(30 days)
The flexible trans-nasal video esophagoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The system can also be used to aid in intubation.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.
The provided text describes a Special 510(k) Premarket Notification for a modified medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through certification of compliance to design control requirements and a description of risk analysis procedures, rather than extensive new clinical or performance studies.
Therefore, the supplied text does not contain detailed information regarding:
- A table of specific acceptance criteria and reported device performance metrics.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance data.
- Specific types of ground truth used or sample sizes for training sets (as this is a modification of an existing device, not a de novo AI device).
Summary of available information:
1. Acceptance Criteria and Reported Device Performance:
The submission states that "V & V activities, including scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification planning." It concludes that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video TNE endoscope with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."
However, specific quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) and the numerical results against these criteria are not provided in the document. The general acceptance criteria would be that the modified device performs as intended and is as safe and effective as the predicate device.
2. Sample size used for the test set and the data provenance:
Not explicitly stated. The submission focuses on design control compliance and functional/performance testing of the device system, rather than a clinical study evaluating diagnostic accuracy on a specific patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable or not provided. This type of information is typically relevant for studies validating diagnostic algorithms, which is not the primary focus of this Special 510(k) for a hardware modification.
4. Adjudication method for the test set:
Not applicable or not provided.
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:
Not applicable. This device is a modified endoscope system, not an AI-powered diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (endoscope, video processor, and sheaths), not a standalone algorithm.
7. The type of ground truth used:
Not explicitly stated, but for a physical device, "ground truth" would likely relate to objective measurements of device function (e.g., image quality, illumination, navigational capabilities, integrity of sheaths, software functionality) rather than clinical diagnostic outcomes requiring expert consensus or pathology.
8. The sample size for the training set:
Not applicable or not provided, as this is a device modification submission for hardware, not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable or not provided.
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KO 72088
Vision-Sciences, Inc. Special 510(k) Premarket Notification: Device Modification July 27, 2007 Modified Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems
510(k) Summary
AUG 2 9 2007
| Owner's Name: | Vision-Sciences, Inc. |
|---|---|
| Address: | 40 Ramland Road SouthOrangeburg, NY 10962 |
| Telephone Number: | (845) 365-0600 |
| Fax Number: | (845) 365-0620 |
| Contact Person: | Lillian Quintero; Director QA/RA |
| Subject Device Name: | Modified Flexible Trans-Nasal Esophagoscope with Digital VideoProcessor and Disposable EndoSheath® Systems |
| Common/Usual Name: | Flexible video endoscope with video processor and disposable sheaths |
| Product Codes: | EOX |
| FDA Regulations: | 21 CFR 874.4710 |
| Device Classification: | Class II |
| Predicate Device Name: | Flexible Fiberoptic Trans-Nasal Esophagoscope with EndoSheath®Systems |
| Common/Usual Name: | Flexible fiberoptic endoscope with sheaths and accessories |
| Product Codes: | EOX |
| FDA Regulations: | 21 CFR 874.4710 |
| Device Classification: | Class II |
| Premarket Notification: | K031786 |
Device Description
The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.
Intended Use
The flexible trans-nasal video esophagoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The system can also be used to aid in intubation.
Performance Testing
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. V & V activities, including scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification planning.
Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video TNE endoscope with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vision-Sciences, Inc. c/o Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave. Ayer, MA 01432
AUG 2 9 2007
Re: K072088
Trade/Device Name: Flexible Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoShealth® Systems
Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: July 27, 2007 Received: July 30, 2007
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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
M.B. Egelkus, MD
Malvina B. Eydelman, M.D. 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. cial 510(k) Premarket Notification: Device Modification July 27, 2007 Modified Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems
510(k) Number (if known):
Device Name: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems
Indications for Use:
The flexible trans-nasal video esophagoscope with EndoSheath® System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction. The system may also be used to aid in intubation.
The digital video processor is intended for use with the VSI flexible video scope.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) OR
Over-the -Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thabolil
(Division Sign-On)
Division of Ophthalmic Ear,
Division of Nose and Throat Devises
K072088
Number
510(k) Number
Page 1 of 1
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.