(12 days)
Not Found
No
The summary describes a modified flexible fiberoptic scope with an integral camera and control unit. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on image quality and physical characteristics, not algorithmic performance.
No.
The device is intended for examination and diagnostic purposes, not for treating or providing therapy.
Yes
The device is intended for "flexible endoscopic examination," which is a diagnostic procedure used to visualize internal structures and identify abnormalities.
No
The device description explicitly states it is a modified flexible fiberoptic ENT scope with an integral camera module and control unit, indicating it is a hardware device.
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 directly on the patient's body to visualize internal structures.
- Device Description: The device is a "flexible fiberoptic ENT scope" with an integral camera. This is a medical device used for direct visualization, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens like blood, urine, tissue, etc., to diagnose diseases or conditions. The description of this device and its intended use do not involve the analysis of such specimens.
Therefore, the VSI Model ENT-2000V Flexible Nasopharyngo-Laryngoscope is a medical device used for direct visualization during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The scope is indicated for use during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The VSI Model ENT-2000V Flexible Nasopharyngo-Laryngoscope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The device described in this 510(k) consists of modified flexible fiberoptic ENT scope. The scope has been modified to include an integral camera module and camera control unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airway, vocal chords, 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)
Validation testing including scope image quality evaluation, focal length, resolution, distortion, reprocessing effects and electrical safety testing is included in Design Validation and Verification planning.
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.
Not Found
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
Ko40984
510(k) Summary
| Trade Name: | Vision Sciences Model ENT-2000V Flexible Nasopharyngo-
Laryngoscope |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760
Registration #1223490 |
| Device Generic Name: | Flexible ENT scopes |
| Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K942265 - Flexible ENT Scope
K990354 - Modified EndoSheath® for Flexible ENT Scopes
Manufactured by:
Vision-Sciences, Inc.
9 Strathmore Road
Natick, MA 01760 |
Product Description: The device described in this 510(k) consists of modified flexible fiberoptic ENT scope. The scope has been modified to include an integral camera module and camera control unit.
Indications for Use:
The 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 - 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. Validation testing including scope image quality evaluation, focal length, resolution, distortion, reprocessing effects and electrical safety testing is included in Design Validation and Verification planning.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VSI Flexible ENT Scope has been shown to be safe and effective for its intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Vision-Sciences, Inc. c/o Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer. MA 01432
Re: K040984
Trade/Device Name: Vision Sciences Model ENT-2000V Flexible Nasopharyngo-Layngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: EOB Dated: April 8, 2004
Received: April 15, 2004
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
Page 2 - Pamela Papineau, RAC
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ahelyl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): _K040984
Device Name: Vision Sciences Model ENT-2000V Flexible Nasopharyngo-Laryngoscope
Indications for Use:
The VSI Model ENT-2000V Flexible Nasopharyngo-Laryngoscope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | AND/OR |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | ||
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510{k) Number
Over-the -Counter Use (21 CFR 807 Subpart D)