FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001

K101552 · Foshan Care Medical Technology Co., Ltd. · CAF · Mar 14, 2011 · Anesthesiology

Device Facts

• Record ID: K101552
• Device Name: FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
• Applicant: Foshan Care Medical Technology Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Mar 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Foshan Care Medical Nebulizer Compressor, Model K Y WH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-31100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KY WH2001 is intended to aerosolize physician- prescribed solutions for inhalation that are approved for nebulization. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended for adult and pediatric patients consistent with the indications for the aerosol medication. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, is not intended for life support nor does it provide any patient monitoring capabilities.

Device Story

AC-powered air compressor; provides compressed air to Hsiner Disposable Nebulizer (Model HS-31100); converts liquid medication into aerosol for inhalation. Used in clinical or home settings; operated by patients or caregivers. Output is aerosolized drug; assists in respiratory therapy. No life support or monitoring functions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

AC-powered air compressor; pneumatic aerosolization principle; standalone device; no software or connectivity.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized physician-prescribed medications approved for nebulization. Not for life support; no patient monitoring.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Reference Devices

• Hsiner Disposable Nebulizer (Model HS-31100)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Foshan Care Medical Technology Company, Limited C/O Mr. S David Piper, PE President Chief Executive Officer Piper Medical 4807 El Camino Avenue, Suite C Carmichael, California 95608

MAR 1 4 25:1

Re: K101552

Trade/Device Name: Medical Nebulizer Compressor, Model KYWH2001 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 18, 2011 Received: March 8, 2011

Dear Mr. Piper:

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.

{1}------------------------------------------------

Page 2- Mr. Piper

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/CDRH/CDRHOffices /ucm 115809.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,
James L. Rosotund
for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

## 510(k) Number (if known): K101552

Device Name: Foshan Care Medical Nebulizer Compressor, Model KYWH2001

## Indications For Use:

The Foshan Care Medical Nebulizer Compressor, Model K Y WH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-31100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KY WH2001 is intended to aerosolize physician- prescribed solutions for inhalation that are approved for nebulization. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended for adult and pediatric patients consistent with the indications for the aerosol medication. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, is not intended for life support nor does it provide any patient monitoring capabilities.

| Prescription Use | <b>X</b> |
|-----------------------------|-------------------|
| AND/OR Over-The-Counter Use | _________________ |

(Part 21 CFR 801 Subpart D)

(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)

f Schultten

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K/01552