(131 days)
Not Found
Not Found
No
The 510(k) summary describes a simple mechanical elbow for use during bronchoscopy and makes no mention of AI or ML.
No
The device is described as an "Elbow" for use during a bronchoscopy procedure to allow CPAP and bi-level ventilation. It is a connection piece for equipment, not a therapeutic device itself that provides treatment.
No
Explanation: The device is described as an elbow used with CPAP and bi-level equipment during a bronchoscopy procedure, which is a therapeutic intervention, not a diagnostic one. Its purpose is to facilitate patient breathing during the procedure, not to diagnose a condition.
No
The device description clearly indicates a physical component ("Bronchoscopy Elbow") that connects to masks, implying a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate CPAP and bi-level therapy during a bronchoscopy procedure by connecting to a mask. This is a therapeutic and procedural support function, not a diagnostic test performed on samples taken from the body.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from diagnostic testing.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Focus on Procedure Support: The device's function is to enable respiratory support during a medical procedure.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
BZD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/institutional environment only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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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.
1
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,
Image /page/1/Picture/8 description: The image shows the words Kwame Ulmer in a stylized font. The letters are large and bold, and they appear to be slightly distressed. To the right of the name is a logo that consists of a circle and a triangle. The logo is also stylized and distressed, and it is made up of thick lines.
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
2
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)
Image /page/2/Picture/11 description: The image shows a digital signature. The signature is for Anya C. Harry. The signature includes the date 2013.11.15 16:26:26 -05'00'. The signature also includes the text DN: US, o=U.S. Government, ou=HHS, ou=FDA, ou=People.
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.