(37 days)
No
The summary describes a standard flexible endoscope with LED illumination and does not mention any AI/ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No.
The device is described as being for "flexible endoscopic examination," which is a diagnostic procedure, not a therapeutic intervention.
No
The intended use states it is for "flexible endoscopic examination". This describes a viewing or imaging function, not a diagnostic one. While the examination may inform a diagnosis, the device itself is not performing the diagnostic process.
No
The device description explicitly mentions hardware components (Scope, BLS-1000, LED based illumination) and performance studies include testing of hardware characteristics (light output, operating temperature, electrical safety).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages." This describes a procedure performed on the patient's body for visual inspection, not a test performed on a sample taken from the patient.
- Device Description: The description focuses on the physical device (scope and light source) used for viewing, not on reagents, kits, or instruments used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
In summary, the Vision Sciences' Flexible ENT Scope is a medical device used for direct visualization within the body, which falls under the category of an endoscope, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flexible ENT scope is indicated for use during flexible endoscopic examination of the upper airway, vocal chords and /or nasal passages.
The Vision Sciences' Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
Product codes
EOB
Device Description
The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airway, vocal chords 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 - Alternative 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. Validation testing including light output, operating temperature and electrical safety testing was included in Design Validation and Verification planning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
16100125
510(k) Summary
Date Prepared (21 CFR 807.92(a)(1): January 15, 2010
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 |
FEB 2 5 2010
Trade Name, Common Name, Classification (21 CFR 807.92(a)(2))
| Subject Device Name: | Vision Sciences Model ENT-3000 Flexible Nasopharyngoscope with BLS-
1000 Battery Powered LED |
|------------------------|-------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible ENT Scopes |
| Product Codes: | EOB |
| FDA Regulations: | 21 CFR 874.4760 |
| Device Classification: | Class II |
Predicate Device Names (21 CFR 807.92(a)(3))
Vision Sciences - Model ENT-3000 Portable Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED Light Source (K050972)
OPTIM Incorporated - "PLS" Portable Light Source (K091829)
| Common/Usual Name: | Endoscope and Accessories |
|---|---|
| Product Codes: | EOB, NTN |
| FDA Regulations: | 21 CFR 874.4760, 21 CFR 876.1500 |
| Device Classification: | Class II |
| Premarket Notification: | K050972, K091829 |
Device Description
The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.
Intended Use
The Flexible ENT scope is indicated for use during flexible endoscopic examination of the upper airway, vocal chords and /or nasal passages.
Safety and Performance
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternative 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. Validation testing including light output, operating temperature and electrical safety testing was included in Design Validation and Verification planning.
Conclusion
Based on the indications for use, technological characteristics, performance and electrical testing and comparison to predicate devices, the VSI ENT-3000 has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
FEB 2 5 2010
Vision-Sciences, Inc. % Ms Stacie Geffner-Atiya 40 Ramland Road South Orangeburg, NY 10962
Re: K100125
Trade/Device Name: Vision Sciences Flexible ENT Scope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: January 8, 2010 Received: January 21, 2010
Dear Ms Stacie 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 individe 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contraction in and warranties. We remind you, however, that device labeling must be truthful and not misler ing
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 offecting 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 (reporting of modical device-related adverse events) (21 CFR 803); 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
Page 2 - Ms Stacie Geffner-Atiya
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. Page 2 - Ms Stacie Geffner-Atiya
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/ReportalProblem/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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rude Thomson h
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neuroloical, and Ear. Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K100125
Vision Sciences Flexible ENT Scope Device Name:
Indications For Use:
The Vision Sciences' Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K100125 510(k) Number_