(289 days)
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No
The summary describes a sterile endoscope cover and does not mention any AI or ML capabilities.
No
The device is described as a sterile jacket placed over an endoscope for examination procedures, which serves as a barrier rather than directly treating a condition.
No
The device is described as an endoscope cover system, which is a sterile jacket placed over an endoscope during examination procedures. Its function is to cover the endoscope, not to diagnose a condition.
No
The device description clearly states it is a "Flexible Endoscope Barrier Sheath," which is a physical, hardware component.
Based on the provided information, the ClearView™ Endoscope Cover System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a sterile jacket placed over an endoscope during examination procedures. This is a physical barrier used during a medical procedure on a patient.
- Device Description: It's described as a "Flexible Endoscope Barrier Sheath." This reinforces its function as a physical barrier.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ClearView™ system does not interact with or analyze such specimens.
Therefore, the ClearView™ Endoscope Cover System falls under the category of a medical device used in vivo (within the body) during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.
Product codes
EOB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical professional
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.
Public Health Service
DEC 3 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Invotec International, Inc. c/o Jeffrey Aull 6833 Phillips Industrial Blvd. Jacksonville, Florida 32256-3029
Rc: K080740
Trade/Device Name: Clearview Endoscope Cover Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class, II Product Code: EOB Dated: December 16, 2008 Received: December 18, 2008
Dear Mr. Aull:
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.
1
Page 2 – Mr. Jeffrey Aull
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,
Malvina B. Eggleston, us
Malvina B. Evdelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K K080740
Device Name:____Flexible Endoscope Barrier Sheath.
Indications For Use: The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.
Prescription Use ×
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Karen H. Baker
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K080740