KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES

K072387 · KARL STORZ Endoscopy-America, Inc. · EOB · Sep 13, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K072387
• Device Name: KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Sep 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The Karl Storz Video Rhino-Laryngoscope System is indicated for use by physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.

Device Story

System comprises flexible endoscopes, camera control unit (CCU), and light source. Endoscope utilizes distal CCD-chip technology to capture visual data from nasal lumens and airway anatomy. Input signals processed by CCU for display on external video monitor. Operated by physicians in clinical settings for ENT diagnostic procedures. Provides real-time visualization to assist clinical decision-making during examination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible endoscope with distal CCD-chip sensor; includes CCU and light source. Class II device (21 CFR 874.4760).

Indications for Use

Indicated for physicians performing endoscopic diagnosis of nasal lumens and airway anatomy.

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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2072387 SEP 1 3 2007

## 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 is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Monika Campbell<br>Senior Regulatory Affairs Specialist<br>Telephone [phone]<br>Fax [phone]<br>E-mail: [e-mail] |
| Device Identification: | Common Name:<br>Video Rhino-Laryngoscope System |

Trade Name: Karl Storz Video Rhino-Laryngoscope System

The Karl Storz Video Rhino-Laryngoscope System is indicated for use by Indication: physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.

Device Description: The KARL STORZ Video Rhino-Laryngoscope System includes flexible endoscopes, CCU and lights source unit. The Rhino-Laryngoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures. The Karl Storz Video Rhino-Laryngoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.

Substantial Equivalence: The Karl Storz Video Rhino-Laryngoscope System is substantially equivalent to the predicate device since the basic features and intended uses

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are the same. The minor differences between the Karl Storz Video Rhino-Laryngoscope System and predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.

Signature: Hawke Campbell

Monika Campbell Senior Regulatory Affairs Specialist

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SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy - America, Inc. c/o Monika Campbell Senior Regulatory Affairs Specialist 600 Corporate Pointe Culver City, CA 90230

Re: K072387

Trade/Device Name: Karl Storz Video Rhino-Laryngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: August 23, 2007 Received: August 24, 2007

Dear Ms. Campbell:

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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egelston, m.d.

Malvina B. Eydelman, 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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K072387

## Indication for Use

510(k) Number (if known): Not assigned yet

Device Name: Karl Storz Video Rhino-Laryngoscope System

Indications for Use: The Karl Storz Video Rhino-Laryngoscope System is indicated for use by physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Thiollet

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Numb

(Posted November 13, 2003)