(131 days)
The Bronchoscopy Elbow can be used with Respironics Masks that incorporate the mating elbow hub design. Use of this elbow with these masks allows CPAP and bi-level the patient during a bronchoscopy procedure. The elbow is for single use in the hospital/institutional environment only.
Not Found
I am sorry, but the provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Bronchoscopy Elbow." This type of document does not contain information about the acceptance criteria or the study that proves the device meets them. It primarily addresses the regulatory aspects of the device and its substantial equivalence to a predicate device.
Therefore, I cannot answer your request based on the given input, as the information you are asking for is not present in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Conter - WO66-G60 Silver Spring, MD 20993-0002
November 20, 2013
Respironics, Inc. Ms. Colleen Witt Regulatory Affairs Manager of Patient Interface 365 Plum Industrial Court PITTSBURGH, PA 15239
Re: K132168
Trade/Device Name: Bronchoscopy Elbow Regulation Number: 21 CFR 868.5905 Regulation Name: Ventilator, Non-Continuous (Respirator) Regulatory Class: II Product Code: BZD Dated: October 21, 2013 Received: October 23, 2013
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. Colleen 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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for
Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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) K132168
Device Name Bronchoscopy Elbow
Indications for Use (Describe)
The Bronchoscopy Elbow can be used with Respironics Masks that incorporate the mating cloow hub design. Use of this elbow with these masks allows CPAP and bi-level the patient during a bronchoscopy procedure. The elbow is for single use in the hospital/institutional environment only.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
The ware with a may to the first for for for for for for free for a see - - - - - - -Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).