(30 days)
The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI flexible endoscopes are flexible endoscopes 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 videoscopes for image visualization and capture.
The provided text describes a Special 510(k) Premarket Notification (K072073) for a modified medical device, the "Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems." This type of submission is for modifications to previously cleared devices under the FDA's "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
The document does not contain the detailed acceptance criteria or a specific study that quantifies device performance against those criteria in a way that typically applies to AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices through design control requirements and general V&V activities.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format of a table. For a Special 510(k) of this nature, the "acceptance criteria" are implied to be adherence to design control requirements and successful completion of verification and validation (V&V) activities to ensure the modified device remains safe and effective and substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance to 21 CFR 820.30 Design Control requirements | Certification of compliance provided. |
| Risk analysis procedure adherence | Description of internal Risk Analysis procedure provided. |
| Biocompatibility | Addressed through comprehensive Design Validation and Verification. |
| Scope/sheath/processor system functional and performance | Addressed through comprehensive Design Validation and Verification. |
| Software validation | Addressed through comprehensive Design Validation and Verification. |
| Substantial equivalence to predicate device (K050972 / K040984 / K024095 / K942265) | Concluded by FDA as substantially equivalent based on indications for use, technological characteristics, and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text refers to "comprehensive Design Validation and Verification" but does not specify the sample sizes for any testing (e.g., number of endoscopes tested, number of sheaths, duration of functional tests). The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The assessment appears to be based on engineering and performance testing rather than clinical evaluation requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a device modification and the V&V activities described, it's unlikely that a clinical adjudication method like 2+1 or 3+1 would have been applied in this context. The V&V would likely involve objective measurements and engineering assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported in this document. This submission is for device modification, focusing on engineering validation and substantial equivalence, not a clinical effectiveness study of human readers with vs. without AI assistance. The device in question is an endoscope system, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This concept does not apply to the device described. This is a medical imaging and intervention device (flexible endoscope with a video processor and disposable sheaths) that is inherently used with a human-in-the-loop (a clinician). It does not involve an AI algorithm operating in a standalone capacity.
7. Type of Ground Truth Used
Based on the description of "V & V activities, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation," the "ground truth" would be established by:
- Engineering specifications and standards: For functional and performance testing (e.g., image resolution, light output, flexibility, durability).
- Biocompatibility standards: For material safety with patient contact.
- Software requirements specifications: For software validation.
The document does not mention the use of expert consensus, pathology, or outcomes data as "ground truth" for the device's performance, as it's not an AI diagnostic device.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device is an endoscope system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reason as above (not an AI/ML algorithm requiring a training set).
Summary of Missing Information:
It's important to reiterate that much of the information requested (sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the evaluation of AI/ML-driven diagnostic or assistive devices. The provided document describes a "Special 510(k)" for a device modification to a flexible endoscope system, which focuses on demonstrating continued safety and effectiveness and substantial equivalence through engineering V&V rather than large-scale clinical performance trials or AI model validation.
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Vision-Sciences, Inc. July 27, 2007
Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scopes 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 South Orangeburg, NY 10962 Telephone Number: (845) 365-0600 Fax Number: (845) 365-0620 Contact Person: Lillian Quintero; Director QA/RA Subject Device Name: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems Common/Usual Name: Flexible video endoscopes with video processor and disposable sheaths Product Codes: EOB FDA Regulations: 21 CFR 874.4760 Device Classification: Class II Predicate Device Name: Flexible Fiberoptic ENT Scopes with EndoSheath® Systems Common/Usual Name: Flexible fiberoptic endoscopes with sheaths and accessories Product Codes: EOB FDA Regulations: 21 CFR 874.4760 Device Classification: Class II Premarket Notification: K050972 / K040984 / K024095 / K942265
Device Description
The VSI flexible endoscopes are flexible endoscopes 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 videoscopes for image visualization and capture.
Intended Use
The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.
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 biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification was a
Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2007
Vision-Sciences, Inc. c/o Pamela Papineau Delphi Medical Devices Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K072073
Trade Name: Flexible Endoscopes with Digital Video Processor and Disposible Endosheath® Systems Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible) and accessories Regulatory Class: Class II Product Code: EOB 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 yours.
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. July 27, 2007
Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems
510(k) Number (if known):
Device Name: Flexible Endoscopes with Digital Video Processor and Disposable EndoSheath® Systems
Indications for Use:
The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.
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)
Ahalut
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K0720
Page 1 of 1
510(k) Number -
§ 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.