APEX MEDICAL XT AUTO CPAP 9S-005200

K083656 · Apex Medical Corp. · BZD · Apr 22, 2009 · Anesthesiology

Device Facts

• Record ID: K083656
• Device Name: APEX MEDICAL XT AUTO CPAP 9S-005200
• Applicant: Apex Medical Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 22, 2009
• 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).

Device Story

XT Auto CPAP 9S-005200 provides continuous positive airway pressure (CPAP) for adult obstructive sleep apnea (OSA) treatment in home environments. Device utilizes pressure and flow sensors on the circuit to monitor patient breathing; incorporates auto-adjusting pressure functionality. Data is captured and available for download. Operated by patients at home; healthcare providers review downloaded data to assess therapy efficacy and adjust treatment. Device builds upon predicate XT-I construction and RT2120 downloading capabilities, with auto-CPAP logic derived from ResMed AutoSet Spirit. Benefits include automated pressure titration to maintain airway patency during sleep.

Clinical Evidence

Bench testing only. Design verification tests were performed to confirm the device meets required acceptance criteria based on risk analysis and product requirements.

Technological Characteristics

Non-continuous ventilator (BZD). Features pressure and flow sensors on the circuit. Includes data downloading capability. Auto-CPAP functionality. Home-use form factor.

Indications for Use

Indicated for adult patients with obstructive sleep apnea (OSA) requiring continuous positive airway pressure therapy.

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 XT1 CPAP MODEL 9S-005 (K070609)
• APEX MEDICAL CPAP RT 21XX (K022650)
• ResMed AutoSet Spirit CPAP (K032480)

Submission Summary (Full Text)

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K083656

Apex Medical Corp.

CPAP 9S-005200

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## 510(k) Summary- XT Auto CPAP 9S005200

Date Prepared: 8th December, 2008

| Applicant name: | Apex Medical Corp. | APR 22 2009 |
|--------------------------|--------------------------------------------------------------------------|-------------|
| Contact Person | Alan Chang | |
| Address: | 9, Min Sheng St. Tu-Cheng, Taipei County, Taiwan, R.O.C. | |
| Phone number: | 886-2-22683100 | |
| Fax numbers: | 886-2-222686525 | |
| Device name | Trade name: Apex medical XT Auto CPAP 9S-005200 | |
| | Common name: CPAP | |
| | Classification name: | |
| | Non-continuous ventilator Class II in accordance with 21 CFR<br>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 XT1 CPAP MODEL 9S-005 (K070609) | |
| | APEX MEDICAL CPAP RT 21XX | (K022650) |
| | ResMed AutoSet Spirit CPAP | (K032480) |
| Reason for<br>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).

### Device Description:

XT Auto CPAP Model 9S-005200 is intended to be used to delivery continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) for adult patients in the home environment. It is a modification of CPAP XT I MODEL 9S-005 (K070609) & RT2120 (K022650). It shares the same construction with XT-I but adds pressure and flow sensor on the circuit and has same downloading function as RT2120. As for the function of auto CPAP, it refers to the predicate Resmed Autoset Spirit (K032480).

#### Substantial Equivalence

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

- 公 Similar intended use
- A Similar operating principle
- A Similar technology
- > Similar manufacturing process

Design verification tests were performed on the new device with the predicate device(s) as a result of the risk analysis and product requirements. All 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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Public Health Service

APR 2 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Chang Director of President Office Apex Medical Corporation Number 9 Minsheng Street Tucheng City, Taipei County CHINA (TAIWAN) 236

Re: K083656

Trade/Device Name: XT Auto CPAP 9S-005200 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 6, 2009 Received: April 8, 2009

#### 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.

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.

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Page 2- Mr. Chang

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours.

Susan Runor

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, 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): ____________________________________________________________________________________________________________________________________________________

XT Auto CPAP 9S-005200 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).

Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Roger

Jision Sign-Off) ് ; ;Islon Sign-On)
Jivision of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number:

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