(91 days)
No
The summary describes a traditional fiberoptic bronchoscope system with a disposable sheath. There is no mention of AI, ML, image processing for analysis, or any data sets for training or testing algorithms. The performance studies are focused on functional and biocompatibility testing of the physical device.
No
The device is primarily for diagnostic examination and specimen gathering, and includes the removal of foreign objects, but it is not explicitly described as a therapeutic device for treating a condition. Its function is to facilitate procedures, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs."
No
The device description explicitly states it consists of a reusable bronchoscope with fiberoptic bundles and a disposable sheath, indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the diagnostic examination of the inside of the trachea and lungs, gathering specimens, and removing foreign objects. This is a direct examination of the body's internal structures.
- Device Description: The device is a bronchoscope system used for visualization and access to the respiratory tract.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). The specimens gathered are likely for subsequent laboratory testing, but the bronchoscope itself is not performing the in vitro diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro to provide information for diagnostic purposes. This bronchoscope is used in vivo to visualize and interact with the body directly.
N/A
Intended Use / Indications for Use
The Vision Sciences (VSI) Bronchoscope and Disposable Sheath System will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs. It may also be used to gather specimens and to find and remove foreign objects in the lungs.
Product codes
Not Found
Device Description
The VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath consists of a reusable bronchoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the suction/biopsy channel. The sheath is removed and disposed of following each procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside of the trachea or windpipe and other major air passages of the lungs.
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
The following in vitro functional tests were performed on the proposed VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath:
- System Functional Testing
- System Cycle Testing
- Sheath Burst Testing
The following biocompatibility data was presented in support of this Premarket Notification:
- Irritation
- Sensitization
- Cytotoxicity
- Acute Systemic Toxicity
Microbial barrier testing was also included.
Key Metrics
Not Found
Predicate Device(s)
Model BF-3C20 Bronchoscope, Model FB-10X Bronchoscope, Model FB-18RX Bronchoscope and Model FI-10P Intubation Scope, Model SF-100 Flexible Fiberoptic Sigmoidoscope and Disposable EndoSheath (K921690), Model SV-100 Flexible Video Sigmoidoscope and Disposable EndoSheath (K932843), Protective Sheath for use with the VSI Model E-F100 ENT endoscope (K961591), Protective Sheath for use with the Machida Models ENT-3L and ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K950809)
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
L963795
DEC 2 3 1996
Vician Sciences In 510(k) Premarket Notification Flexible Fiberoptic Bronchoscope with D
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Vision-Sciences is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." VSI chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | |
|---|---|
| ------------- | -- |
VSI Model B-F100 Bronchoscope with Model BS-F21 Disposable EndoSheath
Owner/Operator:
Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
Manufacturing Site:
EndoSheath: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 Reg. # 1223490
Endoscope:
Vision-Sciences, Inc. 40 Ramland Rd. South Orangeburg, NY 10962 Reg. #2242464
Device Generic Name: Bronchoscope and accessories
Classification:
According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II, Performance Standards (CFR 874.4680).
.227
1
ision Sciences Inc 510(k) Premarket Notification Flexible Fiberoptic Bronchoscope with Disposable EndoSheath® September 20, 1996
Predicate Devices:
Model BF-3C20 Bronchoscope
Manufactured and Distributed by: Olympus Corp. 4 Nevada Dr. Lake Success, NY 11042
-
- Model FB-10X Bronchoscope, Model FB-18RX Bronchoscope and Model FI-10P Intubation Scope
Manufactured and Distributed by: Pentax Precision Instrument Corp. 30 Ramland Road. Orangeburg, NY 10962
- Model FB-10X Bronchoscope, Model FB-18RX Bronchoscope and Model FI-10P Intubation Scope
-
Model SF-100 Flexible Fiberoptic Sigmoidoscope and Disposable 3. EndoSheath (K921690)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 -
Model SV-100 Flexible Video Sigmoidoscope and Disposable 4. EndoSheath (K932843)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
2
-
ર. Protective Sheath for use with the VSI Model E-F100 ENT endoscope (K961591)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760 -
Protective Sheath for use with the Machida Models ENT-3L and ENT-4L, 6. Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K950809)
Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick, MA 01760
Product Description:
Vision Sciences Inc.
510(k) Premarket Notification
The VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath consists of a reusable bronchoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the suction/biopsy channel. The sheath is removed and disposed of following each procedure.
Indications for Use:
The Vision Sciences (VSI) Bronchoscope and Disposable Sheath System will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs. It may also be used to gather specimens and to find and remove foreign objects in the lungs.
3
Vision Sciences Inc. 510(k) Premarket Notification
Safety and Performance:
The following in vitro functional tests were performed on the proposed VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath:
-
- System Functional Testing
-
- System Cycle Testing
-
- Sheath Burst Testing
The following biocompatibility data was presented in support of this Premarket Notification:
-
- Irritation
-
- Sensitization
-
- Cytotoxicity
-
- Acute Systemic Toxicity
Microbial barrier testing was also included.
Conclusion:
Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model B-F100 Bronchoscope with Model BS-F21 Disposable EndoSheath has been shown to be safe and effective for its intended use.
2:30