(11 days)
Not Found
No
The summary describes a modified fiberoptic scope with an LED light source and does not mention any AI/ML components or image processing capabilities.
No
The device is described as an ENT scope for examination of the upper airway, vocal chords, and nasal passages, which is a diagnostic purpose, not therapeutic.
No
The device is described as an endoscope for examination, which is a tool for visualization rather than diagnosing conditions. It facilitates observation, which can be part of a diagnostic process, but the device itself does not perform the diagnosis.
No
The device description explicitly states it consists of a "modified flexible fiberoptic ENT scope" and mentions hardware components like a "battery-powered LED light source (with accessory recharger)". The performance studies also include hardware-related testing such as "light output, operating temperature, scope leak testing, reprocessing effects analysis and electrical safety testing".
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 chords and/or nasal passages." This is a direct examination of anatomical structures within the body, not the analysis of samples taken from the body (which is the hallmark of IVDs).
- Device Description: The description confirms it's a "flexible fiberoptic ENT scope" with a light source. This is a medical device used for visualization, not for performing tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for direct visualization and examination, 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 Flexible ENT Scope 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 replace the integral light guide cable with a battery-powered LED light source (with accessory recharger).
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 1 he varies titled "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 light output, operating temperature, scope leak testing, reprocessing effects analysis and electrical safety testing was 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
050972
Vision-Sciences, Inc. April 15, 2005
Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scope
510(k) Summary
APR 2 9 2005
| Trade Name: | Vision-Sciences ENT-3000 Scope |
|---|---|
| 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 Scope | |
| 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 replace the integral light guide cable with a battery-powered LED light source (with accessory recharger).
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 1 he varies titled "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 light output, operating temperature, scope leak testing, reprocessing effects analysis and electrical safety testing was included in Design Validation and Verification planning.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate Davices, 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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes and a curved body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2005
Vision Sciences, Inc. c/o Pamela Papineau Consultant to Vision Sciences Delphia Medical Device Consulting 5 Whitcomb Ave. Aver, MA 01432
Re: K050972
Trade/Device Name: Vision Sciences Model ENT-3000 Portable Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED Light Source ﺒﻲ
Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Dated: April 15, 2005 Received: April 18, 2005
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 for about in the 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 If your device is elassince (toonal controls. Existing major regulations affecting your device can may or subject to back access 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I 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 Of R Fart 6077, accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byevelle (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) I mis letter will and in your of substantial equivalence of your device to a legally premated 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) 827-8910. 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 other general informational 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting 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. April 15, 2005
Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scope
Page
510(k) Number (if known):
Device Name: Vision-Sciences Flexible ENT Scope
Indications for Use:
The VSI Flexible ENT Scope 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 × (Part 21 CFR 801 Subpart D) AND/OR
Karin Bahr
1086
Number K05097
Over-the -Counter Use (21 CFR 807 Subpart D)
000010