KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING

K973068 · Karl Storz Endoskop GmbH · GCJ · Nov 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973068
• Device Name: KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
• Applicant: Karl Storz Endoskop GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is intended for endoscopic saphenous vein harvesting procedures. These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.

Device Story

Manual surgical instrument set for endoscopic saphenous vein harvesting. Components include 30° endoscope, optical retractor, optical dissector, vein dissectors, grasping forceps, hook scissors, and suction coagulating cannula. Used by surgeons in operating room settings to visualize and dissect saphenous veins for use as vascular grafts. Provides visualization and mechanical tissue manipulation to facilitate minimally invasive vein removal. Benefits include reduced surgical trauma compared to open harvesting techniques.

Technological Characteristics

Manually operated surgical instruments. Materials: surgical grade stainless steel, PTFE, Kynar, and PEEK. Includes optical components (30° endoscope) and mechanical dissection/grasping tools. No electronic or software components.

Indications for Use

Indicated for patients undergoing coronary or vascular surgery requiring saphenous vein harvesting as a graft.

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)

{0}------------------------------------------------

K973068

## 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:<br>Endoscope and Accessories |
| | Trade Name: (optional)<br>Karl Storz Instrument Set for Endoscopic Saphenous Vein<br>Harvesting |

Indication: The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is intended for endoscopic saphenous vein harvesting procedures.

Device Description: The Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting are manually operated surgical devices. The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is composed of Forward Oblique (30°) Endoscope, Optical Retractor and Optical Dissector, Vein Dissectors, Grasping Forceps, Dissecting and Grasping Forceps, and Hook Scissors, Take-apart™ Dissecting Forceps, Dissecting and Grasping Forceps, and Scissors, Take-apart® Bipolar Forceps, and Suction Coagulating Cannula. The body contact portions of the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting are composed of surgical grade stainless steel, PTFE, Kynar and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.

Substantial Equivalence: The Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting 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:

Kevin Kennedy

Kevin Kennan Regulatory Affairs Specialist

000156

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the United States Department of Health & Human Services. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 1997

Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600

> K973068 Trade Name: KSEA Instrument Set for Saphenous Vein Harvesting Regulatory Class: II Product Code: GCJ Dated: August 13, 1997 Received: August 18, 1997

Dear Mr. Kennan:

Re:

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 Quality System Regulation (OS) 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 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Mr. Kevin A. Kennan

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 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" (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/cdrh/dsmamain.html".

Sincerely yours,

J. Oalley Jr.

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known): Not Yet Assigned

Device Name: KSEA Instrument Set for Saphenous Vein Harvesting

Indications for Use: These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973068 |

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

000003