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 use in the home or hospital/institutional environment.

Device Description

XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720 is intended to be used to deriving continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) in adult patients and home environment. It is a modification of XT Auto CPAP Model 9S-005200(K083656). It shares the same construction and auto adjustment algorithm with XT Auto CPAP but adds expiration pressure release with three constant levels in firmware and has the same downloading function as XT Auto CPAP. XT Auto CPAP with Pressure Variation Algorithm provides a release pressure during expiration phase; it is equivalent to Expiratory Pressure Relief (EPR) of the predicate device RESMED S8 ADVANCE (K082979).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 9S-005720, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the device's characteristics and compares them to predicate devices to establish substantial equivalence, rather than setting explicit numerical acceptance criteria for clinical performance metrics. The implicit acceptance criterion is that the new device's performance characteristics are equivalent to the predicate devices, particularly regarding the new "Expiration Pressure Release" feature.

Device Characteristic	Acceptance Criteria (Equivalent to Predicate)	Reported Device Performance (XT Auto CPAP with Pressure Variation Algorithm 9S-005720)
Intended Use	Equivalent to Predicate 1 (RESMED S8 ADVANCE) and Predicate 2 (XT Auto CPAP)	Adult, Obstructive Sleep Apnea (OSA) treatment, home/hospital environment
Outlook	Same as Predicate 2, no effect on performance	Not explicitly detailed, but implied to be similar to Predicate 2
Dimensions (HxWxD)	Same as Predicate 2 (14.5 x 13.0 x 10.0 cm)	14.5 x 13.0 x 10.0 cm
Weight	Same as Predicate 2 (0.8kg)	0.8kg
Tubing	Same as Predicate 2 (Silicon, 1 x 6'/180cm length)	Silicon, 1 x 6'/180cm length
Air Outlet	Equivalent to Predicates (22mm)	22mm
Power Source	Equivalent to Predicates (100 ~ 240 VAC, 50/60Hz, 60/65W)	100 ~ 240 VAC, 50/60Hz, 60/65W
Safety Classification	All comply with IEC60601-1 (Predicate 1: Class II, Predicate 2: Class I)	IEC60601-1 Class II
User	Equivalent to Predicates (Single-user, multi-use)	Single-user, multi-use
Operating Environment	Same as Predicate 2 (+5 ~ 35℃, 15 ~ 95% Non-condensing)	+5 ~ 35℃, 15 ~ 95% Non-condensing
Pressure Range	Equivalent to Predicates (4 ~ 20 cmH2O)	4 ~ 20 cmH2O
Pressure Increment	Equivalent to Predicates (0.5 cmH2O)	0.5 cmH2O
Pressure Setting	Same as Predicate 2, equivalent to Predicate 1 (Complex buttons)	Complex buttons
Pressure Ramp Time	Equivalent to Predicates (0~45 min, 5 minutes per step)	0~45 min, 5 minutes per step
Display	Equivalent to Predicates (LCD display)	LCD display
Pressure Compensate	Equivalent to Predicates (Yes)	Yes
Altitude Compensate	Equivalent to Predicates (Yes)	Yes
Operation Altitude	Same as Predicate 2 (Up to 8000ft)	Up to 8000ft
Leak Compensate	Equivalent to Predicates (Yes)	Yes
Data Transfer	Same as Predicate 2, no effect on performance (By miniUSB)	By miniUSB
Leak Alert	Equivalent to Predicates (Yes)	Yes
Automatically Titrates Pressure in APAP mode	Equivalent to Pedicates, same as Predicate 2 (Yes)	Yes
Humidity Compatibility	Equivalent to Predicates (Yes)	Yes
Expiration Pressure Release	Equivalent to Predicate 1 (Three Constant Levels: 1, 2, 3 cmH2O)	Yes (Three Constant Levels: 1, 2, 3 cmH2O)

