KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110

K981458 · Karl Storz Endoscopy · EOB · May 20, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981458
• Device Name: KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110
• Applicant: Karl Storz Endoscopy
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Rhino-Laryngo-Broncho-Fiberscope is indicated for examination of the nasal sinuses, larynx and bronchi and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Pediatric Broncho-Fiberscope is indicated for examination of the larynx and bronchi in pediatric patients and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Broncho-Fiberscope is indicated for examination of the larynx and bronchi in adult patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Story

Flexible fiberoptic telescopes (Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, Broncho-Fiberscope) used for visualization of nasal sinuses, larynx, and bronchi. Manually operated by qualified surgeons and physicians in clinical settings. Devices utilize fiber-optic technology to transmit images to the operator. Used with additional accessories to facilitate diagnostic and therapeutic interventions. Benefit includes direct visualization of airway and sinus anatomy to assist in clinical decision-making and procedural guidance.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flexible fiberoptic telescopes. Body contact portions composed of medical grade polyurethane. Fiber-optic imaging technology. Manually operated. No electronic or software components.

Indications for Use

Indicated for examination of nasal sinuses, larynx, and bronchi in pediatric and adult patients to perform diagnostic and therapeutic procedures using accessories.

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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Image /page/0/Picture/0 description: The image shows the logo for STORZ Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with the "O" represented by three concentric circles with a dot in the center. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.

1981458

## MAY 20 1998 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: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |

Device Identification: Common Name: Flexible ENT Scopes

> Trade Name: (optional) Karl Storz Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope, 11001 RK, 11002 BC and 11004 B

Indication: The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are designed to be used by qualified surgeons and physicians for examination of the nasal sinuses, larynx, pharynx and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Device Description: Fiberscope, and Broncho-Fiberscope are manually operated surgical devices. The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are flexible fiberoptic telescopes which utilize fiber-optic technology. The body contact portions of the KSEA Intubation Laryngoscope are composed of medical grade polyurethane.

Substantial Equivalence: The KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.

Signed:

Kurm'sinnany
Kevin Kennan

Senior Regulatory Affairs Specialist

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, California 90230-7600 Re: K981458 Rhino-Laryngo-Broncho-Fiberscope Dated: April 20, 1998 Received: April 23, 1998 Regulatory Class: II 21 CFR 874.4760/Procode: 77 EOB 21 CFR 874.4680/Procode: 77 EOQ

Dear Mr. Kennan:

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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 question 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/odrh/dsmaldsmamain.html".

Sincerely yours,

William Yin

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

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in large, bold letters, with the "O" in "STORZ" having a white circle in the middle. Below "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.

1981458

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

Device Name: Rhino-Laryngo-Broncho-Fiberscope, Pediatric Broncho-Fiberscope, and Broncho-Fiberscope

## Indications for Use:

The Rhino-Laryngo-Broncho-Fiberscope is indicated for examination of the nasal sinuses, larynx and bronchi and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Pediatric Broncho-Fiberscope is indicated for examination of the larynx and bronchi in pediatric patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Broncho-Fiberscope is indicated for examination of the larynx and bronchi in adult patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour
(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K981458

| Prescription Use: | <div style="display:flex; align-items:center;"> <span style="margin-right: 5px;">✓</span> </div> |
|--------------------------|--------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |

(Optional Format 1-2-96)

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