(274 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a physical medical device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device isolates the lung for surgical procedures (anesthesia and ventilation), which are not considered therapeutic but rather supportive for the surgery.
No
Explanation: The device is used to isolate a lung for surgical procedures (ventilation/anesthesia), which is a therapeutic/interventional function, not a diagnostic one.
No
The device description clearly outlines physical components like a tube, joint, and cuff, and the performance studies focus on physical properties and material testing, indicating it is a hardware device.
Based on the provided information, the COOPDECH Endobronchial Blocker Tube is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to isolate a lung for surgical procedures, ventilation, or anesthesia. This is a direct intervention on the patient's body for therapeutic or procedural purposes.
- Device Description: The device is a physical tube with a cuff designed to be inserted into the bronchus to block airflow. It's a mechanical device used in vivo (within the living body).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The COOPDECH Endobronchial Blocker Tube does not perform this function. It doesn't analyze biological samples.
Therefore, the COOPDECH Endobronchial Blocker Tube is a medical device used for a procedural intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COOPDECH Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Product codes
CBI
Device Description
The "Coopdech Endobronchial Blocker Tube" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
The "Coopdech Endobronchial Blocker Tube" is intended for use to differentially intubate a patient's bronchus in order to isolate the right or left lung for procedures which require one-lung ventilation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: Hospitals-OR and ICU.
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
The Coopdech Endobronchial Blocker Tube was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests included:
- 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 Retension (internal specification)
- Evaluation of Balloon to Shaft Bond
- The dimension and the ports of the joint connector
- Endotoxin tests
- Biocompatibility tests
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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Image /page/0/Picture/1 description: The image shows the text "K071694" in a bold, handwritten-like font. Below this, the word "CONFIDENTIAL." is printed in a smaller, more formal font. The last line of text reads "DAIKEN MEDICAL CO., LTD" also in a formal font. The text appears to be part of a document or label.
510 (k) SUMMARY
Submitted By:
Masahiko Nishimoto Director, Product Quality Center Daiken Medical Co., Ltd. 2-6-2 Ayumino, Izumi-city Osaka, Japan 594-1157
MAR 2 0 2008
Device:
Trade Name: Coopdech Endobronchial Blocker Tube Tracheal/bronchial differential ventilation tube (w/wo connector) Common Name: Classification Name: Tube, Tracheal/bronchial, differential ventilation (w/wo connector)
Predicate Device or Legally Marketed Devices:
Cook "7.0 Fr. Endobronchial Blocker" (K021920) Cook "Tip Deflecting Endobronchial Blocker" (K013865)
Device Description:
The "Coopdech Endobronchial Blocker Tube" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connecting the bronchial blocker tube to the endotracheal catheter. A cuff, incorporated at the distal tip of the tube, is inflated to block the targeted bronchus.
The "Coopdech Endobronchial Blocker Tube" is intended for use to differentially intubate a patient's bronchus in order to isolate the right or left lung for procedures which require one-lung ventilation.
Indications for Use:
The COOPDECH Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
Substantial Equivalence:
The "Coopdech Endobronchial Blocker Tube" has the same intended use as the Cook "7.0 Fr. Endobronchial Blocker" (K021920) and the Cook "Tip Deflecting Endobronchial Blocker" (K013865). The "Coopdech Endobronchial Blocker Tube" has similar materials and design features as the Cook "7.0 Fr. Endobronchial Blocker" (K021920). Testing elements to verify the design of the Coopdech Endobronchial Blocker Tube are the Cook "Tip Deflecting Endobronchial Blocker" (K013865) indicating the same design features between the two products. The gas barrier property of the "Coopdech Endobronchial Blocker Tube" is at least equal to the Cook "7.0 Fr. Endobronchial Blocker" (K021920).
1
Since the "Coopdech Endobronchial Blocker Tube" contains equivalent specifications, features and performance characteristics compared to both the Cook "7.0 Fr. Endobronchial Blocker" (K021920) and the Cook "Tip Deflecting Endobronchial Blocker" (K013865), DAIKEN ascertained that the "Coopdech Endobronchial Blocker Tube" is substantially equivalent to the above two (2) referenced devices.
Test Data:
.
The Coopdech Endobronchial Blocker Tube was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests included:
- 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 Retension (internal specification) •
- . Evaluation of Balloon to Shaft Bond
- t The dimension and the ports of the joint connector
- Endotoxin tests .
- Biocompatibility tests
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for use as a Bronchial Differential Ventilation Tube.
2
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 with three stripes forming its wing. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2008
Daiken Medical Company, Limited C/O Fumiaki Kanai, Ph.D. President and Chief Executive Officer MIC International 4-2-1 Yushima, Bunkyou-ku Tokyo 113-0034 JAPAN
Re: K071694
Trade/Device Name: Coopdech Endobronchial Blocker Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: February 19, 2008 Received: February 21, 2008
Dear Dr. Kanai:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be 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.
3
Page 2 - Dr. Kanai
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sutte y. Michaioms
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (If known): 071694
Coopdech Endobronchial Blocker Tube Device Name:
Indications for Use:
The COOPDECH Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
Prescription Use
(Per 21 CFR 801 Subpart D)
AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Min 7hM
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: __
K07/694