(48 days)
No
The document describes a standard bronchoscope and video processing system without mentioning any AI/ML capabilities. The focus is on image visualization and capture, not analysis or interpretation using AI/ML.
No.
The device is used for diagnostic purposes (diagnosis, visualization) and for airway management (intubations), but not primarily for treating a disease or condition. While it mentions "endoscopic treatment", the primary uses listed are diagnostic and procedural (intubation).
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways." The term "diagnosis" directly indicates a diagnostic purpose.
No
The device description explicitly mentions hardware components like flexible endoscopes, a video processor, and disposable sheath systems. While there is a digital video processor involved, the overall system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways." This describes a procedure performed directly on the patient's body for visualization and intervention.
- Device Description: The device is a bronchoscope system, which is an instrument used to visualize the airways internally.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The device is a medical device used for direct visualization and intervention within the patient's body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.
The digital video processor is intended for use with the VSI flexible video scope.
Product codes
EOQ
Device Description
The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been subjected to and passed electrical safety, thermal, and ECM testing requirements. The patient contact materials in the endoscope are identical to the materials used in predicate device (Vision Sciences' TNE-5000 (K072088)).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K981543, K082720, K050972, K040984, K024095, K942265
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
KO 91768
1100 0 700
510(k) Premarket Notification: Device Modification Video Bronchoscope with Digital Video Processor and BV Slide-On® EndoSheath® Systems
: . . . .
510(k) Summary
Date Prepared (21 CFR 807.92(a)(1): June 6, 2009
AUG 0 8 2009
Owner's Name (21 CFR 807.92(a)(1):
| Vision-Sciences, Inc. | |
|---|---|
| Address: | 40 Ramland Road South |
| Orangeburg, NY 10962 | |
| Telephone Number: | (845) 365-0600 |
| Fax Number: | (845) 365-0620 |
| Contact Person: | Lillian Quintero; Director QA/RA |
Trade Name, Common Name, Classification (21 CFR 807.92(a)(2))
| Subject Device Name: | BRS-5000 Video Bronchoscope and BV Slide-On® EndoSheath®
Systems with Digital Video Processor |
|------------------------|--------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible Video Bronchoscope with Sheath and Video Processor |
| Product Codes: | EOQ |
| FDA Regulations: | 21 CFR 874.4680 |
| Device Classification: | Class II |
Predicate Device Names (21 CFR 807.92(a)(3))
K072088 Flexible Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems
K021344 Flexible Fiberoptic Bronchoscope with Disposable EndoSheath
Intubation of the airways for Bronchoscopes has received FDA marketing clearance in the following 510(k) Premarket Notifications:
K981543 Olympus Tracheal Intubation Fiberscope K082720 Olympus Tracheal Intubation Fibervideoscope
Common/Usual Name: Product Codes: FDA Regulations: Device Classification; Premarket Notification: Flexible fiberoptic endoscopes with sheaths and accessories EOB. EOO 21 CFR 874.4760 Class II K050972 / K040984 / K024095 / K942265
Device Description
The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
Intended Use
The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.
1
Vision-Sciences, Inc. June 9, 2009
510(k) Premarket Notification: Device Modification Video Bronchoscope with Digital Video Processor and BV Slide-On® EndoSheath® Systems
Technological Characteristics
Vision Sciences believes that the subject device is substantially equivalent to the Vision Sciences' predicate devices. The subject device has very similar material composition and working dimensions; and identical viewing direction, image size, bending, re-processing/sterilization method and working dimensions as In addition, the subject device uses the same video processor as Vision Sciences other the predicate. videoscopes.
Performance Testing
The subject device has been subjected to and passed electrical safety, thermal, and ECM testing requirements. The patient contact materials in the endoscope are identical to the materials used in predicate device (Vision Sciences' TNE-5000 (K072088)).
Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 3 2009
Vision Sciences, Inc c/o Stacie Geffner-Ativa 40 Ramland Road, South Orangeburg, NY 10962
Re: K091768
Trade/Device Name: Flexible Video Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: June 11, 2009 Received: June 16, 2009
Dear Ms. Geffner-Atiya:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Malvina B. Eydelman, M.D. · Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Vision-Sciences, Inc. June 9, 2009
510(k) Premarket Notification: Device Modification Video Bronchoscope with Digital Video Processor and BV Slide-On® EndoSheath® Systems
510(k) Number (if known):
Video Bronchoscope with Digital Video Processor and BV Slide-On® Device Name: EndoSheath® Systems
The bronchoscope and EndoSheath® Technology are designed to be Indications for Use: used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.
The digital video processor is intended for use with the VSI flexible video scope.
Prescription Use X OR Over-the -Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Karen H. Baker
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091768