KSEA MINIATURE ENDOSCOPE, MODEL 11565

K070752 · KARL STORZ Endoscopy-America, Inc. · EOB · May 1, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K070752
• Device Name: KSEA MINIATURE ENDOSCOPE, MODEL 11565
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: May 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The KSEA Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology.

Device Story

KSEA Miniature Endoscope is a manually operated, reusable, flexible fiber optic telescope. Device transmits images from distal to proximal end via fiber optic technology. Used by physicians in clinical settings for visualization of sinus anatomy and pathology. Provides direct visualization to assist in diagnostic and therapeutic procedures. Benefits include minimally invasive access to sinus structures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Flexible fiber optic telescope; 0.5 mm shaft diameter; 100 cm working length; 0° viewing angle; 70° field of view. Reusable, non-sterile delivery. Fiber optic image transmission.

Indications for Use

Indicated for visualization of sinus anatomy and pathology 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.

Predicate Devices

• Olympus Angioscope (K911278)
• Olympus ENF Type XP Rhino-Laryngo Fiberscope (K013591, K011869)
• KSEA Sialoendoscope (K012527)

Submission Summary (Full Text)

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K070752

Image /page/0/Picture/1 description: The image shows the logo for Karl Storz Endoscopy. The logo is black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ ENDOSCOPY" in a smaller font.

## 510(k) SUMMARY

1

| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe<br>Culver City, CA 90230-7600<br>Phone: [phone]<br>Fax: [phone] | MAY - 1 2007 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Crystal Dizol<br>Regulatory Affairs Associate<br>Email: [e-mail] | |
| Date of Submission: | April 26, 2007 | |
| Device Trade Name: | Karl Storz Miniature Endoscope | |
| Common Name: | Flexible fiberscope | |
| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories | |
| Regulation Number: | 21 CFR 874.4760 | |
| Product Code: | EOB | |
| Predicate Device(s): | Olympus Angioscope (K911278)<br>Olympus ENF Type XP Rhino-Laryngo Fiberscope (K013591, K011869)<br>KSEA Sialoendoscope (K012527) | |
| Device Description: | The KSEA Miniature Endoscope is a manually operated, reusable surgical device<br>that is provided to the end-user in a non-sterile condition. The device is a flexible<br>fiber optic telescope which utilizes fiber-optic technology to perform the intended<br>use. | |
| Indications for Use: | The KSEA Miniature Endoscope is indicated for use in visualization of sinus<br>anatomy and pathology. | |
| Technological<br>Characteristics: | The KSEA Miniature Endoscope and its predicate devices are flexible fiber optic<br>telescopes that use fiber optic technology to transmit an image from the distal to<br>the proximal end of the device. | |
| Summary of<br>Substantial<br>Equivalence: | The KSEA Miniature Endoscope is substantially equivalent to the predicate<br>devices since the basic features, design, and intended uses are similar. The<br>minor differences between the KSEA Miniature Endoscope and the predicate<br>devices raise no new issues of safety and effectiveness, as these design<br>differences have no affect on the performance, function, or intended use of the<br>devices. For a comparison between the KSEA Miniature Endoscope and the<br>predicate devices, refer to the attached substantial equivalence chart. | |

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Att: Substantial Equivalence Chart for Karl Storz Miniature Endoscope

:

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KARL STORZ ENDOSCOP

## SUBSTANTIAL EQUIVALENCE CHART FOR KARL STORZ
MINIATURE ENDOSCOPE, 11565

| Manufacturer | Shaft<br>Diameter | Working<br>Length | Viewing<br>Angle | Field of View | Optics | Intended Use |
|---------------------------------------------------------------------------|-------------------|-------------------|------------------|---------------|-------------|---------------------------------------------------------------------------------------------------------|
| KSEA: 11565<br>Miniature Endoscope | 0.5 mm | 100 cm | 0° | 70° | Fiber optic | Used for visualization of sinus anatomy and pathology. |
| Olympus: Angioscope<br>(K911278) | 0.5 mm | 130 cm | 0° | 75° | Fiber optic | Used for viewing the peripheral and/or coronary vessels. |
| Olympus: ENF Type XP<br>Rhino-Laryngo<br>Fiberscope (K013591,<br>K011869) | 1.8 mm | 30 cm | 0° | 75° | Fiber optic | Used for observing the nasal cavity, larynx and pharynx. |
| KSEA: 11576<br>Sialoendoscope<br>(K012527) | 0.75 mm | 30 cm | 0° | 70° | Fiber optic | Used for visualization of the surgical site in salivary gland<br>diagnostic and therapeutic procedures. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

Karl Storz Endoscopy-America, Inc. c/o Crystal K. Dizol 600 Corporate Pointe Culver City, Ca 90230-7600

Re: K070752

Trade/Device Name: KSEA Miniature Endoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope Regulatory Class: Class II Product Code: EOB Dated: March 15, 2007 Received: March 19, 2007

Dear Ms. Dizol:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave a showe 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 I ou may, ateres, mains 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 11 your de roo is onach 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 I tease oc acrised alla I Drivision that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or any I oderal 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 Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by evense (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Crystal K. Dizol

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/industry/support/index.html.

Sincerely yours,

M.B. Eichelman SMD

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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K070752

510(k) Number (if known):

Device Name: KSEA Miniature Endoscope

Indications for Use: The Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Amalot*
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number: K070752

Prescription Use: [\$\checkmark\$] OR Over-The-Counter Use: **__**
(Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)