(70 days)
The Naso-Laryngo-Pharyngoscope is indicated for visualization of the pharynx and larynx.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a device called "Naso-Laryngo-Pharyngoscope". It confirms that the device is substantially equivalent to previously marketed devices and lists its indications for use.
Crucially, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, data provenance, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets. These details are typically found in a clinical study report or a technical summary, which is not provided here.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.
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1 3 1999 JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fiber Imaging Technologies, Inc. c/o Mr. Joseph Ress Medical Device Regulatory Consultants 45 Pontiac Road Newton, MA 02468
Re: K991560 Trade Name: Naso-Laryngo-Pharyngoscope Regulatory Class: II Product Code: 77 EOB Dated: April 30, 1999 Received: May 4, 1999
Dear Mr. Ress:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Roepke Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT FOR INDICATIONS FOR USE
Page 1 of 1
510(K) Number: K 9 4 1560
Device Name: Naso-Laryngo-Pharyngoscope
Indications for Use:
The Naso-Laryngo-Pharyngoscope is indicated for visualization of the pharynx and larynx.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrance of CDRH, Office of Device Evaluation (ODE)
Perscription Use YES
OR
Over-The-Counter Use NO
Taur Bhaffar (HRS)
(Division Sign-Off) Division of Ophthalmic Devices K991560 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.