SIMPLE T YOUTH NASAL MASK

K140268 · Respironics, Inc. · BZD · Oct 20, 2014 · Anesthesiology

Device Facts

• Record ID: K140268
• Device Name: SIMPLE T YOUTH NASAL MASK
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 20, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Device Story

The Simple T Youth Nasal Mask is a patient interface device used to deliver positive airway pressure therapy. It is intended for use by pediatric patients requiring respiratory support. The device functions as a nasal mask, channeling airflow from a CPAP or bi-level device to the patient's nose. It is designed for use in clinical or home settings under the direction of a physician. The mask interface facilitates the delivery of prescribed pressure, aiding in the treatment of respiratory conditions. The device is a non-invasive interface, and its primary benefit is the provision of a comfortable, secure seal for pediatric patients to ensure effective therapy delivery.

Clinical Evidence

No clinical data provided; the submission relied on bench testing and substantial equivalence to legally marketed predicate devices.

Technological Characteristics

The device is a nasal mask interface for respiratory therapy. It is classified as a Class II device under 21 CFR 868.5905 (Product Code BZD). It functions as a passive patient interface for positive airway pressure delivery systems.

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.

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 20, 2014

Respironics, Inc. Ms. Colleen Witt Manager, Regulatory Affairs, Patient Interface 1001 Murry Ridge Lane Murrysville, PA 15668

Re: K140268

Trade/Device Name: Simple T Youth Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Simple T Youth Nasal Mask Regulatory Class: II Product Code: BZD Dated: September 8, 2014 Received: September 9, 2014

Dear Ms. Witt:

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 - Ms. Witt

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,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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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