KSEA FIBERSCOPE

K011793 · KARL STORZ Endoscopy-America, Inc. · LYK · Apr 17, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K011793
• Device Name: KSEA FIBERSCOPE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: LYK · Gastroenterology, Urology
• Decision Date: Apr 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.

Device Story

KSEA Fiberscope is a manually operated, flexible fiberoptic telescope; utilizes fiber-optic technology to provide visualization of pericardium and cardiac chambers. Used by surgeons during endoscopic heart surgery procedures. Device transmits visual information to the clinician to assist in surgical navigation and observation of cardiac structures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Flexible fiberoptic telescope; manually operated; fiber-optic imaging technology. No electronic or software components described.

Indications for Use

Indicated for visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in This Sammary of '910(th) Sale of the Safe Medical Devices Act (SMDA) of 1990 and accordance with and recurrent is accurate 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: | James A. Lee, Ph.D.<br>Regulatory Affairs Specialist |
| Device Identification: | <b>Common Name:</b><br>Flexible Fiberscope<br><br><b>Trade Name:</b> (optional)<br>Karl Storz Fiberscope |

Indication: The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.

Device Description: The KSEA Fiberscope is a manually operated surgical device. The KSEA Fiberscope is flexible fiberoptic telescope which utilizes fiber-optic technology.

Substantial Equivalence: The KSEA Fiberscope is substantially equivalent to the predicate devices since the basic features, design, body contact material and general intended uses are the same. The KSEA Fiberscope does not incorporate any significant change that could affect safety or effectiveness. The minor differences between the KSEA 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.

Kankakee

Signed:

James A. Lee, Ph.D. Regulatory Affairs Specialist

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2002

James A. Lee. Ph.D. Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe 5th Floor Culver City, CA 90230

Re: K011793

Trade Name: KSEA Fiberscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II (two) Product Code: 74 LYK Dated: January 31, 2002 Received: February 1, 2002

Dear Dr. Lee:

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.

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## Page 2 - James A. Lee, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of actived 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 or any I odetar 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 Of It Fur 0077, ideoining (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 preared 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 21 CFR Part 809.10 for in xitro 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Dolotau

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Number (if known): K011793

Device Name: KSEA Fiberscope

Indications for Use: The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011793

**Prescription Use**
**(Per 21 CFR 801.109)**