(88 days)
No
The summary describes a mechanical device for lung isolation and does not mention any AI or ML components or functions.
Yes.
The device is used to isolate a lung for surgery, one-lung ventilation, or one-lung anesthesia, which are medical procedures performed to treat or manage a patient's condition.
No
An endobronchial blocker tube is used to physically isolate a lung for surgical procedures or ventilation. It does not provide any diagnostic information about the patient's condition or disease state.
No
The device description clearly outlines physical components like a bronchial blocker tube, joint connector, and cuff, indicating it is a hardware device, not software-only.
Based on the provided information, the COOPDECH ENDOBRONCHIAL BLOCKER TUBE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- Device Function: The COOPDECH ENDOBRONCHIAL BLOCKER TUBE is a device that is inserted into the body (specifically, the airway) to physically block a bronchus. It is used for surgical procedures and ventilation management, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for isolating the lung for surgery, ventilation, or anesthesia. This is a therapeutic and procedural use, not a diagnostic one based on analyzing samples.
Therefore, the COOPDECH ENDOBRONCHIAL BLOCKER TUBE is a medical device, but it falls under a different classification than IVD.
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.
Patient Population: Patients requiring one lung isolation.
Environment of Use: Hospitals-OR and ICU.
Product codes
CBI
Device Description
The "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connector, 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 (MODIFIED)" is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Bench Testing:
- Analysis of Cuff Pressure at Various Inflation Volumes
- Balloon Burst Testing
- Analysis of Balloon Cuff Inflation Retention
Results: Almost the same results as the predicate device, demonstrating substantial equivalence.
Biocompatibility testing:
Evaluated material changes in the cuff, sheath, and mark directly contacting mucosa.
Results: No biocompatibility concern was raised, showing substantial equivalence to the predicate device.
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
Section 5- 510(k) Summary
- i
ﺗﺮﺗ
- a. Owner/Company name, address DAIKEN MEDICAL CO., LTD. 2-6-2 Ayumino, Izumi-city, Osaka, 594-1157, Japan
Seiji Nakagawa Director, R&D Center 011-81-725-51-3525 Phone: 011-81-725-54-0425 Fax:
b. Contact/Application Correspondent Fumiaki Kanai, Ph.D. President and CEO MIC International (4th Floor) 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan
Phone: 011-81-3-3818-8577 Fax: 011-81-3-3818-8573 Email: kanaif@mici.co.jp
- c. Date prepared November 17, 2009
- d. Name of device
- Trade Name: Common Name:
Classification Name:
Coopdech Endobronchial Blocker Tube Tracheal/bronchial differential ventilation tube (w/wo connector) Tube, Tracheal/bronchial, differential ventilation (w/wo connector) Classification Regulation: 21 CFR 880.5740
DAIKEN MEDICAL CO., LTD. November 17, 2009
MAR-1 6 2010
SECTION 5 5-1 OF 5-5
1
e. Predicate devices
The Coopdech ENDOBRONCHIAL BLOCKER TUBE is substantially equivalent to the following legally marketed devices:
The same trade name with the device for the application;
| 510(k): | K071694 |
|---|---|
| Trade name: | COOPDECH ENDOBRONCHIAL BLOCKER TUBE |
| Product code: | CBI |
Because the same device name as the predicate device is used, we call the device under the application, as "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" in this premarket notification application.
f. Description of the device
The "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" consists of a bronchial blocker tube; advanced through an endotracheal catheter, and a joint connector, 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 (MODIFIED)" is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
g. Indications for Use
Indication 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.
Patients requiring one lung isolation. Patient Population:
Environment of Use: Hospitals-OR and ICU.
DAIKEN MEDICAL CO., LTD. November 17, 2009
SECTION 5 5-2 OF 5-5
2
h. Statement of substantial equivalence
The characteristics of the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" are similar to those of the predicate devices described in Item e above. The similarities include:
- . Same Intended Use
- . Same operating principals
- Same design features .