Study Information

The provided document describes a design verification testing approach to demonstrate substantial equivalence, rather than a clinical study with human subjects.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of human subjects or a dataset. The testing was performed on the device itself and compared to predicate device specifications and waveforms.
- Data Provenance: The study involved "Side by side waveform testing at various pressure and frequency levels with the predicate device(s)" and "Closed-loop control analysis." This suggests the data was generated in a lab setting through device testing, not from patient data or a specific country. This is a retrospective comparison of device characteristics against pre-existing predicate specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of submission is the technical specifications and performance of the legally marketed predicate devices, as well as adherence to relevant standards like IEC 60601-1. Expert consensus was not used to establish the technical "ground truth" for the device's technical performance.
Adjudication method for the test set: Not applicable. The testing described focuses on direct technical comparisons and adherence to standards, not human interpretation requiring adjudication.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided information indicates standalone testing of the device's performance and its algorithm. The "Closed-loop control analysis" specifically refers to the algorithm's performance independent of human input during operation. The device itself operates semi-autonomously based on its pressure variation algorithm.
The type of ground truth used:
- Technical Specifications and Performance of Predicate Devices: The primary "ground truth" was the established and legally marketed characteristics and performance of the RESMED S8 ADVANCE (K082979) and XT Auto CPAP (K083656).
- Regulatory Standards: Adherence to standards like IEC 60601-1 & IEC 60601-1-2, FDA reviewer guidance 638.pdf, FDA Draft Reviewer Guidance for Ventilators (July 1995), and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) served as "ground truth" for safety and other requirements.
- Waveform Matching: For the Expiration Pressure Release feature, the "ground truth" was the waveform of the predicate device (RESMED S8 ADVANCE) at various pressure and frequency levels.
The sample size for the training set: Not applicable. This device is a hardware CPAP machine with an algorithm, not a machine learning model that requires a "training set" in the traditional sense. The algorithm's design and parameters would have been developed by engineers.
How the ground truth for the training set was established: Not applicable. As it's not a machine learning model, there's no "training set." The device's algorithm for auto-adjustment and pressure variation would have been designed based on engineering principles and physiological understanding of OSA.

Summary

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112074

Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 9S-005720 510/k) Premarket Notification Section E - 510(k) Summary

510(k) Summary for Safety & Effectiveness

Date Prepared: 28th September, 2012

DEC 0 6 2012

Applicant name: Apex Medical Corp.

Contact Person Alan Chang

Address:

9, Min Sheng St. Tu-Cheng, Taipei County, Taiwan, R.O.C.

886-2-22683100 Phone number:

886-2-22686525 Fax numbers:

Device name

· Trade name: Apex medical XT Auto CPAP with Pressure Variation Algorithm 9S-005720

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: 70-573

Product Code: 73 BZD

Device Class: II

SE 510(k) number	RESMED	S8 ADVANCE	(K082979)
	Apex Medical	XT Auto CPAP	(K083656)

