(35 days)
No
The summary describes a bronchovideoscope and its compatibility with existing video systems and electrocautery devices. There is no mention of AI, ML, image processing beyond standard video capture, or any algorithms that would suggest AI/ML functionality.
Yes
The device is used for "endoscopic diagnosis and treatment within the airways and tracheobronchial tree" and can be used with "electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment," indicating its role in treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for "endoscopic diagnosis and treatment within the airways and tracheobronchial tree." The term "diagnosis" directly indicates a diagnostic purpose.
No
The device description clearly states that the device is a Bronchovideoscope, which is a physical medical device used for endoscopic procedures. It is designed to be used in conjunction with other hardware components like a video system center, light source, and electrocautery devices. There is no indication that the device itself is solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis and treatment within the airways and tracheobronchial tree." This describes a procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device is a "Bronchovideoscope," which is an instrument used to visualize and access the airways. It's used in conjunction with other equipment for direct examination and intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on visualization and treatment within the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is procedural and diagnostic through direct visualization.
N/A
Intended Use / Indications for Use
The BF Type 240 Bronchovideoscopes have been designed to be used with an Olympus EVIS CV- 200 video system center, light source, documentation equipment, video monitor, Endo-Therapy accessories, electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
The BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
Product codes
Not Found
Device Description
Olympus offers three models: BF-240, BF-P240, and BF-1T240 of Bronchovideoscopes. They are specifically designed to be used in conjunction with the EVIS 200 Video System which was cleared in 510(k) # K931154 and recommended electrocautery devices.
All other characteristics such as optical, product specifications, material, intended use, and indications for use of the BF-240 Bronchovideoscopes remains unchanged except the modifications identified earlier in this section.
Olympus currently markets EVIS BF Type 200Bronchvideoscopes, its associated accessories and ancillary equipment, which were cleared for marketing in 510(k) # K931154. The BF Type 240 Bronchoviseoscopes are substantially equivalent to the BF Type 200 Bronchvideoscopes in design, specifications, materials, intended use, and method of use except the BF-240 allows the user to use the electrocautery devices such as electrosurgical snares and coagulation electrodes during the endoscopic procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Olympus EVIS 200 System - Bronchoscopy (K931154)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
K963033 510 (k) SUMMARY OLYMPUS BF Type 240 BRONCHOVIDEOSCOPES
SEP - 9 1996
| Device Name: | Olympus BF Type 240 Bronchovideoscopes, its associated
and ancillary equipment and endoscopic accessories |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Bronchovideoscope and Accessories |
| Classification Name: | Bronchoscope and Accessories |
| Predicate Devices: | Olympus EVIS 200 System - Bronchoscopy (K931154) |
| Submitted By:
(Contact Person) | Mr. Barry E. Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5481 |
| Summary Preparation Date: | July 26, 1996 |
Statement of Intended Use
BF Type 240 VIDEOBRONCHOSCOPES
The BF Type 240 Bronchovideoscopes have been designed to be used with an Olympus EVIS CV- 200 video system center, light source, documentation equipment, video monitor, Endo-Therapy accessories, electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
ENDOSCOPIC ANCILLARY EQUIPMENT AND ACCESSORIES
All standard set and recommended accessories and equipment submitted in this submission are compatible and should be used with the subject BF 240 Type Bronchovideoscopes. Please refer to Subsection III-A for a copy of the Instruction Manual.
Statement of Indications for Use
The BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.
1
K963033
Device Description
Olympus offers three models: BF-240, BF-P240, and BF-1T240 of Bronchovideoscopes. They are specifically designed to be used in conjunction with the EVIS 200 Video System which was cleared in 510(k) # K931154 and recommended electrocautery devices.
All other characteristics such as optical, product specifications, material, intended use, and indications for use of the BF-240 Bronchovideoscopes remains unchanged except the modifications identified earlier in this section.
Olympus currently markets EVIS BF Type 200Bronchvideoscopes, its associated accessories and ancillary equipment, which were cleared for marketing in 510(k) # K931154. The BF Type 240 Bronchoviseoscopes are substantially equivalent to the BF Type 200 Bronchvideoscopes in design, specifications, materials, intended use, and method of use except the BF-240 allows the user to use the electrocautery devices such as electrosurgical snares and coagulation electrodes during the endoscopic procedure.
General Safety
The Olympus BF Type 240 Bronchovideoscopes are designed, manufactured and tested according to Voluntary Safety Standards IEC 601-1 and IEC 601-2-18.
When compared with the predicate devices. Olympus BF Type 240 Bronchovideoscopes do not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness.