(152 days)
Not Found
No
The description focuses on the mechanical design and function of the device, with no mention of AI or ML.
No
The device is described as an Endobronchial Blocker used for one-lung ventilation during procedures, which is a supportive tool for a medical procedure rather than a device intended to treat or prevent a disease or condition itself.
No
The device is intended for use to isolate a lung for one-lung ventilation during procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical medical device with components like a flexible soft tip, catheter, pilot balloon assembly, and mentions its physical dimensions (9.0 French). It also describes physical performance testing (Bond Strength, Deflection Angles, etc.). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to isolate a lung for one-lung ventilation during medical procedures. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a mechanical device used for blocking a bronchus. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is characteristic of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological markers.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a bronchus of the left or right lung for procedures which require one-lung ventilation.
Product codes
73 CBI
Device Description
The Tip-Delecting Endonomal Biother le dotic bronchoscope to be placed inside a endollacheal tube and a small diameter moreply it uses a flexible soft tip that can be single lumen tube to provide one lang vensily placed into the desired bronchus to be dellected to more than oo dogroos and outside diameter and fits coaxially with a blocked. The device measures 9.0 French in outside diameter up of a blocked. The device modotracheal tube. The proximal end of the catheter is made up of a 7.0 min of larger endotrached to a pilot balloon assembly. This balloon assembly. This balloon f Filtling. One of the 1 litting to octail balloon and maintains inflation untili it is assembly lacintation of this device will include an Arndt Multiport Airway Adapter (Class I, Exempt, §868.5810), a CPAP Adapter (Class I, Exempt, §868.5810), and a syringe (vendor supplied).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bronchus of the left or right lung
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Tip Deflecting Endobronchial Blocker was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Analysis of Bond Strength .
- Analysis of Deflection Angles ●
- Analysis of Cuff Pressure and Dimension at Various Inflation Volumes .
- Balloon Burst Testing .
- Analysis of Balloon Cuff Inflation Retention ●
- Evaluation of Balloon to Shaft Bond .
- Biocompatibility Testing .
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Bronchial Differential Ventilation Tube.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Tip Deflecting Endobronchial Blocker Special 510(k) Premarket Notification Cook Incorporated
APR 2 2 2002
510(k) SUMMARY 9
Lisa Hopkins Submitted By: Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Way PO Box 489 Bloomington, IN 47402 (812) 339-2235
Device:
Trade Name: Proposed Classification Name: Tip Deflecting Endobronchial Blocker Tracheal/Bronchial Differential Ventilation Tube
Predicate Devices or Legally Marketed Devices:
Marketed & Distributed by Cook Incorporated Bronchial Blocker D.C. K962167
Pediatric Endobronchial Blocker Marketed & Distributed by Cook Incorporated D.C. K002288
Device Description:
Device Deserting Endobronchial Blocker is designed for use with a standard The Tip-Delecting Endonomal Biother le dotic bronchoscope to be placed inside a endollacheal tube and a small diameter moreply it uses a flexible soft tip that can be single lumen tube to provide one lang vensily placed into the desired bronchus to be dellected to more than oo dogroos and outside diameter and fits coaxially with a
blocked. The device measures 9.0 French in outside diameter up of a blocked. The device modotracheal tube. The proximal end of the catheter is made up of a 7.0 min of larger endotrached to a pilot balloon assembly. This balloon assembly. This balloon f Filtling. One of the 1 litting to octail balloon and maintains inflation untili it is assembly lacintation of this device will include an Arndt Multiport Airway Adapter (Class I, Exempt, §868.5810), a CPAP Adapter (Class I, Exempt, §868.5810), and a syringe (vendor supplied).
Indications for Use:
Intellections for 030.
The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a The Tip Delicently Endobronial Blooks of the left or right lung for procedures which require one-lung ventilation.
Substantial Equivalence:
Substantial Equivalence.
The Tip Deflecting Endobronchial Blocker is similar to the Cook Bronchial Blocker, D.C. The Tip Deliouing Endobronchial Blocker, D.C. #K002288. The Similari # K502 107 and the Fouldne Endobreneristics of the Tip Deflecting Endobronchial
1
Tip Deflecting Endobronchial Blocker Special 510(k) Premarket Notification Cook Incorporated
Blocker as compared to the predicate devices support a determination of substantial equivalency.
Test Data:
The Tip Deflecting Endobronchial Blocker was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Analysis of Bond Strength .
- Analysis of Deflection Angles ●
- Analysis of Cuff Pressure and Dimension at Various Inflation Volumes .
- Balloon Burst Testing .
- Analysis of Balloon Cuff Inflation Retention ●
- Evaluation of Balloon to Shaft Bond .
- Biocompatibility Testing .
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Bronchial Differential Ventilation Tube.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the wings and body of the bird.
APR 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
April Lavender, RAC Vice President, Regulatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402-0489
Re: K013865
Trade/Device Name: Tip Deflecting Endobronchial Blocker Regulation Number: 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: 73 CBI Dated: April 9, 2002 Received: April 15, 2002
Dear Ms. Lavender:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro rowed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass builed in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimores 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 r ou may a may a second in the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de subject to such 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.
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
3
Page 2 - Ms. April Lavender, RAC
comply with all the Act's requirements, including, but not limited to: registration and issting (21 comply with an the Act 3 requirements, mercains, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic as a carrent of the electronic and forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to oegin manieting of substantial equivalence of your device to a legally premarket nother device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific acrise for your avviro diagnostic devices), please contact the Office of additionally 21 CFR Fall 00710 directions on the promotion and advertising of Compliance at (301) 594--- - Praditionally, roomance at (301) 594-4639. Also, please note the your device, picase connate the Other of esterence to premarket notification" (21CFR Part 807.97). It guiation entitied, "Misoranang of responsibilities under the Act may be obtained from the Other general information on Jour responsibilial and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Tip Deflecting Endobronchial Blocker Special 510(k) Premarket Notification Cook Incorporated
510(k) Number (if known):
Tip Deflecting Endobronchial Blocker Device Name:
Indications for Use:
The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate The Tip Dellecting "Endopronial Brother to isolate the left or right lung for procedures which require one-lung ventilation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CFR 801.109)
OR
Over-the-Co
Division of Cardiovascular & Respiratory Devices
510(k) Number K013865
Over-the-Counter