(30 days)
No
The summary describes standard endoscopic equipment and image processing for visualization and capture, with no mention of AI or ML capabilities for analysis, diagnosis, or other functions.
Yes
The 'Intended Use' section states that the device is intended "to perform various diagnostic and therapeutic procedures."
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "flexible endoscopic examination" and to "perform various diagnostic and therapeutic procedures." Examination and diagnosis are key functions of diagnostic devices.
No
The device description clearly outlines hardware components including flexible endoscopes, a digital video processor, and disposable sheath systems. While software is mentioned for validation, the core device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages" and for performing "various diagnostic and therapeutic procedures." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description details endoscopes, sheaths, and a video processor. These are instruments used for direct visualization and intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.
The digital video processor is intended for use with the VSI flexible video scope.
Product codes (comma separated list FDA assigned to the subject device)
EOB
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 cover 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
upper airway, vocal cords and/or nasal passages
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)
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification was a
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.
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.
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Vision-Sciences, Inc. July 27, 2007
Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems
510(k) Summary
AUG 2 9 2007 Owner's Name: 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 Subject Device Name: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems Common/Usual Name: Flexible video endoscopes with video processor and disposable sheaths Product Codes: EOB FDA Regulations: 21 CFR 874.4760 Device Classification: Class II Predicate Device Name: Flexible Fiberoptic ENT Scopes with EndoSheath® Systems Common/Usual Name: Flexible fiberoptic endoscopes with sheaths and accessories Product Codes: EOB FDA Regulations: 21 CFR 874.4760 Device Classification: Class II Premarket Notification: 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 cover 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 flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Performance Testing
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification was a
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.
1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2007
Vision-Sciences, Inc. c/o Pamela Papineau Delphi Medical Devices Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K072073
Trade Name: Flexible Endoscopes with Digital Video Processor and Disposible Endosheath® Systems Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible) and accessories Regulatory Class: Class II Product Code: EOB Dated: July 27, 2007 Received: July 30, 2007
Dear Ms. Papineau:
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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Egelkus, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Vision-Sciences, Inc. July 27, 2007
Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems
510(k) Number (if known):
Device Name: Flexible Endoscopes with Digital Video Processor and Disposable EndoSheath® Systems
Indications for Use:
The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.
The digital video processor is intended for use with the VSI flexible video scope.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (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)
Ahalut
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K0720
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