- · · Ethylene Oxide Sterilized
- Single Sterile Wrapped .
- . Multiple Length
The materials of the cuff, the sheath, the mark and the O-ring in the joint connector from the predicate device are changed in the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)".
In order to evaluate the above changes, the biocompatibility tests (Section 16), the performance tests -bench (Section 19) and the shelf-life tests (Section 15) were performed. Those tests indicated that the above changes did not raise concern in its safety and performance.
Because there is no other changes in "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" other than the above mentioned material changes, the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)"contains almost equivalent specifications, features and performance characteristics compared to the predicate device, DAIKEN concluded that the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" is substantially equivalent to the predicate device.
DAIKEN MEDICAL CO., LTD. November 17, 2009
SECTION 5 5-3 OF 5-5
3
| Table 1. Comparison Table | ||
|---|---|---|
| Items | Predicate Device | "COOPDECH ENDOBRONCHIAL |
| BLOCKER TUBE (MODIFIED)" | ||
| Intended 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. | Same | |
| Materials | Nylon, Silicone, PP, Nitrile rubber | Nylon, Silicone, PP, Isoprene |
| rubber, Polyurethane | ||
| Design features | Double lumen shaft, multi-port | |
| adaptor, 2 cuffs, | Same | |
| Tests for verifying | ||
| characteristics of the cuff | Analysis of Cuff Pressure at | |
| Various Inflation Volumes Balloon Burst Testing Analysis of Balloon Cuff | ||
| Inflation Retention | Same | |
| Gas barrier property | Gas barrier property was tested by | |
| analyzing the balloon cuff inflation | ||
| retention time as shown in the bench | ||
| test. | Same | |
| Length | 30, 40, 50, 60, 70, 80 cm | Same |
| Sterilization Method | EtO Sterilized | Same |
Table 1. Comparison Table
Bench Testing i.
Because of the material changes in the Cuff, we performed following tests in order to evaluate the material change.
- Analysis of Cuff Pressure at Various Inflation Volumes .
- Balloon Burst Testing
- . Analysis of Balloon Cuff Inflation Retention
We have obtained almost the same results in the above three tests, and thus those results demonstrated that the characteristics of "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" are substantially equivalent to the predicate device. The test results are included in Section 19 Performance testing- Bench.
Biocompatibility testing i.
As mentioned in the above Item h, there are material changes in several parts including
DAIKEN MEDICAL CO., LTD. NOVEMBER 17, 2009
SECTION 5 5-4 OF 5-5
4
the cuff, the sheath and the mark which directly contact mucosa. Therefore, biocompatibility tests were performed to evaluate the material changes.
As same as the predicate device, no biocompatibility concern was raised in such biocompatibility tests of the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)", which showed substantial equivalence regarding biocompatibility between the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" and the predicate device. The test results are included in Section 16 Biocompatibility.
k. Conclusion
Based on the above discussion and enclosed sections regarding substantial equivalence to the predicate device, DAIKEN MEDICAL CO., LTD concludes that the "COOPDECH ENDOBRONCHIAL BLOCKER TUBE (MODIFIED)" is substantially equivalent to the predicate device.
DAIKEN MEDICAL CO., LTD. November 17, 2009
SECTION 5 5-5 OF 5-5
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Daiken Medical Company, Limited C/O Dr. Fumiaki Kanai President and Chief Executive Official MIC International 4-1-17 Hongo, Bunkyo-Ku Tokyo, 113-0033, Japan
MAR 1 6 2010
Re: K093888
Trade/Device Name: Coopdech Endobronchial Blocker Tube Regulation Number: 21CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: II Product Code: CBI Dated: November 17, 2009 Received: December 18, 2009
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. 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.
6
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); 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/ ucm 1 5809.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.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
K093888 510(k) Number (If known):
Device Name: Coopdech Endobronchial Blocker Tube
Indication 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
510(k) Number: