CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235

K063268 · Hsiner Co., Ltd. · BZD · Feb 23, 2007 · Anesthesiology

Device Facts

• Record ID: K063268
• Device Name: CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
• Applicant: Hsiner Co., Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

Device Story

Hsiner CPAP/VPAP masks interface between CPAP/VPAP therapy devices and patient airways; used in home, hospital, or institutional settings. Device delivers prescribed positive airway pressure to patients. Operated by patients or healthcare providers under physician prescription. Design, materials, and performance equivalent to predicate masks; facilitates delivery of aerosol treatments and respiratory therapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance comparisons to predicate devices.

Technological Characteristics

Noncontinuous ventilator (IPPB) mask; intended for CPAP/VPAP therapy delivery. Materials and design equivalent to predicate masks.

Indications for Use

Indicated for patients prescribed CPAP/VPAP therapy in home, hospital, or institutional settings under physician direction.

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

• Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915)
• Respironics Comfort Select Nasal CPAP Mask (K000705, K991648)

Submission Summary (Full Text)

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Hsiner Company CPAP Masks 510(k) Submission

K063268

### 8. 510(k) Summary

.....

In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.

#### 8.1. Submitter Information

Hsiner Company, LTD No. 13, Tyan Shin St., Taya Hsiang Taichung Hsien, Taiwan, ROC

Phone: [phone]

Registration No .: 3003862188 Owner/Operator No .: 9053474

#### 8.2. Name of Device

| Proprietary Name: | CPAP/VPAP Masks |
|----------------------|---------------------------------|
| Common Name: | CPAP Mask |
| Classification Name: | Noncontinuous ventilator (IPPB) |
| Product Code: | BZD |
| Regulation Number: | 868.5905 |
| Device Class: | 2 |

#### Substantially equivalent to: 8.3.

- . Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915)
- Respironics Comfort Select Nasal CPAP Mask (K000705, K991648) .

#### 8.4. Description of the device

The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homecare and hospital settings.

#### 8.5. Intended Use of the Device

The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

#### 8.6. Comparison to Predicate Devices

The Hsiner CPAP/VPAP Masks is equivalent in design, materials and performance to the Predicate devices. All the predicate devices utilize the same principles of operation and have the same intended use

FEB 2 3 2007

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hsiner Company, Limited C/O Mr. Tom Shanks Principal MDVentures 29201 Via Norte Temecula, California 92591

Re: K063268

Trade/Device Name: Hsiner CPAP/VPAP Masks Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 5, 2007 Received: February 8, 2007

Dear Mr. Shanks:

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.

FEB 2 3 2007

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Shanks

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Clive
Chih-Ling Liu, Ph.D.

Chiu Lin, Ph.D. 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 (K052811):

Hsiner CPAP/VPAP Masks Device Name:

Indications for Use:

The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mihail Mihail

K063268

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