NASO-LARYNGO-PHARYNGOSCOPE

K991560 · Fiber Imaging Technologies, Inc. · EOB · Jul 13, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K991560
• Device Name: NASO-LARYNGO-PHARYNGOSCOPE
• Applicant: Fiber Imaging Technologies, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jul 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The Naso-Laryngo-Pharyngoscope is indicated for visualization of the pharynx and larynx.

Device Story

Naso-Laryngo-Pharyngoscope is a flexible endoscope used for direct visualization of pharynx and larynx. Device allows clinicians to inspect anatomical structures; facilitates diagnostic assessment of upper airway. Operated by physicians in clinical settings. Provides visual output for real-time observation; aids in clinical decision-making regarding airway management or pathology identification. Benefits include minimally invasive access to internal structures for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible endoscope for visualization. Mechanical design; no electronic or software components described. Sterilization and material specifications not detailed in provided text.

Indications for Use

Indicated for visualization of the pharynx and larynx in patients requiring endoscopic examination.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.