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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Coopdech Endobronchial Blocker Tube". This is a medical device submission, which typically focuses on demonstrating substantial equivalence to a previously marketed device rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis as might be seen for novel technologies or PMA submissions.

Therefore, the information requested (acceptance criteria, specific study details like sample size, ground truth, MRMC studies, etc.) is not explicitly present in the provided document in the format typically associated with such requests for AI/software-based medical devices or novel clinical devices.

The document discusses various engineering and bench tests performed to assure reliable design and performance, and then asserts substantial equivalence based on these tests and similar specifications to predicate devices. It does not describe a clinical study in the sense of comparing performance against specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) using a defined test set, ground truth established by experts, or AI performance metrics.

Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with numerical performance targets and reported results. Instead, it lists the types of tests performed and generally states that "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."

Acceptance Criteria Category	Reported Device Performance Summary (from text)
Mechanical/Physical Properties
Bond Strength	Analysis performed.
Deflection Angles	Analysis performed.
Cuff Pressure and Dimension at Various Inflation Volumes	Analysis performed.
Balloon Burst Strength	Testing performed.
Balloon Cuff Inflation Retention	Analysis performed (against internal specification).
Balloon to Shaft Bond	Evaluation performed.
Joint Connector Dimensions & Ports	Evaluation performed.
Gas Barrier Property	"at least equal to the Cook '7.0 Fr. Endobronchial Blocker' (K021920)."
Biocompatibility	Biocompatibility tests performed.
Sterility/Contamination	Endotoxin tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the tests.
Data Provenance: Not specified, but given the nature of the tests (bench/engineering tests), it's implied to be laboratory-generated data rather than clinical patient data. There's no mention of country of origin of data or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests performed are engineering/bench tests (e.g., bond strength, burst testing); they don't involve expert-established ground truth on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is described as these are not clinical performance studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical tube, not an AI or imaging diagnostic device. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the described tests, the "ground truth" would be established by engineering standards, physical measurements, and material specifications. For example, a "balloon burst test" 's ground truth would be the pressure at which the balloon bursts, measured against a specified threshold. This is not clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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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" 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).

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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.

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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 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.

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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

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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

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510(k) Number: __

K07/694

Regulation Number and Section

§ 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).