New Device)	Predicate1iCH CPAP9S-007XXX(K120035)	Predicate2XT Auto withPVA 9S005720(K112079)	Comment
ExpirationPressureRelease(PVA)	YesThree ConstantLevels (1, 2, 3cmH2O)	No	YesThree ConstantLevels(1,2,3cmH2O)	Subject isIdentical toPredicate2(K112079)

Table of comparison with predicate devices

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 follows:

(1) Safety and EMC: according to iCH CPAP 9S-007XXX series (K120035) verification procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1& IEC 60601-1-2.
FDA Draft Reviewer Guidance for Ventilators (July 1995) (2)
(3) FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
(4) Side by side waveform testing at various pressure and frequency levels with the predicate device(s).
(5) Algorithm analysis; by comparing the test items as below:
- a. Step function
- PVA waveform with different breathing frequencies and flow volumes b.
- C. PVA feature handling conditions of disordered breathing (apneas and hypopneas)
- PVA waveform upper and lower pressure control d.
- PVA pressure average and tolerance error e.
- f. Performance characteristics of PVA

In conclusion, the above tests demonstrate that the iCH CPAP with PVA 9S-007XXX Series is as safe, as effective, and performs as well as the predicate device - XT Auto CPAP with PVA 9S-005720 (K112079). The relevant test reports are described in this submission. Therefore, we state that the iCH CPAP with PVA 9S-007XXX Series is substantially equivalent to the predicate device - XT Auto CPAP with PVA 9S-005720 (K112079).

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).