(70 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely mechanical.
Yes
The device is used for isolating and ventilating a lung during surgical procedures, which is a medical intervention aimed at treating a patient's condition.
No
The device is used for surgical procedures (isolating and ventilating one lung) and anesthesia, not for diagnosing medical conditions.
No
The device description explicitly states it is a "double lumen tube is made of silicone" and describes physical components like "2 cuffs and separate 15 mm connectors," indicating it is a physical medical device, not software-only.
Based on the provided information, the Silbroncho® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to isolate the left or right lung for surgery, ventilation, or anesthesia. This is a direct intervention on the patient's body for therapeutic or procedural purposes.
- Device Description: The device is a double lumen tube designed for insertion into the airway to manage lung ventilation. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. The Silbroncho® is a device used directly on the patient for a medical procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals - OR and ICU
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mallinckrodt Broncho-Cath - K771219, Vitaid wire reinforced ET tube - K932647
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
3-23-14, Hongo, Bunkyo-ku
| 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 |
| without connectors | |
| Predicate Devices: | Mallinckrodt Broncho-Cath - K771219 |
| Vitaid wire reinforced ET tube - K932647 | |
| Tel - 011-81-3-5689-1913 | |
| 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.
1
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
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 | |
| or the right lung of a patient for surgery, | ||
| one lung ventilation or one lung anesthesia | Same as | |
| Mallinckrodt Broncho-Cath K771219 | ||
| Environments of use | Hospital - OR and ICU | Same as |
| Mallinckrodt Broncho-Cath K771219 | ||
| Patient Population | Patients undergoing surgical procedure | |
| requiring isolation of one lung | Same as | |
| Mallinckrodt Broncho-Cath K771219 | ||
| Technology | ||
| Material | Tube - Silicone | |
| Cuff - Silicone | ||
| Connectors - Polyethylene | Mallinckrodt Broncho-Cath K771219 | |
| Tube -- PVC | ||
| Cuff -- PVC | ||
| Vitaid Wire reinforced ET tube | ||
| K932647 (manufactured by Fuji) | ||
| Tube and Cuff silicone | ||
| Connectors - polyethylene | ||
| Sizes | 33 to 39 French | 35 to 41 French |
| Mallinckrodt Broncho-Cath K771219 | ||
| Design features | Double lumen shaft, 2 cuffs, stylet, Carlens | |
| adapter | Same as | |
| 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.
·
2
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.
3
Page 2 -
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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
Page 3.5