APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720

K112079 · Apex Medical Corp. · BZD · Dec 6, 2012 · Anesthesiology

Device Facts

• Record ID: K112079
• Device Name: APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

XT Auto CPAP 9S-005720 provides continuous positive airway pressure to treat adult OSA. Device monitors patient breathing and automatically titrates pressure; incorporates expiration pressure release (EPR) feature with three constant levels (1, 2, 3 cmH2O) to improve comfort during exhalation. Used in home or clinical settings by patients; operated via LCD interface with complex buttons. Device includes data downloading capabilities via miniUSB. Output is regulated airflow delivered through tubing/mask. Benefits include automated pressure adjustment to maintain airway patency and reduced expiratory resistance. Modification of predicate XT Auto CPAP (K083656) by adding firmware-based expiration pressure release equivalent to ResMed S8 Advance (K082979).

Clinical Evidence

Bench testing only. Verification included safety and EMC testing (IEC 60601-1, IEC 60601-1-2), side-by-side waveform testing at various pressure/frequency levels against predicates, and closed-loop control analysis. No clinical data presented.

Technological Characteristics

Non-continuous ventilator (CPAP). Pressure range 4-20 cmH2O; 0.5 cmH2O increments. Features: auto-titration, expiration pressure release (1-3 cmH2O), leak/altitude compensation, LCD display, miniUSB data transfer. Power: 100-240 VAC. Safety: IEC 60601-1 Class II. Materials: Silicon tubing. Dimensions: 14.5 x 13.0 x 10.0 cm. Weight: 0.8kg.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) who are spontaneously breathing. Intended for home or hospital/institutional use.

Regulatory Classification

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.

Predicate Devices

• RESMED S8 ADVANCE (K082979)
• XT Auto CPAP 9S-005200 (K083656)

Submission Summary (Full Text)

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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:

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).

#### 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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| Device<br>Characteristic | XT Auto CPAP<br>with Pressure<br>Variation<br>Algorithm<br>9S-005720 | Predicate1<br>RESMED S8<br>ADVANCE<br>(K082979) | Predicate2<br>XT Auto CPAP<br>9S-005200<br>(K083656) | Comment |
|-------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended user | Adult | Adult | Adult | Equivalent |
| Outlook | | | | Subject is the<br>same as<br>Predicate 2<br>(K083656),<br>Outlook is no<br>effect on<br>performance. |
| Dimensions<br>(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 the<br>same as<br>Predicate 2<br>(K083656) |
| Weight | 0.8kg | 1.4kg | 0.8kg | Subject is the<br>same as<br>Predicate 2<br>(K083656) |
| Tubing | Silicon, 1 x<br>6'/180cm length | Flexible plastic<br>6'6" 2 m length | Silicon, 1 x<br>6'/180cm length | Subject is the<br>same as<br>Predicate 2<br>(K083656) |
| Air Outlet | 22mm | 22mm | 22mm | Equivalent |
| Power Source | 100 ~ 240 VAC,<br>50/60Hz, 60/65<br>W | 100 ~ 240 VAC,<br>50/60 Hz | 100 ~ 240 VAC,<br>50/60Hz, 60/65<br>W | Equivalent |
| Safety<br>Classification | IEC60601-1<br>Class II | IEC60601-1<br>Class II | IEC60601-1<br>Class I | All comply<br>with<br>IEC60601-1 |
| User | Single-user,<br>multi-use | Single-user,<br>multi-use | Single-user,<br>multi-use | Equivalent |
| Operating<br>Environment | +5 ~ 35℃<br>15 ~ 95%<br>Non-condensing | +5 ~ 36℃<br>10 ~ 95% | +5 ~ 35℃<br>15 ~ 95%<br>Non-condensing | Subject is the<br>same as<br>Predicate 2<br>(K083656) |
| Pressure | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | Equivalent |
| Device<br>Characteristic | XT Auto CPAP<br>with Pressure<br>Variation<br>Algorithm<br>9S-005720 | Predicate1<br>RESMED S8<br>ADVANCE<br>(K082979) | Predicate2<br>XT Auto CPAP<br>9S-005200<br>(K083656) | Comment |
| Range | | | | |
| Pressure<br>Increment | 0.5 cmH2O | 0.5 cmH2O | 0.5 cmH2O | Equivalent |
| Pressure<br>setting | Complex buttons | Complex<br>buttons | Complex<br>buttons | Subject is the<br>same as<br>Predicate<br>2(K083656),<br>and equivalent<br>to Predicate<br>1(K082979) |
| Pressure<br>Ramp Time | 0~45 min, 5<br>minutes per step | 0~45 min, 5<br>minutes per<br>step | 0~45 min, 5<br>minutes per<br>step | Equivalent |
| Display | LCD display | LCD display | LCD display | Equivalent |
| Pressure<br>Compensate | Yes | Yes | Yes | Equivalent |
| Altitude<br>Compensate | Yes | Yes | Yes | Equivalent |
| Operation<br>Altitude | Up to 8000ft | Sea level to<br>8500ft | Up to 8000ft | Subject is the<br>same as<br>Predicate 2<br>(K083656) |
| Leak<br>Compensate | Yes | Yes | Yes | Equivalent |
| Data Transfer | By miniUSB | By Data Card &<br>DB9 adaptor | By miniUSB | Subject is the<br>same as<br>Predicate 2<br>(K083656),<br>besides, Data<br>transfer is no<br>effect on<br>performance. |
| Leak Alert | Yes | Yes | Yes | Equivalent |
| Automatically<br>Titrates<br>Pressure in<br>APAP mode | Yes | Yes | Yes | Equivalent<br>and Subject is<br>the same as<br>Predicate 2<br>(K083656) |
| Humidity | Yes | Yes | Yes | Equivalent |
| Device<br>Characteristic | XT Auto CPAP<br>with Pressure<br>Variation<br>Algorithm<br>9S-005720 | Predicate1<br>RESMED S8<br>ADVANCE<br>(K082979) | Predicate2<br>XT Auto CPAP<br>9S-005200<br>(K083656) | Comment |
| compatibility | | | | |
| Expiration<br>Pressure<br>Release | Yes<br>Three Constant<br>Levels (1, 2, 3<br>cmH2O) | Yes<br>Three Constant<br>Levels(1,2,3<br>cmH2O) | No | Subject is<br>equivalent to<br>Predicate1<br>(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 [phone] or [phone] 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:

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.

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;

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