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 modified iCH CPAP with PVA 9S-007XXX Series is a modification of predicate iCH CPAP with PVA 9S-007XXX (K141522). It changed the material of impeller as well as PCB layout compare to the predicate device. A built-in heated humidifier of iCH CPAP with PVA 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

The provided text describes a 510(k) premarket notification for a medical device, the iCH CPAP with PVA 9S-007XXX Series. This is a modified version of a previously cleared predicate device (K141522). The document focuses on demonstrating substantial equivalence to the predicate device, rather than proving the device meets acceptance criteria in the sense of a clinical performance study with specific metrics like sensitivity or specificity.

Instead, the "acceptance criteria" here are defined by compliance with recognized standards and successful performance of a suite of engineering and functional tests designed to show that the modified device performs as safely and effectively as the predicate. The study described is a design verification and comparison study against a predicate device.

Here's a breakdown based on your request, interpreting "acceptance criteria" as the performance benchmarks and regulatory compliance targets set by the referenced standards and the comparison with the predicate device.

Acceptance Criteria and Reported Device Performance

The document doesn't present a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it establishes acceptance by demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards.

The "acceptance criteria" implicitly include:

Compliance with various safety, EMC, and performance standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 17510-1, ISO 8185).
Demonstration that changes (impeller material, PCB layout) do not negatively impact the device's safety or effectiveness compared to the predicate.
Successful completion of design verification tests, including (but not limited to):
- Safety and EMC tests
- Firmware Validation
- Noise Test
- Performance Tests (Pressure Long-term Stability, Dynamic Pressure Stability, Static Pressure Stability, Maximum Temperature, Maximum Flow, Limitation of Maximum Pressure, Overflow Test, Expected Useful Life Validation)
- Humidification Performance
- PVA Function Comparison Test (Endurance Operation, Dynamic Testing, APAP Auto titration & AHI Test, PVA Waveform comparison, PVA feature handling disordered breathing, PVA Waveform upper and lower pressure control, PVA Pressure Average and Tolerance Error, Performance Characteristics of PVA Comparison)
- Biocompatibility Assessment
- Particle Test
- VOC Test

The reported device performance is that the "modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards" and the "above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."

No specific numerical performance metrics (e.g., accuracy percentages, error rates) are provided in this summary, as the focus is on equivalence and compliance, not novel clinical performance claims.

Study Details

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicitly from Standards & Predicate Comparison):
  - Safety and EMC compliance (ANSI/AAMI ES60601-1, IEC 60601-1-2)
  - Firmware validation according to FDA guidance.
  - Noise levels within acceptable limits (ISO 11201, ISO 7779).
  - Performance (pressure stability, flow, temperature, maximum pressure limitation) meets ISO 17510-1.
  - Humidification performance meets ISO 8185.
  - PVA function comparable to predicate (Endurance, Dynamic, APAP Auto titration & AHI, Waveform, disordered breathing handling, pressure control, average/tolerance error, performance characteristics).
  - Biocompatibility (ISO 10993 series).
  - Particle and VOC emissions meet US EPA standards.
  - Overall substantial equivalence to predicate device (K141522) in terms of intended use, operating principle, technology, and manufacturing process.
- Reported Device Performance:
  - "The modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards..."
  - "...the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522)."
  - Specific comparative details were provided (e.g., intended user, air outlet, user, operating environment, pressure range, increment, ramp time, pressure/altitude compensate, APAP mode, PVA, alarm system) showing equivalence.
Sample size used for the test set and the data provenance
- The document does not specify sample sizes in terms of patient data or clinical cases. This is primarily an engineering and performance verification study, likely using a limited number of device units for testing against established standards and the predicate.
- The data provenance is not explicitly mentioned as a clinical study with patients; rather, it refers to laboratory testing and design verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of this engineering and predicate comparison study. "Ground truth" here is defined by compliance with recognized standards and the performance of the predicate device. The experts involved would be engineers and technical specialists conducting the tests, not clinical adjudicators establishing a diagnostic ground truth from patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study involving human interpretation of results requiring adjudication. Performance is assessed against quantitative engineering specifications and comparative data to the predicate.
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-powered diagnostic tool. No MRMC studies were conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a standalone medical device (CPAP machine) but not an "algorithm only" device in the context of AI/ML. Its performance is measured directly through engineering tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is implicitly established by:
  - Recognized International and National Standards: e.g., ISO 17510-1 for sleep apnea breathing therapy equipment, ISO 8185 for humidifiers, ISO 10993 series for biocompatibility, etc.
  - The Performance of the Predicate Device: The modified device's performance is compared directly to its legally marketed predecessor (K141522) to demonstrate substantial equivalence.
The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a "training set."
How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device submission.

