The Tip Deflecting Endobronchial Blocker is intended for use to differentially intubate a single lumen tube to isolate the left or right lung for procedures which require one-lung ventilation.

Device Description

The Tip-Deflecting Endobronchial Blocker is designed for use with a standard endotracheal tube and a small diameter fiberoptic bronchoscope to be placed inside a single lumen tube to provide one lung ventilation. It uses a flexible soft tip that can be deflected to more than 90 degrees and easily placed into the desired bronchus to be blocked. The device measures 9.0 French in outside diameter and fits coaxially with a 7.0 mm or larger endotracheal tube. The proximal end of the catheter is made up of a pilot balloon assembly. This balloon assembly has one litting to inflate the distal balloon and maintains inflation until it is deflated. Facilitation 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).

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification for the "Tip Deflecting Endobronchial Blocker" manufactured by Cook Incorporated. This document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than establishing entirely new performance criteria or clinical efficacy studies.

Therefore, the requested information elements related to clinical trials, expert adjudication, MRMC studies, standalone algorithm performance, and sample sizes for training/test sets are not applicable or not explicitly detailed in this submission, as it falls under a 510(k) pathway which primarily relies on comparison to existing legally marketed devices.

Here's a breakdown of the available information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify formal, quantifiable "acceptance criteria" with numerical thresholds for performance. Instead, it lists the types of tests performed to assure reliable design and performance, and 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 its use." This implies that the device met the internal design and performance expectations for each test, thereby demonstrating substantial equivalence.

Test Performed	Reported Device Performance (as stated in the document)
Analysis of Bond Strength	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Analysis of Deflection Angles	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Analysis of Cuff Pressure and Dimension at Various Inflation Volumes	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Balloon Burst Testing	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Analysis of Balloon Cuff Inflation Retention	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Evaluation of Balloon to Shaft Bond	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
Biocompatibility Testing	Results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The document refers to "the following tests" which are likely bench tests or in vitro evaluations, not human clinical trials.
Data provenance: Not explicitly stated, but given the nature of a medical device submission, it would be internal testing data from Cook Incorporated. There is no mention of country of origin of data, retrospective or prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission describes device performance through engineering and biocompatibility tests, not clinical evaluations requiring expert interpretation or ground truth establishment in a diagnostic context.

4. Adjudication method for the test set

Not applicable. See point 3.

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 is a medical device for mechanical intervention (lung isolation for ventilation), not an AI-based diagnostic or assistive technology. No MRMC studies were conducted for this device.

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

Not applicable. This is a hardware medical device, not an algorithm or software-only device.

7. The type of ground truth used

Not applicable/Implicit in testing methodology. For mechanical performance tests, the "ground truth" would be established by the physical and chemical properties of the materials and the design specifications against which the device is tested (e.g., a balloon bursting at a certain pressure, a bond breaking at a certain force, biocompatibility standards). These are typically defined engineering and regulatory standards rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

Summary

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K013865

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

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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.

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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

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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

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Tip Deflecting Endobronchial Blocker Special 510(k) Premarket Notification Cook Incorporated

510(k) Number (if known):

K013865

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

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).