KSEA SIALOENDOSCOPES AND ACCESSORIES

K012527 · KARL STORZ Endoscopy-America, Inc. · GCJ · Nov 1, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012527
• Device Name: KSEA SIALOENDOSCOPES AND ACCESSORIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Sialoendoscopes and Accessories are for use by qualified surgeons in the diagnosis and treatment of salivary gland diseases. The Sialoendoscope is used to visualize the salivary gland. The telescope is used to visualize the surgical site. The obturator allows the surgeon to gain access to the surgical site without damaging other tissue layers. The grasping forceps are used to grasp and remove foreign bodies. The stone basket is used to entrap and remove stones during salivary gland endoscopic therapeutic procedures.

Device Story

KSEA Sialoendoscopes are fiber optic micro-endoscopes used by surgeons for salivary gland procedures. The system includes a telescope for visualization, an obturator for accessing the surgical site, grasping forceps for foreign body removal, and a stone basket for stone entrapment and removal. The device is used in a clinical setting to assist in diagnostic and therapeutic interventions. By providing direct visualization and specialized instrumentation, the device enables minimally invasive access to the salivary gland, facilitating the diagnosis and treatment of gland-related pathologies.

Clinical Evidence

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

Technological Characteristics

Fiber optic micro-endoscope. Body contact portions composed of chromium-plated Monel 400 and surgical grade stainless steel. System includes telescope, obturator, grasping forceps, and stone basket.

Indications for Use

Indicated for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases, including visualization of the salivary gland, access to the surgical site, and removal of foreign bodies or stones.

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) SMMARY OF SAFETY AND EFFECTIVENESS

## NOV 0 1 2001

KD12527

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: | James A. Lee<br>Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Miniature Telescope and Accessories |

Trade Name: (optional) KSEA Sialoendoscopes and accessories

Indication: The KSEA Sialoendoscopes and Accessories are used by qualified surgeons in the diagnosis and treatment of salivary gland diseases.

Device Description: The KSEA Sialoendoscope is a fiber optic micro-endoscope. The body contact portions of the KSEA Sialoendoscopes and Accessories are composed of chromium plated Monel 400® and surgical grade stainless steel, which are commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Substantial Equivalence: The KSEA Sialoendoscopes and Accessories are substantially equivalent to the predicate devices since the design, materials and intended uses are identical or similar. The minor differences between the subject and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:

ed:

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 2001

Mr. James A. Lee Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, California 90230

Re: K012527

Trade/Device Name: KSEA Sialoendoscopes and Accessories Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 3, 2001 Received: August 6, 2001

Dear Mr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section - 10(x) premainers s substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatinent date of the Medical Device American be a commence prior to May 20, 1978, the exactions of the Federal Food. Drug, devices mat nave occh recuired in asses approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 II your device is classified (soc above) and existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs occeenents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri o losaanse or our device complies with other requirements of the Act that I DIT has made a sond regulations administered by other Federal agencies. You must of any I cach statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements, and manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystellio (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. James A. Lee

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 premated predicated 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 If you desire specific advice for for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far at 659. Additionally, for questions on the promotion and advertising of Compliance at [phone] 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 Outler general mionnational 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,

Mark N. Melkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 01 2001

## 510(k) Number (if known):

Device Name: KSEA Sialoendoscopes and accessories.

Indications for Use: The KSEA Sialoendoscopes and Accessories are for use by qualified Indications in the diagnosis and treatment of salivary gland diseases. The Sialoendoscope is surgeons in the diagnosis and treament. In salivary gland diagnostic and therapeutic procedures. used to visualize the bargreat the telescope. The obturator allows the surgeon to gain access to the surgical site without damaging other tissue layers. The grasping forceps are used to the surgical site without canneging ount. The stone basket is used to entrap and remove nord, grasp and ressalivary gland endoscopic therapeutic procedures.

K DI2527

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*for* (Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K012527 |
|---------------|---------|
|---------------|---------|

| Prescription Use:<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use: |
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(Optional Format 1-2-96)