HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE

K030572 · Henke Sass Wolf of America, Inc. · EOB · Apr 1, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K030572
• Device Name: HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
• Applicant: Henke Sass Wolf of America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Apr 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.

Device Story

Flexible nasopharyngoscope; tubular endoscopic device. Used by clinicians to visualize or treat nasal cavity, nasal pharynx, and upper respiratory tracts up to vocal chords. Provides direct optical visualization of anatomical structures. Facilitates diagnostic and therapeutic procedures in clinical settings. Benefits include minimally invasive access to upper airway for examination and treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible tubular endoscope. Designed for visualization of nasal/pharyngeal anatomy. Class II device (21 CFR 874.4760).

Indications for Use

Indicated for examination or treatment of the nasal cavity, nasal pharynx, and upper respiratory tracts between the nasal passage and vocal chords. For prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 0 1 2003

Henke Sass Wolf of America, Inc. c/o Lynette L. Howard Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, NJ 08822

Re: K030572

Trade/Device Name: Henke Sass Wolf of America Nasopharyngoscope, Flexible Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: February 12, 2003 Received: February 24, 2003

Dear Ms. Howard:

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 - Lynette L. Howard

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A helyi korentbol

A. Ralph Rosenthal, 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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## STATEMENT OF INDICATION FOR USE

510(k) Number:

Device Name: Henke Sass Wolf Nasopharyngoscope

Indications for Use:

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kuent Boler

(Division Sign-Division of Ophthalmic Ear Nose and Throat Devi

510(k) Number K030572

Prescription Use
(Per 21 CFR 801.109)

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