KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES

K972855 · KARL STORZ Endoscopy-America, Inc. · EOB · Sep 8, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972855
• Device Name: KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Sep 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The KSEA Contact Nasal Micro-Endoscopes are intended to provide visualization of the nasal cavities, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification ..

Device Story

Karl Storz Contact Nasal Micro-Endoscope is a manually operated, reusable surgical device designed for ENT procedures. It provides visualization of nasal cavities and mucosa through both panoramic and tissue-contact viewing modes at high magnification. The device is long enough to access the surgical site. It is used by physicians in clinical or surgical settings to assist in diagnostic and surgical decision-making by providing direct visual feedback of tissue structures. The device is constructed from surgical-grade stainless steel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manually operated, reusable surgical endoscope. Materials: surgical-grade stainless steel. Provides panoramic and tissue-contact visualization at high magnification. No electronic, software, or energy-based components described.

Indications for Use

Indicated for visualization of nasal cavities, including nasal mucosa, during ENT diagnostic and surgical procedures. For use by clinicians in a prescription-only setting.

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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Karl Storz Endoscopy-America

00 Cornorate Pointe Culver City, California 90230-7 Phone [phone]

Toll Free 800 : ax 310 1105

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.

Applicant:

Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 [phone]

Contact:

Regulatory Affairs Specialist

Kevin Kennan

Device Identification:

Common Name Rhinoscope Trade Name Karl Storz Contact Nasal Micro-Endoscopes

Indication: The KSEA Contact Nasal Micro-Endoscopes are intended to provide visualization of the nasal cavities, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification ..

Device Description: The KSEA Contact Nasal Micro-Endoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The KSEA Contact Nasal Micro-Endoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.

Substantial Equivalence: The KSEA Contact Nasal Micro-Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Contact Nasal Micro-Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

Signed: Maika Anderson

Marika Anderson Senior Regulatory Affairs Specialist

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Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 1997

Marika Anderson Senior Regulatory Affairs Specialist Karl Storz Endoscopy America Inc. 600 Corporate Pointe Culver City, CA 90230-7600

K972855 Karl Storz Contact Nasal Micro-Endoscope Dated: July 30, 1997 Received: August 1, 1997 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB

Dear Ms. Anderson:

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, 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketd 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,

h. William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Karl Storz Contact Nasal Micro-Endoscope

Indications For Use:

To provide visualization of the nasal cavities, including the nasal mucosa, during a variety of ENT diagnostic and surgical procedures, utilizing both panoramic and tissue contact vision at high magnification..

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | |
| | |
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K972855 |
| Prescription Use (Per 21 CFR 801.109) | X |
| | OR Over -the-Counter Use |

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