Summary

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

September 15, 2015

Apex Medical Corp. Mr. Frank Lin Director of Quality Management Division No. 9, Min Sheng St. Tu-Cheng District New Taipei City, 23679 Taiwan

Re: K150111

Trade/Device Name: iCH CPAP with PVA 9S-007XXX Series Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (Ippb) Regulatory Class: Class II Product Code: BZD Dated: August 14, 2015 Received: August 17, 2015

Dear Mr. Frank Lin:

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.

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

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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

Enclosure

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Indications for Use

510(k) Number (if known) K150111

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)

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

Date Prepared: 8/14/2015

Applicant name:	Apex Medical Corp.
Contact Person:	Frank Lin
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: BZD
	Device Class: II
Predicate Device	APEX MEDICAL CORP. iCH CPAP with PVA 9S-007XXX series (K141522)
Reason for Submission	Modification of original APEX MEDICAL CORP. iCH CPAP with PVA 9S-007XXX series

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Indications for Use

Device Description

Substantial Equivalence

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

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

DeviceCharacteristic	ModifiediCH CPAP with PVA9S-007XXX series(New Device)	PredicateiCH CPAP with PVA9S-007XXX(K141522)	Comment
Intended user	Adult	Adult	Equivalent
Air Outlet	22mm	22mm	Equivalent
User	single patient reuse	single patient reuse	Equivalent
Operating Environment	+5 ~ 35℃15 ~ 95%Non-condensing	+5 ~ 35℃15 ~ 95%Non-condensing	Equivalent
Pressure Range	4 ~ 20 cmH2O	4 ~ 20 cmH2O	Equivalent

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DeviceCharacteristic	ModifiediCH CPAP with PVA9S-007XXX series(New Device)	PredicateiCH CPAP with PVA9S-007XXX(K141522)	Comment
Pressure Increment	0.5 cmH2O	0.5 cmH2O	Equivalent
Pressure Ramp Time	0~45 min, 5 minutesper step	0~45 min, 5 minutesper step	Equivalent
Pressure Compensate	Yes	Yes	Equivalent
Altitude Compensate	Yes	Yes	Equivalent
Automatically TitratesPressure in APAP Mode	Yes (iCH Auto)	Yes (iCH Auto)	Equivalent
Expiration PressureRelease(PVA)	YesThree ConstantLevels (C1, C2, C3)	YesThree ConstantLevels (C1, C2, C3)	Equivalent
Alarm System	Error 001~~005Warning 001~~007,Low P	Error 001~~005Warning 001~~007,Low P	Equivalent
Impeller Material ofBlower	Plastic	Aluminum	Equivalent
Power Supply	60W (DC 24V, 2.5A)	90W (DC 24V, 3.75A)	Equivalent
Heater Platform	60W (DC 24V, 2.5A)	90W (DC 24V, 3.75A)	Equivalent

Table of comparison with predicate devices

Design verification tests were performed on the new device(s) based on the risk analysis and product requirements. In addition, the PVA function test was conducted with predicate device(s). The verified items are as follows:

