SILBRONCHO DOUBLE LUMEN TUBE

K051522 · Fuji Systems Corp. · CBI · Aug 17, 2005 · Anesthesiology

Device Facts

• Record ID: K051522
• Device Name: SILBRONCHO DOUBLE LUMEN TUBE
• Applicant: Fuji Systems Corp.
• Product Code: CBI · Anesthesiology
• Decision Date: Aug 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Silbroncho® is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

Device Story

Silbroncho® is a double-lumen endotracheal tube; used for isolating and ventilating one lung during surgical procedures. Device features two cuffs, two lumens, and separate 15 mm connectors; includes stylet and movable stopper. Used in hospital OR and ICU settings by clinicians. Provides lung isolation to facilitate one-lung anesthesia or ventilation; benefits patient by allowing surgical access to specific thoracic areas while maintaining ventilation in the contralateral lung.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Silicone tube and cuff, polyethylene connectors. Design: Double lumen shaft, 2 cuffs, 15 mm connectors, stylet, Carlens adapter. Sizes: 33 to 39 French. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring one lung isolation for surgery, one lung ventilation, or one lung anesthesia.

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

• Mallinckrodt Broncho-Cath (K771219)
• Vitaid wire reinforced ET tube (K932647)

Submission Summary (Full Text)

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Systems Silbroncho®

Premarket Notification 510(k) Section 3 – Certifications and Summaries

#### AUG 1 7 2005 Summary of Safety and Effectiveness 3.1

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 7-Jun-05

| Fuji Systems Corporation<br>3-23-14, Hongo, Bunkyo-ku<br>Tokyo, Japan 113-0033 | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Official Contact: | Yoshi Semba - Director, International Division |
| Proprietary or Trade Name: | Silbroncho® tubes |
| Common/Usual Name: | Double lumen tube |
| Classification Name: | Differential ventilation tracheal / bronchial tube with and<br>without connectors |
| Predicate Devices: | Mallinckrodt Broncho-Cath - K771219<br>Vitaid wire reinforced ET tube - K932647 |
| Tel - 011-81-3-5689-1913<br>Fax - 011-81-3-5689-1915 | |

### Device Description:

The Silbroncho® double lumen tube is made of silicone and is available in sizes 33 to 39 French. They are designed as a double lumen tube with 2 cuffs and separate 15 mm connectors for isolating and ventilating one lung during surgical procedures.

Image /page/0/Figure/8 description: The image shows a diagram of a double-lumen endotracheal tube. The diagram includes multiple views of the tube, including a close-up view of the distal end, an overall view of the tube, and a view of the connector assembly. The diagram also labels the different parts of the tube, such as the tracheal tube lumen tip, the tracheal cuff, the endobronchial tube, and the endobronchial cuff. The diagram also shows a stylet and movable stopper.

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# Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 7-Jun-05

### Indications:

| Indications for Use -- | The Silbroncho® is used to isolate the left or right lung of a<br>patient for surgery, one lung ventilation or one lung anesthesia. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | Patients requiring one lung isolation |
| Environment of Use -- | Hospitals - OR and ICU |

## Comparison to Predicate Devices:

| | Fuji Silbroncho® | Predicates |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Indications for use | The Silbroncho® is used to isolate the left<br>or the right lung of a patient for surgery,<br>one lung ventilation or one lung anesthesia | Same as<br>Mallinckrodt Broncho-Cath K771219 |
| Environments of use | Hospital - OR and ICU | Same as<br>Mallinckrodt Broncho-Cath K771219 |
| Patient Population | Patients undergoing surgical procedure<br>requiring isolation of one lung | Same as<br>Mallinckrodt Broncho-Cath K771219 |
| Technology | | |
| Material | Tube - Silicone<br>Cuff - Silicone<br>Connectors - Polyethylene | Mallinckrodt Broncho-Cath K771219<br>Tube -- PVC<br>Cuff -- PVC<br>Vitaid Wire reinforced ET tube<br>K932647 (manufactured by Fuji)<br>Tube and Cuff silicone<br>Connectors - polyethylene |
| Sizes | 33 to 39 French | 35 to 41 French<br>Mallinckrodt Broncho-Cath K771219 |
| Design features | Double lumen shaft, 2 cuffs, stylet, Carlens<br>adapter | Same as<br>Mallinckrodt Broncho-Cath K771219 |

## Differences Between Other Legally Marketed Predicate Devices

There are no significant differences between the proposed device, Fuji Silbroncho® tube, and the identified predicates.

·

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 7 2005

Mr. Paul E. Dryden FUJI Systems Corporation 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K051522

Trade/Device Name: Silbroncho Double Lumen Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/bronchial differential ventilation tube Regulatory Class: II Product Code: CBI Dated: June 7, 2005 Received: June 8, 2005

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreatives (1976, the enactment date of the Medical Device Amendments, or to commerce pror to Milly 20, 1970, in accordance with the provisions of the Federal Food, Drug, devices mat have boon require approval of a premarket approval application (PMA). and Cosmetic 700 (710) that ao novice, subject to the general controls provisions of the Act. The 1 ou may, dicierore, mailer and as act include requirements for annual registration, listing of general voltarely provision 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 If your device is classified (600 world) also and regulations affecting your device can may be subject to sach additions, 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 I rease be advised that I Dr. bristian that your device complies with other requirements of the Act that I Dr Has made a sond regulations administered by other Federal agencies. You must or any i cacial stutures and regulanceds, including, but not limited to: registration and listing (21 Comply with an the 110 - 310 cm ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. CITY art 607), adoning (21 CFR Part 820); and if applicable, the electronic form in the quand of of the Actions 531-542 of the Act); 21 CFR 1000-1050.

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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) I mis reter wifi and in J . The FDA finding of substantial equivalence of your device to a promative nettricated 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), n you don't the Office of Compliance at [phone]. 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 Inter Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clrs
Tin Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use 3.3

Page 1 of 1

| 510(k) Number: | K051522 (To be assigned) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Silbroncho® Tube |
| Indications for Use: | The Silbroncho® is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia. |
| Prescription Use XX | or Over-the-counter use |

(Per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cus

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthesiony, Ocho

510(k) Number: K051522

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