APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES

K141522 · Apex Medical Corp. · BZD · Oct 6, 2014 · Anesthesiology

Device Facts

• Record ID: K141522
• Device Name: APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 6, 2014
• 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 single patient reuse in the home environment.

Device Story

Device provides continuous positive airway pressure (CPAP) to treat adult OSA; home-use device for single-patient reuse. Incorporates Pressure Variation Algorithm (PVA) to provide exhalation pressure relief for patients struggling against high CPAP pressures. PVA reduces pressure during transition from inspiration to expiration; maintains reduced pressure during expiration; returns to therapeutic pressure at end of expiration. PVA automatically suspends if apneas detected; restarts after apneas disappear. Includes built-in heated humidifier to mitigate dry nose/throat symptoms. Device operates in CPAP or APAP modes. Healthcare providers use device settings to titrate therapy; patients use device at home to manage OSA symptoms.

Clinical Evidence

Bench testing only. Verification included safety and EMC testing per IEC 60601-1 and IEC 60601-1-2, side-by-side waveform testing against predicates, and algorithm analysis covering step functions, PVA waveforms across various breathing frequencies/volumes, and PVA performance during disordered breathing (apneas/hypopneas).

Technological Characteristics

CPAP device with 22mm air outlet; pressure range 4-20 cmH2O; 0.5 cmH2O increments. Features pressure ramp (0-45 min), pressure compensation, and altitude compensation. Includes integrated heated humidifier. Software-based Pressure Variation Algorithm (PVA) provides three levels of exhalation pressure relief. Operates in CPAP or APAP modes. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) who are spontaneously breathing. Intended for home 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

• APEX MEDICAL iCH CPAP 9S-007XXX series (K120035)
• APEX MEDICAL XT Auto CPAP with PVA 9S-005720 (K112079)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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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:

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.

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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

| Device<br>Characteristic | iCH CPAP with<br>PVA 9S-007XXX<br>series<br>(New Device) | Predicate1<br>iCH CPAP<br>9S-007XXX<br>(K120035) | Predicate2<br>XT Auto with<br>PVA 9S005720<br>(K112079) | Comment |
|-------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Intended user | Adult | Adult | Adult | Equivalent |
| Outlook &<br>Construction | Image: iCH CPAP with PVA 9S-007XXX series | Image: iCH CPAP 9S-007XXX | Image: XT Auto with PVA 9S005720 | Subject is<br>identical to<br>Predicate 1<br>(K120035), |
| Air Outlet | 22mm | 22mm | 22mm | Equivalent |
| User | Single-user,<br>multi-use | Single-user,<br>multi-use | Single-user,<br>multi-use | Equivalent |
| Operating<br>Environment | +5 ~ 35 °C<br>15 ~ 95%<br>Non-condensing | +5 ~ 36 °C<br>10 ~ 95% | +5 ~ 35 °C<br>15 ~ 95%<br>Non-condensing | Equivalent |
| Pressure<br>Range | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | Equivalent |
| Pressure<br>Increment | 0.5 cmH2O | 0.5 cmH2O | 0.5 cmH2O | Equivalent |
| Pressure Ramp<br>Time | 0~45 min, 5<br>minutes per step | 0~45 min, 5<br>minutes per step | 0~45 min, 5<br>minutes per step | Equivalent |
| Pressure<br>Compensate | Yes | Yes | Yes | Equivalent |
| Altitude<br>Compensate | Yes | Yes | Yes | Equivalent |
| Automatically<br>Titrates<br>Pressure in<br>APAP mode | Yes (iCH Auto) | YES (iCH Auto) | Yes | Identical |

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| Device<br>Characteristic | iCH CPAP with<br>PVA 9S-007XXX<br>series<br>(New Device) | Predicate1<br>iCH CPAP<br>9S-007XXX<br>(K120035) | Predicate2<br>XT Auto with<br>PVA 9S005720<br>(K112079) | Comment |
|--------------------------------------------|----------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------|
| Expiration<br>Pressure<br>Release<br>(PVA) | Yes<br>Three Constant<br>Levels (1, 2, 3<br>cmH2O) | No | Yes<br>Three Constant<br>Levels(1,2,3<br>cmH2O) | Subject is<br>Identical to<br>Predicate2<br>(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).