BRONCHOSCOPY ELBOW

K132168 · Respironics, Inc. · BZD · Nov 20, 2013 · Anesthesiology

Device Facts

• Record ID: K132168
• Device Name: BRONCHOSCOPY ELBOW
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Bronchoscopy Elbow is a patient interface accessory designed for use with specific Respironics masks featuring a mating elbow hub. Device facilitates delivery of CPAP or bi-level ventilation to patients during bronchoscopy procedures. Used in hospital/institutional environments; operated by clinicians. Device allows maintenance of airway pressure while providing access for bronchoscopic instrumentation. Single-use design.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory component for CPAP/bi-level masks; features mating elbow hub design for bronchoscopy access; single-use; hospital/institutional environment.

Indications for Use

Indicated for patients undergoing bronchoscopy procedures requiring CPAP or bi-level ventilation support via compatible Respironics masks in a hospital or institutional setting.

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 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 [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/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)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.