The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.

AI/ML Overview

The provided document describes a Special 510(k) submission for a device modification, not a study evaluating AI performance or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and human reader studies is not available in the provided text.

This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Vision Sciences Model ENT-3000 Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED) to its predicate device. The changes relate to an enhanced LED light source, requiring validation of safety and performance for this modification.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a Special 510(k) for a device modification rather than a new AI or diagnostic device, the "acceptance criteria" discussed are primarily related to safety and performance standards for the modified physical device, specifically the light source. The document lists the following validation testing:

Acceptance Criteria (Type of Testing)	Reported Device Performance
Light Output Testing	Included in Design Validation and Verification planning
Operating Temperature Testing	Included in Design Validation and Verification planning
Electrical Safety Testing	Included in Design Validation and Verification planning
Compliance to 21 CFR 820.30 Design Control requirements	Certified by Vision Sciences
Risk Analysis Procedure	Described by Vision Sciences

Note: The document states that these tests were "included in Design Validation and Verification planning" but does not explicitly provide quantitative results or specific pass/fail values. The overall conclusion states the device has been shown to be "safe and effective for its intended use" based on these tests and comparison to predicate devices, implying these criteria were met.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The testing mentioned (light output, operating temperature, electrical safety) would typically involve engineering tests on the physical device itself rather than data sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable / Not provided. As there's no clinical "test set" for diagnostic accuracy, there's no mention of ground truth established by experts.

4. Adjudication Method:

Not applicable / Not provided. No adjudication method is mentioned as there's no diagnostic accuracy study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not mention any MRMC study or comparative effectiveness study involving human readers, with or without AI assistance. The device is a flexible endoscope, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable / Not provided. Since there's no diagnostic performance study, no ground truth types (pathology, expert consensus, outcomes data) are mentioned. The "ground truth" for this type of submission generally relates to compliance with engineering standards and safety requirements.

8. Sample Size for the Training Set:

Not applicable / Not provided. There is no "training set" in the context of an AI device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable / Not provided. As there's no training set, this information is not relevant.

Summary of what is available about the study:

The submission is a Special 510(k): Device Modification.
The "study" involved Design Validation and Verification Planning, which included:

Light output testing
Operating temperature testing
Electrical safety testing
Compliance to 21 CFR 820.30 Design Control requirements
Internal Risk Analysis procedure

The conclusion stated that "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." This implies that the device successfully met the internal design validation and verification criteria for the modified components.

Summary

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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.

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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.

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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

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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)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K100125 510(k) Number_

Regulation Number and Section

§ 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.