Reason for Submission

New Device

E-I

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

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DeviceCharacteristic	XT Auto CPAPwith PressureVariationAlgorithm9S-005720	Predicate1RESMED S8ADVANCE(K082979)	Predicate2XT Auto CPAP9S-005200(K083656)	Comment
Intended user	Adult	Adult	Adult	Equivalent
Outlook				Subject is thesame asPredicate 2(K083656),Outlook is noeffect onperformance.
Dimensions(HxWxD)	14.5 x 13.0 x 10.0 cm	11.2x16.4x14.5 cm	14.5 x 13.0 x 10.0 cm	Subject is thesame asPredicate 2(K083656)
Weight	0.8kg	1.4kg	0.8kg	Subject is thesame asPredicate 2(K083656)
Tubing	Silicon, 1 x6'/180cm length	Flexible plastic6'6" 2 m length	Silicon, 1 x6'/180cm length	Subject is thesame asPredicate 2(K083656)
Air Outlet	22mm	22mm	22mm	Equivalent
Power Source	100 ~ 240 VAC,50/60Hz, 60/65W	100 ~ 240 VAC,50/60 Hz	100 ~ 240 VAC,50/60Hz, 60/65W	Equivalent
SafetyClassification	IEC60601-1Class II	IEC60601-1Class II	IEC60601-1Class I	All complywithIEC60601-1
User	Single-user,multi-use	Single-user,multi-use	Single-user,multi-use	Equivalent
OperatingEnvironment	+5 ~ 35℃15 ~ 95%Non-condensing	+5 ~ 36℃10 ~ 95%	+5 ~ 35℃15 ~ 95%Non-condensing	Subject is thesame asPredicate 2(K083656)
Pressure	4 ~ 20 cmH2O	4 ~ 20 cmH2O	4 ~ 20 cmH2O	Equivalent
DeviceCharacteristic	XT Auto CPAPwith PressureVariationAlgorithm9S-005720	Predicate1RESMED S8ADVANCE(K082979)	Predicate2XT Auto CPAP9S-005200(K083656)	Comment
Range
PressureIncrement	0.5 cmH2O	0.5 cmH2O	0.5 cmH2O	Equivalent
Pressuresetting	Complex buttons	Complexbuttons	Complexbuttons	Subject is thesame asPredicate2(K083656),and equivalentto Predicate1(K082979)
PressureRamp Time	0~45 min, 5minutes per step	0~45 min, 5minutes perstep	0~45 min, 5minutes perstep	Equivalent
Display	LCD display	LCD display	LCD display	Equivalent
PressureCompensate	Yes	Yes	Yes	Equivalent
AltitudeCompensate	Yes	Yes	Yes	Equivalent
OperationAltitude	Up to 8000ft	Sea level to8500ft	Up to 8000ft	Subject is thesame asPredicate 2(K083656)
LeakCompensate	Yes	Yes	Yes	Equivalent
Data Transfer	By miniUSB	By Data Card &DB9 adaptor	By miniUSB	Subject is thesame asPredicate 2(K083656),besides, Datatransfer is noeffect onperformance.
Leak Alert	Yes	Yes	Yes	Equivalent
AutomaticallyTitratesPressure inAPAP mode	Yes	Yes	Yes	Equivalentand Subject isthe same asPredicate 2(K083656)
Humidity	Yes	Yes	Yes	Equivalent
DeviceCharacteristic	XT Auto CPAPwith PressureVariationAlgorithm9S-005720	Predicate1RESMED S8ADVANCE(K082979)	Predicate2XT Auto CPAP9S-005200(K083656)	Comment
compatibility
ExpirationPressureRelease	YesThree ConstantLevels (1, 2, 3cmH2O)	YesThree ConstantLevels(1,2,3cmH2O)	No	Subject isequivalent toPredicate1(K082979)

Table of comparison with predicates

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Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 95-005720

: ・

・

E-4

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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) FDA Draft Reviewer Guidance for Ventilators (July 1995)
(3) 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 (4) predicate device(s)
(5) Closed-loop control analysis.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 6, 2012

Mr. Alan Chang Senior Director of Quality Management Division Apex Medical Corporation Number 9, Minsheng Street Tucheng City, Taipei County 236 Taiwan, China

Re: K112079

Trade/Device Name: XT Auto CPAP with Pressure Variation Algorithm 9S-005720 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 28, 2012 Received: October 1, 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/CDRH0ffices/ucm] 15809.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,

Kwame Ⓞ. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 95-005720 510(k) Premarket Notification Revised Section D - Statement of Indications for Use

Indications for Use

510(k) Number: _ K112079

XT Auto CPAP with Pressure Variation Algorithm 9S-005720 Device Name:

Indications for Use:

Over-The-Counter Use AND/OR Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lester W. Schultheis Jr 2012.12.04 11:23:55 -05'00'

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices

K112079 510(k) Number;

Page 1 of 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).