(1) Safety and EMC: according to ANSI/AAMI ES60601-1: 2005+C1:09+A2:10, IEC 60601-1-2: 2007 (Edition 3) and FDA reviewer guidance 638 (Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch (includes EMI standard)).
Firmware Validation: FDA Guidance for the Content of Premarket Submissions (2) for Software Contained in Medical Devices (May 11, 2005)
Noise Test (Refer to ISO 11201:2010/ ISO 7779:2010) (3)
Performance Tests (Refer to ISO 17510-1:2007): (4)
- a) Pressure Long-term Stability Test
- b) Dynamic Pressure Stability
- c) Static Pressure Stability
- d) Maximum Temperature

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e) Maximum Flow
Limitation of Maximum Pressure f)
g) Overflow Test
h) Expected Useful Life Validation
Humidification Performance (Refer to ISO 8185:2007) i)
PVA Function Comparison Test (5)
- a) Endurance Operation and Dynamic Testing (Refer to ISO 17510-1:2007)
- b) APAP Auto titration & AHI Test
- c) The comparison for PVA Waveform with different breathing frequencies and flow volumes
- d) PVA feature handling conditions of disordered breathing (apneas and hypopneas)
- e) The comparison for PVA Waveform upper and lower pressure control
- Comparison for PVA Pressure Average and Tolerance Error f)
- g) Performance Characteristics of PVA Comparison
Biocompatibility Assessment (6)
- a) Genotoxicity, Carcinogenicity and reproductive toxicity test (ISO 10993-3:2003)
- b) In vitro cytotoxicity test (ISO 10993-5:2009)
- c) Implantation test (ISO 10993-6:2007)
- d) Irritation and skin sensitization (ISO 10993-10:2010)
- e) Systemic toxicity (ISO 10993-11:2006)
Particle Test: Refer US EPA PM2.5:1997 (7)
VOC Test: Refer US EPA TO-15:1999 (8)

The modified iCH CPAP with PVA 9S-007XXX Series complies with the applicable voluntary and mandatory standards as following:

(1) ANSI/AAMI ES60601-1:2005+C1:09+A2:10. Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (FDA recognition number: 19-5)
(2) IEC 60601-1-2:2007. Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (FDA recognition number: 19-1)
(3) FDA reviewer guidance 638 (Excerpts Related to EMI from November 1993

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Anesthesiology and Respiratory Devices Branch (includes EMI standard)

(4) FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
(5) ISO 5367:2000. Breathing tubes intended for use with anaesthetic apparatus and ventilators. (FDA recognition number: 1-46)
(6) ISO 11201:2010. Noise emitted by machinery and equipment -- Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections.
(7) ISO 7779:2010. Measurement of airborne noise emitted by information technology and telecommunications equipment.
(8) ISO 17510-1:2007. Sleep apnoea breathing therapy -- Part 1: Sleep apnoea breathing therapy equipment.
(9) ISO 8185:2007. Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems.
(10) Determination Of Volatile Organic Compounds (VOCs) In Air Collected In Specially-Prepared Canisters And Analyzed By Gas Chromatography/Mass Spectrometry (GC/MS):1999.
(11) US EPA National Ambient Air Quality Standards (NAAQS) PM2.5:1997.
(12) ISO 10993-1:2009/(R) 2013. Biological Evaluation Of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process. (FDA recognition number: 2-156)
(13) ISO 10993-3:2003. Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. (FDA recognition number: 2-175)
(14) ISO 10993-5:2009. Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. (FDA recognition number: 2-153)
(15) ISO 10993-6:2007. Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation. (FDA recognition number: 2-120)
(16) ISO 10993-10:2010. Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. (FDA recognition number: 2-173)
(17) ISO 10993-11:2006. Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity. (FDA recognition number: 2-176)
(18) IEC 60601-1-11:2010. Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems

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Apex Medical Corp.

Used In The Home Healthcare Environment. (FDA recognition number: 19-6)

In conclusion, the above tests demonstrate that the modified iCH CPAP with PVA 9S-007XXX Series perform as safe and effective as the predicate device - iCH CPAP with PVA 9S-007XXX (K141522). The relevant test reports are described in this submission. Therefore, we state that the modified iCH CPAP with PVA 9S-007XXX Series is substantially equivalent to the predicate device - iCH CPAP with PVA 9S-007XXX Series (K141522).

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).