(72 days)
Not Found
No
The summary describes a physical medical device (an endobronchial tube) and its accessories. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No.
The device is used for intubation and allows selective lung inflation or deflation for various medical procedures, but it does not directly treat a disease or condition.
No
Explanation: The device is an endobronchial tube used for intubation and selective lung inflation/deflation during medical procedures (e.g., thoracic surgery, anesthesia). Its purpose is therapeutic/interventional, not to diagnose a condition.
No
The device description clearly describes a physical, sterile, single-use endobronchial tube with multiple components (lumens, cuffs, pilot balloons, suction catheters, connectors, adapter, stylet). It also mentions biocompatibility testing, which is relevant to physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Kendall SHER-I-BRONCH® Endobronchial Tube is a device that is physically inserted into the body (specifically the main stem bronchus) for procedures like surgery, anesthesia, and bronchospirometry. It directly interacts with the patient's anatomy.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the body. Its function is related to airway management and lung isolation.
Therefore, based on the provided information, the Kendall SHER-I-BRONCH® Endobronchial Tube is a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Kendall SHER-I-BRONCH® Endobronchial Tube is intended for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
The endobronchial tube is intended for use in thoracic surgery, bronchospirometry, administration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The tube in indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Product codes
73 CBI
Device Description
The proposed Kendall SHER-I-BRONCH® Endobronchial Tube is a sterile, single use device which is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung. SHER-I-BRONCH® is available in 28 Fr, 35 Fr, 37 Fr, 37 Fr, 39 Fr and 41 Fr sizes. The tube design incorporates a dual lumen configuration with labeled bronchial and tracheal lumens. The bronchial cuff and corresponding pilot balloon are blue in color, while the tracheal cuff and its pilot balloon are white. Included as sterile items with the SHER-I-BRONCH® are three suction catheters, two 15 mm double swivel airway connectors, one "Y" adapter and one stylet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
main stem bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Biocompatibility testing was performed on the endobronchial tube following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).
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The 31 1998
510(k) Summary
Kendall SHER-I-BRONCH® Endobronchial Tube
In accordance with section 513(i) the SMDA and as described in 21 CFR Part 807.3, final rule dated December 14, 1994, this summary is submitted by:
Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date: March 20, 1996
- Contact Person 1.
David A. Olson Manager Regulatory Affairs (508) 261-8530
Name of Medical Device 2.
Tracheal/Bronchial Differential Ventilation Classification Name Tube Common or Usual Name: Tracheal Tube SHER-I-BRONCH® Endobronchial Tube Proprietary Name:
Identification of Legally Marketed Device 3.
The proposed Kendall SHER-I-BRONCH® Endobronchial Tube is substantially equivalent in intended use function and composition to the commercially available Kendall SHER-I-BRONCH® Endobronchial Tube (510(k) No. K851856) and Mallinkrodt Broncho-Cath® Endobronchial Tube (510(k) No. K771219).
Device Description 4.
The proposed Kendall SHER-I-BRONCH® Endobronchial Tube is a sterile, single use device which is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung. SHER-I-BRONCH® is available in 28 Fr, 35 Fr, 37 Fr, 37 Fr, 39 Fr and 41 Fr sizes. The tube design incorporates a dual lumen configuration with labeled bronchial and tracheal lumens. The bronchial cuff and corresponding pilot balloon are blue in color, while the tracheal cuff and
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Exhibit No. 7 (continued)
its pilot balloon are white. Included as sterile items with the SHER-I-BRONCH® are three suction catheters, two 15 mm double swivel airway connectors, one "Y" adapter and one stylet.
ട. Device Intended Use
The Kendall SHER-I-BRONCH® Endobronchial Tube is intended for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
દ. Product Comparison
The Kendall SHER-I-BRONCH® Endobronchial Tube is equivalent to the referenced predicate device in that they are fabricated from identical materials, have the same function and equivalent indications for use.
7. Nonclinical Testing
Biocompatibility testing was performed on the endobronchial tube following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. The text is in a sans-serif font and is evenly spaced around the curve.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David A. Olson Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048
JAN - 3 2012
Re: K961977
Kendall SHER-I-BROCH® Endobronchial Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tube, tracheal/bronchial, differential ventilation (w/wo connector) Regulatory Class: Two (II) Product Code: 73 CBI Dated: May 16, 1996 Received: May 20, 1996
Dear Mr. Olson:
This letter corrects our substantially equivalent letter of July 31, 1996.
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 (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.
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 - Mr. Olson
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,
Anten vim
Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Kendall SHER-I-BRONCH® Endobronchial Tube
Indications For Use:
The endobronchial tube is intended for use in thoracic surgery, bronchospirometry, administration of endobronchial anesthesia and other uses
bronchospirometry, administration of endina indianton for main bronchospirometry, administration of the tibe in indicated for main
commonly requiring endobronchial intubation or defletion of either commonly requiring endobronchian intubation: "The table in the
stem bronchus intubation and allows for selective inflation or deflation of either lung.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Hung Tanh for TC (Division/Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K961977 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
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