(11 days)
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.
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).
The provided text describes a Special 510(k) Premarket Notification for a device modification, focusing on a change in the light source of an existing ENT scope. As such, the submission primarily addresses safety and effectiveness through design control, risk analysis, and validation testing, rather than comparative performance studies against specific acceptance criteria in the manner you've requested for typical AI/ML device evaluations.
Therefore, many of the requested points regarding acceptance criteria, study types, ground truth, and expert involvement are not applicable to this particular 510(k) submission, as it relates to a physical device modification rather than an AI/ML algorithm.
Here's the information that can be extracted or deduced from the provided documents, along with explanations for the unanswerable points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Performance of Modified Scope | - Certification of compliance to 21 CFR 820.30 Design Control requirements. |
| - Description of internal Risk Analysis procedure. | |
| - Validation testing conducted for: | |
| - Light output | |
| - Operating temperature | |
| - Scope leak testing | |
| - Reprocessing effects analysis | |
| - Electrical safety testing | |
| Substantial Equivalence to Predicate Devices | - The FDA determined the device to be substantially equivalent to legally marketed predicate devices (K942265 – Flexible ENT Scope and K990354 – Modified EndoSheath® for Flexible ENT Scope). |
| Intended Use | - The modified VSI Flexible ENT Scope is "safe and effective for its intended use" (flexible endoscopic examination of the upper airway, vocal chords, and/or nasal passages). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a physical device modification (changing an integral light guide cable to a battery-powered LED light source). It does not appear to involve a "test set" of patient data for evaluating diagnostic performance in the way an AI/ML device would. The "validation testing" mentioned refers to engineering and safety performance tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. There's no indication of clinical "ground truth" establishment in this context, as it's not a diagnostic AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-assisted device. The submission is for a modification to a flexible ENT scope's light source.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the device modification, the "ground truth" for proving safety and performance would be established through engineering specifications, test standards, and regulatory compliance (e.g., electrical safety standards, leak test pass/fail criteria). There is no clinical "ground truth" needed for diagnostic accuracy in this context.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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 RoadNatick, MA 01760Registration #1223490 |
| Device Generic Name: | Flexible ENT scopes |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
| Predicate Devices: | K942265 – Flexible ENT ScopeK990354 – Modified EndoSheath® for Flexible ENT ScopeManufactured by:Vision-Sciences, Inc.9 Strathmore RoadNatick, 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.
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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.
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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
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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
§ 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.