(289 days)
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.
Flexible Endoscope Barrier Sheath.
The provided text is a 510(k) premarket notification approval letter for the "Clearview Endoscope Cover" and does not contain detailed information about acceptance criteria or specific study results that prove the device meets such criteria. A 510(k) summary (which is a separate document typically submitted with the 510(k) application) would generally contain this type of performance data if it were required for substantial equivalence.
Based on the provided text, the device is a Flexible Endoscope Barrier Sheath (ClearView™ Endoscope Cover System). The FDA's letter indicates that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, meaning it does not require a full Premarket Approval (PMA). This type of approval often relies on demonstrating that the new device meets the same performance characteristics as an already approved predicate device, or that any differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the requested information from the given text alone. The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
- Information about a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the application likely contained information (e.g., in a 510(k) summary) that demonstrated the device's performance, but those details are not present in this approval letter itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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.