KSEA ENDOSCOPES FOR DENTAL PROCEDURES

K982658 · KARL STORZ Endoscopy-America, Inc. · EIA · Oct 15, 1998 · Dental

Device Facts

• Record ID: K982658
• Device Name: KSEA ENDOSCOPES FOR DENTAL PROCEDURES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EIA · Dental
• Decision Date: Oct 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Endoscopes for Dental procedures are indicated for use whenever magnification is desirable and/or access is restricted during dental, endodontic, and periodontic procedures.

Device Story

KSEA Endoscopes for Dental Procedures are rigid rod lens endoscopes used for visualization of operative sites during dental, endodontic, and periodontic procedures. Devices are manually operated by dental professionals. They provide magnified views of restricted access areas to assist in clinical decision-making and procedural accuracy. No electronic or automated processing is involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid rod lens endoscope; medical grade stainless steel construction; manually operated; non-powered.

Indications for Use

Indicated for use in dental, endodontic, and periodontic procedures where magnification is desired or access is restricted.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

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OCT 1 5 1998

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## 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] |
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| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Endoscope<br><br>Trade Name: (optional)<br>Endoscopes for Dental Procedures |

Indication: The KSEA Endoscopes for Dental Procedures are designed to be used for examination of the operative site during endodontic procedures.

Device Description: The KSEA Endoscopes for Dental Procedures are manually operated surgical devices. The KSEA Endoscopes for Dental Procedures are rigid rod lens endoscopes. The body contact portions of the KSEA Endoscopes for Dental Procedures are composed of medical grade stainless steel.

Substantial Equivalence: The KSEA Endoscopes for Dental Procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoscopes for Dental Procedures 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: Kevin Kennan

Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1998

Mr. Kevin A. Keenan Senior Regulatory Affaris Specialist Karl Storz Endoscopy-America, Incorporated 600 Corporate Pointe Culver City, California 90230-7600

K982658 Re : Ksea Endoscopes for Dental Procedures Trade Name: Requlatory Class: I Product Code: EIA Dated: July 28, 1998 Received: July 30, 1998

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 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). 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Kennan

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. ula Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: K982658

Device Name: Dental Endopscope

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Indications for Use:

The Endoscopes for Dental procedures are indicated for use whenever magnification is desirable and/or access is restricted during dental, endodontic, and periodontic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="Signature" src="signature.png"/> </div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | k982658 |

| Prescription Use: | OR Over-The-Counter Use: |
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| (Per 21 CFR 801.109) <img alt="Checkbox" src="checkbox.png"/> | |

(Optional Format 1-2-96)