TIP DEFLRCTING ENDOBRONCHIAL BLOCKER

K013865 · Cook, Inc. · CBI · Apr 22, 2002 · Anesthesiology

Device Facts

• Record ID: K013865
• Device Name: TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
• Applicant: Cook, Inc.
• Product Code: CBI · Anesthesiology
• Decision Date: Apr 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Tip Deflecting Endobronchial Blocker is a catheter-based device designed for use with a standard bronchoscope and endotracheal tube (7.0 mm or larger) to achieve one-lung ventilation. The device features a flexible, steerable tip capable of deflection greater than 90 degrees, allowing for precise placement into the target bronchus. It includes a pilot balloon assembly for cuff inflation and maintenance. The device is used in clinical settings by healthcare professionals to block a specific lung, facilitating differential ventilation. It is supplied with an Arndt Multiport Airway Adapter, a CPAP adapter, and a syringe. By enabling selective lung isolation, the device assists clinicians in managing ventilation during thoracic procedures.

Clinical Evidence

Bench testing only. Testing included bond strength analysis, deflection angle analysis, cuff pressure and dimension evaluation at various inflation volumes, balloon burst testing, balloon cuff inflation retention, balloon-to-shaft bond evaluation, and biocompatibility testing.

Technological Characteristics

9.0 French outside diameter catheter; flexible steerable tip with >90-degree deflection; pilot balloon assembly for cuff inflation; coaxial fit with endotracheal tubes 7.0 mm or larger. Includes Arndt Multiport Airway Adapter and CPAP adapter. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring one-lung ventilation during surgical or medical procedures to isolate the left or right lung via differential intubation of a bronchus.

Regulatory Classification

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.

Predicate Devices

• Bronchial Blocker D.C. (K962167)
• Pediatric Endobronchial Blocker (K002288)

Submission Summary (Full Text)

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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 [phone]

#### 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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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 [phone]. 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 [phone] or [phone] 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