← Product Code [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) · K120145 # SIMPLE T NASAL MASK (K120145) _Respironics, Inc. · BZD · Mar 30, 2012 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K120145 ## Device Facts - **Applicant:** Respironics, Inc. - **Product Code:** [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD.md) - **Decision Date:** Mar 30, 2012 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 868.5905 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic, Pediatric ## Indications for Use The Simple T Nasal Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg. ## Device Story Simple T Nasal Mask functions as patient interface for CPAP or bi-level therapy; delivers pressurized air from external flow generator to patient airways. Used in home or hospital/institutional settings; operated by patient or clinician. Device consists of nasal mask assembly; provides seal to facilitate therapeutic pressure delivery. Benefits include maintenance of airway patency for patients requiring respiratory support. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Nasal mask interface for CPAP/bi-level therapy. Mechanical design for patient-to-device connection. No electronic components, software, or energy source. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/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-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Michelle Brinker Manager, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668 MAR 3 0 2012 Re: K120145 Trade/Device Name: Simple T Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB). Regulatory Class: II Product Code: BZD Dated: February 29, 2012 Received: March 1, 2012 Dear Ms. Brinker: 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 - Ms. Brinker 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 /ucm115809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, G 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}------------------------------------------------ Page _ 1_ of _ 1 ## Indications for Use 510(k) Number (if known): Device Name: ___Simple T Nasal Mask The Simple T Nasal Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospitallinstitutional environment. The mask is to be used by patients greater than 66lbs/30kg. 120145 L. Schutter :10(k) Number: 长 :Division Siي ميار livision of Anesthesiology, General Hospital infection Control, Dental Devices **Prescription Use** *X* AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) ි - 19 033 (Please do not WRITE BELOW THIS LINE-CONTINUE on another Page if NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K120145](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K120145) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com