(26 days)
Not Found
No
The description details a mechanical balloon catheter and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for medical interventions such as medicine injection, foreign body removal, and bronchial hemostasis, which are therapeutic actions.
No
The device is used for therapeutic procedures such as medicine injection, foreign body removal, and bronchial hemostasis, as well as for procedures that collect samples (saline injection associated with bronchoalveolar lavage) or visualize anatomy (endoscopic bronchography), which are not strictly diagnostic activities in themselves, as they don't produce a diagnosis.
No
The device description clearly outlines physical components such as an inflatable balloon, catheter, bifurcation, ports, cap, and stopcock, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the B5-2C/B7-2C Balloon Catheters are designed to be used within the body, introduced through an endoscope to perform procedures like selective bronchography, medicine injection, foreign body removal, and hemostasis within the bronchi.
- Intended Use: The intended uses are all interventional procedures performed directly on the patient's anatomy.
Therefore, this device is a medical device used for therapeutic and diagnostic procedures performed in vivo (within the body), not an IVD.
N/A
Intended Use / Indications for Use
B5-2C Balloon Catheter (Color of Branch - Blue) The B5-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.0 mm.
B7-2C Balloon Catheter (Color of Branch - Yellow) The B7-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.8 mm.
Indications for Use:
B5-2C/B7-2C Balloon Catheters (Two Models)
Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveoler lavage, foreign body removal from bronchi, and bronchial hemostasis (tamponade).
Product codes
Not Found
Device Description
The subject balloon catheters are designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through the instrument channel of the endoscope.
The subject device is constructed of the inflatable balloon, catheter, bifucation, irrigation port, air feed cap, and stopcock. The B5 series balloon catheter is 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloon catheter is 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified them by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. The length of both catheters is 1050 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bronchi
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
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Key Metrics
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Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '962901'. The handwriting style is cursive, with some connections between the characters. The characters are bold and dark, contrasting with the white background.
AUG 20 1986 510 (k) SUMMARY
OLYMPUS B5-2C/B7-2C BALLOON CATHETER
| Device Name: | Olympus B5-2C/B7-2C Balloon Catheters |
|---|---|
| Common/Usual Name: | Balloon Catheter |
| Classification Name: | Bronchoscope and Accessories |
| Predicate Devices: | Olympus B5-2C/B7-2C Biliary Balloon Catheter (K904669) |
| Submitted By: | |
| (Contact Person) | Mr. Barry Sands |
| Olympus America Inc. | |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| (516) 844-5474 | |
| Summary Preparation Date: | July 9, 1996 |
Statement of Intended Use
B5-2C Balloon Catheter (Color of Branch - Blue) The B5-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.0 mm.
B7-2C Balloon Catheter (Color of Branch - Yellow) The B7-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.8 mm.
Indications for Use:
B5-2C/B7-2C Balloon Catheters (Two Models)
Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveoler lavage, foreign body removal from bronchi, and bronchial hemostasis (tamponade).
Device Description
The subject balloon catheters are designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through the instrument channel of the endoscope.
1
The subject device is constructed of the inflatable balloon, catheter, bifucation, irrigation port, air feed cap, and stopcock. The B5 series balloon catheter is 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloon catheter is 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified them by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. The length of both catheters is 1050 mm.
General Safety
:
In conclusion, when compared with the predicate biliary balloon (K904669), the subject Olympus B5-2C/B7-2C Balloon Catheter does not incorporate any significant change in the design, specifications, or method of operation that could affect the safety or efficacy of the subject devices.
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